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.
Mots-clés Pascal : Médicament, Recherche développement, Réglementation, Japon, Asie, Responsabilité, Ministère, Bien être économique
Mots-clés Pascal anglais : Drug, Research and development, Regulation, Japan, Asia, Responsibility, Ministry, Welfare
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 93-0297324
Code Inist : 002B02A. Création : 199406.