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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
 

ACKNOWLEDGEMENTS

This report is a synthesis of the results of the multicountry studies carried out by the WHO Essential Drugs and Medicines Policy Unit (EDM) with the cooperation of the following countries: Australia, Cuba, Cyprus, Estonia, Malaysia, Netherlands, Tunisia, Uganda, Venezuela and Zimbabwe. WHO would like to thank the governments of these countries for their cooperation and assistance.

The country studies were conducted by the following national investigators recruited by WHO: Mr George Antoniou (Cyprus), Professor Kamel Boukef (Tunisia), Dr Eibert Rob Heerdink (Netherlands), Dr Susanne Hill (Australia), Dr Charles Maponga (Zimbabwe), Dr Richard Odoi-Adomi (Uganda), Dr Frank Perez Acuna (Venezuela), Dr Julean Perez Pena (Cuba), Professor Dzulkfli Abdul Razak (Malaysia) and Ms Marje Reinans (Sweden).

Dr David Afori-Adjei (Ghana) and Dr Sauwakon Ratanawijitrasin (Thailand) served as advisers, and Mr Eshetu Wondemagegnehu (EDM) coordinated the study.

The guide for collecting data for the multicountry study was developed by Mrs Kari Bremer and Mr Eshetu Wondemagegnehu (EDM) and later refined in a workshop attended by the national investigators, the study advisers, Dr Raffaella Balocco (EDM), Mrs Kari Bremer (EDM) Dr Valerio Reggi (EDM) and Mr Eshetu Wondemagegnehu.

The synthesis paper was prepared by Dr Sauwakon Ratanawijitrasin and Mr Eshetu Wondemagegnehu.

The authors gratefully acknowledge the contribution of the following people, who reviewed and commented on the draft document: Professor Peter Eagles (South Africa), Dr Dennis Ross-Degnon (USA), Dr Kjell Strandberg (Sweden) and Dr Göran Tomson (Sweden).

Thanks also to Dr Jonathan D. Quick (EDM) and Dr Lembit Rägo (EDM) for their invaluable support, Ms Anne Hemsworth (EDM) for the secretarial support and Mr Peter Thorpe, Ms Jacqueline Sawyer and Dr Lalit Dwivedi for editing the paper.

 

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Last updated: May 3, 2013