Approval Review Periods for New Drugs in Japan FY2007 Survey
Kuniaki Yasuda ( The Office of Pharmaceutical Industry Research Senior Researcher)
Shunsuke Ono (Associate Professor, Department of Pharmaceutical Evaluation Science, Graduate School of Pharmaceutical Sciences, The University of Tokyo)
(No. 37: Published December 2007)
The median total review period for new drugs approved in 2006 was 23.4 months, not much different from the 23.9 months for those approved in 2005, and the variation among individual items increased. The median review period for the period from 2001 to 2004 was approximately 17 to 19 months, but it became longer in 2005 and 2006. By review category, the period for ordinary review items was 29.0 months, the longest in the past five years, while the period for priority review items was 17.8 months, which does not indicate a trend toward shortening. Looking at the performance indicator as the approval review period, speeding up of approval review has not necessarily been achieved. Compared to the FY2011 review period targets set by the JCIA (12 months for regular review items and 9 months for priority review items), the review period for items approved in 2006 was 17 months for regular review items and 9 months for priority review items. The percentage of priority review items approved within 12 months is 4.8%, while the percentage approved within 9 months is 10.7%, both of which are low, a large difference from the target of raising the percentage to 50% in FY2011.
In order to shorten the total review period, further efforts are needed to strengthen target management and clarify responsibilities with the aim of shortening the review cycle period for individual items and eliminating variations, to strive to achieve the target for the applicant's work time, and to actively involve the review authorities from the pre-application stage, which will lead to a shorter review period. In addition, it is also necessary to make direct involvement in the item review process. In addition, it is necessary to improve the performance of the review period in all review areas that are directly involved in the item review, and to establish a review system that allows the approval review to progress without delay. On the other hand, there are many areas for improvement on the applicant side, such as the quality of application materials and the way to deal with review authorities. It is hoped that the domestic approval review process will be expedited by improving the performance of both the reviewing authority and the applicant in the approval review process.