Publications

Research Paper Series 2005

(No.25:May 2005)

Comparison on the approval review of new drugs in Japan and the US

Orie Asaka, Yutaka Kawakami and Shunsuke Ono*

  Although the difference between Japan and the US in terms of the approval review time for new drugs has been shrinking in recent years, considerable differences remain in terms of their regulatory organizations, systems, and policies. Although the goal of the regulatory authorities in both Japan and the US is to ensure that more effective drug products can be used safely, in order to protect the health of their respective citizenries, they differ in terms of the methods they use and the responsibilities they assume.

  This research report compares the organizational structures and systems relating to the approval review of new drug products in Japan and the US, and includes a discussion of the differences between the two countries in terms of their attitudes towards approval review and the information that is made available to the public. This report also attempts to identify specific issues and clarify improvements required in the approval review process by soliciting the opinions of former regulatory authority officials in Japan and the US and then, based on this information, looked into what policies might be useful for constructing better regulatory review organizational structures and systems in Japan.

*Faculty of Pharmaceutical Sciences, Kanazawa University

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