Healthy Skepticism Library item: 8123

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Wechsler J.
Taking steps toward harmonization with Europe and Japan
Pharmaceutical Technology 1999 Mar; 23:16, 18, 20-22, 24, 26, 28, 30

Abstract:

The program of the International Conference on Harmonization (ICH) to standardize technical requirements for testing and developing new drugs and biologics in the United States, Europe, and Japan is discussed. Projects include development of a unique reimbursement system of prescription drugs as well as a common technical document (CTD) to harmonize the submission of efficacy, safety, and quality reports. The U.S. Food and Drug Administration (FDA) and European Union (EU) are also developing a mutual recognition agreement (MRA) for inspecting manufacturing facilities. ICH participation has prompted Japan to adopt new global standards for drug testing, making it easier for foreign manufacturers to develop and gain approval of new medicines for the Japanese market.