title: Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC).
abstract: In 1996 the Japanese Diet amended the Pharmaceutical Affairs Law (PAL) and its related laws based on 1996 report of the ad-hoc Committee for Drug Safety Ensuring Measures. Between 1996 and 2000, the drug approval system in Japan underwent a series of radical reforms. We describe in this paper the current system for drug approval, discuss the post-approval reexamination and reevaluation system, conditions under which development and review may be expedited, and mechanisms for approval of off-label usage. Finally, we discuss the impact of the International Conference on Harmonization (ICH) agreement on drug development and review in Japan.
authors: Evaluation Division II, Pharmaceuticals and Medical Devices Evaluation Center, National Institute of Health Sciences, The Ministry of Health Labour and Welfare, Toranomon 3-8-21 Minato-ku, Tokyo 105-8409, Japan. fujiwara@nihs.go.jp
authors: Yasuhiro
authors: Y
authors: Fujiwara
authors: Ken
authors: K
authors: Kobayashi
mesh_terms: D000970:Antineoplastic Agents / Q000592:standards*; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods* / Q000458:organization & administration; D006077:Government Agencies; D006801:Humans; D007391:International Cooperation; D007564:Japan; D011358:Product Surveillance, Postmarketing
chemical_list: D000970:Antineoplastic Agents