New drug approval times and clinical evidence in Japan.
作者： Shunsuke Ono , Chisato Yoshioka , Orie Asaka , Koji Tamura , Taro Shibata
DOI: 10.1016/J.CCT.2005.07.003
关键词: Negatively associated 、 Family medicine 、 Clinical trial 、 Clinical evidence 、 New drug application 、 Investigational New Drug Application 、 Review process 、 Medicine 、 Operations research 、 Drug approval 、 MEDLINE
摘要: Abstract Background Although overall Japanese approval times declined after the establishment of a new review agency, they still vary significantly from one drug application (NDA) to another. The causes these variations have not been investigated quantitatively. Objective To investigate associations between and properties NDAs such as results quality clinical trials examine NDA system. Methods For approved 1996 2003, characteristics including dates, status, applicant characteristics, were obtained survey other public sources. Regulatory at different number in backlog also estimated several Results Approval varied across therapeutic categories, teams, before agency. Use consultation services prior submissions negatively associated with length times. Merger acquisition experience applicants, amount data, teams longer way efficacy was times, but safety profiles products time. foreign data generally Conclusions Several burdens on reviewers, package, regulatory mandates predefined time-line goals outcome process Japan.
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