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
Open this folder and view contentsHarmonization II
Close this folderProtection of trial subjects in clinical trials
View the documentCross-border movement of clinical trial subjects
View the documentCross-border movement of clinical trial subjects and regulatory communication
View the documentEthical principles and protection of trial subjects in China
View the documentRecommendations
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. Drug regulatory authorities have an important role in protecting trial subjects. Drug regulatory authorities are required to keep a complete register of trials carried out in the country and, when possible, these registers should be made public (e.g. through the agency website).

2. When trials are carried out in several countries or where part of a study is carried out in a different country, direct communication between the regulatory authorities of the countries involved should be established. Contact data of responsible people should be available on the agency website.

3. Drug regulatory authorities should pay attention to the informed consent procedure and ensure that complete information is provided to the trial subjects in conformity with international guidelines, in addition to requiring national or local ethical review.

4. WHO should develop guidelines for the effective control of trials by the regulatory authority.

5. WHO should strengthen protection of human trial subjects by developing good clinical practices (GCP) training tools for drug regulatory authorities, promoting training of GCP inspectors, and providing assistance to Member States in setting up GCP inspectorates.

6. Progress should be reported back to the ICDRA.

 

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