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Research Paper Series 2005

(No.30:August 2005)

Approval times and clinical phase times for new drugs in Japan
- Analysis of new drugs approved in 2004 -

Orie Asaka

  Various data on approval times and clinical phase times for new drugs in 2004 in Japan were collected and analyzed in this study. Since 2001, the median approval times have changed to between 17 and 19 months, with the value for 2004 being 17.9 months. The median approval times for the standard and priority NDAs were 21.9 months and 7.8 months, respectively. The median review times for the standard and priority NDAs were 13.6 months and 4.7 months, respectively.

  The median clinical phase time for 2004 was 88.8 months, which was the longest since 1996. The median development period, addition of clinical phase time and approval time, was 115.7 months, which was also the longest since 1996. Such prolongation of development periods are thought to be a reason for the rise in development costs.

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