Approval Review Periods for New Drugs in Japan
Shunsuke Ono, Associate Professor, Faculty of Pharmaceutical Sciences, Kanazawa University
Orie Anzumi (Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
Chisato YOSHIOKA (Faculty of Pharmaceutical Sciences, Kanazawa University)
Koji Tamura (Former Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
(No.14: Published in December 2003)
The approval review system for new drugs in Japan has been successively improved in order to make it comparable to that of advanced European countries and the United States. However, detailed data on the time required for approval review have not been published, making it difficult to assess the extent to which these improvements have led to shorter review times. In this study, we investigated the time required for approval review for items for which applications have been submitted in recent years, and aggregated the data for each major stage of the review process to understand the trends, etc., and examined the relationship between efforts to improve the system and the review period. As a result, it was found that the examination period tended to shorten and the time clock compliance rate improved, indicating that the efforts to improve the system were functioning effectively. In addition, the results for each layer showed that some of the attributes of the applied items were found to be related to the examination period.
In addition, with a view to further shortening the review period and the overall development period, including the review period, we summarized the measures that are desired to further improve the review system and its operation in the future.