139
LAPORAN TAHUNAN ANNUAL REPORT 2011 Biro Pengawalan Farmaseutikal Kebangsaan National Pharmaceutical Control Bureau

LAPORAN TAHUNAN ANNUAL REPORT - npra.gov.my fileLAPORAN TAHUNAN ANNUAL REPORT - npra.gov.my

Embed Size (px)

Citation preview

LAPORAN TAHUNANANNUAL REPORT

2011

Biro Pengawalan Farmaseutikal KebangsaanNational Pharmaceutical Control Bureau

National Pharmaceutical Control Bureau (NPCB) Biro Pengawalan Farmaseutikal KebangsaanLot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor Darul Ehsan, Malaysia

+ 603-7883 5400 + 603-7956 2924

www.bpfk.gov.my

LAP

OR

AN

TAH

UN

AN

A

NN

UA

L RE

PO

RT

2011

1

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Isi KandunganContents

Visi, Misi, Matlamat & Strategi 2 Vision, Mission, Objectives & Strategy

Perutusan Pengarah 4 Director’s Foreword

Pengurusan Tertinggi BPFK 7 NPCB’s Top Management

Sidang Pengarang 8 Editorial Board

Pengenalan: BPFK 9 Introduction: NPCB

Carta Organisasi 10 Organisational Chart

Piagam Pelanggan 12 Client’s Charter

Senarai Perjawatan 14 List of Posts

Jasamu Dikenang 16 Remembering Your Services

Anugerah Perkhidmatan Cemerlang 19 Excellent Service Awards

Pencapaian 21 Achievements

Pendaftaran Produk 27 Product Registration

Penilaian Protokol Analisa dan 45 Evaluation of Protocol Analysis and Data Validasi Validation of Data

Pengujian Sampel 47 Sample Testing

Pemeriksaan Premis 57 Inspection of Premises

Pelesenan 63 Licensing

Surveilans 67 Surveillance

Farmakovigilans 77 Pharmacovigilance

Kosmetik 85 Cosmetics

Variasi 93 Variation

Penyebaran Maklumat, Latihan 97 Information Dissemination, dan Lawatan Trainings and Visitors

Laporan Kewangan 109 Financial Report

Cabaran 113 Challenges

Hala Tuju 119 The Way Forward

Aktiviti Sosial 125 Social Activities

Galeri 131 Gallery

2

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Visi, Misi, Matlamat & StrategiVision, Mission, Objective & Strategies

V I S I

Biro Pengawalan Farmaseutikal Kebangsaan sebagai pusat kecemerlangan unggul dalam bidang regulatori farmaseutikal demi menjamin kesihatan dan kesejahteraan insan sejagat.

M I S I

Biro Pengawalan Farmaseutikal Kebangsaan akan memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal melalui pelaksanaan undang- undang oleh tenaga kerja yang berketerampilan dan usahasama strategik ke arah peningkatan status kesihatan rakyat.

V I S I O N

The National Pharmaceutical Control Bureau will be a centre of excellence on pharmaceutical regulatory matters to ensure the health and well-being of mankind.

M I S S I O N

The National Pharmaceutical Control Bureau shall ensure the quality, efficacy and safety of pharmaceutical products through the implementation of relevant legislation by a competent workforce working together in strategic alliance towards improving the health of the people.

3

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

M A T L A M A T

Memast ikan bahawa bahan- bahan terapeutik yang dibenarkan di pasaran tempatan adalah selamat, berkesan dan berkualit i, serta menentukan bahawa produk semulajadi dan kosmetik yang dibenarkan di pasaran adalah selamat dan berkualiti.

S T R A T E G I

• M em a s t i k a n k e c e k a p a n d a nkeberkesanan organisas i mela lu i pemodenan dan automasi sistem- sistem pejabat, makmal dan pendaftaran, peninjauan serta penambahbaikan perkhidmatan secara berterusan.

• Memperkukuhaktivitipenguatkuasaanundang- undang berkaitan.

• Memastikan suasanakefahamanduahala dan kerjasama berterusan sentiasa wujud antara pihak regulatori dengan sektor swasta melalui sesi dialog dan bimbingan.

• Meningkatkanpotensisertakepakaranwarga kerja.

• Mewujudkansatukumpulantenagakerjayang berdedikasi dan penuh komitmen melalui motivasi, penghargaan serta ganjaran yang berpatutan.

• Mempergiatkanaktivitipenyelidikansertameningkatkan kemudahan- kemudahan bagi tujuan tersebut.

• Mewujudkan satu suasana yangmenggalakkan kerja secara berpasukan dengan s ikap penyayang, ser ta melaksanakan tugas- tugas secara profesional.

O B J E C T I V E

To ensure that therapeutic substances approved for the local market are safe, effective and of quality and also to ensure that natural products and cosmetics approved are safe and of quality.

S T R A T E G I E S

• Toensureorganisationalefficiencyandeffectiveness through modernisation and automation of the office, laboratory and registration systems, with regular review and improvement of services.

• Tostrengthenenforcementactivityofthe related legislations.

• To e n su re c on t i n uou s mu t u a lunderstanding and co-operat ion between the regulatory bodies and the private sector through dialogues and guidance.

• To upgrade personnel potential andexpertise.

• Toattainadedicatedandfullycommittedwork fo rce t h rough mo t i v a t i on , a p p re c i a t i o n , a n d a p p ro p r i a t e remuneration.

• To strengthen research activities andupgrade facilities for such purposes.

• Tocreateworkingenvironmentconducivefor the personnel to work as a team with a caring attitude whilst discharging their duties in a professional manner.

4

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Perutusan PengarahDirector’s Foreword

Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) telah menyaksikan satu lagi tahun yang menarik dan memberangsangkan. Sebagai Agensi Regulatori Ubat Kebangsaan (NDRA), saya amat berbangga atas usaha berterusan jabatan ini bagi mencapai misi iaitu memastikan kualiti, keselamatan dan keberkesanan produk farmaseutikal, serta kualiti dan keselamatan produk semula jadi dan kosmetik, dengan matlamat utama untuk menjamin kesihatan awam. Kami telah berjaya menyahut cabaran dalam memenuhi permintaan serta ekspektasi para pelanggan BPFK.

Selain itu, pada tahun ini juga, penilaian ke atas Program Pemantauan Pematuhan Amalan Makmal Baik (GLP) telah dijalankan di BPFK melalui Mutual Joint Visit (MJV). Hasilnya, Malaysia akan disyorkan sebagai ahli penuh Organisation for Economic and Development (OECD) Mutual Acceptance Data (MAD) untuk GLP. Pengiktirafan ini dijangka akan membawa kesan yang ketara terhadap industri farmaseutikal dan bioteknologi yang menjalankan kajian bukan klinikal.

The National Pharmaceutical Control Bureau (NPCB) has witnessed yet another fascinating and remarkable year. As the National Drug Regulatory Agency, I am pleased to note that we have once again strived to achieve our mission of ensuring the quality, safety and efficacy of pharmaceutical products, as well as the quality and safety of natural products and cosmetics, with the ultimate goal of safeguarding public health. We have risen to the challenges and fulfilled the demands as well as expectations of our clients and stakeholders.

This eventful year was further highlighted by the assessment of NPCB’s Good Laboratory Practice (GLP) Compliance Monitoring Programme through a Mutual Joint Visit (MJV). As a result, Malaysia will be recommended as a full member of the Organisation for Economic and Development (OECD) Mutual Acceptance Data (MAD) for GLP which is expected to have deep impact on the pharmaceutical and biotechnology industries conducting non-clinical studies.

5

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Seh ingga ke ha r i i n i , BPFK te lah berkembang dengan berterusan dan memainkan peranan yang semakin penting sebagai pihak berkuasa regulatori. Menyedari keperluan untuk membangun dan memperkembangkan aktiviti seperti penilaian produk kajian dan pemantauan kese l ama tan p roduk ka j i an se r t a pemeriksaan GLP, Seksyen Penyelidikan Klinikal dan Komplians telah dinaik taraf menjadi sebuah pusat iaitu Pusat Kajian Produk Baru (PKPB). Langkah tersebut telah menunjukkan komitmen kami ke arah meningkatkan keupayaan pemantauan dan pengawalan regulatori.

Selaras dengan pencapaian cemerlang dan pengiktirafan antarabangsa, BPFK telah bekerjasama dengan beberapa pertubuhan yang dikenali di peringkat dunia. Antaranya, BPFK memainkan peranan penting dalam pembangunan modal insan di kalangan negara-negara anggota WHO melalui perkongsian kepakaran dan latihan sangkutan. Ini merupakan salah satu komitmen yang telah diberikan oleh BPFK sebagai Pusat Kolaborasi Pertubuhan Kesihatan Sedunia (WHO) bagi Kawalan Regulatori Farmaseutikal sejak 1996. Di samping itu, BPFK turut terlibat dalam program Amalan Perkilangan Baik (GMP) antarabangsa dan Program Jaminan Kualiti di bawah Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Di rantau ini, penglibatan dan komitmen BPFK yang berterusan sepanjang tahun 2011 dalam usaha harmonisasi ASEAN amat komprehensif di mana jabatan ini telah memainkan peranan aktif dalam ASEAN Consultative Committee for Standards and Quality (ACCSQ) Pharmaceutical Product Working Group (PPWG), Traditional Medicine and Health Supplements Product

For the past decades, the NPCB has continuously grown in prominence as a regulatory authority. Realising the need to cope with the development and expansion of activities such as investigational product evaluation and safety monitor ing as well as GLP inspections, the Clinical Research and Compliance Section was upgraded into a centre namely the Centre for Investigational New Product. This bold move ref lects our commitment towards enhancing the departments overall regulatory capabilities.

In line with attaining international recognition and excellence, NPCB is affiliated with several globally renowned organisations. Our designation as a World Health Organization (WHO) Collaborating Centre for Regulatory Control of Pharmaceuticals since 1996 is on-going with the crucial role of capacity building among WHO member countries via sharing of expertise and attachment trainings. In addition, NPCB continues to be heavily involved in international Good Manufacturing Practice (GMP) and Quality Assurance Programmes under the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Regionally, NPCB’s continuous involvements and commitments in the harmonisation e f fo r ts o f ASEAN have been very comprehensive throughout the year with its active role in the ASEAN Consultative Committee for Standards and Quality (ACCSQ) Pharmaceutical Product Working Group (PPWG), Traditional Medicine and Health Supplements Product Working Group (TMHS PWG) as well as the ASEAN Cosmetic Committee (ACC).

To conclude, I would like to commend and thank all the NPCB staff for another year

6

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Perutusan Pengarah (Sambungan)Director’s Foreword (Continued)

Working Group (TMHS PWG) dan juga ASEAN Cosmetic Committee (ACC).

Oleh itu, saya ingin mengambil kesempatan ini untuk mengucapkan tahniah dan terima kasih kepada semua anggota BPFK atas dedikasi dan usaha yang gigih dalam mengendalikan hal regulatori farmaseutikal serta memberikan perkhidmatan yang berkualiti. Kecemerlangan ini hanya dapat dicapai dengan adanya semangat kerja berpasukan di kalangan semua anggota jabatan ini.

A k h i r k a t a , s u k a c i t a n y a s a y a mempersembahkan Laporan Tahunan BPFK 2011, dengan harapan agar momentum ini akan terus kekal dan membawa BPFK ke tahap yang lebih cemerlang pada tahun 2012.

of tireless effort, exquisite work and sheer dedication in delivering quality service as well as conducting pharmaceutical regulatory matters. The excellent achievements and accomplishments would not have been possible without their collective teamwork.

It is with enormous pleasure that I present to you the NPCB Annual Report for 2011, with the hope that the momentum will continue to carry us to greater heights in 2012.

7

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Pengurusan Tertinggi BPFKNPCB’s Top Management

1. Dr. Tajuddin Akasah Timbalan Pengarah Pusat Kawalan Kualiti Deputy Director of Centre for Quality Control

2. Mdm. Siti Aida Abdullah Timbalan Pengarah Pusat Pendaftaran Produk Deputy Director of Centre for Product Registration

3. Mr. Sulaiman Haji Ahmad Timbalan Pengarah Pusat Komplians dan Pelesenan Deputy Director of Centre for Compliance and Licensing

4. Ms. Sameerah Shaikh Abd. Rahman Timbalan Pengarah Pusat Pasca Pendaftaran Produk Deputy Director of Centre for Post-Registration of

Product

5. Mr. Tan Ann Ling Timbalan Pengarah Pusat Pembangunan Organisasi Deputy Director of Centre for Organisational

Development

6. Dr. Kamaruzaman Salleh Timbalan Pengarah Pusat Kajian Produk Baru Deputy Director of Centre for Investigational New

Product

7. Mr. Mohd Zaidie bin Hj. Che Din Timbalan Pengarah Pusat Pentadbiran Head of Centre for Administration

1

4

7

2

5

3

6

8

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Sidang PengarangEditorial Board

Depan | FrontKiri ke Kanan | Left to Right

•Mdm.TanShihLeng•Mdm.NoraisyahMohdSani•Mdm.MazuwinZainalAbidin•Mdm.AzuraAbdullah•Ms.BelinnaAbuBakar

Belakang | BackKiri ke Kanan | Left to Right

•Mr.AhmadKamalAhmad•Mr.KhairulanwarBurhanuddin•Mr.WayneWong•Mr.AhmadIzhamIsmail

Tidak Hadir | Absent

•Mdm.NikIryaniNikAhmadDamian•Mdm.NikShamsiahNikSalleh•Mdm.WanNurulAinaMiorAbdullah•Mr.NicholasLeowChunWei•Mdm.TanChinLing•Mr.AzriNasruddin•Ms.RachelThong•Mr.AhmadShahirAyob

9

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Pengenalan: BPFKIntroduction: NPCB

B i r o P e n g a w a l a n F a r m a s e u t i k a l Kebangsaan (BPFK) merupakan sebuah agensi regulatori kerajaan di Malaysia yang bertanggungjawab memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal, serta kualiti dan keselamatan produk semulajadi dan kosmetik yang dipasarkan di Malaysia.

Dengan kepakaran dan kemampuan yang dimiliki, BPFK telah diiktiraf sebagai Pusat Kolaborasi bagi Kawalan Regulatori Farmaseutikal pada 10 Mei 1996 oleh World Health Organization (WHO). Dengan pengiktirafan ini, BPFK telah menyediakan latihan dalam jaminan kualiti dan hal ehwal regulatori kepada pegawai-pegawai dari agensi regulatori kebangsaan yang lain.

Di samping itu, BPFK telah diterima sebagai ahli ke-26 dalam Pharmaceutical Inspection Co-operation Scheme (PIC/S) pada 1 Januari 2002. Sejak itu, BPFK telah terlibat secara aktif dalam program Amalan Perkilangan Baik (APB) dan program Jaminan Kualiti Antarabangsa.

Bagi memastikan mutu perkhidmatan yang lebih berkualiti, BPFK telah bekerja keras dalam menaiktarafkan Sistem Pengurusan Kualiti. Pensijilan dari SIRIM, iaitu MS ISO 9001:2000, telah digantikan dengan MS ISO 9001:2008. Selain itu, BPFK telah memperoleh akreditasi MS ISO 17025:2005 bagi Pusat Kawalan Kualiti (PKK) di bawah Skim Akreditasi Makmal Malaysia (SAMM) pada tahun 2010.

The National Pharmaceutical Control Bureau (NPCB) is a government agency that regulates pharmaceutical, traditional and cosmetic products in Malaysia. The NPCB ensures the quality, efficacy and safety of pharmaceutical products as well as the quality and safety of natural products and cosmetics marketed in Malaysia.

In view of its technical expertise and training capabilities, the NPCB was recognised by the World Health Organization (WHO) as a Collaborating Centre in the Regulatory Control of Pharmaceuticals on the 10th May 1996. With this recognition, the NPCB has provided training in the fields of pharmaceutical quality assurance and regulatory affairs to fellows from other National Regulatory Agencies.

In addition, the NPCB successfully gained accession as the 26th member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1st January 2002. Since then, NPCB has been actively involved in international Good Manufacturing Practice (GMP) and Quality Assurance programmes.

In order to improve its services quality, the NPCB continues to strive towards upgrading its Quality Management System. As a result, the NPCB has successfully upgraded its MS ISO certification from version MS ISO 9001:2000 to MS ISO 9001:2008. Furthermore, NPCB has obtained MS ISO 17025:2005 acreditation for Centre for Quality Control under the Malaysian Laboratory Accreditation Scheme (SAMM) in 2010.

10

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Carta OrganisasiOrganisation Chart

Seksyen Penilaian Produk KajianInvestigational Product Evaluation Section

Seksyen Pemonitoran Keselamatan Produk KajianInvestigational Product Safety Monitoring SectionSeksyen Komplians GCPGood Clinical Practice (CGP) Compliance Section

Seksyen Komplians GLPGood Laboratory Practice (GLP) Compliance Section

Unit PembangunanDevelopment Unit

Unit PentadbiranAdministration Unit

Unit KewanganFinance Unit

Seksyen Surveilans & Aduan ProdukPharmacovigillance Section

Seksyen FamakovigilansSurveillance & Complaints Section

Seksyen VariasiVariations Section

Seksyen KosmetikCosmetic Section

Seksyen Koordinasi Kualiti dan Sumber ManusiaManpower and Quality Coordination Section

Seksyen Perhubungan & PolisiInterrelation and Policy Section

Seksyen ICTInformation Communication Technology (ICT) Section

Pengarah Regulatori FarmasiDirector of Pharmacy Regulatory

PUSAT KAJIAN PRODUK BARUCENTRE FOR INVESTIGATIONAL NEW PRODUCT

PUSAT PENTADBIRANCENTRE FOR ADMINISTRATION

PUSAT PASCA PENDAFTARAN PRODUKCENTRE FOR POST REGISTRATION

PUSAT PEMBANGUNAN ORGANISASICENTRE FOR ORGANISATIONAL DEVELOPMENT

PUSAT PENDAFTARAN PRODUKCENTRE FOR PRODUCT REGISTRATION

Seksyen Ubat TerapeutikTherapeutic Medicine Section

Seksyen Biologiks dan KomplementariBiologic and Complementary Section

Seksyen Koordinasi RegulatoriRegulatory Coordination Section

Seksyen Ubat VeterinarVeterinary Medicine Section

Seksyen Bahan Aktif Farmaseutikal (API)Active Pharmaceutical Ingredient (API) Section

PUSAT KOMPLIANS DAN PELESENANCENTRE FOR COMPLIANCE AND LICENSING

Seksyen Amalan Perkilangan BaikGood Manufacturing Practice (GMP) Section

Seksyen Kualiti, Pensijilan, Pelesenan & Amalan Penstoran BaikQuality, Certification, Licensing and Good Distribution Practice Section

PUSAT KAWALAN KUALITICENTRE FOR QUALITY CONTROL

Seksyen Pengujian BiofarmaseutikalPharmaceutical Biology Testing Section

Seksyen Pengujian Produk SemulajadiPharmaceutical Chemistry Testing Section

Seksyen Pengujian Kimia FarmaseutikalNatural Product Testing Section

Sekyen PenyelidikanResearch and Development Section

11

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Seksyen Penilaian Produk KajianInvestigational Product Evaluation Section

Seksyen Pemonitoran Keselamatan Produk KajianInvestigational Product Safety Monitoring SectionSeksyen Komplians GCPGood Clinical Practice (CGP) Compliance Section

Seksyen Komplians GLPGood Laboratory Practice (GLP) Compliance Section

Unit PembangunanDevelopment Unit

Unit PentadbiranAdministration Unit

Unit KewanganFinance Unit

Seksyen Surveilans & Aduan ProdukPharmacovigillance Section

Seksyen FamakovigilansSurveillance & Complaints Section

Seksyen VariasiVariations Section

Seksyen KosmetikCosmetic Section

Seksyen Koordinasi Kualiti dan Sumber ManusiaManpower and Quality Coordination Section

Seksyen Perhubungan & PolisiInterrelation and Policy Section

Seksyen ICTInformation Communication Technology (ICT) Section

Pengarah Regulatori FarmasiDirector of Pharmacy Regulatory

PUSAT KAJIAN PRODUK BARUCENTRE FOR INVESTIGATIONAL NEW PRODUCT

PUSAT PENTADBIRANCENTRE FOR ADMINISTRATION

PUSAT PASCA PENDAFTARAN PRODUKCENTRE FOR POST REGISTRATION

PUSAT PEMBANGUNAN ORGANISASICENTRE FOR ORGANISATIONAL DEVELOPMENT

PUSAT PENDAFTARAN PRODUKCENTRE FOR PRODUCT REGISTRATION

Seksyen Ubat TerapeutikTherapeutic Medicine Section

Seksyen Biologiks dan KomplementariBiologic and Complementary Section

Seksyen Koordinasi RegulatoriRegulatory Coordination Section

Seksyen Ubat VeterinarVeterinary Medicine Section

Seksyen Bahan Aktif Farmaseutikal (API)Active Pharmaceutical Ingredient (API) Section

PUSAT KOMPLIANS DAN PELESENANCENTRE FOR COMPLIANCE AND LICENSING

Seksyen Amalan Perkilangan BaikGood Manufacturing Practice (GMP) Section

Seksyen Kualiti, Pensijilan, Pelesenan & Amalan Penstoran BaikQuality, Certification, Licensing and Good Distribution Practice Section

PUSAT KAWALAN KUALITICENTRE FOR QUALITY CONTROL

Seksyen Pengujian BiofarmaseutikalPharmaceutical Biology Testing Section

Seksyen Pengujian Produk SemulajadiPharmaceutical Chemistry Testing Section

Seksyen Pengujian Kimia FarmaseutikalNatural Product Testing Section

Sekyen PenyelidikanResearch and Development Section

12

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Piagam PelangganClient’s Charter

Masa –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

1. PENDAFTARAN PRODUK

Penilaian Penuh

a) Menilai permohonan pendaftaran: i) Ubat preskripsi 210 hari bekerja* ii) Ubat bukan preskripsi 210 hari bekerja* iii) Ubat baru dan biological 245 hari bekerja*

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Penilaian Ringkas

a) Menilai permohonan pendaftaran produk suplemen kesihatan dan produk semulajadi yang mengandungi: i) Bahan aktif tunggal 60 hari bekerja* ii) 2 atau lebih bahan aktif 80 hari bekerja* b) Pengeluaran notifikasi kosmetik 3 hari bekerja^ c) Pertukaran pemegang pendaftaran 45 hari bekerja*

d) Sijil Produk Farmaseutikal 15 hari bekerja*

e) Pertukaran Tapak Pengilang 45 hari bekerja*

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

2. PELESENAN

a) Pengeluaran lesen pengilang, pemborong dan pengimport 10 hari bekerja*

b) Penilaian Permohonan Lesen Import untuk Percubaan Klinikal (CTIL) dan Kebenaran Mengilang untuk Percubaan Klinikal (CTX): i) Bagi produk yang melibatkan First-in-Man Study, produk biologikal dan Advance Therapy Medicinal Product (ATMP) 45 hari bekerja* ii) Bagi produk-produk selain daripada yang disebutkan di atas 30 hari bekerja*

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

3. UJIAN MAKMAL

a) Pengujian sampel bagi tujuan pendaftaran 65 hari bekerja#

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

* Setelah permohonan lengkap diterima^ Bagi permohonan yang mematuhi keperluan ASEAN Cosmetic Directive (ACD)# Setelah sampel dan dokumen lengkap diterima

13

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Duration–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

1. PRODUCT REGISTRATION

Full Evaluation

a) To evaluate application for registration of: i) Prescription drugs 210 working days* ii) Non-prescription drugs 210 working days* iii) New drugs and biological 245 working days*

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Abridged Evaluation

a) To evalute application for registration of health supplements and traditional products containing: i) Single active ingredient 60 working days* ii) 2 or more active ingredients 80 working days* b) Issuance of cosmetic notification 3 working days^

c) Change of registration holder 45 working days*

d) Certificate of Pharmaceutical Product (CPP) 15 working days*

e) Change of manufacturing site 45 working days*

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

2. LICENSING

a) Issuance of manufacturer’s, wholesaler’s and importer’s license 10 working days*

b) Evaluation of import license application for Clinical Trial License (CTIL) and Clinical Trial Exemption (CTX): i) For products involving First-in-Man Study, biological products and Advance Therapy Medicinal Product (ATMP) 45 working days* ii) For products other than stated above 30 working days*

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

3. LABORATORY TESTING

a) Sample testing for purpose of registration 65 working days#

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

* Upon receipt of complete application^ For applications fulfilling ASEAN Cosmetic Directive (ACD) requirements# Upon receipt of sample and complete documentation

14

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Senarai PerjawatanList of Posts

Pengarah (JUSA C) VU7 1 0 1Director (JUSA C)–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pegawai Farmasi Gred U54/U52/U48/ 197 187 10U54/U52/U48/U44/U41 U44/U41Pharmacist Grade U54/U52/U48/U44/U41–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pegawai Teknologi Maklumat Gred F41 F41 1 1 0Information Technology Officer Grade F41–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Penolong Pegawai Farmasi Gred U36 U36 2 2 0Assistant Pharmacist Grade U36–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Penolong Pegawai Farmasi Gred U32 U32 8 7 1Assistant Pharmacist Grade U32–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Penolong Pegawai Farmasi Gred U29 U29 72 67 5Assistant Pharmacist Grade U29–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Penolong Pegawai Teknologi Maklumat F32 1 1 0Gred F32Assistant Information Technology Officer Grade F32–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Penolong Pegawai Tadbir Gred N36 N36 1 1 0Assistant Administrative Officer Grade N36–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Penolong Pegawai Perangkaan Gred E32 E32 1 1 0Assistant Statistical Officer Grade E32–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Penolong Pegawai Tadbir Gred N27 N27 2 1 1Assistant Administrative Officer Grade N27–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Setiausaha Pejabat N27 3 3 0Secretary’s Office–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pembantu Tadbir Gred N22 N22 1 1 0Administrative Assistant Grade N22–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pembantu Tadbir Gred N17 N17 16 12 4Administrative Assistant Grade N17–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pembantu Tadbir (Stor) Gred N17 N22 1 0 1Administrative Assistant (Store) Grade N17–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pembantu Tadbir (Kewangan) Gred W22 W22 2 2 0Administrative Assistant (Finance) Grade W22–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Jawatan Gred Bil. Jawatan Pengisian Kekosongan Position Grade No. Position Filling Vacancies

15

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Pembantu Tadbir (Kewangan) Gred W17 W17 9 7 2Administrative Assistant (Finance) Grade W17–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pembantu Perpustakaan Gred S17 S17 1 1 0Library Assistant Grade S17–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pegawai Khidmat Pelanggan Gred N17 N17 2 2 0Customer Service Officer Grade N17–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Juruteknik Komputer Gred FT17 FT17 1 1 0Computer Technician Grade FT17–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Operator Mesin Prosesan Data Gred F11 F11 2 0 2Data Processing Machine Operator Grade F11–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pengawal Keselamatan Gred KP 11 KP11 3 3 0Security Guard Grade KP 11–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pembantu Am Pejabat Gred N4 N4 1 0 1Office Assistant Grade N4–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pembantu Am Pejabat Gred N1 N1 4 3 1Office Assistant Grade N1–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pembantu Perawatan Kesihatan U12/U3 10 10 0Gred U12/U3Health Care Assistants Grade U12/U3–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pemandu Kenderaan Bermotor Gred R3/R6 R3/R6 5 4 1Motor Vehicle Driver Grade R3/R6–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––JUMLAH 347 317 30TOTAL –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Jawatan Gred Bil. Jawatan Pengisian Kekosongan Position Grade No. Position Filling Vacancies

16

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Jasamu DikenangRemembering Your Services

Pada tahun 2011, sejumlah 32 orang anggota telah berpindah ke tempat bertugas yang baru, meletak jawatan atau bersara. Kepada semua anggota yang telah meninggalkan BPFK, kami ingin mengucapkan selamat maju jaya. Segala perkhidmatan dan jasa bakti yang telah dicurahkan oleh semua kepada BPFK selama ini amatlah dihargai dan akan dikenang untuk selamanya.

In 2011, a total of 32 members were transferred, resigned or retired. The NPCB would like to thank them and wish them all the best in their future undertakings. All their services as well as contributions to the NPCB would be greatly appreciated and fondly remembered.

Normi binti Abdullah Pegawai Farmasi U52 Hospital Kuala Lumpur Pharmacist Kuala Lumpur General Hospital–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Siti Aisah binti Bahari Pegawai Farmasi U48 Bahagian Perkhidmatan Farmasi Pharmacist Pharmaceutical Services Division–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Rahman bin Baco Pegawai Farmasi U41 Bahagian Perkhidmatan Farmasi Pharmacist Pharmaceutical Services Division–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Amran bin Abu Bakar Pegawai Farmasi U41 Bahagian Perkhidmatan Farmasi Pharmacist Pharmaceutical Services Division–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Rusnah Rejab Penolong Pegawai Farmasi U32 Hospital Sungai Buloh Assistant Pharmacist Sungai Buloh Hospital–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Alif bin Azizan Penolong Pegawai Farmasi U29 Hospital Kuala Lumpur Assistant Pharmacist Kuala Lumpur General Hospital–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Hasnira Yahaya Penolong Pegawai Farmasi U29 Klinik Kesihatan Seremban Assistant Pharmacist Seremban Health Clinic–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Rohaniah bt. Che Seman Penolong Pegawai Farmasi U29 Hospital Ampuan Najihah, Kuala Pilah Assistant Pharmacist Ampuan Najihah Hospital, Kuala Pilah–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Lahung Mering Penolong Pegawai Farmasi U29 Jabatan Kesihatan Negeri Sarawak Assistant Pharmacist Sarawak State Health Department–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Ismajura binti Borhanuddin Penolong Pegawai Farmasi U29 Jabatan Kesihatan Negeri Melaka Assistant Pharmacist Malacca State Health Department–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Kwan Wai Lin Penolong Pegawai Farmasi U29 Bahagian Perkhidmatan Farmasi Assistant Pharmacist Pharmaceutical Services Division–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Marianie binti Omar Pembantu Tadbir N17 Klinik Kesihatan Botanik, Klang Administrative Assistant Botanic Health Clinic, Klang–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Hasli Hisham Haslan Pembantu Tadbir (Kewangan) W17 Hospital Rehabilitasi CherasMohd Nasir Administrative Assistant Cheras Rehabilitation Hospital (Finance)–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Nama Jawatan Gred Tempat Bertukar Name Position Grade Transferred To

17

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Senarai nama anggota BPFK yang telah bersara atau meletak jawatan pada tahun 2011:

The list of NPCB staff retired or resigned in 2011:

Nama Jawatan Gred Tempat Bertukar Name Position Grade Transferred To

Nama Jawatan Gred Bersara / Berhenti Name Position Grade Retired / Resigned

Azura binti Udin Pembantu Tadbir (Kewangan) W17 Hospital Ampang Administrative Assistant Ampang Hospital (Finance)–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––AbdulAlimBinZainal PembantuAmPejabat N4 HospitalPutrajaya Office Assistant Putrajaya Hospital–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Nor Idayu binti Naser Pembantu Perawatan U3 Hospital Tuanku Jaafar, Seremban Kesihatan Health Care Assistant Tuanku Jaafar Hospital, Seremban–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Selvaraja a/l Seerangam Pengarah (JUSA C) VU7 Bersara Director (JUSA C) Retired–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Woo Ai Ling Pegawai Farmasi U44 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Chow Guan Kuan Pegawai Farmasi U44 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Seow Ee Laine Pegawai Farmasi U44 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––P’ngZiyan PegawaiFarmasi U41 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––ZariahbintiHadzam PegawaiFarmasi U41 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Yusni Rizal bin Khairul Anuar Pegawai Farmasi U41 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––James Ooi Joe Behn Pegawai Farmasi U41 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Narqes bt. Mohd. Raimi Pegawai Farmasi U41 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Hiong Len Teng Pegawai Farmasi U41 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

18

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Jasamu Dikenang 2011 (Sambungan)Remembering Your Services 2011 (Continued)

Nama Jawatan Gred Bersara / Berhenti Name Position Grade Retired / Resigned

Pua Ann Nee Pegawai Farmasi U41 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Tan See Hooi Pegawai Farmasi U41 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Khoo Jeng Yih Pegawai Farmasi U41 Berhenti Pharmacist Resigned–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Noribah bt. Baba Penolong Pegawai Farmasi U32 Bersara Pharmacist Assistant Retired–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––ZambinRokiahAbdulRashid PenolongPegawaiFarmasi U29 Bersara Pharmacist Assistant Retired–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Ramly bin Ahmad Pembantu Tadbir N22 Bersara Administrative Assistant Retired–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Anugerah Perkhidmatan CemerlangExcellent Service Awards 19

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Sameerah binti Shaikh Abd. Rahman Pegawai Farmasi U54 Pharmacist U54–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––MazuwinbintiZainalAbidin PegawaiFarmasiU54 Pharmacist U54–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Rosilawati binti Ahmad Pegawai Farmasi U54 Pharmacist U54–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––DatinZahurabintiMohamed@Ismail PegawaiFarmasiU48 Pharmacist U48–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Ahmad Syamsury bin Sulaiman Pegawai Farmasi U48 Pharmacist U48–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Azraini binti Abdul Samat Pegawai Farmasi U48 Pharmacist U48–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Aida Haryati binti Abdul Samat Pegawai Farmasi U48 Pharmacist U48–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Chang Hsio Ling Pegawai Farmasi U44 Pharmacist U44–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Tan Shiau Yi Pegawai Farmasi U44 Pharmacist U44–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Ng Shin Hwei Pegawai Farmasi U44 Pharmacist U44–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Erina Camilla binti Mohd Ghazali Pegawai Farmasi U44 Pharmacist U44–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Nee Yuan Qi Pegawai Farmasi U44 Pharmacist U44–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Yam Pei Ching Pegawai Farmasi U44 Pharmacist U44–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––ZafiahbintiMohdYusof PegawaiTeknologiMaklumatF41 Information Technology Officer F41–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Pada tahun 2011, seramai 26 orang anggota BPFK telah diberikan Anugerah Perkhidmatan Cemerlang. Anugerah ini diberi sebagai tanda pengiktirafan jabatan dan kerajaan terhadap prestasi kerja yang cemerlang.

In 2011, a number of NPCB staff was presented with the Excellent Service Award. The award was given as a gesture of appreciation towards outstanding performance.

Nama Jawatan

Name Post

20

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Nama Jawatan

Name Post

Anugerah Perkhidmatan Cemerlang (Sambungan)Excellent Service Awards (Continued)

Chua Wone Tying Pen. Pegawai Farmasi U32 Pharmacist Assistant U32–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Abdul Ghani bin Yusof Pen. Pegawai Farmasi U32 Pharmacist Assistant U32–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Nor Syazana binti Abdul Aziz Pen. Pegawai Farmasi U29 Pharmacist Assistant U29–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Nik Azniza binti Awang Pen. Pegawai Farmasi U29 Pharmacist Assistant U29–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Rahmah binti Abas Pen. Pegawai Farmasi U29 Pharmacist Assistant U29–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Chong Feng Shin Pen. Pegawai Farmasi U29 Pharmacist Assistant U29–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Nor Azian binti Megat Osman Pembantu Tadbir W22 Administrative Assistant W22–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Mohd Ariff Fikry bin Hasim Pembantu Tadbir W17 Administrative Assistant W17–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Nor Naimah binti Ismail Pembantu Tadbir W17 Administrative Assistant W17–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Norziani binti Mohd Potri Pembantu Tadbir N17 Administrative Assistant N17–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Sri Puvenesvaran Pemandu Kenderaan Bermotor R3 Motor Vehicle Driver R3–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––ZafribinRodzokhi PembantuPerawatanKesihatanU3 Health Care Assistants U3–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

21

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

PENCAPAIANACHIEVEMENTS

22

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

PencapaianAchievements

1. Pada November 2010, BPFK telah berjaya menambah skop akred i tas i MS ISO/ IEC 17025:2005 dari Jabatan Standard Malaysia untuk ujian had merkuri di dalam produk semulajadi menggunakan Cold Vapour Atomic Absorption Spectrometry. Berdasarkan audit pengawasan yang dijalankan pada 5 hingga 6 Disember 2011, BPFK telah berjaya mengekalkan skop akreditasi berikut:

a) Pengujian arsenik, plumbum dan kadmium dalam produk-produk semulajadi melalui Graphi te Furnace Atomic Absorpt ion Spectrometry

b) Kontaminasi mikrobial dalam produk-produk semulajadi berdasarkan Harmonised Method BP 2008

c) Pengecaian kapsul dan tablet dalam produk-produk semulajadi

d) Keseragaman berat untuk kapsul dan tablet dalam produk-produk semulajadi

2. BPFK turut ter l ibat dalam akt iv i t i -akt iv i t i berikut:

a) Menghasilkan piawai rujukan kimia dan biologikal melalui skim kerjasama di antara Negara Association of South East Asian Nations (ASEAN)

b) Mengambil bahagian dalam kajian kolaboratif dan skim ujian profisiensi. Pada tahun 2011, ujian profisiensi telah dijalankan seperti berikut:

i) External Quality Assurance Assessment Scheme Phase 5 anjuran World Health Organisation (WHO)

ii) Chinese Medicine Proficiency Testing anjuran IFM Quality Services Pty Ltd, Australia

iii) Kajian kolaboratif untuk Establishment of the 3rd WHO International Standard for Dihydrostreptomycin by European Directorat for the Quality of Medicines (EDQM)

1. In November 2010, the NPCB had successfully extended the accreditation scope of MS ISO/ IEC 17025:2005 by Department of Standards Malaysia for Mercury Limit Test in natural products using Cold Vapor Atomic Absorption Spectrometry. Based on the surveillance audit conducted on 5th till 6th Dec 2011, NPCB was able to maintain the following accreditation scopes:

a) Arsenic, Lead and Cadmium Limit Test in natural products using Graphite Furnace Atomic Absorption Spectrometry

b) Microbial Contamination Test for natural products based on Harmonised Method BP 2008

c) Disintegration test for capsules and tablets in natural products

d) Weight uniformity test for capsules and tablets in natural products

2. The NPCB is also imperatively involved in the following activities:

a) Establishing chemical and biological reference standard through a cooperation scheme among the Association of South East Asian Nations (ASEAN) Countries.

b) Taking part in various collaborative studies and proficiency testing shemes. In 2011, the following proficiency testings were carried out:

i) External Quality Assurance Assessment Scheme Phase 5 organised by WHO

ii) Chinese Medicine Proficiency Testing organised by IFM Quality Services Pty Ltd, Australia

iii) Collaborative Study for the Establishment of the 3rd WHO International Standard for Dihydrostreptomycin by European Directorat for the Quality of Medicines (EDQM)

iv) pH and Weight per ml test ing of Abacavir Sulphate Oral Solution 20 mg/ml organised by WHO under External

23

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

iv) Ujian pH dan weight per ml Abacavir Sulphate Oral Solution 20mg/ml yang dianjurkan oleh WHO di bawah External Quality Assurance Assessment Scheme (EQAAS)

v) Ujian logam kadmium, merkuri, arsenik dan plumbum dalam air anjuran Jabatan Kimia Malaysia

vi) Potentiometric titration (non-aqueous): Mebendazole anjuran Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health, Thailand

c) M e l a k s a n a k a n p e n y e l i d i k a n d a n pembangunan tatacara pengujian berikut:

i) Pembangunan tatacara penguj ian untuk:

- Penentuan Azela ic Acid dalam keluaran kosmetik menggunakan kaedah Gas Chromatography Mass Spectrometry (GCMS)

- Ident i f ikas i Cl indamycin dalam keluaran kosmetik menggunakan kaedah High Performance Liquid Chromatography (HPLC)

- Penentuan B is-2 (e thy lhexy l ) -phthalate dalam keluaran kosmetik dan farmaseutikal menggunakan kaedah GCMS

- Analisis pengesahan Ortosiphon stamineus (Misai Kucing) dalam produk semulajadi dengan menggunakan penanda kimia Sinensetin dengan kaedah HPLC

- Penyaringan alkaloid Lobeline dalam produk semulajadi yang mengandungi Lobelia spp. menggunakan kaedah HPLC dan GCMS

- Anal is is pengesahan Eurycoma longifolia (Tongkat Ali) dalam produk semulajadi dengan menggunakan penanda kimia Eurycomanone dengan kaedah HPLC

Quality Assurance Assessment Scheme (EQAAS)

v) Heavy Metal Test of cadmium, arsenic, mercury & lead in water by Department of Chemistry Malaysia

vi) Potentiometric titration (non-aqueous): Mebendazole organised by Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health, Thailand

c) Research and development of test ing methodologies:

i) Development of testing methodologies for:

- Determination of Azelaic acid in cosmetic using Gas Chromatography M a s s S p e c t ro m e t r y ( G C M S ) method

- Identi f icat ion of Cl indamycin in cosmetic using High Performance Liquid Chromatography (HPLC) method

- Determination of Bis-2 (ethylhexyl)-p h t h a l a t e i n c o s m e t i c a n d pharmaceutical products using GCMS method

- Authentication analysis of Orthosiphon stamineus (Misai Kucing) in natural products by using marker compound sinensitin via HPLC method

- Screening of Lobeline alkaloid in natural products containing Lobelia spp by using HPLC and GCMS method

- Authentication analysis of Eurycoma longifolia (Tongkat Ali) in natural products by using marker compound Eurycomanone via HPLC method

24

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pencapaian (Sambungan)Achievements (Continued)

ii) Berjaya menjalankan validasi ke atas tatacara pengujian berikut:

- Penyaringan alkaloid Lobeline dalam produk semulajadi yang mengandungi Lobelia spp. menggunakan kaedah HPLC dan GCMS

- P e n y a r i n g a n e p h e d r i n e d a n pseudoephdrine di dalam produk semulajadi melalui kaedah HPLC

- Analisis pengesahan Ortosiphon stamineus (Misai Kucing) dalam produk semulajadi dengan menggunakan penanda kimia Sinensetin dengan kaedah HPLC

- Penentuan Azela ic Acid dalam keluaran kosmetik menggunakan kaedah GCMS

d) Membangun dan mengesahkan tatacara pengujian untuk Burkholderia cepacia yang mana mikroorganisma ini dikesan hadir di dalam produk farmaseutikal, semulajadi dan kosmetik. Oleh itu, terdapat keperluan untuk memastikan semua produk bebas daripada kontaminasi mikroorganisma ini.

3. BPFK telah terl ibat dalam beberapa buah jawatankuasa seperti berikut:

a) Sebagai sekretariat dan ahli bagi Technical Committee for Development of Malaysian Herbal Monograph dan terlibat dalam:

i) Pembangunan tatacara penguj ian Monograf Herbal Malaysia Volum 3

ii) Verif ikasi pengujian bahan mentah untuk Monograf Hebal Malaysia di bawah projek New Key Economic Area (NKEA)

b) S e k re t a r i a t k e p a d a J a w a t a n k u a s a Penyelidikan Klinikal Kebangsaan (JPKK) yang dipengerusikan oleh Y. Bhg. Dato’ Sri Dr. Hasan Bin Abdul Rahman, Ketua Pengarah Kesihatan Malaysia. Jawatankuasa ini bertanggungjawab:

i) Mewujudkan dasar dan merancangkan aktiviti percubaan klinikal di Malaysia

ii) Successfully validated the following developed in-house methods:

- Screening of Lobeline alkaloid in natural products containing Lobelia spp us i ng HPLC and GCMS method

- S c re e n i n g o f e p h e d r i n e a n d pseudoephedrine in natural products using HPLC method

- Authentication analysis of Orthosiphon stamineus (Misai Kucing) in natural products using marker compound sinensitin by HPLC method

- Determination of Azelaic acid in cosmetic using GCMS method

d) Developing and validating testing method for Burkholderia cepacia which had been traced in the pharmaceuticals, natural products and cosmetics. Hence, there is a need to ensure that the products are free from this microorganism contamination.

3. NPCB was also involved in the fol lowing committees as the:

a) Secretar iat and member of Technical Committee for Development of Malaysian Herbal Monograph and involved in:

i) Development of testing methodologies for Malaysian Herbal Monograph Volume 3

ii) Verification of raw material testing for Malaysian Herbal Monograph under the New Key Economic Area (NKEA) project

b) Secretariat to the National Committee for Clinical Research (NCCR) which is chaired by the Director General of Health Malaysia, Y. Bhg. Dato’ Sri Dr. Hasan Bin Abdul Rahman. The NCCR is responsible to:

i) Establish policies and plan clinical trial activities in Malaysia

25

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

ii) Me l ibatkan pakar-pakar d i KKM, akademia dan industri farmaseutikal melalui konsep smart partnership untuk mempertingkatkan kajian klinikal

iii) Mengenal pasti infrastruktur yang sedia ada dan mengambil langkah yang sesuai dalam menaik tarafkannya

iv) Menganjurkan program-program latihan seperti Amalan Klinikal Baik (GCP), Amalan Makmal Baik (GLP), Biostatistik serta latihan lain yang berkaitan dengan pembangunan insan

v) Mengambil tindakan pro-aktif dalam mempertingkatkan kajian klinikal di Malaysia seiring dengan pembangunan di negara-negara maju.

c) Sekretariat kepada Jawatankuasa Kecil Garispanduan Good Cl inical Practice . Jawatankuasa ini telah berjaya mengemaskini dan menerbitkan Malaysian Guidelines for Good Clinical Practice Edisi Ketiga pada Oktober 2011.

4. Pemeriksaan Mutual Joint Visit (MJV) telah diadakan ke atas Malaysia pada 14 hingga 19 November 2011. MJV ini adalah untuk meni la i Program Pemantauan Pematuhan Good Laboratory Practice (GLP) BPFK dan menilai kecekapan serta kemahiran dalam menjalankan pemeriksaan oleh para inspektor BPFK. Pemeriksaan Fasiliti Kajian ini dilaksanakan di Environmental Technology Research Centre (ETRC), SIRIM Berhad. Pemeriksaan MJV ini telah di jalankan oleh tiga orang pakar GLP dari GLP Working Group yang terdiri dari:

a) Dr. Andrew Gray (Ketua Inspektor) Medicines & Healthcare Products Regulatory

Agency (MHRA) London, United Kingdom

b) Dr. Christoph Moor Federal Office for the Environment (FOEN)

Berne, Switzerland

c) Dr. Hitoshi Someya Japan Pharmaceuticals and Medical Devices

Agency (JPMA) Tokyo, Japan

ii) Utilize all experts available in the Ministry of Health Malaysia, academia and pharmaceutical industries through “smart partnership” concepts in enhancing clinical research

iii) Identify available infrastructures and take necessary steps in improving them

iv) Organise training programmes such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Biostatistics and other training related to human development

v) Take pro-active action at all times in enhancing clinical research in Malaysia in tandem with the development in developed nations.

c) Secretariat to the subcommittee for the Malaysian Guidelines for Good Clinical Practice. The subcommittee had updated and published the Malaysian Guidelines for Good Clinical Practice Third Edition in October 2011 in line with the current requirements.

4. The Mutual Joint Visit (MJV) Inspection was conducted in Malaysia from 14th t i l l 19th November 2011. The MJV involved assessing the NPCB GLP Compliance Monitoring Programme as well as observing the competency and skill of inspection by the NPCB Inspectors. The observation of inspection was carried out at Environmental Technology Research Centre (ETRC), SIRIM Berhad. The MJV was conducted by three GLP Experts from the GLP Working Group which consisted of :

a) Dr. Andrew Gray (Lead Inspector) Medicines & Healthcare Products Regulatory

Agency (MHRA) London, United Kingdom

b) Dr. Christoph Moor Federal Office for the Environment (FOEN)

Berne, Switzerland

c) Dr. Hitoshi Someya Japan Pharmaceuticals and Medical Devices

Agency (JPMA) Tokyo, Japan

26

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pencapaian (Sambungan)Achievements (Continued)

5. Sebagai Pusat Kolaborasi Pertubuhan Kesihatan Sedunia (WHO) dalam pengawalan regulatori farmaseutikal, BPFK telah menganjurkan Seminar WHO untuk Kawalan Regulatori terhadap Bahan Aktif Farmaseutikal (API) pada tahun 2011. Selain itu, Malaysia melalui BPFK, telah dipilih sebagai tuan rumah kepada WHO Consultative Meeting on Combating Substandard / Spurious / Falsely-labelled / Falsified / Counterfeit (SSFFC) Medicines and Building Global Capacity for Surveillance and Monitoring of SSFFC yang Kedua.

6. BPFK terus memainkan peranan yang aktif dalam usaha harmonisasi ASEAN melalui penganjuran International Conference on Harmonization (ICH) - Global Corporation Group (GCG) – ASEAN Training Workshop on ICH Guidelines Q5C (Stability Testing for Biologicals / Biological Products) dan ASEAN Consultative Meeting for Standards & Quality (ACCSQ) on Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) yang Ke-15.

5. As a WHO Collaborating Centre for regulatory control of pharmaceuticals, NPCB had organised the WHO Awareness Seminar on Regulatory Control of API in 2011. In addition, NPCB was also given the honour to host the 2nd WHO Consultative Meeting on Combating Substandard / Spurious / Falsely-labelled / Falsified / Counterfeit (SSFFC) Medicines and Building Global Capacity for Surveillance and Monitoring of SSFFC.

6. NPCB continues to play an active role in ASEAN harmonisation efforts by organising the International Conference on Harmonization (ICH) - Global Corporation Group (GCG) – ASEAN Training Workshop on ICH Guidelines Q5C (Stability Testing for Biologicals / Biological Products) and the 15th ASEAN Consultative Meeting for Standards & Quality (ACCSQ) on Traditional Medicines and Health Supplements Product Working Group (TMHS PWG).

PENDAFTARAN PRODUKPRODUCT REGISTRATION

27

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

28

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pendaftaran ProdukProduct Registration

Sebagai sekretariat kepada Pihak Berkuasa Kawalan Dadah (PBKD), BPFK berperanan dalam mengendalikan permohonan pendaftaran produk-produk entiti kimia baru / ubat baru, bioteknologi, preskripsi, bukan preskripsi, produk suplemen kesihatan, produk semulajadi serta produk veterinar.

Mulai Januari 2011, semua pendaftaran produk dijalankan menerusi sistem atas talian (online) melalui sistem QUEST3 (menggantikan sistem QUEST2) termasuk bagi produk entiti kimia baru dan bioteknologi yang menggunakan sistem manual pada tahun-tahun sebelumnya.

Bagi memastikan semua produk farmaseutikal yang didaftarkan adalah selamat, berkesan dan berkualiti serta produk semulajadi yang didaftarkan adalah selamat dan berkualiti, penilaian secara menyeluruh meliputi aspek keselamatan, keberkesanan dan kualiti dijalankan sebelum dibentangkan dalam mesyuarat PBKD.

Selain itu, kawalan regulatori terhadap bahan aktif farmaseutikal dilaksanakan dengan mengenakan keperluan teknikal tambahan berhubung bahan aktif farmaseutikal sebagai sebahagian daripada keperluan dalam pendaftaran baru. Keperluan teknikal bahan aktif farmaseutikal perlu dikemukakan semasa permohonan pendaftaran produk. Penilaian maklumat ini dibuat serentak dengan penilaian dossier permohonan pendaftaran produk.

Walau bagaimanapun, pengawalan bahan aktif farmaseutikal dilaksanakan secara prospektif dan berperingkat yang mana ia dimulakan secara sukarela untuk ubat Entiti Kimia Baru mulai 1 April 2011 dan diikuti pelaksanaan secara mandatori pada 1 Januari 2012.

Sepanjang tahun 2011, sebanyak dua belas mesyuarat PBKD telah diadakan dan sehingga Disember 2011 sebanyak 1,067 produk telah didaftarkan (merangkumi semua kategori produk) dan 602 permohonan pendaftaran produk yang telah ditolak kerana tidak mematuhi kriteria pendaftaran produk atau lambat mengemukakan maklumbalas melebihi tempoh yang ditetapkan.

As the secretariat to the Drug Control Authority (DCA), NPCB plays a crucial role in the processing of registration application for new chemical entity (NCE) / new drug, biotechnology, prescription, non-prescription, health supplements, natural as well as veterinary products.

Since January 2011, all registration applications were submitted via the online system known as QUEST3 (an upgraded version of QUEST2 system). These included applications for NCE and biotechnology products that were processed through manual submission in previous years.

To ensure that all registered pharmaceutical products are safe, efficacious and of quality as well as registered traditional products are safe and of quality, products will have to be thoroughly assessed with regards to the safety, efficacy and quality aspects before getting tabled to DCA meeting.

In addition, regulatory control on active pharmaceutical ingredient (API) has been implemented with the enforcement of additional technical requirement related to API as part of the requirement for new registration application. Technical requirement on API need to be submitted together with the registration application. The assessment is done simultaneously with the assessment of dossier for the registration of finished product.

However, the regulatory contro l on API was implemented prospectively and in stages whereby it started voluntarily for NCE on 1st April 2011 and will be followed by mandatory implementation on 1st January 2012.

In 2011, 12 DCA meetings were held and until December 2011, a total of 1,067 applications for product registration were tabled to the DCA (for all categories of products) and a total of 602 registration applications were rejected basically due to non-compliance to the registration criteria or no response to the queries submitted within a specified time frame.

29

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Jadual 1 : Produk Ubat Baru yang diluluskan oleh PBKD pada tahun 2011Table 1 : New Chemical Entity Proucts Approved by the DCA in 2011

Bil. Nama Produk No. Product Name

1 Pradaxa 150 mg Hard Capsule––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 2 Brilinta 90 mg Film- Coated Tablet––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 3 Evoltra 1mg/ml Concentrate For Solution For Infusion ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 4 Foster 100/6 mcg/Dose Pressurired Inhalation Solution––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 5 Vimovo 500 mg/20 mg Modified -Release Tablets––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 6 Saphris Sublingual Tablet 5 mg Saphris Sublingual Tablet 10 mg––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 7 Twynsta Tablet 40/5 mg Twynsta Tablet 40/10 mg Twynsta Tablet 80/5 mg Twynsta Tablet 40/10 mg––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 8 Jevtana 60 mg Concentrate And Solvent For Solution For Infusion––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 9 Duodart 0.5 mg/ 0.4 mg Capsules––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 10 Relestat ( Epinastine Ydrochloride Ophtqalmic Sollution ) 0.05 mg/ml––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 11 Daxas 500 mcg Film-Coated Tablets––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 12 Tasigna 150 mg Capsule––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 13 Xarelto 15 mg Film-Coated Tablet Xarelto 20 mg Film-Coated Tablet––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 14 Azyter 15 mg/g Eye Drops––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 15 Temodal 2.5 mg/ml Powder For Solution For Infusion––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 16 Kombiglyze Xr Tablet 2.5/1000 mg Kombiglyze Xr Tablet 5/500 mg Kombiglyze Xr Tablet 5/1000 mg––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 17 Aloxi Solution For Injection 250 mcg/5 ml––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 18 Trobalt Tablet 50 mg Trobalt Tablet 100 mg Trobalt Tablet 200 mg Trobalt Tablet 300 mg Trobalt Tablet 400 mg–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

30

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pendaftaran Produk (Sambungan)Product Registration (Continued)

Jadual 2 : Produk bioteknologi yang diluluskan oleh PBKD pada tahun 2011Table 2 : Biotechnology products approved by the DCA in 2011

Bil. Nama Produk No. Product Name

1 Nesp Injection Syringe 20mcg Nesp Injection Syringe 30mcg Nesp Injection Syringe 40mcg Nesp Injection Syringe 120mcg––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 2 Binocrit 2000 iu/1 ml Solution For Injection In A Pre-Filled Syringe Binocrit 4000 iu/0.4 ml Solution For Injection In A Pre-Filled Syringe Binocrit 10,000 iu/1 ml Solution For Injection In A Pre-Filled Syringe Binocrit 40,000 iu/1 ml Solution For Injection In Pre-Filled Syringe––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 3 Ilaris Powder For Solution For Injection––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 4 Human-Albumin 20 % Behring (Low Salt) Solution For Infusion––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 5 Stelara 45mg/0.5ml Solution For Injection In Prefilled Syringe Stelara 90mg/ml Solution For Injection In Prefilled Syringe––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 6 Octaplas SD* Blood Group A Solution For Infusion Octaplas SD* Blood Group B Solution For Infusion Octaplas SD* Blood Group Ab Solution For Infusion Octaplas SD* Blood Group O Solution For Infusion––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 7 Flebogamma 5 % Dif* Solution For Infusion––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 8 Kiovig 100mg/ml Solution For Infusion––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 9 Gonal-F® 75 iu (5.5 mcg) Powder And Solvent For Solution For Injection––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 10 Gonal-F® 450 iu/0.75 ml Powder And Solvent For Solution For Injection––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 11 Gonal-F® Solution For Injection In Pre-Filled Pen––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 12 Nplate 250 mcg Powder For Solution For Injection–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

31

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

a) Penerimaan Permohonan Pendaftaran Produk

Rajah 1 di bawah menunjukkan penurunan dalam bilangan penerimaan permohonan dari tahun 2007 hingga tahun 2011. Jumlah kumulatif penerimaan permohonan sehingga akhir tahun 2011 adalah sebanyak 66,672 permohonan. Pelaksanaan sistem QUEST3 yang menjalankan proses penyaringan sebelum pembayaran yuran pemprosesan dibuat turut menyumbang kepada penurunan permohonan yang diterima pada tahun 2011 kerana hanya produk yang didapati lengkap melalui proses penyaringan sahaja yang akan diterima.

Bagi produk veterinar, pendaftaran produk hanya bermula pada 1 Ogos 2007 bagi produk sedia ada di pasaran. Sehingga 2011, bilangan permohonan pendaftaran secara kumulatif yang diterima bagi produk veterinar adalah sebanyak 2,850 permohonan.

a) A p p l i c a t i o n s R e c e i v e d f o r P ro d u c t Registration

Figure 1 shows a decline in the number of registration application received from 2007 to 2011. The cumulative number of applications received until the end of 2011 was 66,672. The decline could be due to the implementation of screening phase before an application is approved for payment in the QUEST3 System whereby only complete applications approved after the screening will be accepted for further evaluation.

The registration of veterinary products commenced on 1st August 2007 for existing products in the market. As of 2011, the cumulative number of applications received for veterinary products were 2,850.

Rajah 1 : Bilangan Permohonan yang Diterima Mengikut Kategori Produk (2007 – 2011)Figure 1 : Number of Applications Received by Product Categories (2007-2011)

Rajah 2 menujukkan sebahagian besar daripada bilangan permohonan yang diterima adalah daripada produk semulajadi iaitu sebanyak 46%.

Figure 2 shows that a large percentage of applications received were from natural products (46%).

500

0

1,000

1,500

2,000

2007

555

560

1,32

50 0

2008

604

483

1,12

057

00

2009

Tahun/Year

Bila

ngan

/Num

ber

s

492

381

902

1,92

40

2010

402

268

671

312

0

2011

510

5264

344

154

PreskripsiPrescription

Bukan PreskripsiNon-prescription

SemulajadiNatural

VeterinarVeterinary

Suplemen KesihatanHealth Supplements

32

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pendaftaran Produk (Sambungan)Product Registration (Continued)

Rajah 2 : Permohonan Pendaftaran yang Diterima Mengikut Kategori Produk 2011Figure 2 : Registration Applications Received based on Product Category 2011

Rajah 3 : Taburan Produk yang Didaftarkan (2007-2011)Figure 3 : Distribution of Products Registered (2007-2011)

b) Bilangan Produk yang Didaftarkan

Selaras dengan penurunan permohonan yang diterima, Rajah 3 menunjukkan bilangan produk yang didaftarkan bagi semua kategori produk bagi tahun 2011 turut menurun berbanding tahun-tahun sebelumnya.

b) Registered Products

In line with the decline in the number of applications received, Figure 3 shows a decrease in the number of products registered for all categories of products in 2011 as compared to the previous years.

PreskripsiPrescription

Bukan PreskripsiNon-prescription

SemulajadiNatural

VeterinarVeterinary

Suplemen KesihatanHealth Supplements

36%

11%

3%

46%4%

2011

300

0

600

900

1,200

1,500

2007

449

413

1,34

20 0

2008

409

272

953

0 0

2009

Tahun/Year

Bila

ngan

/Num

ber

s

412

313

1,04

00 0

2010

441

235

582

540

2011

325

5546

752

168

PreskripsiPrescription

Bukan PreskripsiNon-prescription

SemulajadiNatural

VeterinarVeterinary

Suplemen KesihatanHealth Supplements

33

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 4 : Produk yang Didaftarkan Mengikut Kategori 2011Figure 4 : Products Registered Based on Category 2011

Rajah 4 menunjukkan pecahan bilangan produk yang didaftarkan mengikut kategori pada tahun 2011. Produk semulajadi merupakan produk yang paling banyak didaftarkan iaitu 44% diikuti dengan 30% produk preskripsi, 16% suplemen kesihatan, 5% bukan preskripsi dan 5% veterinar.

Figure 4 shows the breakdown of products registered in 2011 based on product category. Natural products recorded the highest percentage with 44% followed by 30% prescription products, 16% health supplements, 5% non-prescription and 5% veterinary products.

c) Bilangan Permohonan yang Ditolak

Rajah 5 menunjukkan jumlah permohonan penda f ta ran p roduk yang d i to lak te lah meningkat. Ini adalah berikutan polisi PBKD yang diperkenalkan pada tahun 2008 di mana permohonan akan dibentangkan ke mesyuarat PBKD untuk ditolak bagi pemohon yang tidak memberikan maklumbalas yang diminta dalam tempoh enam (6) bulan.

c) Rejected Products

Figure 5 shows an increasing trend in the total number of product registration applications rejected. This was due to the introduction of DCA policy in 2008 whereby an application will be tabled to DCA for rejection if the applicant failed to provide the required documentations within six (6) months from the time of product dossier submission.

PreskripsiPrescription

Bukan PreskripsiNon-prescription

SemulajadiNatural

VeterinarVeterinary

Suplemen KesihatanHealth Supplements

30%

16%

5%

44%

5%

2011

34

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pendaftaran Produk (Sambungan)Product Registration (Continued)

Rajah 5 : Bilangan Permohonan Pendaftaran yang Ditolak (2007-2011)Figure 5 : Number of Registration Applications Rejected (2007-2011

Rajah 6 : Permohonan Pendaftaran yang Ditolak Mengikut Kategori Produk 2011Figure 6 : Registration Application Rejected Based on Category 2011

Rajah 6 menunjukkan sebahagian besar permohonan produk yang ditolak pada tahun 2011 adalah daripada produk semulajadi, veterinar dan preskripsi.

Figure 6 shows that the majority of rejected products in 2011 were natural products, veterinary and prescription products.

50

0

100

150

200

250

300

350

2007

9059

191

0 0

2008

171

112

332

0 0

2009

Tahun/Year

Bila

ngan

/Num

ber

s

115

8413

7

0

2010

205

108

184

36 0

2011

145

1921

817

050

PreskripsiPrescription

Bukan PreskripsiNon-prescription

SemulajadiNatural

VeterinarVeterinary

Suplemen KesihatanHealth Supplements

PreskripsiPrescription

Bukan PreskripsiNon-prescription

SemulajadiNatural

VeterinarVeterinary

Suplemen KesihatanHealth Supplements

24%

9%

28%

36%

3%2011

35

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 7 : Bilangan Produk yang Dibatal Mengikut Kategori Produk (2007-2011)Figure 7 : Number of Products Cancelled Based on Product Category (2007-2011)

d) Bilangan Produk yang Dibatal / Digantung

Pada tahun 2011, Rajah 7 menunjukkan terdapat penurunan dalam bilangan produk yang dibatalkan bagi semua kategori produk berbanding tahun-tahun sebelumnya. Terdapat 12 produk semulajadi yang dibatalkan pada tahun 2011 yang sebahagian besarnya disebabkan oleh isu campur palsu.

Dengan merujuk kepada Rajah 8, 29 yang terdiri daripada 15 produk preskripsi dan 14 produk semulajadi produk telah digantung pendaftaran. Alasan penggantungan termasuklah kegagalan mengemukakan laporan kajian bioekuivalens dalam tempoh yang ditetapkan bagi produk preskripsi dan status pengilang tempatan lemah bagi produk semulajadi.

d) Cancelled and Suspended Products

In 2011, Figure 7 shows a reduction in the number of cancelled products for all categories as compared to the previous years. There were 12 natural products cancelled for the year 2011 mainly due to the adulteration issue.

Based on Figure 8, 29 products consisting of 15 prescription products and 14 natural products were suspended. Reasons for suspension of products included failure to submit bioequivalence report within a specified time frame for prescription products and poor status of local manufacturers for natural products.

20

0

40

60

80

100

2007

0 264

0 0

2008

9015

780 0

2009

Tahun/Year

Bila

ngan

/Num

ber

s

9 1140

0

2010

140

4900 0

2011

0 012

0 0

PreskripsiPrescription

Bukan PreskripsiNon-prescription

SemulajadiNatural

VeterinarVeterinary

Suplemen KesihatanHealth Supplements

36

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pendaftaran Produk (Sambungan)Product Registration (Continued)

Rajah 8 : Bilangan Produk yang Digantung Mengikut Kategori Produk (2007-2011)Figure 8 : Number of Products Suspended Based on Product Category (2007-2011)

20

0

40

60

80

100

120

2007

0 0 0 0 0

2008

118

1 0 0 0

2009

Tahun/Year

Bila

ngan

/Num

ber

s

30 3 0

2010

120 2 00 0

2011

150

140 0

PreskripsiPrescription

Bukan PreskripsiNon-prescription

SemulajadiNatural

VeterinarVeterinary

Suplemen KesihatanHealth Supplements

e) Sumber Utama Produk Berdaftar

Rajah 9, 10 dan 11 menunjukkan peratusan produk berdaftar mengikut sumber negara pada tahun 2011. Secara keseluruhan, produk tempatan merupakan sumber utama bagi produk berdaftar. Walau bagaimanapun, negara China kekal sebagai sumber utama bagi produk semulajadi pada tahun 2011 sebagaimana ditunjukkan dalam Rajah 11.

e) Main Source of Registered Products

Figure 9, 10 and 11 showed the percentage of registered products based on source countries in 2011. Overall, local products were the main sources of registered products. However, China remained as the main source of natural products in 2011; as shown in Figure 11.

37

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 9 : Peratusan Produk Preskripsi Berdaftar Mengikut Sumber Negara 2011Figure 9 : Percentage of Registered Prescription Products Based on Source Countries 2011

Rajah 10 : Peratusan Produk Bukan Preskripsi Berdaftar Mengikut Sumber Negara 2011Figure 10 : Percentage of Registered Non Prescription Products Based on Source Countries 2011

India

Jerman

Amerika Syarikat

Thailand

Perancis

Kanada

United Kingdom

Itali

Malaysia

Lain-lain

12%

6%

4%

4%

3%3%

3%

28%

33%

4%

2011

Amerika Syarikat

Australia

Thailand

Jerman

United Kingdom

India

Indonesia

New Zealand

Malaysia

Lain-lain

14%

6%

4%

2%3%

2%2%

14%

49%

4%

2011

38

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pendaftaran Produk (Sambungan)Product Registration (Continued)

Rajah 11 : Peratusan Produk Semulajadi Berdaftar Mengikut Sumber Negara 2011Figure 11 : Percentage of Registered Natural Products Based on Source Countries 2011

Malaysia

Cina

Amerika Syarikat

Taiwan

India

Indonesia

Australia

New Zealand

Lain-lain

15%

69%

2%

1%1%

4%2%

2%

4%

2011

f) Aktiviti-aktiviti Lain yang Berkaitan dengan Pendaftaran Produk

i) P e n g e l u a r a n S i j i l P r o d u k Farmaseutikal

Rajah 12 menunjukkan sejumlah 14,607 Sijil Produk Farmaseutikal telah dikeluarkan kepada pemohon antara tahun 2007 hingga 2011. Dari jumlah 2,561 Sijil Produk Farmaseutikal yang telah dikeluarkan pada tahun 2011, 11% adalah bagi pengeksportan ke Singapura. Rajah 13 menunjukkan pecahan peratusan bagi Negara ASEAN lain dan juga majoriti 37% untuk negara-negara lain.

f) Other Act iv i t ies Related to Product Registration

i) Issuance of Certificate of Pharmaceutical Products (CPP)

Figure 12 shows a total of 14,607 Certificates of Pharmaceutical products (CPP) being issued to applicants from 2007 till 2011. From the 2,561 certificates issued in 2011, 11% were for exportation of products to Singapore. Figure 13 showed the percentage for other ASEAN countries and also a majority of 37% for other countries.

39

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 12 : Bilangan Sijil Produk farmaseutikal yang Dikeluarkan(2007-2011)Figure 12 : Number of Certificate of Pharmaceutical Products Issued (2007-2011)

Rajah 13 : Pengeluaran Sijil Produk Farmaseutikal ke Negara-negara Utama 2011Figure 13 : Issuance of Certificate of Pharmaceutical Product 2011

Singapura

Brunei

Vietnam

Indonesia

Kemboja

Myanmar

Cina

Hong Kong

Sri Lanka

Macau

Lain-lain

11%

8%

4%

5%

6%

4%6%4%

37%

9%

6%

2011

500

0

1,000

1,500

2,000

2,500

3,000

3,500

2007 2008 2009

Tahun/Year

Bila

ngan

/Num

ber

s

2010 2011

3,1943,052 3,059

2,7412,561

40

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pendaftaran Produk (Sambungan)Product Registration (Continued)

ii) Pembaharuan Pendaftaran Produk

Bagi setiap produk berdaftar di Malaysia, status pendaftaran perlu diperbaharui setiap lima (5) tahun. Permohonan pembaharuan pendaftaran produk perlu dikemukakan oleh pemohon sekurang-kurangnya enam (6) bulan sebelum tarikh luput pendaftaran. Rajah 14 menunjukkan sebanyak 3,876 permohonan pembaharuan pendaftaran telah diluluskan pada tahun 2011.

Rajah 15 menunjukkan pecahan kategori

produk yang telah diperbaharui pendaftaran bagi tahun 2011. Lebih daripada 50% daripada jumlah keseluruhannya adalah meliputi kategori produk komplementari yang terdiri daripada produk semulajadi dan juga suplemen kesihatan. Bilangan permohonan pembaharuan bagi produk preskripsi dan bukan preskripsi adalah lebih kurang sama iaitu 25% dan 22% masing-masing.

ii) Renewal of Product Registration

For every registered product in Malaysia, the registration status has to be renewed in every five (5) years. Renewal Applications should be submitted by applicants at least six (6) months before the registration expires. Figure 14 shows that 3,876 applications for the renewal of product registration had been approved in 2011.

Figure 15 il lustrated the breakdown of product categories that had been renewed for registration in 2011. More than 50% of the total renewals consisted of complimentary products such as natural products and health supplements. The percentage of renewal applications for prescription and non-prescription products was rather similar with 25% and 22% respectively.

Rajah 14 : Permohonan Pembaharuan Pendaftaran Produk (2007-2011)Figure 14 : Application for the Renewal Product Registration (2007-2011)

500

0

1,000

1,500

2,000

2,500

3,000

3,500

4,000

2007 2008 2009

Tahun/Year

Bila

ngan

/Num

ber

s

2010 2011

3,1363,284

2,9303,166

3,876

41

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 15 : Kategori Produk bagi Pembaharuan Pendaftaran 2011Figure 15 : Registration Renewal Based on Product Category 2011

PreskripsiPrescription

Bukan PreskripsiNon-prescription

KomplementariComplementary

2011

25%

53%

22%

iii) Pertukaran Pemegang Pendaftaran Produk

Rajah 16 menunjukkan bilangan permohonan pertukaran pemegang pendaftaran yang terendah bagi tahun 2011 berbanding dengan beberapa tahun sebelumnya. Jumlah permohonan yang diluluskan adalah separuh daripada jumlah yang direkodkan pada tahun 2007. Berdasarkan jumlah keseluruhan pada tahun 2011, 58% adalah terdiri daripada permohonan yang melibatkan kategori produk preskripsi, disusuli dengan produk semulajadi sebanyak 25% dan 16% bagi produk bukan preskripsi.

iii) Change of Product Regist rat ion Holder

As shown in Figure 16, the lowest number of application for the change of product registration holder was recorded in 2011 compared to previous years. The total number of applications approved had reduced to about half of the figure reported in 2007. From the total number of applications in 2011, 58% were prescription products, followed by 25% for natural products and 16% non-prescription products.

42

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pendaftaran Produk (Sambungan)Product Registration (Continued)

Rajah 16 : Permohonan Pertukaran Pemegang Pendaftaran Produk (2007-2011)Figure 16 : Application for Change of Product Registration Holder (2007-2011)

iv) Verifikasi Status Pendaftaran Produk bagi Aktiviti Penguatkuasaan

Antara aktivit i Bahagian Penguatkuasa Farmasi adalah penguatkuasaan terhadap peraturan-peraturan di bawah Peraturan Kawalan Dadah dan Kosmetik 1984. Produk-produk yang dirampas akan disahkan status pendaftaran oleh BPFK sebelum tindakan undang-undang diambil.

Rajah 17 menunjukkan jumlah verifikasi status pendaftaran produk bagi tempoh 2007 hingga 2011. Berbanding dengan tahun sebelumnya, jumlah pengesahan status pendaftaran bagi tahun 2011 didapati menurun dengan lebih kurang 4,000 verifikasi. Merujuk kepada Rajah 18, pertanyaan verifikasi yang paling tinggi adalah daripada Cawangan Penguatkuasa Negeri Johor iaitu sebanyak 32%. Manakala bagi cawangan di negeri Pahang, Perlis, Terengganu dan Wilayah Persekutuan Labuan, masing-masing menyumbang kepada 1% dari jumlah keseluruhannya.

iv) Product Registration Status Verification for Enforcement Activities

The registration status of products seized by the Pharmacy Enforcement Division under the Control of Drugs and Cosmetics Regulations 1984 would require verification by NPCB before any legal action is taken.

Figure 17 shows the number of registration status verified from 2007 til l 2011. As compared to previous year, the number of registration status verified had reduced about 4,000 verifications in 2011. With reference to Figure 18, the most number of verification requests was from the Johor State Pharmacy Enforcement Division with 32% while other branches in Pahang, Perlis, Terengganu and Labuan contributed to 1% each of the overall number of verifications.

Bilangan/Numbers

Tahu

n/Ye

ar

2011 275

2010 387

2009 462

2008 358

2007 541

0 100 200 300 400 500 600

43

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 17 : Verifikasi Status Pendaftaran Produk (2007-2011)Figure 17 : Product Registration Status Verification (2007-2011)

Rajah 18 : Taburan Verifikasi Status Pendaftaran Produk Mengikut Cawangan Penguatkuasa Farmasi Negeri 2011Figure 18 : Distribution of Product Registration Status Verification Based on State Pharmacy Enforcement Division 2011

Bilangan/Numbers

Tahu

n/Ye

ar

2011 6,880

2010 10,983

2009 9,339

2008 7,926

2007 4,216

0 2,000 4,000 6,000 8,000 10,000 12,000

Johor

Kedah

Kelantan

Melaka

Negeri Sembilan

Pahang

Perak

Perlis

Pulau Pinang

Selangor

Terengganu

Sabah

Sarawak

WP Kuala Lumpur

WP Labuan

6% 32%

12%

4%5%

3%

4%4%

13%

7%6%

1%

1%1%

1%

2011

44

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Mukasurat ini sengaja dibiarkan kosong.This page was intentionally left blank.

PENILAIAN PROTOKOL ANALISA DAN DATA VALIDASI

EVALUATION OF PROTOCOL ANALYSIS AND VALIDATION DATA

45

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

46

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Penilaian Protokol Analisa dan Data ValidasiEvaluation Of Protocol Analysis and Validation Data

Penilaian protokol analisa dan data validasi merupakan aktiviti yang penting dalam memastikan keselamatan dan kualiti produk. Ia dijalankan untuk memastikan bahawa kaedah yang digunakan dalam pengujian sampel adalah sesuai.

Rajah 19 menunjukkan jumlah protokol analisa dan data validasi yang dinilai dari tahun 2007 hingga 2011. Pada tahun 2008, terdapat perubahan drastik bagi jumlah protokol analisa dan data validasi yang dinilai. Ini berikutan daripada pertukaran kaedah pendaftaran produk farmaseutikal daripada pengujian sampel pra-pendaftaran kepada penilaian protokol analisa. Sebelum ini, hanya penilaian protokol analisa sahaja akan dijalankan sebelum pengujian.

Selain itu, juga terdapat penurunan jumlah data validasi yang dinilai pada tahun 2011. Tidak dapat dinafikan, ia berkemungkinan besar berikutan penaiktarafan sistem atas talian BPFK iaitu QUEST2 kepada QUEST3 di mana masa diperlukan untuk mengadaptasi sistem baru yang dibangunkan.

Evaluation of protocol analysis and validation data is crucial in ensuring the quality and safety of products. The evaluation of protocol analysis ensures that the methods used in sample testings are suitable.

Figure 19 shows the number of protocol analysis and analytical method validation data evaluated from 2007 till 2011. In 2008, there was a drastic change in the number of protocol analysis and protocol validation evaluated. This was due to the procedural review whereby testing of pre-registration samples for pharmaceuticals was replaced by evaluation of analytical method validation data. Previously, only evaluation of protocol of analysis was carried out prior to pre-registration testing.

Moreover, the number of analytical method validation data showed a slight decrease in 2011. This was probably due to the system upgrade from QUEST2 to QUEST3 whereby a transition period was needed to adapt to the new system.

Rajah 19 : Penilaian Protokol Analisia dan Data Validasi (2007 – 2011)Figure 19 : Evaluation of Protocol Analysis and Analytical Method Validation Data (2007 – 2011)

500

0

1,000

1,500

2,000

2,500

2007

1,24

3

576

2008

460

1,93

9

2009

Tahun/Year

Bila

ngan

/Num

ber

s

76

2,23

3

2010

5

1,82

0

2011

2

1.61

2

Protokol AnalisaProtocol Analysis

Data ValidasiValdiaoon Data

PENGUJIAN SAMPELSAMPLE TESTING

47

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

48

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pengujian SampelSample Testing

Pengujian sampel dijalankan untuk memastikan keselamatan dan kualiti produk. Pengujian dijalankan berpandukan spesifikasi farmakopia-farmakopia antarabangsa, prosedur dalaman BPFK dan protokol analisa pengilang yang telah diluluskan. Produk-produk yang diuji adalah sampel pendaftaran, pengawasan, aduan, Adverse Drug Report (ADR) dan juga sampel dari Cawangan Penguatkuasa Farmasi (CPF) yang disyaki mengandungi bahan campurpalsu. Rajah 20 menunjukkan kategori-kategori sampel yang diterima untuk pengujian pada tahun 2011.

Sample testing is carried out to ensure the quality and safety of the product. These tests are conducted based on international pharmacopoeia specifications, internal procedures as well as approved protocol specifications. The samples for testing were from registration, surveillance, complaint, Adverse Drug Report (ADR) and adulterated samples from Pharmacy Enforcement Division (CPF). Figure 20 shows the different categories of samples received for testing in 2011.

Rajah 20 : Jenis-jenis Sampel Mengikut Kategori, 2011Figure 20 : Types of Samples Received for Testing in 2011 by Categories

PENDAFTARANREGISTRATION

• Preskripsi Prescription• Bukan preskripsi Non-prescription• Semulajadi Natural

SURVEILANSSURVEILLANCE

• Preskripsi Prescription• Bukan preskripsi Non-prescription• Semulajadi Natural• Kosmetik Cosmetic• Veterinar Veterinary

CPF • Preskripsi Prescription• Bukan preskripsi Non-prescription• Semulajadi Natural• Kosmetik Cosmetic

ADUAN DAN ADRCOMPLAINT & ADR

• Preskripsi Prescription• Bukan preskripsi Non-prescription• Semulajadi Natural• Kosmetik Cosmetic• Veterinar Veterinary

LAIN-LAINOTHERS

• Preskripsi Prescription• Bukan preskripsi Non-prescription• Semulajadi Natural• Kosmetik Cosmetic• Veterinar Veterinary

49

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 21 : Jumlah Sampel yang Diterima Mengikut Kategori (2007 – 2011)Figure 21 : Number of Samples Received Based on Category (2007 – 2011)

Rajah 21 menunjukkan jumlah sampel yang diterima mengikut kategori bagi tahun 2007 hingga 2011. Pada tahun 2011, sejumlah 3,027 sampel telah diterima untuk pengujian berbanding 3,722 sampel pada tahun 2010. Faktor-faktor yang menyebabkan penurunan ini adalah seperti berikut:

i) Pengujian sampel farmaseutikal pra-pendaftaran telah digantikan dengan penilaian data validasi dan juga pengujian sampel pos-pendaftaran pada tahun 2008. Walau bagaimanapun, pengujian sampel pra-pendaftaran produk semulajadi masih lagi diteruskan memandangkan jumlah kegagalan produk semulajadi masih tinggi.

ii) Sampel daripada semua Cawangan Penguatkuasa Farmasi (CPF) kecuali CPF Kuala Lumpur dan CPF Selangor telah dihantar ke makmal forensik Bahagian Perkhidmatan Farmasi (BPF) bagi tujuan penyaringan. BPFK hanya menerima sampel dari semua CPF yang mana keputusan pengujian digunakan sebagai bukti mahkamah.

Figure 21 shows the breakdown of the samples received according to different categories. In 2011, a total of 3,027 samples were received for testing as compared to 3,722 samples in 2010. The decline was due to the following factors:

i) Pre-registration testings of pharmaceutical samples were replaced by the evaluation of analytical method validation data and post-registration testing in year 2008. However, pre-registration testing of natural products was continued due to the significantly high failure rate of natural product samples.

ii) Samples from all State Pharmacy Enforcement Divisions (CPF) except CPF Kuala Lumpur and CPF Selangor were sent to the Forensic Laboratory of Pharmaceutical Services Division for screening purposes. NPCB would only receive sample from any CPF if the result of the analysis was to be used as evidence in court.

500

0

1,000

1,500

2,000

2,500

PendaftaranRegistration

2,07

61,

487

1,11

674

860

7

PengawasanSurveillance

2,29

42,

296

2,23

62,

190

2,02

6

AduanComplaints

Kategori/Category

Bila

ngan

/Num

ber

s

149

132

103

116

83

ADR

0 0 0 0 68

CPFEnforcement

268 40

81,

099

660

212

Lain-�lainOthers

7 53 0 8 31

2007

2008

2009

2010

2011

50

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pengujian Sampel (Sambungan)Sample Testing (Continued)

Pengujian Sampel

Rajah 22 menunjukkan jumlah sampel yang diuji mengikut kategori sampel. Pada tahun 2011, sebanyak 3,143 sampel telah diuji berbanding 4,371 sampel pada tahun 2010, iaitu penurunan sebanyak 28%. Penurunan jumlah beberapa kategori sampel yang diterima untuk pengujian telah menyumbang kepada penurunan jumlah sampel yang diuji pada tahun 2011.

Sample Testing

Figure 22 shows the breakdown of samples tested according to sample categories. In 2011, a total of 3,143 samples were tested. This was a reduction of 28% from 4,371 samples in 2010. The reduction in the number of samples received had indeed contributed to the decrease in number of samples tested in 2011.

Rajah 22 : Jumlah sampel yang diuji mengikut kategori (2007 – 2011)Figure 22 : Number of samples tested based on category (2007 – 2011)

Jadual 3 : Bilangan sampel yang tidak menepati spesifikasi, 2011Table 3 : Number of samples with out of specification result, 2011

500

0

1,000

1,500

2,000

2,500

3,000

PendaftaranRegistration

2,12

81,

640

1,21

786

954

6

PengawasanSurveillance

2,76

12,

099

2,13

52,

491

2,03

8

AduanComplaints

Kategori/Category

Bila

ngan

/Num

ber

s

155

122

129

114

97

ADR

0 0 0 0 39

CPFEnforcement

270 36

977

5 889

361

Lain-�lainOthers

8 3 3 8 62

2007

2008

2009

2010

2011

Bil. Diuji Bil. Gagal % Gagal Samples Tested Failed Samples % Failed

Sampel Preskripsi Prescription 3 1 33.3 Pendaftaran ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Registration Bukan Preskripsi Non-Prescription 1 1 100 Sample ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Semulajadi Natural 542 38 7 –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Jumlah Total 546 40 7.33% –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Sampel Preskripsi Prescription 483 73 15.1 Pengawasan ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Surveillance Bukan Preskripsi Non-Prescription 314 60 19.1 Sample ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Semulajadi Natural 543 64 11.8 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Kosmetik Cosmetics 698 40 5.73 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Veterinari Veterinary 0 0 0 –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Jumlah Total 2,038 237 11.63% ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

51

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Bil. Diuji Bil. Gagal % Gagal Samples Tested Failed Samples % Failed

Sampel Aduan Preskripsi Prescription 23 4 17.4 Complaint Sample ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Bukan Preskripsi Non-Prescription 18 6 33.3 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Semulajadi Natural 9 7 77.8 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Kosmetik Cosmetics 47 12 25.5 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Veterinari Veterinary 0 0 0 –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Jumlah Total 97 29 29.9% –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– CPF Preskripsi Prescription 1 1 100 Enforcement ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Bukan Preskripsi Non-Prescription 4 0 0 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Semulajadi Natural 343 243 70.8 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Kosmetik Cosmetics 13 2 15.4 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Lain-lain Veterinary 0 0 0 –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Jumlah Total 361 246 68.14% –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Sampel ADR Preskripsi Prescription 4 0 0 ADR Sample ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Bukan Preskripsi Non-Prescription 5 2 40 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Semulajadi Natural 27 8 29.6 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Kosmetik Cosmetics 3 0 0 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Veterinari Veterinary 0 0 0 –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Jumlah Total 39 10 25.64% –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Lain-lain 62 14 22.58% Others –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Jumlah Total 3,143 576 18.33% ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Jadual 3 menunjukkan 18.33% sampel yang diuji didapati tidak menepati spesifikasi. Kebanyakannya adalah sampel yang diterima dari CPF dan juga daripada aktiviti farmakovigilans yang dijalankan oleh Pusat Pasca Pendaftaran Produk.

Table 3 shows that 18.33% of the samples tested failed to meet the required specification. Most of these samples were received from CPF as well as samples from pharmacovigilance activities carried out by the Centre for Post Registration of Products.

52

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pengujian Sampel (Sambungan)Sample Testing (Continued)

Rajah 23 : Bilangan sampel yang diuji dan dikesan bahan campurpalsu (2007 – 2011)Figure 23 : Number of natural (traditional) samples tested and adulterated (2007 – 2011)

Rajah 24 : Bilangan sampel dikesan positif bahan campurpalsu mengikut kategori (2011)Figure 24 : Number of adulterated samples by category (2011)

300

0

600

900

1,200

1,500

2007

Tahun/Year

Bila

ngan

/Num

ber

s

Bilangan sampelyang diujiNumber of samples tested

2007 2007 2007 2007

Bilangan sampel yang dikesan bahancampurpalsuNumber of adulterated samples

114

728

138

593

184

1,203

308

1,358

230

853

CPFEnforcement

PendaftaranRegistration

PengawasanSurveillance

12%

86%

2%

2011

Rajah 23 menujukkan sejumlah 853 sampel semulajadi telah disaring untuk pengesanan bahan campur palsu pada tahun 2011 dan 26.9% daripadanya iaitu 230 sampel didapati mengandungi bahan campur palsu.

Figure 23 shows that a total of 853 natural samples were screened for adulterants in 2011 where 26.9% or 230 samples were found to be adulterated.

53

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Jadual 4 : Bahan-bahan Campurpalsu yang Dikesan di Dalam Sampel Produk SemulajadiTable 4 : List of Adulterants Detected in Natural Product Samples

Sampel Sampel Bahan-bahan Campurpalsu Sampel CPF Pengawasan Pendaftaran Adulterants CPF Sample Surveillance Sample Registration Sample

Ubat ED / ED Drugs1 72.34% - -––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Steroid / Steroids2 10.42% 6.21% 2.63%––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– NSAIDs3 3.70% - -––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Antihistamin / Antihistamines 9.09% 11.25% 21.43%––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Antidiabetik / Antidiabetics - 8.33% -––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Agen Pelangsing / Slimming Agents 40.17% 1.56% 3.70%––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Lain-lain / Others4 5.88% 6.90% -–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

1 sildenafil, tadalafil, sildenafil analogs (acetildenafil, hydroxyhomosildenafil, homosildenafil, thiosildenafil, hydroxythiohomosildenafil, thiohomosildenafil, thiodimethylsildenafil), acetildenafil analog (nor-acetildenafil) dan tadalafil analog (aminotadalafil)

2 betamethasone, dexamethasone, prednisolone, prednisone, cortisone

3 diclofenac, mefenamic acid, ketoprofen, phenylbutazone

4 statins, niacinamide, phenolphthalein, psilocaine, cimetidine

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Jadual 4 menunjukkan senarai bahan campur palsu yang dikesan dalam sampel produk semulajadi pada tahun 2011 dan kebanyakan bahan campur palsu ini menpunyai indikasi berikut:

- Untuk kesihatan lelaki- Untuk kesakitan otot dan sendi- Untuk mengurangkan berat badan- Untuk batuk dan selsema

Piawai Rujukan

Bahan piawai rujukan digunakan sebagai bahan perbandingan untuk pengesahan dan kuantifikasi bagi sesuatu bahan yang diuji. Ia merupakan aspek yang penting dalam pengujian sampel. Unit Piawaian Rujukan ditubuhkan pada 1994 bagi menjalankan aktiviti-aktiviti yang melibatkan pembelian, pengeluaran, penyimpanan, pembekalan dan pengurusan bahan dan piawai rujukan.

Table 4 shows the list of adulterants detected in natural product samples in the year 2011. Majority of these adulterants have the following indications:

- For men’s health- For joint and muscle pain- For reduction/control of body weight- For cough and cold

Reference Standards

Reference standard is used as a measurement base for confirmation and quantification of substance during quality control testing. This is a critical element in sample testing. The Reference Standard Unit which was established in 1994 is responsible for all activities pertaining to procurement, production, storage, distribution and handling of reference materials and standards.

54

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pengujian Sampel (Sambungan)Sample Testing (Continued)

Selain daripada kegunaan dalam makmal BPFK, piawai rujukan tersebut juga dibekalkan kepada agensi-agensi kerajaan dan pengilang farmaseutikal di Malaysia. Rajah 25 menunjukkan pembekalan piawai rujukan telah meningkat pada tahun 2011 berbanding dengan tahun 2010. Peningkatan pembekalan piawai rujukan ke makmal BPFK adalah disebabkan oleh pertambahan inventori piawai rujukan primer serta kesanggupan pengilang farmaseutikal menghantar piawai rujukan kerja untuk kegunaan makmal bagi menjalankan pengujian produk-produk berkenaan.

Apart from utilisation in NPCB laboratory, these reference standards were also supplied to other government agencies and pharmaceutical industries in Malaysia. Figure 25 shows an increased supply of reference standards in 2011 compared to 2010. The increment in the supply of reference standards to NPCB laboratory was due to an increase in the primary standards inventory as well as the willingness of the manufacturers in sending their reference / working standards for the testing of their products.

Rajah 25 : Bekalan Piawai Rujukan (2007 – 2011)Figure 25 : Supply of Reference Standards (2007 – 2011)

Piawai Rujukan kerja / sekunder BPFK disediakan dengan cara pemiawaian Analytical Reference Material menggunakan piawai rujukan primer sebagai rujukan. Selain itu, BPFK juga bekerjasama dengan negara-negara ASEAN yang lain untuk menghasilkan Piawai Rujukan ASEAN. Rajah 26 menunjukkan bilangan piawai rujukan ASEAN dan BPFK yang disediakan bagi tahun 2007 hingga 2011. Jumlah piawai rujukan yang dihasilkan pada tahun 2011 menurun berbanding dengan tahun 2010. Ini disebabkan oleh kekurangan piawai rujukan primer dan terdapat sesetengah tatacara pemiawaian yang menggunakan bahan kimia berbahaya seperti dioxane. Bagi mengatasi situasi ini, BPFK telah merancang untuk membeli lebih banyak piawai rujukan primer pada tahun 2012 supaya proses pemiawaian dapat berjalan dengan lancar.

NPCB Working / Secondary Standards are produced by standardisation of certified reference materials against primary standards. Apart from this, the NPCB also collaborates with other ASEAN countries to produce ASEAN Reference Standards. Figure 26 shows the number of ASEAN and NPCB reference standards produced from 2007 till 2011. There was a decrease in the production of reference standards in 2011 as compared to the previous year. This was caused by the unavailability of primary reference standards as well as standardisation methods involving the use of dangerous chemicals such as dioxane. To overcome this situation, the NPCB had planned to purchase more primary standards in 2012 to ensure that more standardisations could be carried out.

500

0

1,000

1,500

2,000

2,500

3,000

3,500

2007

248

3,45

1

2008

218

2,72

6

2009

Tahun/Year

Bila

ngan

/Num

ber

s

350

2,14

2

2010

153

2,00

1

2011

81

2,07

1

508

527

372

250 36

8Agensi KerajaanGovernment Agencies

SwastaPrivate Industries

Makmal BPFKNPCB Laboratory

55

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 26 : Bilangan Piawai Rujukan yang Disediakan (ASEAN dan BPFK, 2007-2011)Figure 26 : Number of Reference Standards Produced (ASEAN and NPCB, 2007-2011)

Bilangan/Numbers

Tahu

n/Ye

ar

2011 107

2010 144

2009 109

2008 126

2007 96

0 30 60 90 120 150

56

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Mukasurat ini sengaja dibiarkan kosong.This page was intentionally left blank.

PEMERIKSAAN PREMISINSPECTIONS OF PREMISES

57

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

58

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pemeriksaan PremisInspections of Premises

Pemeriksaan premis dijalankan bagi memastikan pematuhan terhadap keperluan Amalan Perkilangan Baik (APB), Amalan Pengedaran Baik (AEB) atau Amalan Makmal Baik (GLP).

Pemeriksaan Amalan Perkilangan Baik (APB)

Rajah 27 menunjukkan bilangan pemeriksaan APB yang telah dijalankan dari tahun 2007 hingga 2011. Sebanyak 303 pemeriksaan APB telah dijalankan pada tahun 2011. Pemeriksaan APB yang dijalankan adalah merangkumi pemeriksaan rutin dan pemeriksaan bukan rutin. Rajah 28 menunjukkan sebanyak 67 pemeriksaan telah dijalankan ke atas premis farmaseutikal, 114 premis tradisional, 107 premis kosmetik dan 15 premis-premis lain seperti premis pengilang veterinary serta Bahan Aktif Farmaseutikal (API).

Inspections of premises are conducted to ensure the compliance towards the requirements of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) or Good Laboratory Practice (GLP).

G o o d M a n u f a c t u r i n g P r a c t i c e ( G M P ) Inspections

Figure 27 shows the number of GMP inspections conducted from 2007 till 2011. A total of 303 GMP inspections were carried out in 2011. These GMP inspections consisted of both routine inspections and non-routine inspections. Figure 28 shows that inspections were conducted on 67 pharmaceutical product manufacturers, 114 traditional product manufacturers, 107 cosmetics manufacturers and 15 inspections on other premises such as veterinary product manufacturers and Active Pharmaceutical Ingredient (API).

Rajah 27 : Bilangan Pemeriksaan APB, 2005 – 2011Figure 27 : Number of GMP Inspections, 2005 – 2011

30

0

60

90

120

150

2007

51

121

2008

46

111

2009

Tahun/Year

Bila

ngan

/Num

ber

s

50

75

2010

52

85

2011

67

107

144

140

109

100

114

FarmaseutikalPharmaceutical

TradisionalTraditional

KosmetikCosmetics

Lain-lainOthers

5 9 12

7

15

59

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Penilaian Pelan Susun Atur Premis Pengilang

Sebanyak 25 pelan susun atur premis pengilang telah dinilai dan diluluskan pada tahun 2011 untuk mematuhi keperluan APB semasa. Pelan susun atur yang telah diluluskan tersebut terdiri daripada 3 premis farmaseutikal, 10 premis tradisional, 5 premis kosmetik, 4 premis veterinar dan 3 premis lain-lain.

Pemeriksaan Amalan Pengedaran Baik (AEB)

BPFK telah memperkenalkan Garis Panduan AEB bermula Januari 2011. Pelaksanaan garis panduan ini adalah bagi menggantikan penggunaan Garis Panduan Amalan Penstoran Baik (ASB) yang diperkenalkan pada tahun 1995. Garis panduan ini adalah selaras dengan perkembangan keperluan regulatori semasa di mana kawalan terhadap keadaan penstoran produk ubat berdaftar dan kosmetik bernotifikasi bukan sahaja melibatkan aspek penstoran sahaja, tetapi turut meliputi proses pengedaran sehingga ke pengguna akhir. Proses pengedaran produk-produk ubat berdaftar dan kosmetik bernotifikasi berpotensi terdedah kepada risiko yang tidak diingini sekiranya aspek kualiti tidak dikekalkan sepanjang proses penstoran dan pengedaran.

Sepanjang tahun 2011, pemeriksaan AEB telah dijalankan ke atas sebanyak 50 premis pengimport

Evaluation of Manufacturer’s Suggested Layout Plan

In 2011, 25 layouts from manufacturers had been evaluated and approved by NPCB to ensure that the renovation and development of new manufacturing facilities comply with the current GMP requirements. These layouts included 3 pharmaceutical premises, 10 traditional premises, 5 cosmetic premises, 4 veterinary premises and 3 other premises.

Good Distribution Practice (GDP) Inspections

The NPCB had introduced the Guidelines on GDP since January 2011. This guideline had replaced the Guidelines on Good Storage Practices (GSP) which was introduced in 1995. The introduction of GDP guidelines was in line with the development of current regulatory requirements whereby regulatory control over the storage condition of registered pharmaceutical products and notified cosmetics shall also include distribution before they reach the consumers. The quality of registered pharmaceutical products and notified cosmetics might be compromised if the storage condition and distribution process is not proper.

In 2011, GPD inspections were conducted on 50 importer or wholesaler premises in Kuala Lumpur

Rajah 28 : Bilangan Pemeriksaan yang telah Dijalankan pada Tahun 2011Figure 28 : Number of Inspections Conducted in 2011

FarmaseutikalPharmaceutical

TradisionalTraditional

KosmetikCosmetics

Lain-lainOthers

22%(67)

39%(120)

34%(107)

5%(15)

2011

60

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Pemeriksaan Premis (Sambungan)Inspections of Premises (Continued)

atau pemborong di sekitar Kuala Lumpur dan Selangor. Pemeriksaan AEB di jangka akan berkembang pada masa akan datang sementara usaha-usaha dan langkah promosi terus giat dilaksanakan bagi meningkatkan kesedaran terhadap keperluan AEB.

Pemeriksaan Good Laboratory Practice (GLP)

Pada tahun 2011, BPFK telah melaksanakan pemeriksaan GLP seperti berikut:

i) Pra-pemeriksaan untuk memastikan Fasil it i Kajian mempunyai sumber dan kepakaran untuk menjalankan kajian GLP. Tiga (3) pra-pemeriksaan telah dijalankan di:

a) Herbal Medicine Research Centre (HMRC), Institut Penyelidikan Perubatan (IMR) pada 18 hingga 19 Januari 2011

b) Perbadanan Bioteknologi Melaka pada 17 hingga 18 Februari 2011

c) InfoKinetics Sdn. Bhd. pada 20 hingga 21 Julai 2011

ii) Pemeriksaan untuk menverifikasi komplians kepada GLP dan keperluan Program Pemantauan Pematuhan GLP BPFK. Tiga (3) pemeriksaan telah dijalankan di:

a) Environmental Technology Research Centre (ETRC), SIRIM Berhad pada 21, 24 dan 25 Januari 2011

b) Perbadanan Bioteknologi Melaka pada 9 hingga 11 Ogos 2011

c) IMR pada 27 hingga 29 Julai 2011

iii) Satu (1) Pemeriksaan Pengawasan dijalankan di ERTC, SIRIM pada 16 hingga 18 November 2011

iv) Pemeriksaan Luar Biasa untuk menverifikasi tindakan pembetulan yang telah diambil oleh pihak fasiliti kajian selepas pemeriksaan dijalankan. Dua (2) Pemeriksaan Luar Biasa telah dijalankan di:

a) ERTC, SIRIM pada 13 Januari 2011

b) Perbadanan Bioteknologi Melaka pada 27 April 2011

and Selangor. Such inspections will be expanded in the future as NPCB continues its efforts to promote GDP requirements to relevant parties.

Good Laboratory Practice (GLP) Inspection

In 2011, NPCB had conducted the following GLP inspections:

i) Pre-Inspections to verify that the Test Facility has the resources to undertake GLP studies. Three (3) pre-inspections were carried out at:

a) Herbal Medicine Research Centre (HMRC), Institute of Medical Research (IMR) on 18th till 19th Jan 2011

b) Melaka Biotechnology Corporation on 17th till 18th February 2011

c) InfoKinetics Sdn. Bhd. on 20th till 21th July 2011

ii) Inspection to verify compliance to the Principles of GLP and NPCB GLP Compliance Programme. Three (3) inspections were carried out at:

a) The Environmental Technology Research Centre (ETRC), SIRIM Berhad on 21st, 24th and 25th January 2011

b) Melaka Biotechnology Corporation on 9th till 11th August 2011

c) IMR on 27th till 29th July 2011

iii) One (1) Surveillance Inspection was carried out at ETRC, SIRIM on 16th till 18th November 2011

iv) Extraordinary Inspection to verify the corrective actions that had been made by the Test Facility after Pre-Inspection. Two (2) Extraordinary Inspections were carried out at:

a) ETRC, SIRIM on 13th January 2011

b) Melaka Biotechnology Corporation on 27th April 2011

61

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Pemeriksaan Pusat Kajian Bioekuvalens (BE)

Akreditasi pusat kajian BE tempatan akan berkuat kuasa pada tahun 2012. Oleh itu, Gap Analysis dijalankan untuk membantu pusat kajian BE tempatan bagi mengenal pasti kekurangan/kelemahan mereka dalam mendapat akreditasi. Semua pusat kajian BE tempatan yang terlibat dengan Gap Analysis perlu mengambil tindakan pembetulan yang sesuai untuk tujuan penambahbaikan.

BPFK telah menjalankan empat (4) pemeriksaan analisis ke atas Pusat Kajian BE tempatan pada tahun 2011 seperti berikut:

a) Pusat Pengajian Sains Farmasi, Universiti Sains Malaysia (USM)

b) Pusat Penyelidikan Dadah dan Ubat-ubatan, USM

c) Biopharmaceut ics and Pharmacokinet ics Laboratory, USM

d) University of Malaya Bioequivalence and Testing Centre (UBAT)

Pemeriksaan ini meliputi aspek klinikal yang mematuhi keperluan prinsip Good Clinical Practice (GCP) dan juga aspek bioanalitikal yang mematuhi keperluan prinsip Good Laboratory Practice (GLP).

Inspection on Bioequivalence (BE) Centres

The accreditation of local BE Centres will take effect in 2012. Therefore, Gap Analysis is done to assist local BE Centres in identifying their shortcomings/weaknesses in getting accreditated. All local BE Centres involved with the Gap Analysis should take the required corrective actions for improvement.

NPCB had conducted Gap Analysis to four (4) local bioequivalence centres in 2011. The BE centres involve were listed as below:

a) Pusat Pengajian Sains Farmasi, Universiti Sains Malaysia (USM)

b) Centre for Drug Research, USM

c) Biopharmaceut ics and Pharmacokinet ics Laboratory, USM

d) University of Malaya Bioequivalence And Testing Centre (UBAT)

The gap analysis was conducted based on Good Clinical Practice (GCP) for the clinical site and Good Laboratory Practice (GLP) principles for the bioanalytical site.

62

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Mukasurat ini sengaja dibiarkan kosong.This page was intentionally left blank.

PERLESENANLICENSING

63

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

64

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

PerlesenanLicensings

Pemprosesan Lesen

Pengeluaran Lesen Pengilang, Lesen Mengimport dan Lesen Pemborong Keluaran Berdaftar adalah berdasarkan peruntukan Peraturan 12 Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984 (Pindaan) 2006. Rajah 29 menunjukkan sebanyak 1,667 lesen telah dikeluarkan pada tahun 2011 yang terdiri daripada 255 Lesen Pengilang, 375 Lesen Mengimport dan 1,037 Lesen Pemborong. Ini merupakan satu peningkatan sebanyak 3.03% berbanding tahun 2010 di mana hanya 1,618 lesen dikeluarkan.

Senarai Keluaran (Tambahan) Lesen Pengilang/Mengimport

Sebanyak 578 permohonan untuk memasukkan keluaran berdaftar ke dalam senarai keluaran telah diproses sepanjang tahun 2011. Jumlah keluaran berdaftar yang terlibat adalah sebanyak 2,169. Senarai Keluaran (Tambahan) ini dikeluarkan berdasarkan permohonan yang dikemukakan apabila terdapat produk yang baru didaftarkan.

Penarikan Balik Lesen Pengilang

Di bawah Peraturan 17(1) Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984 (Pindaan) 2006,

Processing of Licenses

The issuance of Manufacturing License, Import License and Wholesaler License is in accordance to the Regulation 12 of the Control of Drugs and Cosmetics Regulations 1984 (Revised) 2006. Figure 29 shows a total of 1,667 licences being issued in 2011. They consisted of 255 Manufacturing Licences, 375 Import Licences and 1,037 Wholesaler Licences. This was an increment of 3.03% from the total number of 1,618 licences issued in 2010.

Additional Lists for Registered Products

A total of 578 applications consisted of 2,169 registered products for additional lists were processed in 2011. These additional lists were issued based on the applications submitted for newly registered products.

Revocation of Manufacturering Licence

Under the provisions of sub-regulation 17(1) of the Control of Drugs and Cosmetics Regulation 1984 (Revised) 2006, any Manufacturing Licence may be revoked. In 2011, a total of three (3) traditional product Manufacturering Licences were revoked due to adulteration issues.

Rajah 29 : Jumlah Lesen Pengilang, Mengimport dan Pemborong dikeluarkan (2007– 2011)Figure 29 : Number of Manufacturing License, Import License and Wholesaler’s License Issued (2007 – 2011)

200

0

400

600

800

1,000

1,200

2007

301

1,06

3

2008

257

1,08

9

2009

Tahun/Year

Bila

ngan

/Num

ber

s

255

955

2010

264

1,03

5

2011

255

1,03

7

576

397

358

319 37

5

PengilangManufacturer

MengimportImport

PemborongWholesaler

65

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

lesen pengilang keluaran berdaftar boleh ditarik balik. Pada tahun 2011, terdapat tiga (3) kes penarikan balik Lesen Pengilang produk tradisional kerana didapati mengilangkan produk yang dicampurpalsu.

Sijil Amalan Perkilangan Baik (APB)

Sijil APB dikeluarkan untuk tujuan pengeksportan keluaran berdaftar dan kosmetik bernotifikasi yang diki langkan oleh pengi lang tempatan sebagai pengesahan tahap pematuhan APB pengilang tersebut. Rajah 30 menunjukkan sebanyak 526 sijil APB telah dikeluarkan sepanjang tahun 2011. Pengurangan pengeluaran sijil APB berbanding tahun sebelumnya adalah berikutan implementasi penuh sistem notifikasi kosmetik di peringkat ASEAN oleh Indonesia dan Myanmar.

Pengeluaran Lesen Import Percubaan Klinikal (CTIL), Permit Mengilang Produk Tidak Berdaftar (CTX) dan Permohonan Variasi

Pada tahun 2011, BPFK telah menilai 82 protokol baru bagi percubaan klinikal di Malaysia untuk produk farmaseutikal, produk biologikal, produk bioteknologi, vaksin, herbal, supplemen kesihatan dan lain-lain. Selain itu, pusat ini juga telah menilai 12 produk tidak berdaftar yang dikilangkan di Malaysia untuk tujuan

G o o d M a n u f a c t u r i n g P r a c t i c e ( G M P ) Certificates

GMP certificates are issued for the purpose of exportation of locally manufactured registered products. They endorse local manufacturers’ compliances towards current GMP requirements. Figure 30 shows that a total of 526 GMP certificates were issued in 2011. The reduction in the number of GMP certificates issued as compared to the previous year was due to the full implementation of cosmetics notification system among ASEAN members by Indonesia and Myanmar.

Issuance of Clinical Trial Import Licence (CTIL), Clinical Trial Exemption (CTX) and Variation Application

In 2011, the NPCB had evaluated a total of 82 new applications to conduct clinical trials on pharmaceutical, biological, biotechnology, vaccine, herbal, health supplements products and others in Malaysia. Besides, this centre had also reviewed 12 CTX applications to manufacture unregistered products

Rajah 30 : Pengeluaran Sijil APB (2007 – 2011)Figure 30 : Issuance of GMP Certificates (2007 – 2011)

100

0

200

300

400

500

600

2007 2008 2009

Tahun/Year

Bila

ngan

/Num

ber

s

2010 2011

406

507536

603

526

66

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Perlesenan (Sambungan)Licensings (Continued)

kajian BE. Sebanyak 255 pemohonan variasi telah diproses pada tahun 2011. Ini meliputi tambahan kuantiti produk, tambahan pusat penyelidikan, tambahan atau penukaran pintu masuk pengimportan, penukaran pemohon, pemanjangan tempoh luput produk kajian, tambahan atau penukaran tapak pengilang / pembungkus, penukaran penyelidik utama, pembaharuan dan lain-lain. Rajah 31 menunjukkan sebanyak 224 CTIL, 12 CTX dan 255 kelulusan permohonan variasi telah dikeluarkan hasil daripada penilaian protokol di atas.

locally for BE study. There were also 255 variation applications being processed in year 2011. Among the variation applications received were additional quantity, additional trial sites, change or additional entry ports, manufacturer / repacker, change of investigator, renewal and others. Figure 31 shows that 224 CTIL, 12 CTX and 255 variations were issued as a result of the evaluations above.

Rajah 31 : Jumlah Permohonan Lesen Import Percubaan Klinikal (CTIL), Kebenaran Mengilang (CTX) dan Variasi (2007 – 2011)Figure 31 : Number of Application for Clinical Trial Import License (CTIL), Clinical Trial Exemption (CTX) and Variation (2007 – 2011)

50

0

100

150

200

250

300

350

400

2007

231

321

2008

268

351

2009

Tahun/Year

Bila

ngan

/Num

ber

s

208

343

2010

234

151

2011

224

255

2 4 2 6 12

Permohonan Lesen ImportPercubaan Klinikal (CTIL)Clinical Trial Import License (CTIL)

Permohonan KebenaranMengilang (CTX)Clinical Trial Exemption (CTX)

Permohonan VariasiVariation

Pemeriksaan GCP & GLPGCP & GLP Inspections

0 0 0 4 13

SURVEILANSSURVEILLANCE

67

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

68

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

SurveilansSurveillance

Objektif utama aktiviti surveilans di bawah Program Pengawasan Mutu Produk Berdaftar / Kosmetik Bernotifikasi adalah bagi memantau kualiti produk-produk berdaftar / bernotifikasi yang dipasarkan di Malaysia dan memastikan komplians terhadap spesifikasi atau piawaian yang telah ditetapkan oleh Kementerian Kesihatan Malaysia.

Persampelan Produk

Pada tahun 2011, sejumlah 3,284 produk telah berjaya disampel berbanding 2,897 produk pada tahun 2010. Ini merupakan peningkatan sebanyak 13.4%. Rajah 32 menunjukkan pencapaian aktiviti persampelan dari tahun 2007 hingga 2011. Pecahan kategori produk yang dipantau bagi tahun 2011 adalah seperti berikut: kosmetik, 1,751 (53.32%), produk semulajadi, 697 (21.23%), produk preskripsi, 524 (15.96%), produk bukan preskripsi, 232 (7.07%), dan produk suplemen kesihatan, 80 (2.44%).

The main objectives of surveillance activities under the Post-Marketing Surveillance Programme are to monitor the quality of registered products / notified cosmetics placed on the market and to ensure their compliance with the specifications or standards set by the Ministry of Health Malaysia.

Product Sampling

In 2011, a total of 3,284 products were successfully sampled compared to 2,897 products in 2010. This was an increase of 13.4%. Figure 32 shows the achievement for sampling activities from 2006 till 2011. The breakdown of product categories that were monitored in 2011 were as follows: cosmetics, 1,751 (53.32%), natural products, 697 (21.23%), prescription products, 524 (15.96%), non-prescription products, 232 (7.07%) and health supplements, 80 (2.44%).

Rajah 32 : Bilangan Produk yang Disampel (2007 - 2011)Figure 32 : Number of Products Sampled (2007 - 2011)

Pemantauan Kepatuhan Pelabelan

Kesemua produk yang disampel disemak pelabelannya bagi memastikan pematuhan kepada keperluan pelabelan seperti yang telah ditetapkan oleh PBKD. Dari jumlah 4,076 label produk yang disemak, sebanyak 1,521 (37%) amaran dan 44 (1%) arahan panggil balik telah dikeluarkan bagi produk yang tidak mematuhi keperluan pelabelan.

Labelling Compliance Monitoring

All products that had been sampled were checked to ensure compliance to the labeling requirements specified by the DCA. From a total of 4,076 product labels that had been inspected, 1,521 (37%) warnings and 44 (1%) recall instructions had been issued for products that did not comply with the labeling requirements.

Bilangan/Numbers

Tahu

n/Ye

ar

2011 3,284

2010 2,897

2009 2,656

2008 2,272

2007 2,538

0 500 1,000 1,500 2,000 2,500 3,000 3,500

69

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Jadual 5 : Keputusan Pemeriksaan Label / Sisip Bungkusan Mengikut Kategori Produk Bagi Tahun 2011Table 5 : Results of Inspection of the Label / Package Inserts by Product Category for 2011

JumlahKategori Produk Lulus Amaran Panggil Balik PemeriksaanProduct Category Pass Warning Recall Total Inspected

Preskripsi 1,013 (95.12%) 49 (4.6%) 3 (0.29%) 1,065Prescription

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Bukan Preskripsi 274 (88.97%) 34 (11.04%) 0 308Non-Prescription

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Suplemen Kesihatan 161 (79.31%) 39 (19.22%) 3 (1.48%) 203Health Supplement

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Produk Semulajadi 754 (89.66%) 49 (5.83%) 38 (4.52%) 841Natural Product

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Kosmetik 309 (18.63%) 1,350 (81.38%) 0 1,659Cosmetics

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––JUMLAH TOTAL 2,511 (61.61%) 1,521 (37.32%) 44 (1.09%) 4,076

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Keputusan Pengujian Makmal

Sejumlah 2,091 produk telah dianalisa oleh BPFK pada tahun 2011. Sebanyak 1,910 telah lulus ujian makmal manakala 185 produk telah gagal ujian makmal. Pecahan produk yang gagal ujian makmal mengikut kategori termasuk: 66 produk preskripsi, 45 produk semulajadi, 32 produk bukan preskripsi, 25 produk suplemen kesihatan dan 17 produk kosmetik. Rajah 33 menunjukkan keputusan pengujian produk dari tahun 2007 hingga 2011.

Laboratory Testing Results

A total of 2,091 products were analysed by NPCB in 2011. 1,910 products passed while the remaining 185 products failed the laboratory testings. A breakdown of products that failed laboratory testing by product categories included: 66 prescription products, 45 natural products, 32 non-prescription products, 25 health supplements and 17 cosmetics. Figure 33 shows the results of product testing from 2007 till 2011.

70

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Surveilans (Sambungan)Surveillance (Continued)

Rajah 33: Keputusan Pengujian Produk (2007-2011)Figure 33: Results of Product Testing (2007-2011)

Rajah 34 : Jenis-jenis kegagalan ujian makmal bagi produk-produk yang telah diuji pada tahun 2011Figure 34 : The types of failure for products tested in 2011

Tindakan susulan kegagalan uj ian makmal ini kemudiannya diambil berdasarkan tahap atau risiko kegagalan berkenaan. Rajah 34 menunjukkan jenis-jenis kegagalan ujian makmal manakala Rajah 35 pula menunjukkan analisis bagi bilangan kegagalan ujian untuk setiap produk yang diuji pada tahun 2011.

Following these results, actions were taken based on the level and risk of failure. Figure 34 shows the types of failures while Figure 35 shows the analysis of the number of failures for each product tested in 2011.

Bilangan Produk/Numbers of Products

Jeni

s K

egag

alan

/Typ

e o

f Fa

ilure

Physical ApperanceUniformity of Content

Deposition of Emitted DoseFriability

DissolutionPreservativesDegradation

DisintegrationAdulteration Screening

Uniformity of WeightHeavy Metal

Microbial ContaminationAssay

15

10

8

5

5

4

2

1

1

42

31

25

17

0 10 20 30 40

500

0

1,000

1,500

2,000

2,500

3,000

2007

232

2,56

3

2008

142

1,82

1

2009

Tahun/Year

Bila

ngan

/Num

ber

s

140

129

185

1,96

8

2010

1,11

5

2011

1,91

0

GagalFail

LulusPass

71

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 35 : Bilangan Kegagalan Ujian Bagi Setiap Produk yang Diuji pada Tahun 2011Figure 35 : Number of Failure for Each Product Tested in 2011

Tindakan Punitif

Sebanyak 88 arahan panggil balik telah dikeluarkan ke atas produk-produk yang gagal analisa makmal di mana produk ini memberikan risiko kesihatan terhadap pengguna. Satu (1) produk kategori semulajadi telah diarahkan panggil balik Tahap I atas sebab risiko kesihatan yang sangat tinggi di mana produk dikesan mengandungi paras merkuri yang tinggi, lima (5) produk telah diarahkan panggil balik Tahap II dan 82 arahan panggil balik Tahap III dikeluarkan untuk produk-produk yang didapati substandard yang menjurus kepada risiko kesihatan. Rajah 36 menunjukkan bilangan produk yang dipanggil balik mengikut tahap panggil balik.

Punitive Action

A total of 88 recall instructions had been issued to products that failed laboratory testing and posed health risk to consumers. One (1) natural product had been directed Degree I recall due to its high risk to consumers as the product was found to contain a high level of mercury, five (5) products had been directed Degree II recalls and 82 Degree III recalls directives were issued for products found substandard and might lead to health risk. Figure 36 shows the number of products that had been recalled according to the degree of recall.

1 ujian1 test

2 ujian2 test

3 ujian3 test

4 ujian4 test

5 ujian5 test

82%(132)

2%(4)14%

(22)

1% (1)1% (1)

2011

72

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Surveilans (Sambungan)Surveillance (Continued)

Rajah 36 : Panggil Balik Produk Mengikut Kategori Bagi Tahun 2011Figure 36 : Categories of Products Recall in 2011

Jadual 6 : Senarai Produk Yang Dibatalkan Pendaftaran / Notifikasi pada Tahun 2011Table 6 : List of Products Cancelled in 2011

Selain arahan panggil balik, sebanyak 41 amaran telah dikeluarkan kepada produk-produk yang gagal ujian-ujian lain seperti ujian pengecaian dan ujian keseragaman berat, dan 31 amaran dikeluarkan atas sebab isu berkaitan tatacara ujian yang tidak mematuhi spesifikasi yang ditetapkan.

Bagi tahun 2011, sejumlah lapan (8) produk kategori semulajadi dan empat (4) kosmetik telah dibatalkan pendaftaran / notifikasi atas sebab keselamatan. Jadual 6 menunjukkan produk-produk yang telah dibatalkan pendaftaran / notifikasi pada tahun 2011.

Apart from recall directives, a total of 41 warnings were issued to products which did not conform to other parameters such as disintegration and uniformity of weight, and 31 warnings were given to products for issues related to the non-compliance to specification of test procedures.

In year 2011, a total of eight (8) natural products registrations and four (4) cosmetics notifications had been cancelled due to safety concerns. Table 6 shows the list of products that have been cancelled in 2011.

Nombor PemegangBil. Nama Produk Pendaftaran/Notifikasi Pendaftaran/Notifikasi Sebab PembatalanNo. Product Name Registration/Notification Registration/Notification Reason of Cancellation No. Holder

1. Chi Kat Pills MAL07090990T Nature Pack Enterprise Found to contain ephedrine.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––2. Derma-Rx Arbutin-R Cream NOT090601556K DRx Aesthetics Sdn Bhd Found to contain tretinoin and hydroquinone.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––3. DS.1 Blemish Control Cream NOT091201931K Atomic Biotech Chemical Found to contain azelaic acid. Sdn. Bhd.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

5

0

10

15

20

25

Tahap IDegree I

Tahap IIDegree II

Tahap IIIDegree III

0 0 0 01

Tahap Panggil Balik/Recall Degree

Bila

ngan

Pro

duk

Num

ber

of

pro

duc

ts

21

01 1

2620

519

12

PreskripsiPrescription

Bukan PreskripsiNon-prescription

Suplemen KesihatanHealth Supplements

Produk SemulajadiNatural Products

KosmetikCosmetics

73

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Nombor PemegangBil. Nama Produk Pendaftaran/Notifikasi Pendaftaran/Notifikasi Sebab PembatalanNo. Product Name Registration/Notification Registration/Notification Reason of Cancellation No. Holder

4. Ezee Sunblock Cream NOT100601213K Ez”s Cosmetic Found to contain very high level of mercury.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––5. HB” Lite MAL09032133TC Metro Signature Sdn Bhd Found to contain promethazine.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––6. Herbaios-Zuekertec Capsule MAL08091522T Sinar Aman Pharmaceutical Found to contain glibenclamide (M) Sdn. Bhd. and metformin.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––7. HUO LI BAO capsule 500mg MAL09062214TC Wai Kang Enterprise Found to contain frusemide and chlorpheniramine.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––8. JCare-in MAL07124653TC Usaha Kiara Sdn. Bhd. Found to contain glibenclamide.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––9. JCare-su MAL07090966TC Usaha Kiara Sdn. Bhd. Found to contain glibenclamide.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––10. Mistura Zhike MAL08042248T Metro Signature Sdn Bhd Found to contain ephedrine and pseudoephedrine.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––11. Sensual Whitening Cream NOT100751321K Sensere Marketing Sdn Bhd Found to contain very high level of mercury.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––12. Twee Hong Suah MAL20034112T Hong Yang Hoo Pharma Found to contain very high level Sdn Bhd of mercury.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Projek Produk Semulajadi Mengandungi Red Yeast Rice

Red Yeast Rice atau nama saintifiknya Monascus purpureus mengandungi kompaun wujud secara semulajadi yang boleh bertindak untuk merendahkan tahap kolesterol. Kompaun ini dikenali sebagai monacolins atau lovastatin. Berikutan itu, PBKD telah menetapkan kandungan maksimum lovastatin dalam produk-produk ini sebagai 1% w/w dan dosej pengambilan harian tidak melebihi 10mg bagi produk yang mengandungi Monascus purpureus. Keperluan ini telah diumumkan melalui pekeliling bertarikh 5 Jun 2010.

Susulan itu, sejumlah 26 produk berdaftar yang mengandungi Red Yeast Rice telah disampel dan diuji bagi memastikan produk-produk berdaftar yang terdapat di pasaran Malaysia mematuhi keperluan ini. Kandungan lovastatin yang dijumpai pada produk-produk tersebut adalah dalam julat dari 0.03 - 1% w/w dan dosej maksimum lovastatin adalah dari 0.19 - 20.93 mg sehari. Dari jumlah 26 produk yang diuji ini, empat (4) produk didapati tidak mematuhi keperluan yang ditetapkan dan telah diarahkan untuk dipanggil balik dari pasaran serta meminda dos pengambilan seharian bagi memastikan pengambilan seharian di bawah paras terapeutik lovastatin.

Project on Natural Product Containing Red Yeast Rice

Red Yeast Rice or its scientific name Monascus purpureus contains naturally occurring cholesterol lowering effect compound cal led monacol ins, particularly lovastatin. As a result, the DCA had set a limit of maximum 1% w/w and maximum daily intake of 10 mg lovastatin for products containing Monascus purpureus. This requirement was stated in a circular dated 5th June 2010.

Subsequently, 26 products containing Red Yeast Rice had been sampled and tested to ensure products marketed in Malaysia comply with this requirement. Lovastatin content found in these products ranged from 0.03-1% w/w and maximum lovastatin intake was from 0.19 – 20.93 mg per day. From the 26 products tested, four (4) products did not comply with the requirement and were recalled from market. The dosages were reviewed to ensure daily intake of lovastatin is below the therapeutic level.

74

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Surveilans (Sambungan)Surveillance (Continued)

Projek Produk Semulajadi Mengandungi Bahan Rhizoma rhei

Rhizoma rhei merupakan sejenis tumbuhan yang mempunyai banyak kegunaan perubatan. Salah satu indikasi yang biasa dikaitkan dengan tumbuhan yang bersifat laksatif ini adalah bagi mengurangkan berat badan.

Pada tahun 2011, produk-produk yang mengandungi bahan akti f Rhizoma rhei telah disampel bagi menjalankan ujian penyaringan memandangkan produk-produk ini berpotensi untuk ditambah dengan bahan campur palsu. Sebanyak 32 produk telah diuji dan didapati kesemua produk-produk yang disampel ini bebas dari bahan campur palsu yang biasa dikaitkan dengan penggunaan mengurangkan berat badan. Ujian penyaringan ini akan diteruskan bagi memastikan produk-produk berisiko tidak dicemari dengan bahan yang tidak dibenarkan.

Rangkaian Hubungan ASEAN dan Antarabangsa (Kualiti dan Keselamatan)

Seperti mana tahun-tahun sebelumnya, Malaysia meneruskan perkongsian maklumat kualit i dan keselamatan produk-produk kesihatan termasuk kosmetik melalui ASEAN Post Marketing Alert System (PMAS) dan Rapid Alert Notification System (RAS). Pada tahun 2011, Malaysia telah menjadi penyelaras bagi PMAS yang diambil alih dari negara Singapura. Melalui aktiviti PMAS ini, sebanyak 111 laporan telah diterima dari negara-negara ASEAN yang melibatkan keseluruhan 131 produk. Dari sejumlah ini, Malaysia telah mengeluarkan sebanyak 12 laporan kepada ahli rangkaian PMAS.

Manakala, sejumlah 160 laporan telah diterima dari rangkaian perkongsian maklumat RAS, dan lima (5) daripadanya telah membawa kepada keputusan panggil balik secara sukarela oleh pemegang pendaftaran produk berkenaan.

Aduan Produk

Tahap kualiti, keselamatan dan keberkesanan sesuatu produk berdaftar / kosmetik bernotifkasi dapat dipantau melalui aduan-aduan yang dikemukakan kepada BPFK. Pada tahun 2011, sebanyak 840 aduan keluaran berdaftar dan kosmetik bernotifikasi telah diterima berbanding 751 aduan pada tahun 2010 yang melibatkan 634 (75.48%) produk preskripsi, 178 (21.19%) produk bukan preskripsi, 20 (2.38%) kosmetik bernotifikasi dan 8 (0.95%) produk semulajadi. Rajah 37 menunjukkan bilangan aduan yang diterima mengikut kategori.

Project on Herbal Medicine Containing Rhizoma rhei

Rhizoma rhei is a plant with a variety of medicinal value. One of its common usages is associated with weight loss due to its laxative effect.

In 2011, products containing Rhizoma rhei had been sampled for screening tests as these products have the potential for adulteration. A total of 32 products had been tested and found not to contain adulterants usually associated with weight loss. This screening test would be continued to ensure that products with potential risk of adulteration do not contain prohibited ingredients.

ASEAN and International Networking On Quality and Safety

As in previous years, Malaysia continues in sharing of information on quality and safety of health products, including cosmetics, through the ASEAN Post Marketing Alert System (PMAS) and Rapid Alert Notification System (RAS). In 2011, Malaysia has taken over the responsibility as coordinator for the PMAS from Singapore. Through the PMAS, a total of 111 reports were received from the ASEAN countries involving a total of 131 products. Of this, Malaysia has issued a total of 12 reports to the PMAS network.

Meanwhile, a total of 160 reports were received from the RAS information sharing network and five (5) of them has led to a voluntary recall by the registration holder of the product.

Product Complaints

The quality, safety and efficacy of registered products / notified cosmetics can be monitored through product complaint submissions to NPCB. In 2011, a total of 840 complaints on registered products and notified cosmetics were received compared to 751 complaints in 2010 involving 634 (75.48%) prescription products, 178 (21.19%) non-prescription products, 20 (2.38%) notified cosmetics and 8 (0.95%) natural products. Figure 37 shows the number of complaints received by category.

75

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Peningkatan aduan ini disebabkan terdapat beberapa laporan aduan berkenaan isu persamaan rupa bentuk dan warna label antara produk yang boleh menjurus kepada risiko kejadian medication error.

Sehubungan dengan ini, bagi memastikan keselamatan pesakit, Drug Registration Guidance Document (DRGD) telah menegaskan keperluan bahawa label bagi produk-produk yang didaftarkan oleh pemegang pendaftaran yang sama perlu dibezakan mulai September 2011.

Tindakan regulatori ke atas aduan yang diterima diambil berdasarkan hasil siasatan dalaman yang dijalankan, ujian makmal dan laporan penyiasatan oleh pihak syarikat / pengilang. BPFK turut mengadakan beberapa siri perbincangan dengan pihak syarikat / pengilang serta pihak lain yang berkaitan untuk mencegah aduan daripada berulang. BPFK juga telah menjalankan audit ke atas pengilang susulan daripada aduan bagi memastikan bahawa tindakan penambahbaikan dilakukan oleh pihak pengilang sebagaimana yang dilaporkan di dalam laporan penyiasatan aduan.

The rise in the number of complaints received had been contributed by the complaints regarding similarity of labellings and designs between products which could lead to medication error.

Therefore, in order to ensure patient safety, the Drug Registration Guidance Document (DRGD) had stated that the labels between products that belonged to the same registration holder should be clearly distinguished starting from September 2011.

The regulatory actions on the complaints received were taken based on the findings from internal investigations conducted, laboratory testing and investigation reports from companies / manufacturers. NPCB had also held a number of discussions with the companies / manufacturers and other relevant parties to prevent complaints from recurring. NPCB also conducted follow-up audits on the manufacturers to ensure that actions were taken by the manufacturers as reported in the investigation reports.

Rajah 37 : Bilangan Aduan Produk Mengikut Kategori 2011Figure 37 : Number of Product Complaints Based on Categories 2011

Bilangan/Numbers

Tahu

n/Ye

ar

EfikasiEfficacy

KualitiQuality

LabelLable

PembungkusanPackaging

Lain-lainOthers

0 50 100 150 200 250 300 350 400

19

108

242

374

97

76

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Mukasurat ini sengaja dibiarkan kosong.This page was intentionally left blank.

FARMAKOVIGILANSPHARMACOVIGILANCE

77

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

78

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

FarmakovigilansPharmacovigilance

Pelaporan Kesan Advers Ubat

Pada tahun 2011, sebanyak 9,385 laporan kesan advers telah diterima iaitu peningkatan sebanyak 33% berbanding dengan tahun 2010. Peningkatan yang ketara juga didapati pada pelaporan kesan advers selepas imunisasi (AEFI). Ini adalah disesabkan program imunisasi vaksin HPV oleh Kementerian Kesihatan Malaysia (KKM). Peningkatan pelaporan ADR juga disumbangkan oleh aktiviti promosi dan sesi pendidikan kepada anggota professional di fasiliti KKM serta di seminar anjuran persatuan professional.

Laporan kesan advers yang diterima melibatkan 10,202 produk yang disyaki dimana sebanyak 9,566 (93.8%) adalah produk preskripsi, manakala 497 (4.9%) produk bukan preskripsi dan 139 (1.4%) adalah produk lain iaitu ubat semulajadi, produk tidak berdaftar, kosmetik dan makanan.

Monitoring Product Safety Profile

In year 2011, a total of 9,385 adverse reaction reports were received which is an increase of 33% from year 2010. A marked increase was also seen in Adverse Event Following Immunization (AEFI) reports this year. This increment is mainly contributed by the Ministry of Health’s National Immunisation Programme for Human Papilloma Virus (HPV) Vaccines, continuous promotional activities and educational sessions for healthcare professionals conducted in the Ministry of Health’s facilities as well as seminars sponsored by professional associations.

The adverse reaction reports received involved 10,202 suspected products, of which 9,566 (93.8%) were prescription products, 497 (4.9%) were non-prescription products and 139 (1.4%) categorised under Others which includes natural medicine, unregistered products, cosmetics and food.

Rajah 38 : Bilangan Laporan Kesan Advers Ubatan (ADR) & AEFI yang Diterima (2007-2011)Figure 38 : Number of ADR & AEFI Reports Received (2007-2011)

3,068

4,826

5,850

7,079

9,385

792 787 1,000 1,063

1,665

2,363 2,543

0

Tahun/Year

Bila

ngan

Lap

ora

n/N

umb

er o

f R

epo

rts

4000

6000

8000

2000

1000

0

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

3000

5000

7000

9000

1014 26 13 52 68 39 75 132 214

1,529

3,138

1,0501,613

2,2952,504

2,993

4,694

5,636

5,550

6,202

Laporan AEFIAEFI Reports

Jumlah LaporanTotal Reports

Laporan ADRADR Reports

777778 974

79

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 39 : Laporan Kesan Advers Mengikut Kategori Produk 2011Figure 39 : Number of Adverse Reaction Reports by Product Category 2011

Bilangan/Numbers

Kat

ego

ri P

rod

uk/P

rod

uct

Cat

ego

ry

Bukan PreskripsiNon-prescription

Produk Tidak BerdaftarUnregistered Products

Produk SemulajadiNatural Products

MakananFood

KosmetikCosmetics

497

PreskripsiPrescription 9,566

88

35

11

5

0 2,000 4,000 6,000 8,000 10,000

Selain vaksin, ubat kardiovaskular menyumbang kepada bilangan terbanyak iaitu 1,655 (16.2%) dan diikuti oleh ubat anti-infektif iaitu sebanyak 1,414 (13.9%) dan seterusnya ubat analgesik iaitu sebanyak 636 (6.2%). Trend ini adalah sama dengan trend pada tahun 2009 dan 2010.

Kesan advers yang paling banyak dilaporkan melibatkan kesan pada Application Site Disorder iaitu sebanyak 43% diikuti dengan kesan 33% Skin And Appendages Disorders dan 26% Central And Peripheral Nervous System Disorders.

Excluding vaccines, cardiovascular drugs contributed the highest number of reports amounting to 1,655 (16.2%) reports followed by 1,414 (13.9%) reports for anti-infective drugs and 636 (6.2%) reports for analgesics. This trend is similar to that observed in the year 2009 and 2010.

The largest number of suspected adverse reactions reports involved Application Site Disorder (43%) followed by Skin and Appendages Disorders (33%) and Central and Peripheral Nervous System Disorders (26%).

80

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Farmakovigilans (Sambungan)Pharmacovigilance (Continued)

Rajah 40 : Laporan Kesan Advers Mengikut Kelas Farmakologi 2011Figure 40 : Adverse Reaction Reports by Pharmacological Group 2011

Bilangan Produk / Number of Products

Kel

as F

arm

ako

log

i / P

harm

aco

log

ical

Gro

up

579

0 500 1,000 1,500 2,000 2,500 3,000

CosmeticAntivenom

DermatologicalFood

AntirheumaticAntispasmodic

Eye PreparationsAnesthetic

AntihistamineMinerals

Contrast MediaCorticosteroid

Immunosuppresive AgentAntidepressant

HormoneVitamin

AntiemeticAntiulcer

Traditional MedicineAnticoagulant

AntigoutAntiasthmatic

AntiviralAntipsychotic

AntituberculosisAntiepileptic

AntihyperlipidemicAntidiabetic

AntineoplasticOthers

AnalgesicAntiinfectives

CardiovascularVaccine

1117182936394646505153666882100109110116118130

188206228

272310

372412

6361,414

1,6553,193

81

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 41 : Laporan Kesan Advers Mengikut Kategori Pelapor 2011Figure 41 : Adverse Drug Reaction (ADR) Reports by Reporters 2011

Penyumbang utama kepada jumlah pelaporan ADR yang diterima ialah pengamal kesihatan profesional dari KKM dimana pegawai farmasi KKM merupakan pelapor tertinggi iaitu sebanyak 4,267 (45%) diikuti oleh jururawat KKM iaitu sebanyak 2,063 (22%) dan doktor KKM sebanyak 1,295 (14%).

The majority of reporters comprised of healthcare professionals from the Ministry of Health with pharmacists taking a leading role with 4,267 (45%) reports followed by nurses with 2,063 (22%) reports and doctors contributing a total of 1,295 (14%) reports.

1,000

0

2,000

3,000

4,000

Tahun/Year

Bila

ngan

/Num

ber

s

2007

1,07

51,

283

0 6140

924

00

2008

1,27

22,

401

321

475

117

312

2009

1,34

03,

358

2514

468

628

116

2010

1,41

84,

160

388

248

612

234

19

2011

1,29

54,

267

2,06

318

569

114

274

2

MOH Doctor

MOH Pharmacist

MOH Nurse

GP, Private Specialist

Registered Holder

University

Others

Beberapa program telah disertai dan diadakan dengan tujuan untuk meningkatkan kesedaran terhadap kepentingan pelaporan kesan advers dan meningkatkan mutu pelaporan. Berikut adalah antara program yang telah disertai / dianjurkan:

NPCB carried out and participated in several programmes with the aim to strengthen and improve the quality of adverse drug reaction reports. The programmes participated / conducted are listed as below:

82

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Farmakovigilans (Sambungan)Pharmacovigilance (Continued)

Bil. Program Tarikh PenganjurNo. Programme Date Organiser

1 Program Kenali Ubat Anda April 2011 Hospital Jelebu Kenali Ubat Anda Programme Jelebu Hospital

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––2 Bengkel Pengurusan Laporan ADR & May 2011 Pejabat Kesihatan Daerah Seremban Medication Error Seremban District Health Office ADR & Medication Error Workshop

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––3 Bengkel Pengurusan AEFI dan Sistem June 2011 Bahagian Perkhidmatan Farmasi Rangkaian Sejuk Pharmaceutical Services Division AEFI and Cold Chain System Management Workshop

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––4 Sesi Kelab JurnalBil. 06/2011 July 2011 Biro Pengawalan Farmasutikal Journal Club Session 06/2011 Kebangsaan National Pharmaceutical Control Bureau

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––5 Sesi Pembentangan Latihan Dalaman September Biro Pengawalan Farmasutikal Pusat Pasca Pendaftaran Produk 2011 Kebangsaan Internal Training Session for Centre for National Pharmaceutical Control Bereau Post Registration of Products

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––6 Kursus Medication Safety March 2011 Jabatan Kesihatan Negeri Sembilan Medication Safety Course Negeri Sembilan State Health Department

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––7 Bengkel Meningkatkan Kualiti Pelaporan March 2011 Biro Pengawalan Farmasutikal Kesan Advers Ubat dan Vaksin Kebangsaan ADR Reporting Workshop National Pharmaceutical Control Bureau

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––8 Hospital Pharmacy Course (PHR528) January 2011 Fakulti Farmasi, Universiti Teknologi MARA (UiTM), Puncak Alam, Selangor Faculty of Pharmacy, Universiti Teknologi MARA (UiTM), Puncak Alam, Selangor

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––9 Pharmacy Practice Course (PHAR4563) November Fakulti Farmasi, Cyberjaya University 2011 College of Medical Sciences Faculty of Pharmacy, Cyberjaya University College of Medical Sciences

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––10 Bengkel Pelaporan Kesan Advers Ubat May 2011 Jabatan Kesihatan Wilayah Persekutuan ADR Reporting Workshop Kuala Lumpur & Putrajaya Department of Health Kuala Lumpur & Putrajaya Federal Territory

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––11 Traditional and Complementary Medicine June 2011 Malaysian Pharmaceutical Society (MPS) Seminar

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

83

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Jadual 7 : Direktif yang diarahkan PBKD pada Tahun 2011Table 7 : Directives issued by the DCA in 2011

Mesyuarat Mesyuarat ProdukBil. MADRAC PBKD Terlibat DiskripsiNo. MADRAC DCA Products Description Meeting Meeting Involved

1 120 240 All Class labelling updates regarding use during pregnancy (24/3/11) (26/5/11) antipsychotic & potential risk to newborns & drugs 121 • Neonates exposed to antipsychotic drugs during the (19/5/11) third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

• These complications vary in severity. In some cases, neonates required intensive care unit support and prolonged hospitalisation.

• Antipsychoticdrugsshouldbeusedduringpregnancy only if the potential benefit justifies the potential risk to the foetus.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––2 120 242 All beta Strengthened warnings against use in preterm labour (24/3/11) (28/7/11) agonists & • Serious adverse reactions including death have been 122 reported after administration of terbutaline/salbutamol (21/7/11) to women in labour. • In the mother, these include increased heart rate, transient hyperglycaemia, hypokalaemia, cardiac arrhythmias, pulmonary oedema and myocardial ischaemia.

• Increasedfoetalheartrateandneonatalhypoglycaemia may occur as a result of maternal administration.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Tindakan Regulatori Pihak Berkuasa Kawalan Dadah (PBKD)

Sepanjang tahun 2011, Jawatankuasa Penasihat Kesan Advers Ubat Kebangsaan (MADRAC) telah mencadangkan beberapa tindakan regulatori dan telah diluluskan oleh PBKD. Jadual 7 menyenaraikan direktif yang telah diarahkan oleh PBKD terhadap isu keselamatan produk farmaseutikal yang diterima daripada agensi regulatori antarabangsa yang lain dan juga data dari institusi tempatan.

Drug Control Authority (DCA) Regulatory Action

During the course of 2011, the following regulatory actions were proposed by MADRAC and approved by the DCA. Table 7 shows the major directive actions issued by the DCA on certain pharmaceutical products following alerts received from other international regulatory agencies as well as data from local institutions.

84

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Farmakovigilans (Sambungan)Pharmacovigilance (Continued)

Mesyuarat Mesyuarat ProdukBil. MADRAC PBKD Terlibat DiskripsiNo. MADRAC DCA Products Description Meeting Meeting Involved

3 122 242 All 5-alpha Class labelling updates to warn about potential risk of (21/7/11) (28/7/11) reductase high grade prostate cancer inhibitors (5-ARIs) • Men aged 55 and over with a normal digital rectal examination and PSA ≤3.0ng/mL at baseline taking finasteride 5 mg/day in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8-10 prostate cancer.

• Similar results were observed in a 4-year placebo- controlled clinical trial with dutasteride.

• However, whether the effect of 5-ARIs to reduce prostate volume, or study-related factors, impacted the results of these studies have not been established.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––4 122 242 All products Class labelling updates to include warning of (21/7/11) (28/7/11) containing exacerbation of myasthenia gravis fluoroquinolones

• Fluoroquinoloneshaveneuromuscularblockingactivity and may exacerbate muscle weakness in patients with myasthenia gravis.

• Post-marketing serious adverse events, including deaths and requirement for ventilator support have been been associated with fluoroquinolones use in persons with myasthenia gravis.

• Avoid fluoroquinolonespatientswith knownhistoryof myasthenia gravis.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––5 122 243 All products Contraindication & boxed warnings for risk of serious (21/7/11) (25/8/11) containing hepatotoxicity ketoconazole • Contraindicated inpatientswithacuteorchronic liver disease.

• Very rare cases of serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation have occurred with the use of oral ketoconazole. Some of these cases occurred within the first month of treatment, including some within the first week.

• Assessliverfunction,priortotreatmenttoruleoutacute or chronic liver disease, and monitor at frequent and regular intervals during treatment, and at the first signs or symptoms of possible hepatotoxicity.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

KOSMETIKCOSMETICS

85

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

86

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

KosmetikCosmetics

Produk-produk kosmetik di Malaysia dikawal di bawah Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984 melalui prosedur notifikasi. Produk-produk tersebut dipantau secara berterusan menerusi Program Pengawasan Mutu Produk Kosmetik Bernotifikasi bagi memastikan semua produk kosmetik bernotifikasi di pasaran adalah selamat, berkualiti dan mengandungi tuntutan yang dapat disokong dengan data yang mencukupi.

Aktiviti-aktiviti pengawasan tersebut merangkumi proses penyaringan maklumat dan formulasi produk kosmetik bagi memastikan ianya bebas dari bahan larangan dan semua bahan-bahan yang digunakan adalah dalam had dan mengikut syarat yang dibenarkan, pengendalian audit ke atas Fail Maklumat Produk, pensampelan dan pengujian produk untuk ujian kualiti bagi memastikan produk kosmetik mematuhi piawaian kualiti yang ditetapkan, semakan label dan tuntutan produk, audit pengilang kosmetik bagi memastikan produk tersebut dikilangkan oleh pengilang kosmetik yang mempunyai fasiliti yang sesuai untuk mengilang produk kosmetik dan mematuhi keperluan Amalan Perkilangan Baik (APB) bagi produk kosmetik, pengendalian aduan orang ramai, perkongsian maklumat berkenaan status keselamatan produk dengan negara anggota ASEAN, pemantauan kesan advers akibat penggunaan produk kosmetik serta pemantauan iklan-iklan produk kosmetik.

Setiap permohonan notifikasi baru secara atas talian akan disaring secara automatik melalui sistem auto-screening bagi mengesan produk yang mengandungi bahan larangan dan melebihi had yang dibenarkan atau mempunyai nama yang tidak dibenarkan untuk produk kosmetik. Sistem penyaringan automatik tersebut adalah dinamik dan penetapan kriteria penyaringan sentiasa dikemaskini dari semasa ke semasa mengikut keperluan terkini terutamanya dari segi aspek keselamatan bahan dan produk. Oleh itu, selain daripada pengemaskinian peringkat dalaman, sebarang permohonan tambahan bahan baru oleh pihak syarikat ke atas senarai bahan kosmetik sedia ada di dalam sistem QUEST3 perlu melalui penilaian tahap keselamatan samada berdasarkan data sokongan yang dikemukakan dan/atau ujian yang tertentu sebelum ditambah ke dalam pangkalan data kosmetik.

Pada tahun 2011, sejumlah 69,747 produk kosmetik telah dinotifikasikan dengan pihak BPFK, KKM. Ianya menunjukkan jumlah peningkatan sebanyak 31 % berbanding dengan tahun 2010.

Cosmetic product is regulated under the Control of Cosmetic and Drug Regulation 1984 through notification procedure. The safety, quality and claimed benefit of all notified cosmetics are continuously monitored via active Post Market Surveillance (PMS) programme.

The PMS activities consist of screening of product formulation and information to ensure that these cosmetics do not contain any prohibited or harmful substances and all restricted ingredients are used within the allowed limit and condition of use, audit on the Product Information File (PIF), sample collection and testing, monitoring of label compliance, audit of premises to ensure compliance with the Guidelines for Cosmetic Good Manufacturing Practice (GMP), investigation of complaints, initiation of warning and information sharing system between ASEAN countries, monitoring of adverse reactions from cosmetic products and monitoring of cosmetic advertisement.

The online notification submission to the NPCB is equipped with an auto-screening system that captures product containing prohibited item and item that exceeds its allowed limit, or product with certain prohibited name. It is a dynamic system and the screening criterias will be updated consistently subject to current needs and focus mainly on the safety of both the ingredients and finish product. Apart from internal updates to the existing screening criteria that is self-initiated by the authority, any request by the company for additional ingredient to be added into the Quest 3 ingredient database requires the submission of safety assessment document that includes scientific data and/or lab/clinical test.

In 2011, a total of 69,747 cosmetics had been notified with the NPCB, MOH which showed an increment of 31% compared to the total notified cosmetics in the previous year.

87

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 42 : Bilangan Produk Kosmetik yang Bernotifikasi (2008 - 2011)Figure 42 : Number of Notified Cosmetic Products (2008 - 2011)

Bilangan pembatalan notifikasi didapati meningkat pada tahun 2011 berbanding tahun-tahun sebelumnya. Peningkatan ini disebabkan oleh penggunaan sistem auto-screening yang membolehkan pengenal pastian produk-produk yang mengandungi bahan larangan atau melebihi had yang dibenarkan dengan lebih cepat. Selain itu, pelaksanaan aktiviti surveilans yang lebih

The number of notification cancellation increased in 2011 compared to the previous years. This was due to the availability of the auto-screening system which expedited the determination of products containing banned substance or substance exceeding the allowable limit. The increased was also due to a proactive

Rajah 43 : Bilangan Pembatalan Notifikasi Produk Kosmetik (2008 - 2011)Figure 43 : Number of Cosmetics Notification Cancellation (2008 - 2011)

Bilangan/Numbers

Tahu

n/Ye

ar

2011

2010

2009

2008

0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000

67,747

53,262

37,466

30,531

Bilangan/Numbers

Tahu

n/Ye

ar

2011

2010

2009

2008

0 500 1,000 1,500 2,000 2,500

2,359

1,076

293

328

88

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Kosmetik (Sambungan)Cosmetics (Continued)

Rajah 44 : Sebab Pembatalan Notifikasi Produk Kosmetik bagi Tahun 2011Figure 44 : Reasons for Cosmetic Notification Cancellation in 2011

aktif bagi terhadap produk kosmetik di pasaran bagi mengenalpasti produk yang tidak mematuhi keperluan yang ditetapkan juga turut menjadi faktor terhadap peningkatan tersebut.

Daripada jumlah keseluruhan pembatalan notifikasi pada tahun 2011, sebahagian besar iaitu sebanyak 79.9% pembatalan adalah hasil daripada penyaringan maklumat produk yang dikemukakan semasa permohonan notifikasi manakala selebihnya adalah susulan daripada aktiviti pemantauan produk dalam pasaran.

Hasil daripada aktiviti penyaringan tersebut, sebanyak 1,886 notifikasi produk telah dibatalkan kerana didapati mengandungi formulasi yang tidak mematuhi keperluan yang ditetapkan dalam Guidelines for Control of Cosmetic Product in Malaysia manakala 209 pembatalan lagi adalah disebabkan oleh tuntutan atau nama produk yang di luar skop kosmetik serta kegagalan pihak syarikat mendapatkan surat kuasa yang sah bagi tujuan notifikasi. Selain itu, sebanyak 251 pembatalan dikeluarkan bagi produk di pasaran yang didapati dikilangkan di premis yang gagal mematuhi keperluan APB atau premis yang tidak bersesuaian bagi pengilangan kosmetik manakala pembatalan bagi 13 produk lagi adalah hasil daripada semakan label yang mendapati bahawa produk tersebut bukan digunakan untuk tujuan kosmetik dan produk-produk yang gagal ujian makmal.

surveillance approach taken by the NPCB which led to a faster detection of non-compliant products in the market.

A majority of 79.9% of the notification cancellations in 2011 was from the screening activity during notification submissions while the remaining was through the monitoring of non-compliant products through post market surveillance activities.

A total of 1,886 products were found to contain prohibited substances or used beyond the permitted limit and condition laid down in the stipulated guidelines during screening whereas 209 products were found to have either names / claimes that were beyond the cosmetic scope of use or the companies were unable to obtain the required letter of authorisation for notification purpose. Apart from that, 251 cancellations were issued due to failure of the manufacturers to comply with the Good Manufacturing Practice (GMP) requirements or not having proper manufacturing premises. 13 other cancellations were for products found to be indicated for other non-cosmetic uses or for failing laboratory tests.

Penyaringan Formulasi ProdukScreening of Product Formula

Isu GMPGMP Issue

Sampel SurveilansSurveillance Samples

Lain-lainOthers2011

79.9%(1,886)

10.6%(251)

8.9%(209)

0.6%(13)

89

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 45 : Bilangan Sijil Penjualan Bebas Yang Dikeluarkan (2008-2011)Figure 45 : Number of Certificate of Free Sale Issued (2008-2011)

Pengeluaran Sijil Penjualan Bebas

Rajah 45 menunjukkan sebanyak 2,694 Sijil Penjualan Bebas telah dikeluarkan pada tahun 2011. Bilangan untuk Sijil Penjualan Bebas telah meningkat sebanyak 41 % berbanding tahun 2010 dan kesemua sijil tersebut telah dikeluarkan mengikut tempoh yang ditetapkan iaitu kurang daripada 2 minggu.

Issuance of Certificate of Free Sales

Figure 45 shows that a total of 2,694 certificates were issued in 2011. This was an increment of 41% compared to 2010 and all of them were issued within the dedicated time frame of less than 2 weeks.

Pengeluaran Permit bagi Ujian Pemasaran dan Penilaian In-house

Sejumlah 4,419 permit untuk tujuan ujian pemasaran dan penilaian in-house telah dikeluarkan kepada pihak syarikat. Rajah 46 menunjukkan bahawa jumlah pengeluaran tersebut tidak jauh berbeza dengan jumlah permit yang dikeluarkan berbanding dengan tahun lepas.

Issuance of Market Sampling Permit and In- House Evaluation Permit

In 2011, a total of 4,419 permits for both market sampling and in-house evaluation permit were issued to requesting companies. Figure 46 shows that there was no significant difference in terms of the total issuance of such permits as compared to the previous year.

Bilangan/Numbers

Tahu

n/Ye

ar

2011

2010

2009

2008

0 500 1,000 1,500 2,000 2,500 3,000

2,694

1,913

1,936

1,667

90

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Kosmetik (Sambungan)Cosmetics (Continued)

Rajah 46 : Bilangan Permit Untuk Ujian Pemasaran dan Permit Penilaian In-House yang Telah Dikeluarkan (2008-2011)Figure 46 : Number of Market Sampling Permit and In-House Evaluation Permit Issued (2008-2011)

Pengendalian Audit Fail Maklumat Produk

Rajah 47 menunjukkan bahawa terdapat 664 audit yang telah dijalankan ke atas Fail Maklumat Produk pada tahun 2011. Pengauditan Fail Maklumat Produk dilaksanakan terhadap produk kosmetik berdasarkan kriteria tertentu. Antaranya produk pemutih kulit, produk berisiko tinggi seperti produk untuk kegunaan sekitar mata dan produk kegunaan bayi, produk dari pengilang atau syarikat yang mempunyai sejarah panggilbalik produk, aduan produk, gagal ujian makmal, pengilang yang mempunyai status Amalan Pengilangan Baik (APB) yang lemah serta lain-lain yang dikenalpasti semasa proses penyaringan maklumat produk. Antara kriteria tambahan yang telah dikenalpasti termasuk produk dengan tuntutan yang mengelirukan dan berpotensi untuk membuat tuntutan melampaui skop takrifan kosmetik atau produk yang disyorkan untuk tujuan rawatan seperti mesotherapy, minyak urut bagi tujuan rawatan serta produk pelangsingan badan.

Product Information File (PIF) Audit

Figure 47 shows that a total of 664 PIF audits were conducted in 2011. PIF audits were conducted on products having certain criterias such as whitening products, high risk products to be used around the eye area and baby products, manufacturers or companies with history of product recalls, product complaints, products that failed laboratory testing and manufacturers with poor Good Manufacturing Practice (GMP) status as well as input gathered during the product screening processes. Other criterias include confusing product names, products with claims that are beyond the scope and definition of cosmetic or possibly aimed or intended for the treatment of certain health condition such as mesotherapy, massage oil with therapeutic indication and slimming products.

Bilangan/Numbers

Tahu

n/Ye

ar

2011

2010

2009

2008

0 1,000 2,000 3,000 5,000 6,000 7,000 8,000

4,419

4,482

6,024

5,743

91

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 47 : Bilangan Audit Fail Maklumat Produk (2008-2011)Figure 47 : Number of Product Information File (PIF) Audit (2008-2011)

Pengesahan Status Notifikasi

BPFK sentiasa bekerjasama dengan bahagian Penguatkuasa Farmasi untuk menjaga kesejahteraan pengguna. Antara komitmen yang diberikan oleh BPFK termasuk menjalankan pengesahan status notifikasi kosmetik bagi membantu pihak Penguatkuasa Farmasi dalam menjalankan aktiviti pengawasan mutu produk kosmetik di pasaran. Pada tahun 2011, jumlah produk yang terlibat untuk pengesahan notifikasi adalah sebanyak 1,231.

Penambahbaikan Terhadap Isu Semasa

Pada tahun 2011, terdapat 1 (satu) arahan yang dikeluarkan oleh Pengarah Kanan Perkhidmatan Farmasi dan 2 (dua) pekeliling yang dikeluarkan oleh Pengarah Regulatori BPFK berkaitan produk kosmetik bagi memaklumkan pemegang notifikasi mengenai keperluan baru yang ditetapkan bagi notifikasi produk kosmetik bagi menjamin keselamatan pengguna.

Verification on the Notification Status

The NPCB works closely with the Pharmacy Enforcement Division with the ultimate aim to protect the safety and well being of the public. The NPCB is committed to assist in verifying the notification status of cosmetics available in the market for the purpose of enforcement activity. In 2011, a total of 1,231 products were sent to NPCB for status verification.

Improvements on Current Issues

In 2011, 1 directive and 2 circulars were issued by the Director of Pharmaceutical Services and the Director of the NPCB respectively. As a result of continuous effort to ensure public safety, these directives / circulars were issued to inform all notification holders regarding the new requirements for cosmetic notification.

Bilangan/Numbers

Tahu

n/Ye

ar

2011

2010

2009

2008

0 100 200 300 400 500 600 700

664

377

285

12

92

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Kosmetik (Sambungan)Cosmetics (Continued)

Jadual 8 : Senarai Arahan /Pekeliling Berkenaan Produk Kosmetik yang Dikeluarkan pada Tahun 2011Table 8 : List of Directive/Circulars Concerning Cosmetic Products Issued in 2011

Bil. Tajuk Arahan / Pekeliling Tarikh DikeluarkanNo. Directive / Circular Date Issued

1. Produk Dengan Nama, Tuntutan Dan Kegunaan Untuk Melansingkan 31 March 2011 Badan Tidak Dikelaskan Sebagai Produk Kosmetik Products with Names, Claims and the Intended Use of Slimming Shall not be classified as Cosmetic Products

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––2. Penggunaan Doktor Gigi Di Dalam Iklan-Iklan Produk Pergigian 4 April 2011 The Use of Dentists in Dental Product Advertisements

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––3. Pekeliling Untuk Memaklumkan Larangan Penggunaan Bahan 5 October 2011 2-Aminophenol (O-Aminophenol: CI 76520) And Its Salts Prohibition of the Use of 2-Aminophenol (O-Aminophenol: CI 76520) And Its Salts

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

VARIASIVARIATION

93

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

94

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

VariasiVariation

Matlamat utama variasi adalah menilai permohonan bagi sebarang perubahan maklumat produk berdaftar kecuali produk kosmetik dan veterinar bagi memastikan keselamatan, keberkesanan dan kualiti produk.

Di antara perubahan-perubahan maklumat termasuk pengemaskinian maklumat di dalam sisip bungkusan, perubahan pada formulasi produk, nama produk, label, saiz pek, keadaan penyimpanan, jangka hayat dan pertukaran tapak pengilangan.

Sebanyak 53,702 permohonan variasi telah diterima pada tahun 2011. Daripada jumlah ini, 144 permohonan adalah permohonan variasi QUEST3. Rajah 48 menunjukkan bahawa hampir 60% daripada bilangan permohonan yang diterima adalah untuk produk-produk preskripsi termasuk ubat baru, biologics dan ubat generik.

The main aim of variation is to evaluate any application for changes in the information of registered products except cosmetics and veterinary products to ensure the safety, quality and efficacy of the product.

Some of the changes include updates to the product package insert, changes to the product formulation, product name, labeling, pack sizes, storage conditions, shelf-life and manufacturing site.

A total of 53,702 variation applications were received in 2011 in which 144 applications were QUEST3 applications. Figure 48 shows that almost 60% of the variation applications were for prescription products which included new chemical entities, biologics and generic products.

Rajah 48 : Permohonan Variasi yang Diterima Pada Tahun 2011Figure 48 : Variation Applications Received in 2011

Daripada jumlah 45,938 permohonan variasi yang diproses pada tahun 2011, sebanyak 27,544 iaitu 60% telah diluluskan manakala 18,394 iaitu 40% telah ditolak. Faktor utama yang menyumbang kepada penolakan permohonan adalah:

i) Pertukaran yang dibuat tidak mematuhi keperluan regulatori

ii) Dokumen yang dikemukakan tidak lengkap

iii) Dokumen yang dilampirkan tidak berkaitan dengan maklumat yang dikehendaki

iv.) Permintaan dari pemohon kerana kesilapan permohonan

From a total of 45,938 variation applications processed in 2011, 27,544 or 60% applications were approved while 18,394 or 40% were rejected. The major factors contributing to the rejection of applications included:

i) The changes made did not comply with the regulations

ii) The documents submitted were incomplete

iii) The documents attached were irrelevant to the information required

iv) Requested by applicant due to wrong submission

PreskripsiPrescription

Bukan PreskripsiNon-Prescription

Produk SemulajadiNatural Product

Suplemen KesihatanHealth Supplement

58%(31,078)

23%(12,568)

4%(1,946)

15%(8,110)

2011

95

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Rajah 49 : Permohonan Variasi yang Diproses Mengikut Kategori Produk Tahun 2011Figure 49 : Variation Submissions Processed According to Product Category in 2011

Bilangan permohonan variasi yang telah diterima dari tahun 2008 hingga 2010 adalah konsisten. Pada tahun 2011 pula, bilangan permohonan variasi yang telah diterima telah menunjukkan peningkatan sebanyak 7.1% berbanding dengan purata bilangan permohonan variasi yang telah diterima dari tahun 2008 hingga 2010, iaitu 49,867.

The number of applications received from 2008 till 2010 had been consistent. In 2011, there was an increase of 7.1% in the number of variation applications received compared to the average number of 49,867 variation applications received from 2008 till 2010.

Rajah 50 : Permohonan Variasi yang Diterima dan Diproses (2007 – 2011)Figure 50 : Variation Submissions Received and Processed (2007 – 2011)

10,000

0

20,000

30,000

40,000

50,000

60,000

2007 2008 2009

Tahun/Year

Bila

ngan

/ N

umb

er

2010 2011

DilulusApproved

DitolakRejected

39,4

56

35,3

79

49,4

25

44,5

71 50,5

22

49,6

53 53,7

02

46,6

04

45,8

40

45,9

38

Bilangan / Number

Per

mo

hona

n /

Sub

mis

sio

ns

PreskripsiPrescription

Bukan PreskripsiNon-�Prescription

Produk SemulajadiNatural Product

Supplemen KesihatanHealth Supplement

0 5,000 10,000 15,000 20,000 25,000

DilulusApproved

DitolakRejected9,009

16,716

2,124

4,843

5,168

6,393

817

868

96

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Variasi (Sambungan)Variation (Continued)

Rajah 51 : Permohonan Pertukaran Tapak Pengilang yang Diterima (2007 – 2011)Figure 51 : Change of Manufacturing Site Applications Received (2007 – 2011)

Peningkatan yang ketara dalam bilangan permohonan variasi diterima untuk tahun 2011 adalah disebabkan oleh beberapa faktor seperti pelaksanaan Risalah Maklumat Ubat Pengguna, pertukaran pemilik produk untuk sejumlah produk yang besar dan pertukaran formulasi produk untuk mematuhi keperluan bioequivalens (BE) di Malaysia.

Rajah 51 menunjukkan sebanyak 205 permohonan pertukaran tapak pengilangan telah diterima pada tahun 2011. Bilangan ini merupakan penurunan daripada 450 permohonan pada tahun 2010 dan 481 permohonan pada tahun 2009.

Antara faktor-faktor yang mungkin mendorong kepada bilangan permohonan pertukaran tapak pengilangan yang lebih tinggi pada tahun 2009 dan 2010 adalah:

a) Pemindahan lokasi pengilangan

b) Pengembangan lokasi yang sedia ada

c) Percantuman antara syarikat

d) Pelantikan pengilang ubat tradisional yang baru akibat penggantungan lesen pengilang yang lama oleh PBKD.

The significant increase in the number of variation applications received in 2011 was due to several factors such as the implementation of Patient Information Leaflet, changes in product ownership for a large number of products and changes in the product formulation in order to comply with the bioequivalence (BE) requirement in Malaysia.

Figure 51 shows that a total of 205 change of manufacturing site applications were received in 2011 which was a decline from 450 applications in 2010 and 481 applications in 2009.

Among the factors that might contribute to the higher number of applications for the change of manufacturing site in 2009 and 2010 included:

a) Transfer of premises to different locations

b) Upgrading of the current premises

c) Mergers between companies

d) Appoinment of a new traditional medicine manufacturer due to the suspension of previous manufacturing license by the DCA

Bilangan / Number

Tahu

n/Ye

ar

2011

2010

2009

2008

2007

0 100 200 300 400 500

205

450

481

226

263

PENYEBARAN MAKLUMAT,LATIHAN DAN LAWATAN

INFORMATION DISSEMINATION,TRAININGS AND VISITORS

97

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

98

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Penyebaran Maklumat, Latihan dan LawatanInformation Dissemination, Trainings and Visitors

Pengurusan Sistem Teknologi Maklumat

Pemantauan sistem komputer di BPFK dan pengurusan Helpdesk BPFK dijalankan oleh Unit IT yang merupakan sebahagian daripada seksyen ICT. Tanggungjawab Unit IT adalah untuk memastikan penggunaan sistem komputer dan Helpdesk berjalan lancar semasa hari bekerja. Fungsi Helpdesk BPFK merangkumi pemantauan aduan dan masalah yang dihadapi oleh para pelanggan BPFK, serta penawaran tatacara penyelesaian masalah kepada para pelanggan. Selain itu, seksyen ICT juga menjalankan tugas-tugas seperti pengurusan sistem QUEST3, pengurusan laman web BPFK, pembangunan sistem QUEST3 plus, dan pembangunan laman web baru BPFK. Amalan staf dari seksyen ICT adalah untuk sentiasa memastikan tidak berlaku sebarang gangguan kepada semua sistem tersebut.

Management of Information Technology (IT) System

Within the ICT section of this center, there is an established IT Unit that effectively oversees the computer systems in NPCB, and also handles the Helpdesk of NPCB. The Helpdesk of NPCB is mainly for monitoring the problems encountered by customers of NPCB, as well as provided expertise solutions to enhance customer service. The QUEST3 system, QUEST3 plus development, website updating and website development are all under the jurisdiction and care of this particular section as well. The staffs of the ICT section are dedicated in their efforts to keep the systems mentioned above up and running, and also to constantly improve these systems.

Rajah 52 : Bilangan Aduan QUEST2 / QUEST3 yang Diselesaikan (2007-2011)Figure 52 : Number of Resolved QUEST 2 / QUEST3 Complaints (2007-2011)

Pengurusan Laman Web BPFK

Laman web rasmi BPFK telahpun dikemaskinikan dengan artikel baru, dokumen dan sebarang maklumat yang berkaitan dengan aktiviti regulatori dalam tahun ini. Dirancangkan proses pembangunan laman web baru BPFK akan dimulakan pada tahun 2012, dengan matlamat untuk mencapai 5 star rating dalam Malaysia Government Portals and Websites Assessment (MGPWA) 2012 oleh MAMPU.

Maintenance of the NPCB Website

The website has been updated with several new articles, documents and information relevant to regulatory activities. The process of revamping the NPCB website has been initiated with the aim to achieve a 5 star rating during the Malaysia Government Portals and Websites Assessment (MGPWA) 2012.

Bil. Aduan yang Diselesaikan / No. of Resolved Complaints

Tahu

n/Ye

ar

2011 2,490

2010 2,091

2009 1,715

2008 1,825

2007 1,204

0 500 1,000 1,500 2,000 2,500

99

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Jadual 9 : Bilangan dan Jenis Pertanyaan yang Diterima (2007-2011)Table 9 : Numbers and Types of Enquiries Received (2007-2011)

Pengurusan Pertanyaan

BPFK memainkan peranan penting dalam pengurusan pertanyaan yang diterima daripada pegawai perubatan, pihak industri dan orang awam. Semua pertanyaan ini diterima melalui telefon, e-mel, faks/surat dan walk-in. Jadual 9 menunjukkan bahawa jumlah pertanyaan yang diterima pada tahun 2011 adalah 3,032.

Penerbitan Berita Ubat-Ubatan dan Laporan Tahunan BPFK

Sebanyak 4 edisi Berita Ubat-Ubatan (majalah mengenai polisi PBKD) dan 1 naskhah Laporan Tahunan BPFK telah diterbitkan untuk edaran pada tahun 2011.

Pengurusan dan Penyelarasan Sesi Dialog dengan Pihak Industri

Salah satu tanggungjawab BPFK adalah untuk memastikan pihak industri dimaklumkan apabila terdapat sebarang pengemaskinian dalam sistem regulatori yang berkaitan dengan pihak industri. Isu-isu regulatori yang mungkin dihadapi oleh pihak industri juga boleh dibawa bincang dengan BPFK. Ini adalah untuk meningkatkan tahap keberkesanan sistem regulatori secara keseluruhan untuk manfaat bersama. Maka, BPFK sentiasa mengekalkan kerjasama dan hubungan

Handling of Enquiries

The NPCB plays a vital role in handling enquiries made by healthcare professionals, industry players and the general public. These enquiries are received via phone, e-mail, fax/letter, and walk-in customers. Table 9 shows that 3,032 enquiries had been received in 2011.

Publications, Namely the NPCB Annual Report, and the Berita Ubat-Ubatan

A total of 4 editions of Berita Ubat-Ubatan (a newsletter concerning DCA policies) were published in the year 2011, along with one edition of the NPCB Annual report.

Organising and Coordinating Dialogues with Relevant Industrial Associations

As an organisation responsible for the pharmaceutical regulatory landscape of the country, the NPCB collaborates and works closely with various local industrial associations to keep the relevant bodies up-to-date about current regulatory affairs. Also, the NPCB seeks to enhance the effectiveness of the regulatory system by establishing good communication with local industrial associations via regular dialogues. In the year

Jenis Pertanyaan 2007* 2008* 2009 2010 2011Type of Enqueries

Telefon Phone - - 1,273 1,696 1,980–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Emel E-mail - - 1,183 1,228 370

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Pertanyaan walk-in Walk-in 267 337 151 134 682

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Faks dan Surat Fax and Letter - - 0 4 0

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Jumlah Total 1,731 2,322 2,607 3,062 3,032

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

* Bilangan pertanyaan untuk telefon, e-mel, faks dan surat tidak dapat dikemukakan kerana data yang dikumpulkan pada tahun 2007 tidak diasingkan kepada kategori seperti di atas.

* The number of enquiries for phone, e-mail, fax and letters could not be presented as the data collected then was not separated into these subcategories.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

100

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Penyebaran Maklumat, Latihan dan Lawatan (Sambungan)Information Dissemination, Trainings and Visitors (Continued)

erat dengan pihak industri melalui penganjuran sesi dialog mengikut keperluan. Pada tahun 2011, BPFK telah menganjurkan 9 sesi dialog dengan persatuan yang berikut:

of 2011, a total of 9 dialogues sessions were held with the following associations:

Jadual 10 : Dialog antara BPFK dengan Persatuan-persatuan 2011Table 10 : Dialogues between NPCB and Associations 2011

Bil. Persatuan atau Industri TarikhNo. Association or Industry Date

1. Cosmetic, Toiletry and Fragrance Association of Malaysia (CTFA) 12 January 2011 19 May 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––2. Federation of Malaysian Manufacturers Malaysian Cosmetics and Toiletries 12 January 2011 Industry Group (FMM MCTIG) 19 May 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––3. Malaysian Organization of Pharmaceutical Industries (MOPI) 18 February 2011 6 July 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––4. Pharmaceutical Association of Malaysia (PhAMA) 18 February 2011 19 August 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––5. ‘Pengeluar-pengeluar Ubat Tradisional Melayu Malaysia’ (PURBATAMA) 21 April 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––6. ‘Persatuan Pengeluar Ubat Tradisional China Malaysia’ (PPUCM) 11 May 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––7. Federation of Chinese Physicians and Medicine Dealers Association of 11 May 2011 Malaysia (FCPMDAM)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––8. Pharmacy Enforcement Division (CPF) 10 August 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––9. Direct Selling Association of Malaysia (DSAM) 5 December 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––10. Malaysian Direct Distribution Association (MDDA) 5 December 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––11. Malaysian Dietary Supplement Association (MADSA) 5 December 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Penyelarasan Latihan, Seminar dan Kursus

Program Continuous Professional Development (CPD) merupakan program yang dianjurkan untuk meningkatkan tahap kompetensi dan pengetahuan pegawai farmasi dan penolong pegawai farmasi. Penganjuran sesi CPD di BPFK dikendalikan oleh Pusat Pembangunan Organisasi dan pada tahun 2011, sebanyak 190 sesi CPD telah dianjurkan. Ini merangkumi ceramah, seminar, bengkel, sesi Echo-Training dan sesi Journal Club. Selain itu, warga BPFK juga dihantar ke latihan, seminar dan kursus yang berkaitan dengan bidang kerja di bawah anjuran pihak kementerian.

Coordinate Trainings, Seminars and Courses

The Centre for Organizational Development is responsible for coordinating trainings, seminars and courses for NPCB as part of the Continuous Professional Development (CPD) Programme which is a programme to ensure constant knowledge development for pharmacist and assistant pharmacists. NPCB has organised a total of 190 CPD sessions which include educational talks, seminars, workshops, Echo-Training sessions and Journal Club sessions in 2011. Also, NPCB has sent its staff to relevant trainings, seminars and courses organized by other organizations for the aforementioned purpose.

101

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

BPFK telah menganjurkan latihan berkenaan teknik pemeriksaan menurut Garis Panduan Amalan Pengedaran Baik kepada pegawai-pegawai penguatkuasa farmasi yang terlibat secara langsung bagi pemeriksaan ke atas penstoran, pengendalian dan pengedaran produk-produk berdaftar dan kosmetik bernotifikasi. Bengkel tersebut telah diadakan pada 11 hingga 13 April 2011. Objektif utama latihan ini adalah untuk menyelaraskan praktis pemeriksaan ke atas pemborong-pemborong dan pengimport-pengimport produk berdaftar dan juga kosmetik bernotifikasi di kalangan pemeriksa-pemeriksa yang terdiri daripada pegawai-pegawai penguatkuasa farmasi dari setiap Cawangan Penguatkuasa Farmasi Negeri dan juga pemeriksa-pemeriksa daripada BPFK.

BPFK telah menganjurkan Seminar APB Berkaitan Veterinar 2011 pada 20 hingga 21 September 2011 di Hotel Grand Dorsett Subang yang mana seminar ini terbuka kepada 100 orang peserta dari kalangan pihak industri tempatan yang terlibat dengan kawalan regulatori ke atas produk veterinar oleh BPFK. Seminar ini turut mendapat kerjasama daripada Malaysian Pharmaceutical Society (MPS) dan Malaysian Animal Health and Nutrition Industries Association (MAHNIA) dan telah dihadiri oleh seramai 67 orang peserta termasuk wakil dari Bahagian Perkhidmatan Farmasi, Kementerian Kesihatan Malaysia.

Objektif seminar ini dianjurkan adalah untuk menyampaikan maklumat terkini berkaitan keperluan

An inspection techniques training based on the Guidelines on Good Distribution Practices (GDP) 2011 was organised by NPCB for pharmacy enforcement officers who are directly involved with the inspection on storage, handling and distribution of registered products. The workshop was conducted on 11th till 13th April 2011. The main objective of this training was to synchronise and harmonise the inspection practices upon importers and wholesalers of registered products as well as notified cosmetics among GDP inspectors (both pharmacy enforcement officers and NPCB inspectors).

The GMP Seminar on Veterinary 2011 was organised by NPCB on 20th till 21th September 2011 at the Grand Dorsett Hotel, Subang Jaya. This seminar targeted participants from local industries who were involved in the regulatory control of veterinary products under NPCB. This seminar also gained tremendous support from the Malaysian Pharmaceutical Society (MPS) and the Malaysian Animal Health and Nutrition Industries Association (MAHNIA). A total of 67 participants attended the seminar, including participants from the Pharmaceutical Services Division, Ministry of Health Malaysia.

One of the objectives of the seminar was to disseminate current information regarding the requirements for the registration of veterinary products and licensing of premises involved in any activity related with registered

Rajah53 : Bilangan Sesi Latihan (CPD) yang Dikendalikan (2007-2011)Figure 53 : Number of Continuous Professional Development (CPD) Sessions Handled (2007-2011)

50

0

100

150

200

2007 2008 2009

Tahun/Year

Bil.

Ses

i CP

DN

o. o

f C

PD

Ses

sio

ns

2010 2011

57

71

92103

190

102

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Penyebaran Maklumat, Latihan dan Lawatan (Sambungan)Information Dissemination, Trainings and Visitors (Continued)

pendaftaran produk veterinar dan keperluan pelesenan premis yang menjalankan aktiviti berkaitan produk veterinar berdaftar di Malaysia. Selain itu, seminar ini juga bertujuan untuk memperkenalkan keperluan asas APB dan AEB kepada pengilang, pengimport dan pemborong produk veterinar ke arah implementasi pengawalan regulatori produk veterinar di Malaysia.

Seminar APB untuk Pengilang Ubat Tradisional dan Kosmetik 2011 telah diadakan pada 13 hingga 14 Disember 2011 di Holiday Inn Kuala Lumpur, Glenmarie, Shah Alam. Penceramah-penceramah bagi seminar ini terdiri daripada pegawai-pegawai dari Pusat Komplians dan Pelesenan, Pusat Kawalan Kualiti dan Pusat Pasca Pendaftaran Produk. Objektif seminar ini diadakan adalah untuk meningkatkan kefahaman pengilang-pengilang produk tradisional berdaftar dan kosmetik bernotifikasi berkaitan keperluan asas APB.

Beberapa langkah telah diambil bagi memperkenalkan Garis Panduan AEB, iaitu dengan mengadakan siri latihan dan taklimat kepada pegawai-pegawai farmasi di hospital, klinik kesihatan, dan wakil-wakil industri. Selain itu, satu bengkel penyelarasan pemeriksaan AEB juga telah dijalankan pada 11 hingga 13 April 2011 dengan kerjasama Seksyen Pelesenan CPF, KKM. Objektif utamanya adalah untuk menyelaraskan praktis pemeriksaan AEB.

Selaku Agensi Pemantau Pematuhan Kebangsaan (APPK), BPFK bersama-sama STANDARDS MALAYSIA telah menjalankan 5 Latihan Dalaman kepada para Inspektor mereka dari bulan Februari hingga September 2011. Siri latihan ini bertujuan untuk mencapai harmonisasi dalam interpretasi prinsip-prinsip OECD GLP di antara inspektor dari kedua-dua Agensi Pemantau Pematuhan Kebangsaan (APPK).

Penyelarasan Lawatan Pelawat Tempatan dan Pelawat Antarabangsa

BPFK merupakan satu-satunya badan regulatori di Malaysia yang dilantik sebagai WHO Collaborating Center for Regulatory Control of Pharmaceuticals. BPFK sering menjalankan latihan atau menyelaraskan lawatan untuk pelawat dari dalam dan luar negara. Pada tahun 2011, jumlah pelawat dalam negara yang disambut oleh BPFK adalah 149, manakala jumlah pelawat dari luar negara adalah 37. Pelawat dari luar negara berasal dari negara-negara yang berikut: United States of America, Korea, Nigeria, Bangladesh, Syria, Kuwait, Thailand, Lebanon, Jordan, Philippines,

veterinary products in Malaysia. In addition, the seminar also aimed to introduce basic GMP and GDP requirements to veterinary product manufacturers, importers and wholesalers towards the implementation of veterinary product regulatory control in Malaysia.

The GMP Seminar for Traditional Medicines and Cosmetics Manufacturers was held on 13-14 December 2011 at Holiday Inn Kuala Lumpur, Glenmarie, Shah Alam. The speakers for this seminar were officers from the Centre for Compliance and Licensing, Centre for Quality Control and Centre for Post Registration of Products. The objective of this seminar was to increase the understanding of manufacturers of traditional medicines and cosmetics regarding basic GMP requirements.

Several steps had been taken to introduce the GDP Guidelines such as the organisation of a series of training and briefing to pharmacists in hospitals, clinics and representatives from the industry. In addition, a workshop was conducted on 11th-13th April 2012 together with the Licensing Section of the Pharmacy Enforcement Division, Ministry of Health Malaysia to synchronise and harmonise the GDP inspection practices.

As the National Compliance Monitoring Authority (CMA), NPCB in conjunction with STANDARDS MALAYSIA had conducted 5 in-house trainings for their GLP Inspectors from February till September 2011. The trainings were conducted to harmonize the understanding and interpretation among the Compliance Monitoring Authorities (CMAs) inspectors pertaining to Principles of OECD GLP and to exchange views on any GLP issues.

Coordinate Visits by Local and International Visitors

The NPCB represents a good training ground for pharmaceutical quality assurance and regulatory affairs as it is the only WHO Collaborating Center for Regulatory Control of Pharmaceuticals in Malaysia. In 2011, NPCB has received a total of 149 local visitors and 37 international visitors. The international visitors are from the following countries: United States of America, Korea, Nigeria, Bangladesh, Syria, Kuwait, Thailand, Lebanon, Jordan, Philippines, Bolivia, Democratic People’s Republic of Korea (North Korea), Vietnam, Sri Lanka, India, United Kingdom, Japan and Switzerland. The training fields provided in this year

103

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Bolivia, Democratic People’s Republic of Korea (North Korea), Vietnam, Sri Lanka, India, United Kingdom, Japan dan Switzerland. Antara latihan yang diberikan pada tahun ini termasuk amalan pengilangan baik, analisi farmaseutikal, pendaftaran produk dan sistem pelesenan.

include but were not limited to good manufacturing practice, pharmaceutical analysis, product registration, and licensing system.

Rajah 54 : Bilangan Pelawat (2007-2011)Figure 54 : Number of Visitors (2007-2011)

50

0

100

150

200

250

2007

228

65

2008

66

24

2009

Tahun/Year

Bil.

Pel

awat

/ N

o. o

f V

isit

ors

170

136 14

9

114

2010

23

2011

37

Pelawat Dalam NegaraLocal Visitors

Pelawat Luar NegaraInternaoonal Visitors

104

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Penyebaran Maklumat, Latihan dan Lawatan (Sambungan)Information Dissemination, Trainings and Visitors (Continued)

Pelawat AntarabangsaInternational Visitors

Organisasi Bil. Pelawat Negara TarikhOrganisation No. of Visitors Country Date

ImmunoBiologics Corp (IBC) 1 United States 26 January 2011–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Korea Food & Drug Admnistration (KFDA) 4 South Korea 17 March 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––National Agency for Food and Drug 2 Nigeria 28 March - Administration and Control (NAFDAC) 8 April 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Directorate General of Drug Administration, 2 Bangladesh 18 - 22 April 2011Ministry of Health & Family Welfare

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Directorate General of Drug Administration, 1 Bangladesh 23 - 27 May 2011Ministry of Health & Family Welfare

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Intellectual Property & Innovation, 7 United States 29 June 2011United States Trade Representative

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––- Ministry of Health, Syria 9 Syria, Kuwait, 14 July 2011- Healthcare Planning & Development, Kuwait Lebanon, - WHO Country Office, Lebanon Jordan, - WHO Country Office, Jordan Philippines,- Bureau of Health Devices & Technology, Thailand, Department of Health, Philippines Bolivia- WHO Regional Office for the Eastern Mediterranean (EMRO), Egypt

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––National Clinical Lab for Medicine, 2 Democratic People’s 5 September -Pharmaceutical Control Authority Republic of Korea 28 October 2011 (North Korea)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Ministry of Health, Vietnam 2 Vietnam 3 - 7 October 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Medical Technology & Supplies, 1 Sri Lanka 3 - 7 October 2011National Drug Regulatory Authority

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Directorate General of Drug Administration, 1 Bangladesh 3 - 14 October 2011Ministry of Health & Family Welfare

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––National Research Institute for Panchakarma 1 India 10 October 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Organisation for Economic Cooperation & 4 United Kingdom, 14 - 19 NovemberDevelopment (OECD) Japan, Switzerland 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

105

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Pelawat TempatanLocal Visitors

Institusi Bil. Pelawat Delegasi TarikhInstitution No. of Visitors Delegates Date

Ministry of Health, Malaysia 18 State Deputy Director 5 May 2011 of Health (Pharmacy)

*from each state–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Department of Standards Malaysia, Ministry of 7 7 Officers from 24 May 2011Science Technology & Innovation (MOSTI) Standards Malaysia

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––- The Policy and International Relations 5 5 Representatives 29 June 2011 Division, Ministry of Health, Malaysia- Intellectual Property Corporation of Malaysia (MyIPO)- Ministry of International Trade and Industry (MITI) - Ministry of Domestic Trade, Co-operatives And Consumerism

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––WHO Representative Office, Malaysia 5 5 Representatives 14 July 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––International Medical University (IMU) 13 2 Lecturers and 7 September 2011 11 Students

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Institute of Bioscience 17 16 Post-graduate 1 December 2011 Students and 1 Representative

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Kuala Lumpur General Hospital (HKL) 2 Pharmacists from the 15 December 2011 Pharmacy Resource and Information Centre / National Pharmacy Call Centre (NPCC)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––International Islamic University Malaysia (UIAM) 74 1 Lecturer and 16 December 2011 73 Students (Kuantan Campus)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––MARA University of Technology (UiTM) 8 Students from the 27 December 2011 Pharmacy Faculty

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

106

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Penyebaran Maklumat, Latihan dan Lawatan (Sambungan)Information Dissemination, Trainings and Visitors (Continued)

Penyertaan BPFK dalam Aktiviti Antarabangsa 2011Participation of NPCB in International Events 2011

Mesyuarat/Latihan/Bengkel Tarikh TempatMeetings/Trainings/Workshops Date Venue

WHO/Tropical Disease Research (TDR) Training Workshop on 10-13 January 2011 Lucknow, IndiaGood Laboratory Practice (GLP)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––EUCRAF Workshop: Next Generation and Biosimilar 3-4 February 2011 Freiburg, GermanyMonoclonal Antibodies

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Regional Haematology and Oncology meeting 3-6 March 2011 Yangon, Myanmar

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 36th ASEAN Consultative Committee Meeting for 14-18 March 2011 Siem Reap, Standards and Quality (ACCSQ) Cambodia

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––World Health Organisation Global Learning Opportunities for 14-18 March 2011 Jakarta, IndonesiaVaccine Quality (GLO/VQ) Course on Evaluation of Clinical Data of New Vaccines for Registration

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 10th Meeting of the ASEAN TMHS Scientific 28 March – Siam City Hotel, Committee (ATSC), TWG on Stability Study and Shelf-Life 1 April 2011 Bangkok, ThailandMeeting, TWG on Safety Data and Efficacy Data Requirements Meeting

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 25th Meeting of the Working Group on Good Laboratory 5-7 April 2011 Paris, FrancePractice

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 1st ASEAN-USP Scientific Symposium 26-27 April 2011 Bangkok, Thailand

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 1st APEC Harmonisation Centre (AHC) Workshop 26-28 April 2011 Korea– Asia’s Role in Global Drug Development

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 1st WHO National Regulatory Authority (NRA) 3-5 May 2011 Bangkok, ThailandStrategic Forum

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Good Clinical Practice (GCP) Monitoring and Training Course 4-9 June 2011 Riyadh, Saudi Arabia

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 18th ASEAN Consultative Committee for Standards 7-10 June 2011 Singaporeand Quality (ACCSQ) Pharmaceutical Product Working Group (PPWG) Meeting

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Workshop on International Regulatory Capacity Enhancement 8-10 June 2011 Sao Paulo, Brazilfor Influence Vaccines (WIRCEIV)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Conference US-China Food and Drug Law – Ensuring Quality 13-14 June 2011 Beijing, ChinaImproving Safety, Expanding Access

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 1st Seminar on Understanding Biopharmaceutical 14-16 June 2011 Seoul, KoreaRegulatory Systems

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 16th ASEAN Cosmetic Committee (ACC) and 15th 21-23 June 2011 Brunei DarussalamASEAN Cosmetic Scientific Body (ACSB) Meetings; ASEAN Cosmetic Testing Laboratory Network (ACTLN)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

107

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Mesyuarat/Latihan/Bengkel Tarikh TempatMeetings/Trainings/Workshops Date Venue

WHO Working Group Meeting on Interaction of Herbal 23-25 June 2011 Milan, ItalyMedicines and Other Medicines

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––File Review of Products Submitted for 2011: Second Round 11-15 July 2011 Geneva, Switzerlandof Application of Vaccine Prequalification

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Attachment training on GLP Inspections and study with the 22-26 August 2011 MHRA, London & United Kingdom Good Laboratory Practice Monitoring Site Inspection diAuthority(UKGLPMA),MedicinesandHealthcareproducts AstraZeneca,Regulatory Agency (MHRA), United Kingdom Cheshire, United Kingdom

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Quality of Active Pharmaceutical Ingredients (API) 14-16 September Hyderabad, India 2011*Co-organised by WHO, The European Directorate for The Quality of Medicines & Healthcare (EDQM) and Drug Information Association (DIA)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––API Assesment Session Meetings organised by WHO 19-23 September Denmark 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Attachment Training for the Evaluation of Phase I Clinical Study 10-14 October 2011 Federal Agency for(First In Human) Medicines and Health Products (FAMHP), Belgium

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––2011 APEC Good Regulatory Review Practice Workshop on 11-15 October 2011 Taipei, TaiwanMedical Products

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 5th Round of Malaysia-European Union Free Trade 18-21 October 2011 Brussels, BelgiumAgreement (MEUFTA)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––China-ASEAN Meeting for Head of Drug Regulatory Agencies 22-23 October 2011 Nanning, Guangxi(Drug Safety Forum)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Health Products & Food Branch (HPFB) International 23-28 October 2011 Ottawa, CanadaRegulatory Forum 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Attachment Training for GMP, Biotechology / 24-28 October 2011 Melbourne, AustraliaBiopharmaceutical, Therapeutic Goods Administration (TGA)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Attachment Training on Regulatory Aspect of Traditional and 24-28 October 2011 Nonthaburi, ThailandHerbal Medicines

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Training on Authentication Analysis of Herbal Medicinal Product 11-22 November Yogyakarta, 2011 Indonesia

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 16th ASEAN Consultative Committee Meeting for 14-18 November Makati City, Standards and Quality Traditional Medicines and Health 2011 PhilippinesSupplements Product Working Group (ACCSQ TMHS PWG)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

108

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Mesyuarat/Latihan/Bengkel Tarikh TempatMeetings/Trainings/Workshops Date Venue

Federation of Asian Pharmaceutical Association (FAPA) 19-21 November Taipei, TaiwanIndustrial Pharmacy Conference on Generics in Asia 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Training Course on Good Governance of Medicines for 20 November – JapanPharmaceutical Regulation Authorities 15 December 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Copenhagen Assessment Meeting for the WHO 21-25 November Copenhagen, Prequalification of Medicines Programme 2011 Denmark

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 27th Meeting of the ASEAN Working Group 14-16 December Hanoi, VietnamPharmaceutical Development (AWGPD) 2011

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––The 12th Meeting of the ASEAN Technical Scientific 19-23 December Bangkok, ThailandCommittee (ATSC) and Technical Workshing Group (TWG) 2011for Traditional Products and Health Supplements

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

LAPORAN KEWANGANFINANCIAL REPORT

109

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

110

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Laporan KewanganFinancial Report

Sepanjang tahun 2011, BPFK telah menerima peruntukan sebanyak RM27,804,355 untuk perbelanjaan Mengurus dan RM2,278,500 untuk projek Pembangunan. Pecahan peruntukan tersebut seperti jadual di bawah:

In 2011, NPCB had received an allocation or RM27,804,355 for Operating Expenditure and RM2,278,500 for Development Expenditure. The breakdown of the allocation is as follows:

Jadual 11 : Peruntukan dan Perbelanjaan Mengurus BPFK bagi tahun 2011Table 11 : NPCB Operating and Expenditure 2011

Kod Objek Jenis Perbelanjaan Peruntukan (RM) Perbelanjaan (RM) Baki (RM)Object Code Expenditure Allocation (RM) Expenditure (RM) Balance (RM)

Perbelanjaan Asal Dipinda Bersih % - % Original Amended Actual Expenditure

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––10000 Emolumen 9,462,000 17,943,345 17,967,928.62 100.14 24,583.62 0.14 Emolument

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––20000 Perkhidmatan & 9,231,566 9,458,869 8,916,534.89 94.27 542,334.11 5.73 Bekalan Services & Supply

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––30000 Harta Modal 397,040 397,040 381,992.25 99.96 15,047.75 0.04 Asset

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––40000 Pemberian & Kenaan 4,817 4,817 4,816.34 99.99 0.66 0.01 Bayaran Tetap Gift and Fixed Payment

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––50000 Perbelanjaan Lain 284 284 284 100.00 - - Other Expenditure

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Jumlah 19,095,707 27,804,355 27,271,556.10 98.08 532,968.90 1.92 Total

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Jadual 12 : Peruntukan dan Perbelanjaan Pembangunan BPFK bagi Tahun 2011Table 12 : NPCB Development Allocation and Expenditure 2011

Kod Objek Jenis Perbelanjaan Peruntukan (RM) Perbelanjaan (RM) Baki (RM)Object Code Expenditure Allocation (RM) Expenditure (RM) Balance (RM)

Perbelanjaan Asal Dipinda Bersih % - % Original Amended Fixed Expenditure

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––00105 Latihan & Moda l Insan 15,000 120,000 109,642.25 99.91 10,357.75 0.09RMK-9 Training & Human Resources

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––94000 Projek NKEA/ 435,000 435,000 435,000 100.00 - -NKEA NKEA Project

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––BP Projek NKEA/ 1,723,500 1,723,500 1,723,454.50 99.99 45.50 0.0101100 NKEA ProjectNKEA

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

111

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Jadual 13 : Ringkasan Kutipan Hasil Tahun 2011Table 13 : Summary of Revenue 2011

Kutipan Hasil BPFK diterima melalui pelbagai bayaran untuk pendaftaran produk, notifikasi kosmetik, perlesenan, perkhidmatan makmal dan bayaran-bayaran yang lain.

NPCB obtained its revenue from various payments for product registractions, cosmetic notifations, licenses, laboratory tests as well as other payments.

Pengkelasan Kod Hasil Tahun Jumlah Kemaskini Classes of Revenue Total

Kod PerkaraCode Item

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––73199 Jualan Bahan Cetak 880.00 Selling Printed Materials

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––72499 Proses Perkhidmatan Makmal 20,190.00 Laboratory Test

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Amalan Perkilangan Baik 475,650.00 Good Manufacturing Practice

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Lesen Borong 464,000.00 Wholesale License

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––71499 Lesen Import 196,500.00 Import License

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Lesen Import Klinikal 118,000.00 Clinical Trial License

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Lesen Pengilangan 275,000.00 Manufacturing License

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––72199 Daftar Ubat 9,310,750.00 Product Registration

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Perakuan Penjualan 272,960.00 Certificate of Free Sales

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Tukar Pemegang 240,500.00 Change of Holder

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Pertukaran Tapak Kilang 56,000.00 Change of Site

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Daftar Ubat Eksport 19,800.00 Export Product Registration

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––71999 Bayaran-bayaran Lain 2.88 Other Payments

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––73999 Jualan-Jualan Lain 47,910.00 Others Sales

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––73301 Jualan Harta Benda Kerajaan 630.00 Selling of Asset

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––74299 Sewa Bangunan (kantin) 4,250.00 Rental (canteen)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––JUMLAH TOTAL 11,503,022.88

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

112

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Mukasurat ini sengaja dibiarkan kosong.This page was intentionally left blank.

CABARANCHALLENGES

113

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

114

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

CabaranChallenges

1. Cabaran utama yang dihadapi bagi pendaftaran produk adalah untuk memastikan supaya jangka masa penilaian permohonan pendaftaran produk mematuhi piagam pelanggan. Penambahbaikan dalam proses penilaian termasuk sistem atas talian dibuat secara berterusan tanpa mengabaikan aspek kualiti, keselamatan serta keberkesanan produk. Bebarapa tindakan yang telah diambil termasuk:

i) Perbincangan khas secara individu dengan syarikat pemohon yang mempunyai masalah dengan permohonan. Sesi perbincangan ini adalah bertujuan untuk meningkatkan pemahaman pemohon daripada segi keperluan pendaftaran serta menyelesaikan masalah yang dihadapi oleh pemohon demi melancarkan pemprosesan permohonan.

ii) Menghubungi pemohon melalui telefon, menjawab emel atau membuat temujanji dengan pemohon serta memberi tunjukajar penggunaan sistem atas talian.

iii) Mengadakan bengkel dan sesi latihan untuk pemohon.

iv) Pembentukan Jawatankuasa Teknikal yang terdiri daripada BPFK dan persatuan yang mewakili pihak industri bagi tujuan mencapai persefahaman terhadap polisi sedia ada serta mencapai persetujuan terhadap polisi baru yang akan dikuatkuasakan.

v) Mengemaskini Drug Registration Guidance Document (DRGD) melalui pelbagai bengkel dan mesyuarat supaya keperluan pendaftaran produk dapat difahami oleh pemohon.

vi) Bagi produk generik dalam kategori Racun Berjadual dan Bukan Racun Berjadual, template maklumat produk telah disediakan dan dipaparkan pada laman BPFK sebagai panduan dalam penyediaan maklumat produk pada Part A dan sisip bungkusan. Apabila pemohon menggunakan template tersebut, penilaian permohonan akan dimudahkan dan maklumat produk-produk generik dengan bahan aktif yang sama akan menjadi lebih konsisten.

vii) Pegawai-pegawai telah dihantar untuk mengikuti latihan dalaman dan di luar BPFK untuk meningkatkan pengetahuan dan kemahiran supaya lebih kompeten dalam menjalankan tugas sebagai penilai permohonan pendaftaran.

1. The major challenge in product registration is to ensure the compliance to client’s charter with respect to application processing timeline. Improvement in the evaluation process including the online system is ongoing without compromising the quality, safety and efficacy of products. Among the measures taken included:

i) Specific discussions with applicants identified to have problems with their applications. These sessions were intended to improve the level of understanding among applicants in terms of registration requirements and also to solve problems faced by applicants in order to facilitate the application process.

ii) Communicate with applicants via phone, emails or appointments to provide guidance and advice in utilising the online registration system.

iii) Organising workshops and training sessions for applicants.

iv) Formation of Technical Committee comprising of the NPCB and associations in order to achieve mutual understanding on existing policies and reaching agreements on new policies that will be enforced.

v) Updating the Drug Registration Guidance Documents (DRGD) via series of workshops and meetings for better understanding among applicants on the registration requirements.

vi) For generic products, both Scheduled Poison and Non-Scheduled Poison, templates on product information had been prepared and uploaded on NPCB’s website. These templates can be used by applicants as a guide in preparing product information in Part A and package insert. By utilising these templates, product evaluation would be simplified and information among generic products with the same active ingredient would be more consistent.

vii) Officers were sent for in-house trainings and other external trainings to enhance their knowledge and skills to be more competent as an evaluator of application for product registration.

115

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

2. Bagi produk veterinar, cabaran utama yang dihadapi adalah untuk mengatasi tunggakan permohonan pendaftaran produk veterinar sedia ada. Selain itu, proses penilaian produk veterinar dijejaskan oleh:

i) Masalah Sistem QUEST3 yang berfungsi dengan kurang baik,

ii) Formulasi produk / kombinasi baru yang tidak didaftarkan di mana-mana negara rujukan,

iii) Kesukaran dalam memperolehi sumber rujukan (selain daripada Racun Berjadual),

iv) Pemohon juga mengambil masa yang lama untuk melengkapkan permohonan,

v) Kegagalan pengilang dalam mematuhi keperluan amalan pengilangan baik (APB).

3. Pertambahan sumber manusia, kemudahan

makmal dan peralatan analisis adalah diperlukan untuk menjayakan aktiviti-aktiviti berikut:

i) Pengembangan skop pengujian makmal dan penilaian data validasi dalam produk-produk vaksin, produk-produk bioteknologi, bahan aktif farmaseutikal (API) dan penanda kimia (biomarker) dalam produk semulajadi bagi menangani cabaran perkembangan produk dalam arena regulatori.

ii) Pembangunan metodologi baru di samping menjalankan aktiviti validasi ke atas tatacara pengujian produk semulajadi yang telah dibangunkan.

4. Cabaran untuk meneruskan usaha ke arah 100% permohonan lesen secara atas talian melalui Sistem QUEST3.

5. Cabaran untuk membantu dan meningkatkan kefahaman APB di kalangan industri tempatan. Contohnya, mengadakan lebih banyak dialog dan perbincangan dengan syarikat yang lemah dalam pematuhan APB.

6. Usaha untuk sentiasa melatih dan mempertingkatkan ilmu pengetahuan dan kemahiran sejajar dengan kemajuan teknologi dalam industri pengilangan produk farmaseut ika l khususnya produk berasaskan bioteknologi.

2. For veterinary products, the main challenge is to address the outstanding (backlog) applications for the current products under evaluation. Besides, the evaluation process of veterinary products is affected by:

i) The technical instability of QUEST3 System,

ii) Formulation / combination of products that have not been registered in any of the reference countries,

iii) Difficulties in retrieving references (other than Scheduled Poison),

iv) Applicants taking a long period to provide complete documentation,

v) Failure of manufacturers to comply with the Good Manufacturing Practice (GMP) requirements.

3. Ensuring sufficient manpower, laboratory facilities and equipment is essential in order to achieve following activities:

i) Expansion in laboratory testing and analytical data evaluation on vaccines, biotechnology products, active pharmaceutical ingredients (API) as well as marker compounds in natural products in order to address the challenges from evolving regulatory landscape.

ii) Planned method development as well as comprehensive validation activities on the in-house developed methods on natural and cosmetic products.

4. NPCB strives to achieve 100% online applications for licensing (through the QUEST3 System).

5. It is a challenge to facilitate and enhance the understanding towards GMP among local manufacturers. For instance, more dialogues and discussions with companies with poor GMP compliance.

6. Efforts to continuously train and improve the GMP auditors’ inspection knowledge and skills in line with new technology advancements in pharmaceutical manufacturing, especially in biotechnology products.

116

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Cabaran (Sambungan)Challenges (Continued)

7. Clinical Research Malaysia (CRM) merupakan Entry Point Project 2 yang dikenalpasti dalam National Key Economic Area (NKEA). Antara sasaran yang ditetapkan oleh CRM adalah peningkatan bilangan penyelidikan klinikal yang akan dijalankan di Malaysia ke 1000 kajian klinikal menjelang tahun 2020.

Pembinaan satu badan regulatori yang matang, kompetitif dan berpengalaman merupakan salah satu cabaran yang perlu ditangani dalam penwujudan satu ekosistem yang boleh meransangkan penumbuhan penyelidikan klinikal di Malaysia.

Bagi menangani cabaran ini, pegawai-pegawai penilai di BPFK hendaklah diberi latihan spesifik dalam bidang-bidang yang innovatif dan kompleks seperti berikut untuk meningkatkan kemahiran dan kepakaran penilaian pegawai:

i) Penyelidikan klinikal peringkat awal termasuk penyelidikan first-in-human and exploratory clinical trial

ii) Advanced Therapy Product termasuk cell-based therapy, tissue engineered product and gene-therapy medicinal product

Kemahiran penilaian seseorang pegawai dalam bidang-bidang tersebut boleh dimantapkan melalui latihan sangkutan dengan badan-badan regulatori yang berpengalaman seperti EMA, USFDA, Australian TGA dan sebagainya. Dengan ini, Malaysia dapat menarik lebih banyak pelaburan dari sponsor untuk menjalankan kajian percubaan klinikal di Malaysia di samping merealisasikan sasaran yang ditetapkan oleh CRM.

8. Mewujudkan sistem pengurusan data untuk membolehkan analisa laporan SUSAR yang diterima serta mempunyai sistem pemantauan yang lebih kukuh.

9. Mengklasifikasi serta manganalisa laporan SUSAR berdasarkan system klasifikasi Medical Dictionary for Regulatory Activities (MeDRA) untuk kesan advers.

10. Cabaran untuk membantu Malaysia mencapai status pematuhan penuh kepada Sistem Mutual Acceptance of Data (MAD) menjelang akhir tahun 2012. Untuk menjadi non-OECD member adhering to MAD system, BPFK telah dinilai oleh pasukan OECD GLP semasa pemeriksaan Mutual Joint Visit (MJV) pada 16-18 November 2011. Mesyuarat

7. Clinical Research Malaysia (CRM) has been identified as Entry Point Project 2 under the Health National Key Economic Areas (NKEA) of the Economic Transformation Programme. Among the goals set by the CRM includes increasing the number of clinical trials to be conducted in Malaysia by the year 2020 to 1,000 clinical trials.

Building a more mature, competitive and experienced regulatory environment has been identify as one of the issues and challenges that needs to be addressed in creating a supportive ecosystem to stimulate the growth of clinical research in Malaysia.

In order to build and enhance the ecosystem, evaluators from NPCB are required to undergo specialised training in the following innovative and challenging fields to improve their technical knowledge and efficiency in evaluation clinical trial application:

i) Early phase clinical trial including first-in-human trial and exploratory clinical trial

ii) Advanced Therapy Product including cell-based therapy, tissue engineered product and gene-therapy medicinal product.

To bolster the expertise in said, officers are required to have an attachment training with other more experienced regulatory authorities, such as European Medicines Agency, US Food and Drug Administration, Australian TGA etc. With a more competent regulatory environment, Malaysia can no doubt attract more international clinical trials besides being an important step forward to the realisation of goal set by CRM.

8. Establishing a data management system to analyze the SUSAR reports received to facilitate a more robust monitoring system.

9. To classify and analyze SUSAR reports in accordance to Medical Dictionary for Regulatory Activities (MeDRA) classification for adverse events.

10. The challenge in helping Malaysia to achieve the status of full adherence to the Mutual Acceptance of Data (MAD) System by the end of 2012. To become a non-OECD member adhering to MAD system, NPCB had gone through a Mutual Joint

117

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Penutup telah berlangsung dengan jayanya pada 19 November 2011 dan telah dihadiri oleh Dato’ Eisah A. Rahman selaku Pengarah Perkhidmatan Farmasi, Kementerian Kesihatan Malaysia, Dr. Tajuddin Akasah, Pemangku Pengarah BPFK, inspektor-inspektor BPFK dan pasukan OECD GLP. Komen-komen yang diberi oleh pasukan OECD GLP dalam Mesyuarat Penutup adalah positif dan menggalakkan. Berita ini akan menjadikan BPFK lebih hampir untuk menjadi non-OECD member adhering to MAD system. Dengan menjadi non-OECD member adhering to MAD system, BPFK menghadapi cabaran untuk memastikan Program Pemantauan Pematuhan GLP BPFK memenuhi keperluan OECD GLP dan memastikan Fasiliti Kajian di Malaysia mematuhi keperluan GLP.

11. Cabaran yang dihadapi dalam pemantauan keselamatan produk termasuk:

i) Pelaporan kesan advers oleh pihak swasta terutamanya pengamal perubatan masih berkurangan walaupun laporan keseluruhan ADR menunjukkan peningkatan.

ii) Penerimaan laporan ADR yang tidak lengkap dengan maklumat-maklumat yang penting bagi membolehkan analisa yang tepat dilakukan. Ini menyebabkan pelapor perlu dihubungi semula bagi memperolehi maklumat tambahan.

iii) Tiada sistem signal detection yang mantap untuk memudahkan langkah-langkah proaktif diambil bagi ubat-ubatan yang mempunyai isu-isu keselamatan dan tindakan pencegahan dapat dilakukan dengan segera. Buat masa ini signal detection dilakukan melalui pemantauan secara manual.

iv) Bilangan laporan ADR yang diterima semakin meningkat sejak beberapa tahun yang lalu. Siasatan perlu dijalankan terutama pada kesan advers yang serius supaya dapat membuat penilaian yang baik. Dengan peningkatan bilangan laporan dan keperluan untuk menghubungi pelapor bagi memperoleh informasi tambahan untuk membuat analisis, kemampuan dan keupayaan staf BPFK perlu ditingkatkan supaya dapat menangani beban kerja ini.

Visit (MJV) Inspection by the OECD GLP inspection team on 16-18 November 2011 as mentioned above. The Exit Meeting was successfully held on the 19 November 2011, attended by Dato’ Eisah A.Rahman, the Senior Director of Pharmacy, Dr. Tajuddin Akasah, the Acting Director of NPCB, inspectors from NPCB and OECD GLP team. The comments given by the OECD GLP Experts during the Exit Meeting were positive and encouraging. The news will make NPCB a step closer to becoming a non-OECD member adhering to MAD system. By becoming the non-OECD member adhering to MAD system, NPCB will be faced with the challenges of ensuring that its Compliance Monitoring Programme fulfills the OECD GLP requirements and that the Test Facilities in Malaysia are in compliance with the requirements of the OECD Principles of GLP.

11. The challenges in product safety monitoring included:

i) Adverse event reports by private healthcare professional especially from general practitioners are lacking despite the general increase in the number of ADR reports.

ii) The ADR reports received lack vital information and these have hampered the process of causality assessment. The reporter has to be contacted to provide further information.

iii) Unavailability of an efficient ADR signal detection system to facilitate proactive action on medicines with safety issues and to enable the implementation of prompt preventive action. Currently, signal detection is monitored manually.

iv) The number of ADR reports received has consistently increased over the years. Investigations have to be carried out, especially on serious adverse effects, for accurate causality assessment. With the increase in number of reports and the need to contact the reporters to acquire additional information, the capacity of NPCB staff has to be increased in order to handle the workload.

118

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Cabaran (Sambungan)Challenges (Continued)

12. Cabaran yang dihadapi dalam variasi produk termasuk:

i) Asean Variation Guideline (AVG)

Malaysia telah diberikan penghormatan oleh ASEAN Consultative Committee on Standards and Quality–Pharmaceutical Product Working Group (ACCSQ–PPWG) untuk menerajui dalam perangkaan ASEAN Variation Guideline (AVG). Pada akhir tahun 2011, draf AVG ke-7 adalah dalam peringkat kompilasi dan akan dibentangkan pada mesyuarat ACCSQ–PPWG yang akan datang untuk adoption.

ii) Permohonan Variasi Produk QUEST3

Memandangkan lebih banyak produk akan didaftarkan melalui sistem QUEST3 pada masa hadapan, bilangan permohonan variasi untuk produk QUEST3 juga akan meningkat. Pada masa kini, permohonan variasi untuk produk QUEST3 diproses secara manual di mana surat kepada dan dari pemohon perlu diproses dan dihantar secara manual yang mengambil lebih banyak masa berbanding kepada permohonan online.

13. Cabaran yang dihadapi dalam notifikasi produk kosmetik termasuk:

i) Pihak pemegang notifikasi dan pengilang masih kekurangan kemahiran teknikal untuk menjalankan penilaian keselamatan terhadap produk siap serta bahan-bahan yang digunakan dalam formulasi produk kosmetik.

ii) Kurangnya kesedaran dan tanggungjawab di kalangan pihak syarikat yang memasarkan dan mengiklankan produk kosmetik secara tidak berasas dan melampaui skop takrifan kosmetik. Ia menjadi cabaran kepada pihak BPFK untuk meningkatkan kesedaran di kalangan pengguna agar tidak tertipu dengan tuntutan-tuntan sedemikian yang dinyatakan pada label dan iklan produk kosmetik.

14. Pengurusan sistem QUEST3 merupakan salah satu cabaran terbesar untuk BPFK memandangkan sistem ini belum lagi stabil dari segi teknikal dan gangguan teknikal sering berlaku. Staf dari seksyen ICT dipaksa sering membuat kerja penyelenggaraan dan pengemaskinian data untuk memastikan kelancaran penggunaan sistem QUEST3 supaya tidak menjejaskan proses kerja warga BPFK dan juga pelanggan BPFK.

12. The challenges in product variation included:

i) Asean Variation Guideline (AVG)

Malaysia was given the honor by the ASEAN Consultative Committee on Standards and Quality - Pharmaceutical Product Working Group (ACCSQ–PPWG) to lead the drafting of the ASEAN Variation Guideline (AVG). At of the end of 2011, the 7th AVG draft is in the compilation stage and will be tabled in the upcoming ACCSQ – PPWG meeting for adoption.

ii) Variation Applications for QUEST3 Products

As more products will be registered via the QUEST3 system in the near future, there will also be an increase in variation applications for QUEST3 products. Currently, variation for QUEST3 products are processed manually where letters to and from the applicants have to be processed and issued manually which consumes more time compared to online applications.

13. The challenges faced in cosmetic notification include:

i) Many notification holders and manufacturers are still lacking of the technical expertise to conduct safety evaluations on their finished product and on the ingredients in the product formulation.

ii) Companies lack awareness / responsibility when marketing / advertising cosmetic products including making unsubstantiated claims exceeding the scope of cosmetics products on the promotional materials. This poses a challenge for NPCB to educate the public so that they do not fall victim to these types of promotion and advertisements.

14. Amongst the challenges faced by the NPCB, the management of the QUEST3 system is one of the constant ones. This is because the system is not technically stable hence the Centre for Organisational Development has to do constant maintenance works to ensure that there are no interruptions of usage of the system.

HALA TUJUTHE WAY FORWARD

119

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

120

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Hala TujuThe Way Forward

1. Keperluan pendaftaran akan dikaji semula dari masa ke masa selaras dengan keperluan yang telah ditetapkan di peringkat antarabangsa bertujuan untuk meningkatkan jaminan kualiti, keselamatan dan keberkesanan produk-produk yang berdaftar dengan PBKD. Selain itu, melalui sistem pendaftaran yang setanding dengan negara-negara maju, produk-produk tempatan akan diterima di luar negara dan secara tidak langsung, meningkatkan eksport produk tempatan ke luar negara. Ini akan membantu meningkatkan ekonomi negara selaras dengan matlamat kerajaan dalam program transformasi ekonomi.

2. Mulai 2012, PBKD akan menguatkuasakan keperluan-keperluan berikut :

i) Kawalan secara mandatori bagi bahan aktif farmaseutikal bagi ubat dalam kategori Entiti Kimia Baru.

ii) Keperluan kajian bioekuivalens bagi semua

produk generik dalam bentuk Immediate Release, Oral and Solid Dosage Form yang mengandungi bahan aktif Racun Berjadual.

iii) Keperluan mengemukakan sijil analisa dan data stabiliti bagi kelompok pilot bagi produk yang dikilangkan oleh pengilang tempatan.

iv) Keperluan Amalan Perkilangan Baik mengikut piawaian PIC/S bagi produk farmaseutikal yang dikilangkan di premis pengilang luar Negara.

3. Garipanduan pendaftaran akan dikemaskini dari masa ke masa untuk meningkatkan kefahaman pemohon daripada segi keperluan pendaftaran. Garispanduan Requirements for Higher Treatment Claims / Indications untuk produk semulajadi dan suplemen kesihatan sedang disediakan. Garispanduan ini akan mengambilkira keperluan regulatori Negara-negara ASEAN lain, Eropah, Kanada dan Australia.

4. BPFK juga akan membantu dan memberi sokongan kepada syarikat pengilang tempatan dan pemohon yang terlibat dalam Program Transformasi Ekonomi Kerajaan. Melalui projek seperti Entry Point Project 3 (EPP3) yang bertujuan untuk meningkatkan eksport produk generik tempatan, permohonan pendaftaran produk akan diproses dengan cepat (dalam tempoh 60 hari bekerja sekiranya permohonan yang dikemukakan adalah lengkap dan memenuhi semua keperluan PBKD). BPFK akan terus membantu syarikat pengilang tempatan yang menjalin usahasama dengan syarikat multinasional yang melibatkan peralihan teknologi (technology transfer) dengan mempercepatkan pemprosesan permohonan pendaftaran.

1. The registration requirement will be revised from time to time in line with international requirements in order to improve quality assurance, safety and efficacy of registered products by the DCA. In addition, with an advanced registration system in place, local products will be accepted in overseas. This will indirectly increase the export of local products and boost the economic growth in line with the objective in the economic transformation programme.

2. From 2012 onwards, the DCA will enforce the following requirements:

i) Mandatory regulatory control on Active Pharmaceutical Ingredients (API) for New Chemical Entities (NCE).

ii) Bioequivalence study reports for all generics in immediate release, oral and solid dosage form for products containing Scheduled Poisons.

iii) Certificate of Analysis and stability data of pilot batches for local products.

iv) Good Manufacturing Practice requirements (in accordance to the PIC/S Standards) for pharmaceutical products manufactured by overseas manufacturers.

3. The Drug Registration Guidance Document will be updated from time to time to improve the understanding among applicants regarding product registration requirements. In addition, the Guideline on the Requirements for Higher Claims / Indications for natural products and health supplements is being prepared. This guideline will take into consideration the regulatory requirements in ASEAN countries, Europe, Canada and Australia.

4. NPCB will also assist and provide continuous support to local manufacturers and applicants involved in the Government’s Economic Transformation Programme (ETP). With projects (such as Entry Point Project 3 (EPP3)) aimed to increase the exports of local generic products, the registration application process will be expedited (within 60 working days provided the application is complete and complies with all DCA requirements). NPCB will continue to assist companies and local manufacturers that are engaged in collaboration with multinational companies (involving technology transfer) by facilitating the registration application process.

121

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

5. Bagi produk veterinar, pelesenan terhadap semua premis pengilang produk veterinar tempatan dijangka bermula pada 1 Januari 2012.

6. Pegawai-pegawai penilai akan menjalani latihan dalam dan luar negara bagi meningkatkan kemahiran dan kompetensi dalam bidang tugas masing-masing. Pembangunan sumber manusia dari segi jumlah kakitangan serta pembangunan infrastruktur juga akan dipertingkatkan bagi menyediakan persekitaran kerja yang selesa dan selamat supaya keadaan bagi menjamin prestasi kerja pada paras yang tertinggi.

7. BPFK akan menggiatkan usaha untuk mentauliahkan lebih ramai juruaudit kawalan kualiti makmal (dalam bidang kimia dan mikrobiologi) untuk mengukuhkan pematuhan Amalan Perkilangan Baik (APB) dalam industri tempatan.

8. Penambahan skop akreditasi untuk MS ISO/IEC 17025:2005 seperti yang dinyatakan di bawah:

i) Ujian had merkuri untuk produk semulajadi menerusi ‘Direct Combustion Mercury Analyser’.

ii) Ujian identifikasi sildenafil, tadalafil dan vardenafil di dalam produk semulajadi.

iii) Ujian kontaminasi mikrobial untuk produk semulajadi berdasarkan BP 2012.

iv) Ujian identifikasi dan kandungan lovastatin di dalam kapsul ‘red yeast rice’.

v) Ujian had arsenik, plumbum dan kadmium untuk produk kosmetik menggunakan ‘Graphite Furnace Atomic Absorption Spectrometry’.

vi) Ujian had merkuri untuk produk kosmetik dengan menggunakan ‘Cold Vapour Atomic Absorption Spectrometry’.

vii) Ujian identifikasi dan kandungan hydroquinone di dalam krim produk kosmetik.

viii) Ujian kontaminasi mikrobial untuk produk kosmetik.

9. Meneruskan penglibatan aktif dalam pembangunan Monograf Herba Malaysia bersama dengan institusi kerajaan yang berkaitan, universiti dan industri produk semulajadi tempatan.

5. Licensing for the premises of all local veterinary product manufacturers is expected to be implemented by 1 January 2012.

6. Evaluators will undergo local and overseas training in order to enhance their skills and competencies in their relevant job scopes. Human resource development in terms of number of staff and infrastructure will also be enhanced to provide a conducive and safe working environment to ensure maximum performance level.

7. The NPCB is determined to train and authorise more competent / qualified quality control laboratory auditors (in chemical & microbiology) for the purpose of enhancing GMP compliance among local pharmaceutical industries.

8. Extension of MS ISO/IEC 17025:2005 Accreditation scope with the addition of the following tests:

i) Mercury Limit Test for natural products using Direct Combustion Mercury Analyser.

ii) Identification Test for Sildenafil, Tadalafil and Vardenafil in natural products.

iii) Microbial Contamination Test for natural products based on BP 2012.

iv) Identification and Quantification Test for Lovastatin in Red Yeast Rice Capsule.

v) Arsenic, Lead and Cadmium Limit Test for Cosmetic Products using Graphite Furnace Atomic Absorption Spectrometry.

vi) Mercury Limit Test for Cosmetic Products using Cold Vapor Atomic Absorption Spectrometry

vii) Identification and Quantification Test for Hydroquinone in cream of Cosmetic Products

viii) Microbial Contamination Test for Cosmetic Products.

9. Continue to participate in the development of Malaysian Herbal Monograph in collaboration with other government institutions, universities and local natural product industries.

122

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Hala Tuju (Sambungan)The Way Forward (Continued)

10. Penubuhan unit-unit baru dalam pengujian bahan aktif farmaseutikal (API), produk-produk vaksin dan bioteknologi untuk memastikan keselamatan, kualiti dan efikasi produk-produk ini.

11. BPFK juga akan terlibat dalam pembangunan ‘ASEAN Non-Pharmacopoeia Analytical Method under ASEAN Working Group on Pharmaceutical Development’ (AWGPD) fokus kepada pengesanan bahan campurpalsu farmaseutikal di dalam produk semulajadi.

- Verifikasi tatacara pengesanan betamethasone, cortisone, prednisolone dan prednisone di dalam produk semulajadi menggunakan kaedah HPLC.

12. Menjalankan ujian percubaan untuk produk vaksin / biotek mengikut tatacara pembuat dan farmakopia.

13. Terlibat dalam ujian profisiensi untuk:

- Esei Gentamicin yang dianjurkan oleh Thailand

- Ujian kontaminasi mikrobial bagi produk semulajadi dan kosmetik yang dianjurkan oleh IFM, Australia

14. Memperkenalkan dan menjalankan pemeriksaan Amalan Edaran Baik (AEB) terhadap pengimport dan pemborong berlesen di seluruh negara.

15. Menjalankan pemeriksaan Amalan Penyediaan Baik (GPP) ke atas fasiliti kesihatan KKM dan swasta.

16. Terlibat dalam pengendalian projek kerajaan Rural Transformation Centre (RTC) yang bertujuan membantu membangunkan pengilang-pengilang kecil dan sederhana atau individu awam yang berminat untuk terlibat dalam aktiviti pengilangan produk tradisional berdaftar dan kosmetik bernotifikasi.

17. Sistem laporan SUSAR yang sedia ada adalah menerusi penghantaran borang CIOMS melalui e-mel ke [email protected]. Laporan yang diterima akan disaring, diklasifikasikan dan dimasukkan ke dalam pangkalan data secara manual. Oleh itu, infrastruktur semasa tidak membolehkan laporan serta analisa dibuat dengan efisien dan cepat. Bagi mengatasi kelemahan ini, satu sistem sedang dibangunkan dengan menggunakan QUEST3+ untuk membolehkan laporan SUSAR dibuat secara online dan terus ke pangkalan data yang disediakan. Ini akan

10. To establish new laboratory testing units to venture into analytical testing of Active Pharmaceutical Ingredient (API), vaccines and biotechnology products in order to ensure the safety, quality and efficacy of these products.

11. The NPCB will also take part in the development of ASEAN Non-Pharmacopoeia Analytical Method under ASEAN Working Group on Pharmaceutical Development (AWGPD) focusing on the detection of pharmaceutical adulterants in natural products.

- To verify method for detection of betamethasone, cortisone, prednisolone and prednisone in adulterated natural products by using HPLC.

12. To conduct trial run test for vaccine / biotech products according to manufacturer’s protocol and pharmacopoeia method.

13. To take part in Proficiency Testing for:

- Gentamicin Assay organised by Thailand

- Microbial Contamination Test for natural products and cosmetics organised by IFM, Australia

14. To introduce and perform Good Distribution Practice (GDP) inspections upon licensed wholesalers and importers as well as importers for notified cosmetics throughout the country.

15. To conduct Good Preparation Practice (GPP) inspections on government and private healthcare facilities.

16. To assist in the handling of Rural Transformation Centre (RTC), a government project aimed to help develop small and medium manufacturers, or individuals who are interested to manufacture traditional medicines and notified cosmetics.

17. The current system for SUSAR report submission is done v ia emai l ing the CIOMS form to [email protected]. These reportswill then be manually screened, sorted and entered into a database for compilation and analysis. As such, the current infrastructure is not conducive to enable timely monitoring as well as analysis of the SUSAR reports received. To

123

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

membolehkan lebih tumpuan untuk diberikan kepada pemantauan serta analisa laporan SUSAR yang diterima.

18. Selaras dengan arahan di bawah peraturan 29, Peraturan-peraturan Kawalan Dadah dan Kosmetik 1984, Bilangan 1 Tahun 2011, akreditasi pusat-pusat kajian bioekuivalens (BE) dalam negara dari segi pematuhan terhadap prinsip Good Clinical Practice (GCP) dan Good Laboratory Practice (GLP) akan mula berkuatkuasa sepenuhnya pada tahun 2012. Beberapa Pusat kajian BE tempatan serta luar negara telah dikenal pasti bagi menjalankan pemeriksaan penuh.

19. BPFK berusaha bersungguh-sungguh agar Malaysia mendapatkan status pematuhan penuh terhadap Sistem Mutual Acceptance of Data (MAD) bagi OECD Principles of GLP. Dengan menjadi ahli bukan OECD yang mematuhi MAD, semua data bukan klinikal yang dijalankan di Malaysia akan diterima pakai oleh negara ahli OECD yang lain. Ini sekaligus menjana perkembangan Malaysia sebagai salah satu pusat kajian bukan klinikal di rantau Asia Tenggara.

20. Pemantauan Keselamatan Produk:

i) Meningkatkan kualiti pelaporan laporan kesan advers ubat yang berkualiti

Usaha berterusan untuk melatih Pegawai Farmasi hospital / klinik kesihatan / institusi dalam meningkatkan mutu laporan kesan advers ubat dan ketepatan causality assessment laporan kesan advers.

ii) Pengurangan risiko pesakit terhadap kesan advers ubat

Memantapkan aktiviti berkaitan dengan risk minimisation termasuk kajian/penyelidikan melibatkan kesan advers ubat melalui pembentukan Jawatankuasa Pemantauan Klinikal Kesan Advers Ubat (ADR Clinical Monitoring Committee) peringkat kebangsaan.

iii) Meningkatkan komunikasi risiko ubat

Meningkatkan keberkesanan aktiviti risk communication bagi memastikan maklumat keselamatan sesuatu ubat itu sampai kepada sasarannya. Antaranya pengedaran Drug Safety News (REAKSI) dan bulletin MADRAC melalui emel kepada pegawai farmasi di hospital dan kesihatan.

counter this shortcoming, a system is currently under development incorporating the QUEST3+ infrastructure to enable real time SUSAR reporting online by the reporter and thus allowing more man hours to be focused on monitoring and analysis of these reports.

18. A directive has been issued under the Sub Regulation 29, Regulation for Control of Drug and Cosmetic 1984, Number 1 Year 2011, accreditation for local bioequivalence (BE) centre in compliances to Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) will be fully enforced in 2012. Several local as well as oversea BE centres have been identified for full BE inspection.

19. NPCB is committed to achieve full adherence to Mutual Acceptance of Data (MAD) System of OECD GLP. By being a non-OECD member adhering to the MAD, all non-clinical data produced in Malaysia will be accepted in other member countries. This will boost Malaysia as one of the non-clinical studies hubs in Southeast Asia.

20. Product Safety Monitoring:

i) Increase the quality of ADR reporting

NPCB will continue to train pharmacists in hospitals / health clinics / institutions in the effort to improve the quality of ADR reporting and causality assessment.

ii) Minimise patients’s risk of adverse events

To strengthen activities related to risk minimisation, such as conducting studies/research related to ADR. A national ADR clinical Monitoring Committee will be established to facilitate this.

iii) Improve risk communication

Enhance the effectiveness of risk communication activities to ensure that the safety information of a particular medicine reaches its target. Example, the circulation of Drug Safety News (REAKSI) and MADRAC bulletin by emails to the pharmacist in hospitals and health centres.

124

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Hala Tuju (Sambungan)The Way Forward (Continued)

21. Variasi Produk:

i) ASEAN Variation Guideline (AVG)

Draf AVG ke-7 akan dibentangkan dalam Mesyuarat ACCSQ-PPWG yang akan datang untuk adoption. Isu-isu berbangkit pada masa depan akan dibincangkan dalam format Q&A.

ii) Modul Variasi Dan Pertukaran Tapak Pengilangan Sistem QUEST3

Seksyen Variasi akan terus berusaha untuk memastikan modul variasi, pertukaran tapak pengilangan dan Rekod Status Variasi direka bentuk mengikut kesesuaian semasa dan masa hadapan. Matlamat rekabentuk modul adalah untuk memastikan kesinambungan proses bermula dari permohonan daripada pengguna sehingga pengumuman keputusan permohonan tersebut.

22. Notifikasi Produk Kosmetik:

i) Persampelan produk kosmetik

Bagi meningkatkan keberkesanan Program Pengawasan Mutu Produk Kosmetik Bernotifikasi di pasaran, selain penyampelan rutin terhadap produk pemutih kulit, produk untuk mata, produk untuk bayi dan produk untuk body contour / slimming, kriteria dan skop penyampelan produk kosmetik turut diperluaskan kepada produk-produk seperti pewarna rambut, produk dengan nama yang mengelirukan dan produk yang berpotensi untuk membuat tuntutan yang melampaui skop takrifan kosmetik.

ii) Program kesedaran pengguna

Bagi meningkatkan kesedaran tentang penggunaan produk kosmetik yang selamat, BPFK akan mengeluarkan artikel untuk rujukan orang ramai.

23. BPFK berancang untuk meningkatkan tahap kecekapan sistem QUEST3 bagi melancarkan proses penggunaan sistem tersebut. Selain itu, rancangan untuk tahun depan adalah untuk membangunkan satu sistem yang baru, iaitu Sistem QUEST3+, dengan tujuan menghasilkan satu sistem yang lebih cekap, berkesan dan lebih baik dari segi kebolehgunaannya.

21. Product Variation:

i) ASEAN Variation Guideline (AVG)

The 7th AVG draft will be presented to the ACCSQ-PPWG meeting for adoption. Any issues arising in the future will be discusses in the form of Q & A.

ii) QUEST3 Variation and Change of Manufacturing Site Module

The Variation Section will work to ensure that the Variation, Change of Manufacturing Si te and Variation Status Record modules will be designed according to the current and future suitability. The aim of this module design is to ensure a smooth process flow starting from the applicant’s submission until the release of the results of the submission.

22. Cosmetic Notification:

i) Sampling of cosmetic products

The Cosmetic Section routinely samples whitening products, products used around the eye area, baby products and body contour / slimming products. To increase the effectiveness of the Post Market Surveillance system, the criteria and scope of product sampling had been broadened to include hair dyes and products with ambiguous, suspicious or misleading names and functions and other products with the potential to be promoted beyond the scope of cosmetics.

ii) Consumer awareness programme

As part of the effort to promote the safe use of cosmetic product to the consumer, the NPCB will issue related articles to the public on a regular basis.

23. The NPCB aims to improve the QUEST3 system to enhance efficiency of the system and subsequently our service towards customers. Plans to develop a new system namely QUEST3+ are also underway with the aim and hope that this new system will be surpassingly efficient and user friendly as compared to the old systems.

AKTIVITI SOSIALSOCIAL ACTIVITIES

125

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

126

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Aktiviti SosialSocial Activities

Persatuan Suri Dan Anggota Wanita Perkhidmatan Awam Malaysia (PUSPANITA)

Sehingga akhir tahun 2011, bilangan ahli PUSPANITA Cawangan Kecil BPFK adalah seramai 234 orang.

Association of Wives and Ladies of Malaysian Civil Service (PUSPANITA)

As of December 2011, there was a total of 234 PUSPANITA members at NPCB.

Tarikh Aktiviti Tahun 2011 Bilangan PesertaDate Activities in 2011 Number of Participants

12 February Mesyuarat Puspanita BPFK Bil 01/2011 11 PUSPANITA NPCB Committee Meeting 01/11

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––8 March Ceramah Beauty and Grooming - Mesyuarat Agung Puspanita Cawangan Kecil BPFK Beauty and Grooming Talk The NPCB PUSPANITA Annual General Meeting

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––15 March Mesyuarat Puspanita BPFK Bil 02/2011 13 PUSPANITA NPCB Committee Meeting 02/11

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––15 April Kelas Tajwid/Bacaan al-Quran Bil 01/2011 25 Session 1/2011 of ‘Tajwid/Bacaan al-Quran’ Class

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––22 April Kelas Tajwid/Bacaan al-Quran Bil 02/2011 23 Session 2/2011 of ‘Tajwid/Bacaan al-Quran’ Class

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––26 April Mesyuarat Puspanita dan Kelab BPFK - PUSPANITA and The NPCB Club Meeting

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––19, 24, 26 May Pertandingan Bola Tampar - Volley Ball Competition

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––20 May Kelas Tajwid/Bacaan al-Quran Bil 03/2011 18 Session 3/2011 of ‘Tajwid/Bacaan al-Quran’ Class

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––23 May Mesyuarat PUSPANITA BPFK Bil 03/2011 19 PUSPANITA NPCB Committee Meeting 03/11

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––1 June Senamrobik Bil 01/11 55 Aerobic Exercise Session 01/11

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––27 June Kelas Bacaan al-Quran Bil 04/2011 13 Session 4/2011 of ‘Bacaan al-Quran’ Class

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––15 July Perbincangan AJK untuk program-program bulan 11 Ramadhan 1432H Committee Meeting for Programme during Ramadhan

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

127

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

15 July Bengkel Penyediaan kuih Tart oleh Chef Rusnah 22 Baking Workshop by Chef Rusnah

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––20 July Ceramah: Parenting Adolescent oleh Dr. Harlina Siraj 100 Seminar: Parenting Adolescent by Dr. Harlina Siraj

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––20 - 21 July Pertandingan Karom - Carrom Tournament

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––22 July Bengkel Panduan Penyusuan Susu Ibu untuk persediaan 49 bulan Ramadhan Workshop – Breastfeeding Guide for Ramadhan

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––1 August Program Tadarus al Quran bermula - ‘Tadarus al Quran’ Programme

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––11 August Sesi ceramah oleh Ustaz Roslan bin Mohamed 121 Seminar session by Ustaz Roslan bin Mohamed

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––23 August Majlis Khatam al-Quran 106 ‘Khatam al-Quran’ Ceremony

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––8 September Pertandingan Futsal BPFK - Futsal Tournament

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––15 September Kelas Senamrobik dan Poco-poco 52 Aerobic Exercise and Poco-poco Dance Class

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––22 September Mesyuarat Puspanita BPFK Bil 04/2011 10 PUSPANITA NPCB Committee Meeting 04/11

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––23 September Kelas Bacaan al-Quran Bil 05/2011 10 Session 5/2011 of ‘Bacaan al-Quran’ Class

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––14 October Kelas Bacaan al-Quran Bil 06/2011 11 Session 6/2011 of ‘Bacaan al-Quran’ Class

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––21 October Pertandingan Memasak - Cooking Competition

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––28 October Pasaria PUSPANITA - PUSPANITA Fair

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––9 November Seminar Agama - Pentadbiran & Pengurusan Pewarisan Harta 102 - Wasiat, Faraid dan Hibah Religious Seminar – ‘Pentadbiran & Pengurusan Pewarisan Harta - Wasiat, Faraid dan Hibah’

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––12 November Pertandingan bowling - Bowling Tournament

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––19 December Mesyuarat Puspanita BPFK Bil 05/2011 8 PUSPANITA NPCB Committee Meeting 05/11

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Tarikh Aktiviti Tahun 2011 Bilangan PesertaDate Activities in 2011 Number of Participants

128

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Aktiviti Sosial (Sambungan)Social Activities (Continued)

Badan Kebajikan Kakitangan Islam (BAKKI)

BAKKI merupakan badan yang ditubuhkan untuk tujuan menjalankan aktiviti kebajikan, pendidikan dan keagamaan untuk anggota beragama Islam di organisasi ini. Badan ini memainkan peranan yang penting dalam memberi ilmu pengetahuan agama kepada kakitangan beragama Islam. Di samping itu, BAKKI juga menguruskan tabung kebajikan bagi memberi bantuan kepada ahli yang memerlukannya.

Muslim Staff Welfare Association (BAKKI)

BAKKI is an association formed to organize various activities related to welfare, education and religion for its members at NPCB. It plays an important role in providing religious knowledge to members. Furthermore, BAKKI also manages the welfare fund for its members.

Tarikh Aktiviti Tahun 2011Date Activities in 2011

11 February Majlis bacaan surah Yasin dan Tahlil Allahyarham Tn. Hj. Tawil Bin Hj. Talip ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

16 June Menghadiri Majlis Ujian Tilawah Al-Quran Peringkat Wilayah Persekutuan di Masjid Negara Participation in ‘Majlis Ujian Tilawah Al-Quran Peringkat Wilayah Persekutuan’ at National

Mosque ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

24 June Menghadiri rakaman Forum Perdana Ehwal Islam yang bertajuk Amalan Cara Hidup Sihat dan Pendermaan Organ 2011 di Putrajaya

Participation in ‘Forum Perdana Ehwal Islam yang bertajuk Amalan Cara Hidup Sihat dan Pendermaan Organ 2011’ at Putrajaya

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––29 July Majlis Doa selamat dan Bacaan Yaasin untuk menyambut bulan Ramadhan ‘Majlis Doa selamat dan Bacaan Yaasin’ to celebrate Ramadhan

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––11 August Mengadakan Ceramah yang bertajuk Ramadhan dan Identiti - anjuran bersama dengan

PUSPANITA BPFK Ramadhan and Identity Seminar - co-organised with NPCB PUSAPANITA

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––22 August Mengeluarkan poster untuk jemputan ibadah korban Invitation poster for ‘ibadah korban’

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

129

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

3 November Mengeluarkan poster untuk Hari Raya Aidiladha Poster for ‘Hari Raya Aidiladha‘ celebration

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––4 November Majlis bacaan yasin dan tahlil untuk Allahyarham Tn. Hj. Akasah Bin Hj.Ttaib beserta bacaan

doa selamat ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

20 December Mengadakan Ceramah bertajuk Pekerjaan Sebagai Satu Ibadah yang disampaikan oleh Ustaz Mat Taib dari Bahagian Bahasa Arab, UM

‘Pekerjaan Sebagai Satu Ibadah’ Seminar by Ustaz Mat Taib ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Tarikh Aktiviti Tahun 2011Date Activities in 2011

130

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Aktiviti Sosial (Sambungan)Social Activities (Continued)

Tarikh Aktiviti Tahun 2011 TempatDate Activities in 2011 Venue

31 March Mesyuarat Agung Tahunan 2011 Dewan Anggerik Annual General Meeting 2011 Anggerik Hall

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––8 April Mesyuarat AJK Kelab BPFK Bilik Bunga Raya26 August Committee Meeting Bunga Raya Meeting Room

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––26 April i) Volley Ball Bilik Teratai ii) Carrom Teratai Meeting Room iii) Futsal iv) Congkak v) Bowling vi) Net Ball vii) Ping Pong viii) Dart ix) Badminton

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––May Kejohanan Bola Tampar BPFK Volley Ball Tournament NPCB

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––9 June Persahabatan Futsal Sportsbarn, Futsal Friendly Match Petaling Jaya

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––13 - 14 July Kejohanan Karom Dewan Anggerik Carrom Tournament Anggerik Hall

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––8 September Kejohanan Futsal SportsCity, Futsal Tournament Petaling Jaya

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––27 March Persahabatan Bola Sepak Padang MPPJ16 June Football Friendly Matches MPPJ Field28 July

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––13 September Jamuan Merdeka Raya 2011 BPFK Merdeka Raya Celebration 2011 NPCB

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Kelab BPFK

Aktiviti-aktiviti yang dianjurkan atau diadakan oleh Kelab BPFK pada tahun 2011 adalah seperti berikut:

NPCB Club

The activities organised or carried out in 2011 by the NPCB Club were as follows:

GALERIGALLERY

131

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

132

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

GaleriGallery

WHO Consultative Meeting on Combating Substandard / Spurious / Falsely-labelled / Falsified / Counterfeit (SSFFC) Medicines and Building Global Capacity for Surveillance and Monitoring of SSFFC

133

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

134

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Galeri (Sambungan)Gallery (Continued)

The 15th ASEAN Consultative Committee Meeting for Standards and Quality on Traditional Medicines and Health Supplements Product Working Group

135

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

International Conference on Harmonisation - Global Cooperation Group (ICH-GCG) ASEAN Training Workshop on ICH Q5C: Stability Testing for Biotechnological/ Biological Products

WHO Seminar on the Quality Assessment of Active Pharmaceutical Ingredients (API) & Awareness Seminar on Regulatory Control of API

The Good Manufacturing Practice (GMP) Seminar on Veterinary 2011

136

Bir

o P

eng

awal

an F

arm

aseu

tika

l Keb

ang

saan

Nat

iona

l Pha

rmac

eutic

al C

ontr

ol B

urea

u

Galeri (Sambungan)Gallery (Continued)

Mutual Joint Visit (MJV) by the Organisation for Economic Cooperation’s and Development (OECD) Good Laboratory Practice (GLP) Working Group to NPCB

Seminar on Good Distribution Practice (GDP)

137

Lap

ora

n Ta

huna

n 20

1120

11 A

nnua

l Rep

ort

Exhibition Booth at the APHM International Healthcare Conference & Exhibition 2011

LAPORAN TAHUNANANNUAL REPORT

2011

Biro Pengawalan Farmaseutikal KebangsaanNational Pharmaceutical Control Bureau

National Pharmaceutical Control Bureau (NPCB) Biro Pengawalan Farmaseutikal KebangsaanLot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor Darul Ehsan, Malaysia

+ 603-7883 5400 + 603-7956 2924

www.bpfk.gov.my

LAP

OR

AN

TAH

UN

AN

A

NN

UA

L RE

PO

RT

2011