Duration of Approval Review for New Drugs in Japan (Drugs Approved from 1996 to 2005)
Kuniaki Yasuda (Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
(No. 35: Published December 2006)
The study analyzed the impact of year-to-year changes and individual product characteristics on the review period for new drugs approved in Japan in 2005, which was 6.5 months longer for regular review items and 16.8 months longer for priority review items than in 2004. The percentage of approved products within 12 months was 46.4% in the U.S., but none in Japan, while the percentage of priority review products was 90.0% in the U.S. and 20.8% in Japan. The difference in the examination period between Japan and the U.S. was reduced. Although it is said that the difference in examination time between Japan and the U.S. has been shrinking, there is still a large difference between the two countries. In order to improve this situation, it is necessary to increase the number of examiners and improve the quality of review materials prepared by applicant companies, and it is also necessary for the review authorities to provide the direction and clear review criteria for domestic drug approval review to new drug development companies in advance and to strengthen the clinical trial consultation function. In other words, the establishment of a rational work process that allows domestic approval review without delay from the pre-application stage is likely to contribute to faster review by improving the quality of application materials prepared by new drug development companies and reducing the amount of unnecessary work after application.