Drug Evaluation Committee RMP Follow-up Survey on the Implementation Status of Post-Marketing Surveillance, etc. (1st interim results)
Pharmacovigilance Subcommittee
July 2025
With the issuance on July 18, 2024 of a revised notice based on the "Study Group on Regulatory Framework for Strengthening Drug Discovery and Securing Stable Supply," the positioning, implementation, and approach to post-marketing surveillance, etc. (including all-case surveillance) are expected to change significantly in the future.
In light of this background, a survey was conducted to ascertain changes in the implementation of post-marketing surveillance, etc. before and after the issuance of the revised notice by examining PMDA's published materials (RMPs and review reports), and the first interim results were compiled.
We hope that the results will be of help to all companies involved in post-marketing surveillance operations.
Prepared in June 2025
Committee on Evaluation of Pharmaceutical Products, Japan Pharmaceutical Manufacturers Association
PV Subcommittee Continuing Issues Response Team 3
RMP Follow-up Survey (1st interim results)
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