Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Close this folderHarmonization II
View the documentRegional harmonization initiatives - the Association of South-East Asian Nations (ASEAN)
View the documentHarmonization in the Americas
View the documentCentralized drug registration system in the Gulf Region
View the documentRecommendations
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Recommendations

It was recognized that international harmonization is characterized by a number of initiatives undertaken in different parts of the world. Such initiatives reflect specific local or regional needs and circumstances. Although these activities and their products may be useful examples and supply important technical knowledge, no single initiative can currently be considered a model for international application or implementation.

1. Countries should take into account local factors, priorities, possible implications, and implementation capacity when evaluating harmonization initiatives and guidance materials produced elsewhere.

2. The development of international regulatory requirements and guidelines should be based on demonstrated public-health needs and should not be driven by technological progress alone.

3. WHO should continue to support regional and local harmonization initiatives aimed at strengthening regulatory capacity and achieving public health goals.

4. Progress should be reported back to the ICDRA.

 

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