Drug development and registration in Japan: threshold of transition.

The responsibility for the regulation of pharmaceuticals is situated within the Pharmaceutical Affairs Bureau (PAB) of the Japanese Ministry of Health and Welfare. The scientific evaluation of the application is undertaken by a series of committees consisting of independent senior members of the medical and scientific community whereas all communication between them and the pharmaceutical company is conducted through PAB offices (Koseisho). As in the U.S., the Japanese drug application covers product quality, safety, and efficacy, but the actual data requirements differ between the two countries. Some of these differences have a basis in Japanese regulations whereas others emulate from demands set by senior members of the medical fraternity who carry great sway in Japan. These cause concern to international pharmaceutical companies since they may require studies to be duplicated with consequent delays. Moves toward the achievement of global harmonization of regulatory requirements with the associated benefits of reducing the numbers of animals sacrificed in the total development program and of important new medications reaching patients earlier are discussed.