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
Close this folderHarmonization I
View the documentThe harmonization process of ICH
View the documentEuropean contribution to a global approach to regulation
View the documentThe harmonization process of ICH - philosophy, process and future
View the documentImpact of ICH on non-ICH countries
View the documentICH - its value to a first-line medicines regulator
View the documentRecommendations
Open this folder and view contentsHarmonization II
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

1. WHO should continue involvement in the ICH Steering Committee, adopting a more proactive role by proposing topics for guideline development and expressing opinions on the potential public health implications of the guidelines proposed by ICH.

2. In the light of the wide range of regulatory environments, WHO should support non-ICH Member States and regional harmonization initiatives by evaluating the usefulness, feasibility and impact of implementing ICH guidelines.

3. WHO should continue to produce briefing notes on ICH meetings for regulatory officials of non-ICH countries and consider ways of making them widely available, including use of the Internet.

4. In order to improve access to essential drugs of good quality, especially in developing countries, WHO should assess the benefits and risks to public health of implementing selected ICH drug quality guidelines on manufacturing standards for generic products in non-ICH countries, and intensify its efforts to develop international standards and guidelines for the regulatory assessment of generic products. WHO should offer specific advice to national authorities in non-ICH countries.

5. Progress should be reported back to the ICDRA.

 

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