Clinical trials in Japan-New GCP

摘要

The first regulation on clinical trials(old GCP)was introduced in 1990 as a notification of The Director General of Pharmaceutical Affairs Bureau(at that time). Although this one had Been accepted widely in Japan, it did not meet The requirements of The International Conference Of Harmonization(ICH)guidelines on Good Clinical Practice(GCP)in 1996 May. In 1996 Jun, the Ministry of Health and Welfare(MHW) Amended Pharmaceutical Affairs Law(PAL), And the related MHW ordinance was established Conformed to the advice of the MHW Central Pharmaceutical Affairs Council in 1997 Mar.