title: [Impact of the last 15 years: from PMDEC to PMDA --looking back at the first stage of the PMDEC].
abstract: The Ministry of Health and Welfare (MHW) (renamed the Ministry of Health, Labour and Welfare [MHLW] in Jan. 2001) amended the Pharmaceutical Affairs Law, resulting in a fundamental reform of the review system for New Drug Applications, based on the 1996 report of the ad-hoc Committee for Drug Safety Ensuring Measures. One of the most important changes in the review system was the establishment of the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) on July 1, 1997 followed by the Pharmaceuticals and Medical Devices Agency (PMDA) in 2004. In five years, the drug approval system in Japan underwent a series of significant reforms, such as adopting new GCP based on the ICH/E6 (R1), changes relating to ethnic factors in the acceptability of foreign clinical data (ICH/E5 (R1)), and the establishment of a Common Technical Document (CTD) (ICH/M4). The addition of the PMDEC has greatly improved the speed of review for new drugs, especially oncology drugs and orphan drugs. We discuss the philosophy of PMDA in relation to the concept of regulatory science.
authors.affiliation: Pharmaceuticals and Medical Devices Agency (PMDA), Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013.
authors.forename: Kazushige
authors.initials: K
authors.lastname: Morimoto
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Fujiwara
authors.forename: Akira
authors.initials: A
authors.lastname: Kawahara
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*; D006077:Government Agencies / Q000266:history*; D049673:History, 20th Century; D049674:History, 21st Century; D007564:Japan; D007880:Legislation, Drug / Q000266:history; D007883:Legislation, Medical / Q000266:history; D004364:Pharmaceutical Preparations / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations