Research Paper Series 2004

(No.24:November 2004)

Approval Times for New Drugs in Japan
-Analysis of new drugs approved in 2003-

Shunsuke Ono* and Orie Asaka

  In this study, precise data on approval times for new drugs in 2003 in Japan were collected and review performance was evaluated. The study results showed that the median approval time was 19.1 months, which was slightly longer than in either 2001 or 2002. The median approval times for the standard and priority NDAs were 20.5 months and 8.2 months, respectively. The median review times for the standard and priority NDAs were 11.3 months and 4.4 months, respectively.

  In addition to the information on approval times, this report refers to the analysis of clinical phase durations.

*Faculty of Pharmaceutical Sciences, Kanazawa University

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