Drug Evaluation Committee The Impact of Notifications Related to the "Study Group on Regulatory Framework for Strengthening Drug Discovery Capabilities and Ensuring Stable Supplies" Revealed through the Results of a Survey of the Pharmaceutical Industry
Pharmacovigilance Subcommittee
February 2026
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
Pharmacovigilance Subcommittee
Continuing Issues Response Team 3 (KT3)
Pharmaceutical and Medical Device Regulatory Science, PMDRS, 56(6), 436-440 (2025)
Special Feature: The Future of Postmarketing Safety Surveillance of Drugs in Japan
Related to the "Study Group on the Drug Regulatory System to Enhance Drug Discovery and Ensure Stable Supply, etc.," which emerged through survey results in the pharmaceutical industry Impact of the Notice; Additional Safety Monitoring Activities
Hiroaki Sasa, Kazuhiro Uchinoh, Naoko Tsukube, Masaya Tanaka, Kazuma Koizumi, Makoto Miyazaki
Link to the article (J-STAGE link)
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Recent changes in the environment surrounding the pharmaceutical industry have led to a decline in the attractiveness of the domestic market and drug lag/drug loss due to differences in pharmaceutical regulatory systems between Japan and other countries. In response, the Ministry of Health, Labour and Welfare (MHLW) established a study group of experts, and based on the results of the study group, on July 18, 2024, the "How to proceed with the study on the formulation of the implementation plan for post-marketing surveillance of pharmaceutical products" and "Q&A on the use-results survey of ethical drugs by the all-case surveillance method" notifications were partially revised. The "Notice" was partially revised. Against this backdrop, the Regulatory Science Foundation of Japan (RFSJ) has planned a "Special Feature: Future of Post-Marketing Safety Surveillance of Pharmaceuticals in Japan".
The Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee, Pharmacovigilance Subcommittee, Continuing Issues Response Team 3 (KT3) published a report entitled "The Impact of the Notification Related to the "Study Group on Regulatory Affairs to Enhance Drug Discovery and Ensure Stable Supply"; Additional Safety Monitoring Activities" on the theme of "The Impact of the Notification Related to the "Study Group on Regulatory Affairs to Enhance Drug Discovery and Ensure Stable Supply," as revealed through survey results in the pharmaceutical industry. Based on the information on the approved products, we conducted a survey* on the status of post-marketing surveillance before and after the issuance of the above-mentioned notice. This paper introduces the results of the survey and discusses the impact of the notice.