A Comparison of Japan-U.S. Drug Approval Processes for New Drugs
Orie Azumi (Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
Yutaka Kawakami (Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
Shunsuke Ono (Former Assistant Professor, Faculty of Pharmaceutical Sciences, Kanazawa University)
(No. 25: Issued in May 2005)
In recent years, the difference in approval review times for new drugs between Japan and the U.S. has been shrinking, but there are still significant differences in terms of review systems, systems, and measures. Although both Japanese and U.S. review authorities aim to make more effective drugs safer for use in order to protect the health of their citizens, their roles and methods are different.
In this research report, we compare the systems and institutions for the review of new drug approvals in Japan and the U.S., and discuss the differences in their approaches to the review and their efforts to disclose information. In addition, by interviewing the opinions of former Japanese and U.S. review authorities, we attempted to gain a more concrete understanding of the problems and to identify areas that need to be improved in the approval process. Based on these results, we discussed useful measures to establish a better Japanese examination system and system.