Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC).
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.
Fujiwara
Yasuhiro
Y
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
Kobayashi
Ken
K
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
D000970:Antineoplastic Agents