Maeda Hideki, Kurokawa Tatsuo
Division of Drug Development and Regulatory Science, Graduate School of Pharmaceutical Sciences, Keio University, 1-5-30, Shibakoen, Minato-ku, Tokyo, Japan; Oncology, Clinical Development Department, Global Development, Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan.
J Clin Pharmacol. 2015 May;55(5):481-9. doi: 10.1002/jcph.458. Epub 2015 Feb 4.
In this study, we comprehensively and historically studied the review time of oncology drugs approved by the regulatory authorities in Japan with publicly available information. A total of 120 applications of oncology drugs were approved in Japan between April 2001 and July 2014. The review time peaked with 732.0 days (24.4 months) in 2005, and showed a tendency to decline gradually each year thereafter. After 2012, a significant reduction of the review time was seen in comparison to the median of 13-year median time. In addition, we compared the review time with that in the United States. The median review time lag with the United States was significantly peaked in 2005. After 2005, the review time lag with the FDA has decreased, but lag did not significantly reduce by 2014. We also examined factors influencing the review time in Japan with multiple regression analysis. It was found that the factors related to a use of overseas data and expedited program for accelerating the reviews influenced the direction of shortening the review time. We consider that regulatory authorities in Japan need to keep making efforts to reduce the review time further and eliminate the review time lag with the United States.
在本研究中，我们利用公开可得信息，全面且历史性地研究了日本监管机构批准的肿瘤药物的审评时间。2001年4月至2014年7月期间，日本共批准了120项肿瘤药物申请。审评时间在2005年达到峰值，为732.0天（24.4个月），此后逐年呈逐渐下降趋势。2012年之后，与13年中位时间的中位数相比，审评时间显著缩短。此外，我们还将审评时间与美国的进行了比较。与美国的中位审评时间差距在2005年显著达到峰值。2005年之后，与美国食品药品监督管理局（FDA）的审评时间差距有所减小，但到2014年差距仍未显著缩小。我们还通过多元回归分析研究了影响日本审评时间的因素。结果发现，与使用海外数据及加速审评的快速程序相关的因素影响了审评时间缩短的方向。我们认为，日本监管机构需要继续努力进一步缩短审评时间，并消除与美国的审评时间差距。
