Approval Review Periods for New Drugs in Japan A Survey of Drugs Approved in 2003
Shunsuke Ono (Associate Professor, Faculty of Pharmaceutical Sciences, Kanazawa University)
Orie Azumi (Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
(No. 24: Published November 2004)
The approval review system for new drugs in Japan has undergone major changes in recent years through the reorganization of the review system in order to enhance and improve it. the Pharmaceuticals and Medical Devices Agency was established in April 2004, aiming to further shorten the approval review period for new drugs.
In this survey, we attempted to assess the review performance of new drugs approved in 2003 by ascertaining the details of the time required for review. The results showed that the median review period was 19.1 months, and although there has been no significant change since 2001, there was a slight trend toward extension in 2003. When divided into normal and priority review items, the median duration was 20.5 months and 8.2 months, respectively. The median time taken by the authorities (examination processing time) was 11.3 months and 4.4 months for Normal and Priority review items, respectively. In addition to the reduction of the examination period, there has recently been a growing interest in reducing the overall development period, including the examination period, and therefore, this survey also includes some analysis of the development period.