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(2003; 20 pages) [French] [Spanish]
10th ICDRA: an international basis for medicines regulation
The International Conference of Drug Regulatory Authorities (ICDRA) was set up by WHO to develop international consensus on medicines regulation issues. Given new regulation issues brought about by globalization and development of free markets, and increased regulatory responsibilities - for instance, in relation to the introduction of innovative treatments - such a forum is essential.
The 10th ICDRA (see: http://www.who.int/medicines/organization/qsm/activities/drugregul/icdra.shtml) took place in June in Hong Kong and was marked by recognition that access to medicines is a global and shared issue, commitment to improving medicines quality in developing countries, and concern regarding how to ensure the safety of traditional and complementary medicines. Recommendations were made on: access to drugs and vaccines; regulatory reform; medicines safety; regulation of clinical trials; harmonization; combating counterfeiting; herbal medicines; homeopathy; new technologies and e-commerce. The recommendations are now serving as a basis for action on medicines regulation by WHO Member States and WHO.
A pre-ICDRA workshop entitled, The Impact of Regulation on the Safe Use of Drugs, provided a venue for drug regulatory authority staff to discuss new trends in medicines safety and to prioritize issues for discussion and recommendations during the ICDRA sessions.