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

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Isi KandunganContents

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

Perutusan Pengarah 4 Directors Foreword

Pengurusan Tertinggi BPFK 7 NPCBs Top Management

Sidang Pengarang 8 Editorial Board

Pengenalan: BPFK 9 Introduction: NPCB

Carta Organisasi 10 Organisational Chart

Piagam Pelanggan 12 Clients 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

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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.

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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.

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Perutusan PengarahDirectors 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 NPCBs 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.

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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, NPCBs 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

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Perutusan Pengarah (Sambungan)Directors 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.

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Pengurusan Tertinggi BPFKNPCBs 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

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Sidang PengarangEditorial Board

Depan | FrontKiri ke Kanan | Left to Right

Mdm.TanShihLengMdm.NoraisyahMohdSaniMdm.MazuwinZainalAbidinMdm.AzuraAbdullahMs.BelinnaAbuBakar

Belakang | BackKiri ke Kanan | Left to Right

Mr.AhmadKamalAhmadMr.KhairulanwarBurhanuddinMr.WayneWongMr.AhmadIzhamIsmail

Tidak Hadir | Absent

Mdm.NikIryaniNikAhmadDamianMdm.NikShamsiahNikSallehMdm.WanNurulAinaMiorAbdullahMr.NicholasLeowChunWeiMdm.TanChinLingMr.AzriNasruddinMs.RachelThongMr.AhmadShahirAyob

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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.

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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

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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

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Piagam PelangganClients 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

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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 manufacturers, wholesalers and importers 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

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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/U41Pegawai Teknologi Maklumat Gred F41 F41 1 1 0Information Technology Officer Grade F41Penolong Pegawai Farmasi Gred U36 U36 2 2 0Assistant Pharmacist Grade U36Penolong Pegawai Farmasi Gred U32 U32 8 7 1Assistant Pharmacist Grade U32Penolong Pegawai Farmasi Gred U29 U29 72 67 5Assistant Pharmacist Grade U29Penolong Pegawai Teknologi Maklumat F32 1 1 0Gred F32Assistant Information Technology Officer Grade F32Penolong Pegawai Tadbir Gred N36 N36 1 1 0Assistant Administrative Officer Grade N36Penolong Pegawai Perangkaan Gred E32 E32 1 1 0Assistant Statistical Officer Grade E32Penolong Pegawai Tadbir Gred N27 N27 2 1 1Assistant Administrative Officer Grade N27Setiausaha Pejabat N27 3 3 0Secretarys OfficePembantu Tadbir Gred N22 N22 1 1 0Administrative Assistant Grade N22Pembantu Tadbir Gred N17 N17 16 12 4Administrative Assistant Grade N17Pembantu Tadbir (Stor) Gred N17 N22 1 0 1Administrative Assistant (Store) Grade N17Pembantu Tadbir (Kewangan) Gred W22 W22 2 2 0Administrative Assistant (Finance) Grade W22

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

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Pembantu Tadbir (Kewangan) Gred W17 W17 9 7 2Administrative Assistant (Finance) Grade W17Pembantu Perpustakaan Gred S17 S17 1 1 0Library Assistant Grade S17Pegawai Khidmat Pelanggan Gred N17 N17 2 2 0Customer Service Officer Grade N17Juruteknik Komputer Gred FT17 FT17 1 1 0Computer Technician Grade FT17Operator Mesin Prosesan Data Gred F11 F11 2 0 2Data Processing Machine Operator Grade F11Pengawal Keselamatan Gred KP 11 KP11 3 3 0Security Guard Grade KP 11Pembantu Am Pejabat Gred N4 N4 1 0 1Office Assistant Grade N4Pembantu Am Pejabat Gred N1 N1 4 3 1Office Assistant Grade N1Pembantu Perawatan Kesihatan U12/U3 10 10 0Gred U12/U3Health Care Assistants Grade U12/U3Pemandu Kenderaan Bermotor Gred R3/R6 R3/R6 5 4 1Motor Vehicle Driver Grade R3/R6JUMLAH 347 317 30TOTAL

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

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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 HospitalSiti Aisah binti Bahari Pegawai Farmasi U48 Bahagian Perkhidmatan Farmasi Pharmacist Pharmaceutical Services DivisionRahman bin Baco Pegawai Farmasi U41 Bahagian Perkhidmatan Farmasi Pharmacist Pharmaceutical Services DivisionAmran bin Abu Bakar Pegawai Farmasi U41 Bahagian Perkhidmatan Farmasi Pharmacist Pharmaceutical Services DivisionRusnah Rejab Penolong Pegawai Farmasi U32 Hospital Sungai Buloh Assistant Pharmacist Sungai Buloh HospitalAlif bin Azizan Penolong Pegawai Farmasi U29 Hospital Kuala Lumpur Assistant Pharmacist Kuala Lumpur General HospitalHasnira Yahaya Penolong Pegawai Farmasi U29 Klinik Kesihatan Seremban Assistant Pharmacist Seremban Health ClinicRohaniah bt. Che Seman Penolong Pegawai Farmasi U29 Hospital Ampuan Najihah, Kuala Pilah Assistant Pharmacist Ampuan Najihah Hospital, Kuala PilahLahung Mering Penolong Pegawai Farmasi U29 Jabatan Kesihatan Negeri Sarawak Assistant Pharmacist Sarawak State Health DepartmentIsmajura binti Borhanuddin Penolong Pegawai Farmasi U29 Jabatan Kesihatan Negeri Melaka Assistant Pharmacist Malacca State Health DepartmentKwan Wai Lin Penolong Pegawai Farmasi U29 Bahagian Perkhidmatan Farmasi Assistant Pharmacist Pharmaceutical Services DivisionMarianie binti Omar Pembantu Tadbir N17 Klinik Kesihatan Botanik, Klang Administrative Assistant Botanic Health Clinic, KlangHasli 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

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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 HospitalNor 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) RetiredWoo Ai Ling Pegawai Farmasi U44 Berhenti Pharmacist ResignedChow Guan Kuan Pegawai Farmasi U44 Berhenti Pharmacist ResignedSeow Ee Laine Pegawai Farmasi U44 Berhenti Pharmacist ResignedPngZiyan PegawaiFarmasi U41 Berhenti Pharmacist ResignedZariahbintiHadzam PegawaiFarmasi U41 Berhenti Pharmacist ResignedYusni Rizal bin Khairul Anuar Pegawai Farmasi U41 Berhenti Pharmacist ResignedJames Ooi Joe Behn Pegawai Farmasi U41 Berhenti Pharmacist ResignedNarqes bt. Mohd. Raimi Pegawai Farmasi U41 Berhenti Pharmacist ResignedHiong Len Teng Pegawai Farmasi U41 Berhenti Pharmacist Resigned

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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 ResignedTan See Hooi Pegawai Farmasi U41 Berhenti Pharmacist ResignedKhoo Jeng Yih Pegawai Farmasi U41 Berhenti Pharmacist ResignedNoribah bt. Baba Penolong Pegawai Farmasi U32 Bersara Pharmacist Assistant RetiredZambinRokiahAbdulRashid PenolongPegawaiFarmasi U29 Bersara Pharmacist Assistant RetiredRamly bin Ahmad Pembantu Tadbir N22 Bersara Administrative Assistant Retired

Anugerah Perkhidmatan CemerlangExcellent Service Awards 19

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Sameerah binti Shaikh Abd. Rahman Pegawai Farmasi U54 Pharmacist U54MazuwinbintiZainalAbidin PegawaiFarmasiU54 Pharmacist U54Rosilawati binti Ahmad Pegawai Farmasi U54 Pharmacist U54DatinZahurabintiMohamed@Ismail PegawaiFarmasiU48 Pharmacist U48Ahmad Syamsury bin Sulaiman Pegawai Farmasi U48 Pharmacist U48Azraini binti Abdul Samat Pegawai Farmasi U48 Pharmacist U48Aida Haryati binti Abdul Samat Pegawai Farmasi U48 Pharmacist U48Chang Hsio Ling Pegawai Farmasi U44 Pharmacist U44Tan Shiau Yi Pegawai Farmasi U44 Pharmacist U44Ng Shin Hwei Pegawai Farmasi U44 Pharmacist U44Erina Camilla binti Mohd Ghazali Pegawai Farmasi U44 Pharmacist U44Nee Yuan Qi Pegawai Farmasi U44 Pharmacist U44Yam Pei Ching Pegawai Farmasi U44 Pharmacist U44ZafiahbintiMohdYusof 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

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Nama Jawatan

Name Post

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

Chua Wone Tying Pen. Pegawai Farmasi U32 Pharmacist Assistant U32Abdul Ghani bin Yusof Pen. Pegawai Farmasi U32 Pharmacist Assistant U32Nor Syazana binti Abdul Aziz Pen. Pegawai Farmasi U29 Pharmacist Assistant U29Nik Azniza binti Awang Pen. Pegawai Farmasi U29 Pharmacist Assistant U29Rahmah binti Abas Pen. Pegawai Farmasi U29 Pharmacist Assistant U29Chong Feng Shin Pen. Pegawai Farmasi U29 Pharmacist Assistant U29Nor Azian binti Megat Osman Pembantu Tadbir W22 Administrative Assistant W22Mohd Ariff Fikry bin Hasim Pembantu Tadbir W17 Administrative Assistant W17Nor Naimah binti Ismail Pembantu Tadbir W17 Administrative Assistant W17Norziani binti Mohd Potri Pembantu Tadbir N17 Administrative Assistant N17Sri Puvenesvaran Pemandu Kenderaan Bermotor R3 Motor Vehicle Driver R3ZafribinRodzokhi PembantuPerawatanKesihatanU3 Health Care Assistants U3

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PENCAPAIANACHIEVEMENTS

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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

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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

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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

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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

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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

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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.

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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

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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

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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

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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

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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

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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

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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 11

40

0

2010

140

4900 0

2011

0 012

0 0

PreskripsiPrescription

Bukan PreskripsiNon-prescription

SemulajadiNatural

VeterinarVeterinary

Suplemen KesihatanHealth Supplements

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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.

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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

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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.

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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

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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

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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.

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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

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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

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PENILAIAN PROTOKOL ANALISA DAN DATA VALIDASI

EVALUATION OF PROTOCOL ANALYSIS AND VALIDATION DATA

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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

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1,000

1,500

2,000

2,500

2007

1,24

3

576

2008

460

1,93

9

2009

Tahun/Year

Bila

ngan

/Num

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s

76

2,23

3

2010

5

1,82

0

2011

2

1.61

2

Protokol AnalisaProtocol Analysis

Data ValidasiValdiaoon Data

PENGUJIAN SAMPELSAMPLE TESTING

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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

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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.

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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

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149

132

103

116

83

ADR

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CPFEnforcement

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099

660

212

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2007

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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

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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

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155

122

129

114

97

ADR

0 0 0 0 39

CPFEnforce