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Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance
(2002; 187 pages) View the PDF document
Table of Contents
View the documentACRONYMS
View the documentPREFACE
View the documentACKNOWLEDGEMENTS
View the documentEXECUTIVE SUMMARY
Open this folder and view contents1. DRUG REGULATION: OBJECTIVES AND ISSUES
Open this folder and view contents2. MULTICOUNTRY STUDY ON EFFECTIVE DRUG REGULATION
Open this folder and view contents3. PROFILE OF THE COUNTRIES
Open this folder and view contents4. REGULATORY FRAMEWORK
Open this folder and view contents5. REGULATORY CAPACITY
Open this folder and view contents6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE
Open this folder and view contents7. INSPECTION AND SURVEILLANCE
Open this folder and view contents8. PRODUCT ASSESSMENT AND REGISTRATION
Open this folder and view contents9. CONTROL OF DRUG PROMOTION AND ADVERTISING
Open this folder and view contents10. DRUG QUALITY CONTROL LABORATORY
Open this folder and view contents11. ASSESSING REGULATORY PERFORMANCE
Open this folder and view contents12. CONCLUSIONS AND RECOMMENDATIONS FOR EFFECTIVE DRUG REGULATION
Open this folder and view contentsANNEX 1: GUIDE FOR DATA COLLECTION TO ASSESS DRUG REGULATORY PERFORMANCE
 

ACRONYMS

ADEC

Australian Drug Evaluation Committee

ADR

adverse drug reaction

ADRAC

Adverse Drug Reactions Advisory Committee (Australia)

APMA

Australian Pharmaceutical Manufacturers’ Association

ASEAN

Association of South-East Asian Nations

CAVEME

Cámera Venezolana del Medicamento [Venezuelan Medicines Chamber]

CENAVIF

Centro Nacional de Vigilancia Farmacológica de Venezuela [Venezuelan National Pharmacovigilance Centre]

DCA

Drug Control Authority (Malaysia)

DCQSS

Drug Control of Quality and Supply Sector (Cyprus)

DDC

Drugs and Cosmetics Directorate (Venezuela)

DIP

Direction de l’Inspection Pharmaceutique [Pharmaceutical Inspection Directorate] (Tunisia)

DIPC

Drug Information and Poisoning Centre (Cyprus)

DPM

Direction de la Pharmacie et du Médicament [Pharmacy and Medicines Directorate] (Tunisia)

DRA

drug regulatory authority

FDA

Food and Drug Administration (United States of America)

GDP

good distribution practice

GMP

good manufacturing practice

GNP

gross national product

HIV

human immunodeficiency virus

ICH

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use

INH/INHRR

Instituto Nacional de Higiene Rafael Rangel [Rafael Rangel National Institute of Health] (Venezuela)

KOAG

Keuringsraad Openlijke Aanprijzzing Geneesmiddlelen [Inspection Board for Public Advertising of Medicines] (Netherlands)

LAREB

Landelijke Registratie Evaluatie Bijwerkingen [National Registration and Evaluation of Adverse Drug Events] (Netherlands)

LAVE

Laboratorios Venezolanos [Venezuelan Laboratories]

LNCM

Laboratoire National de Contrôle des Médicaments [National Medicines Monitoring Laboratory] (Tunisia)

MAB

Medicines Advertisement Board (Malaysia)

MADRAC

Malaysia Adverse Drug Reaction Advisory Committee

MCAZ

Medicines Control Agency of Zimbabwe

MEB

Medicines Evaluation Board (Netherlands)

MOPI

Malaysian Organization of Pharmaceutical Industries

MSDSC

Direccion General Sectorial de Contraloria Sanitaria [Main Sectorial Directorate of Sanitary Comptrollership] (Venezuela)

CECMED

Centro para el control Estatal de la Calidad de los Medicamentos [National Centre for Drug Quality Control (NCDQC)](Cuba)

NDA

National Drug Authority (Uganda)

Nefarma

Netherlands Pharmaceutical Manufacturers Association

NPCB

National Pharmaceutical Control Bureau (Malaysia)

OTC

over-the-counter [medicines]

PhAMA

Pharmaceutical Association of Malaysia

PMAA

Proprietory Medicines Association of Australia

QC

quality control

RBPP

Revisory Board of Pharmaceutical Products (Venezuela)

RIVM

Rijksinstituut voor Volksgezondheid & Milieu [National Institute of Public Health and Environment] (Netherlands)

SAM

State Agency of Medicines (Estonia)

SOP

standard operating procedure

SPC

summary of product characteristics

TGA

Therapeutic Goods Administration (Australia)

TGAL

Therapeutic Goods Administration Laboratory (Australia)

WHO

World Health Organization

 

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Last updated: May 3, 2013