A Comparison of Japan-U.S. Approval Review of New Drugs
Orie Azumi（ The Office of Pharmaceutical Industry Research Senior Researcher)
Yutaka Kawakami ( The Office of Pharmaceutical Industry Research Senior Researcher)
Shunsuke Ono (Former Assistant Professor, Faculty of Pharmaceutical Sciences, Kanazawa University)
(No. 25: May 2005 issue)
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 their 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.