(2002; 166 pages)
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.