Links to major regulatory information of Reviews.
Regulations and Notifications
Application for Approval
October 23, 2024 PMSB/ELD Notification No. 1023-3
Submission/Application
September 6, 2024 Administrative Notice
Review Timeline
March 30, 2012 PFSB/ELD Administrative Notice
January 17, 2011 PFSB/ELD Administrative Notice
June 9, 2010 PFSB/ELD-CND Administrative Notice
Early Approval System
- Partial Revision of “Handling of Conditional Approval of Drugs”[122KB]
October 23, 2024 PMSB/ELD Notification No. 1023-2
October 20, 2017 PSEHB/PED Notification No. 1020-1
Review Process
April 17, 2008 Pharmaceuticals & Medical Devices Agency
Related Information
Promoting Medical Product development in Japan
November 2024
August, 2024