Cover Letter Template Created for Use in the Simplified Review System in the Asian Region
Nov 06, 2025
The JPMA International Affairs Committee/Asia Subcommittee has prepared a cover letter template and a utilization cade (attached) for examination reports with the aim of promoting the use of the simplified examination system in Asian countries using Japanese examination reports.
When an application is submitted under the simplified review system using the Japanese review report, the cover letter is expected to facilitate direct inquiries by regulatory authorities in Asian countries to the Pharmaceuticals and Medical Devices Agency (PMDA) regarding questions in the review report, thereby shortening the approval review period. This is expected to shorten the approval review period.
The Asia Subcommittee of the International Affairs Committee will continue to support JPMA member companies in their efforts to bring innovative drugs to patients in the Asian region in a timely manner.
For more information on the simplified review system in Asian countries using Japanese review reports, please refer to the PMDA website below.
International Affairs] Simplified Review of Overseas Drugs
Attachment
Reference Information
We have also asked the Japan Federation of Pharmaceutical Manufacturers and Associations (JFPMA) to make this matter known to the public, and the content of this request was featured in the Nikkan Yakugyo (published on October 3, 2025).
JFYRN disseminates template usage guide to promote the use of simplified review in Asian countries.