Cover Letter Template Created for Use in the Simplified Review System in the Asian Region
November 06, 2025
The International Committee and Asian Subcommittee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) have created a cover letter template for examination reports and a utilization cade (attached) 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 Committee will continue to support activities by member companies of the Pharmaceutical Manufacturers Association of Japan (PMMA) to ensure the prompt delivery of innovative drugs to patients in the Asian region.
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
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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.