Enhancing Review Efficiency · RDC Nº. 60/2014 Homeopathic Drug RDC Nº. 26/2007 Herbal Medicines RDC Nº. 26/2014 Biological Drug RDC Nº. 55/2010 Specific Drugs RDC Nº 24/2011

Agência Nacional de Vigilância Sanitária - Anvisa


Meiruze FreitasSuperintendence of Syntetic Dugs and

Biological Products - SUMEDBrazilian Health Regulatory Agency ANVISA

Tokyo – September, 10th 2015

Enhancing ReviewEfficiency


SUMED´s Flow Chart

SUPERINTENDENCE OF DRUGS ANDBIOLOGICAL PRODUCTS (SUMED)

GENERAL OFFICE OF DRUGS (GGMED)

GENERAL OFFICE OF BIOLOGICAL PRODUCTS (GGPBS)

Labeling Department (CBREM)

Appeal Decisions Department (COREC)

IP Department (COOPI)

Brazilian Pharmacopeia

Department COFAR)

Clinical Trials Department (COPEC)


SUMED´s Flow Chart

GENERAL OFFICE OF DRUGS (GGMED)

Office of Safety and Efficacy Evaluation

(GESEF)

Office of Drug Registration

Evaluation(GRMED)

Office of Post‐ Approval Changes Evaluation

(GEPRE)

Department of Therapeutic

Equivalence (CETER)

Department of Specific and Notified

Drugs (COGEN)

API Department (COIFA)

Herbal Drugs Department (COFID)


SUMED´s Flow Chart

GERENAL OFFICE OF BIOLOGICAL PRODUCTS, BLOOD, TISSUES, CELLS AND ORGANS (GGPBS)

Office of Biological Products(GPBIO)

Office of blood, tissues, cells and organs (GSTCO)


General Objectives

To harmonize technical and administrativeprocedures;

To create offices according to their specificknowledge;

To promote more transparency on the Agency´sdecisions;

To reduce the review time by simplifying the workprocess.


Evaluation of Drugs Applications, Post Approval ChangesApplications, Drugs Registrations Renewal;

“in situ” inspections of the above applications‐Implementation of audits on review process ;

Inspections on Pharmaceutical Equivalence andBioequivalence/Bioavailability Centers;

Evaluation of Safety and Efficacy (clinical trials);

Drafting and reviewing legislation.

Performance of SUMED


Team Reviewing at SUMED

Health Regulation Experts

Regulation Technicians

Administrative Personnel

BiologistsBiomedicsLawyers

Pharmacists PhysiciansStatisticianChemistsEngineers


Good Work Practices

SUMED

Transparency

Legislation Review

Information System

Changing the work process

Sharing responsabilities


Anvisa´s website - Transparency

Information about

registered products

Information on the dossiers

analysis queue at ANVISA website

Talk with the Agency


Anvisa´s website - Transparency

Approval letter

Information on the

approved clinical trials

labeling of

medicines

registered and sold in Brazil


Total 1.148 medicamentos registrados

Channels of communication


Drug Registration

•In Brazil, drugs need to be registered.

•The registration must be renewed every five years.

•Categories of Drugs registered in Brazil:

“New” drugs (innovative and others)Synthetic and semi-synthetic drugs

Biologicals (includes biossimilars)

Herbal medicines

“Copies” (Synthetic and semi-synthetic drugs)Generic Drugs

Similar Drugs (“brand generic”)


Drug Registration – Category of medicines

CATEGORY OF DRUGS

NEW DRUGS

BIOLOGICALS

HERBAL MEDICINES

GENERIC DRUGS

HOMEOPHATICS

NOTIFIED

SPECIFIC DRUGS

SIMILAR


Drug Registration

Each of categories have their specific legislations and requirements

DRUG REGISTRATI

ON

QUALITY EFICACY

SAFETY LEGAL DOCUMENTATION


Drug Registration – main requirements

Company Authorization (AFE)

Good Manufacturing Practices (GMP certificates)

Information about API used – drug master file / DCB (CommonBrazilian Nomination)

Production Report (quanti/qualitative formula, role of each excipiente,production details, sumarized validation report)

Quality Control Report

Analythical Method Validation

Stability studies of 3 pilot batches (Zone IVb)

Pharmaceutical equivalence and bioequivalence for “copies” (CenterCertified by Anvisa)

Clinical trials for “news”


Drug Registration – legislation

Registration ResolutionSynthetic and semi-synthetic drugs (news, generics and similars)

RDC Nº. 60/2014

Homeopathic Drug RDC Nº. 26/2007

Herbal Medicines RDC Nº. 26/2014

Biological Drug RDC Nº. 55/2010

Specific Drugs RDC Nº 24/2011

Notified RDC Nº 199/2006

Post-Registation Resolution

Drug Post Registration RDC Nº 48/2009

Drug Post Registration for biologicals RDC Nº 24/2013


Drug Registration – main complementary legislation

Subject Resolution

Bovine spongiform encephalopathy (BSE) RDC Nº 305/2002 and RDC Nº 68/2003

List of Groups and Specific Therapeutic Indication RDC nº 138/2003

Analytical and Bioanalytical Validation Guideline RE Nº 899/2003 and RDC Nº 27/2012

Stability studies guideline RE Nº 1/2005

Leaflets RDC Nº 47/2009

Labeling RDC Nº 71/2009

Pilot Batches Notification Guideline IN Nº 02/2009

Pharmaceutical equivalence and dissolution profile RDC Nº 31/2010

BE/BA studies exemption guideline RDC Nº 37/2011

Stability studies for biological products RDC Nº. 50/2011


Drug Registration - Legislation Review

Focus on health risk;

Sharing responsibility with the regulated sector;

Regulatory Convergence with international standards.


• Clarifying Anvisa’s technical requirements;• New product presentation;• Regulatory and technical advice;• Enterprises associations representatives.

http://www10.anvisa.gov.br/Parlatorio/login.seam?cid=184

Face to face meetings (no fee is required)


Separating applications according to thecomplexity and risk;

Gradual implementation of electronicsubmission starting with new drugs;

Establishing previous submission meetingstarting to new drugs;

Reduction in review time by work process changes


Reduction in review time by work process changes

“In situ" analysis of registration or post‐registration requests;

– Allows rapid exchange of information between the analyst and the regulated industry.


International Cooperation/Groups

United States, Canada, China, Japan, Portugal, EMA, Cuba and ArgentinaPAHO – Pan American Health OrganizationWHO – World Health OrganizationPMDA – Pharmaceuticals and Medical Devices AgencyIGDRP – International Generic Drug Regulators Programs


Contacts

Web Site: http://www.anvisa.gov.brCall Center:

0800 642 9782. Free call from any state of Brazil.

Working hours from 7am to 7 pm, Monday to Friday, except holidays. Contact us:

http://www.anvisa.gov.br/institucional/faleconosco/FaleConosco.asphttp://portal.anvisa.gov.br/wps/portal/anvisa/ouvidoria

Twitter: @anvisa_oficialE‐mail: [email protected]

Phone number: + 55 (61) 3462 6724


BRASÍLIA D.F

Anvisa Headquarter

Agência Nacional de Vigilância Sanitária - AnvisaTHANK YOU

Documents

Enhancing Review Efficiency · RDC Nº. 60/2014 Homeopathic Drug RDC Nº. 26/2007 Herbal Medicines RDC Nº. 26/2014 Biological Drug RDC Nº. 55/2010 Specific Drugs RDC Nº 24/2011