Drug Evaluation Committee Slide "Current Status and Issues of Post-Marketing Surveillance, etc. in Japan - GPSP Questionnaire Survey" (July 5, 2025, 27th Annual Meeting and Conference of the Japanese Society for Drug Informatics)
Pharmacovigilance Subcommittee
July 2025
This document is the presentation slides for the following general presentations (oral presentations).
The 27th Annual Meeting of the Japanese Society for Drug Information (2025/7/5)
General Abstract (Oral Presentation) 2) Database Research, Postmarketing Surveillance (O-09)
"Current Status and Issues of Postmarketing Surveillance, etc. in Japan - GPSP Questionnaire Survey"
Purpose: Post-marketing Surveillance, etc. (Surveillance, etc.) is undergoing a period of change in response to various changes in the environment, as typified by the revision of notifications, etc. based on the "Study Group on the Drug Regulatory System to Enhance Drug Discovery and Ensure Stable Supplies, etc.". The Pharmacovigilance Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) conducted a questionnaire survey to research the current status of surveys and other activities.
The survey was conducted from December 2, 2024 to January 19, 2025, targeting a total of 84 member companies of the Japan Pharmaceutical Manufacturers Association, the US Association of Research Pharmaceutical Manufacturers and Associations, and the European Federation of Pharmaceutical Manufacturers and Associations (EFPMA). The survey was conducted by the Ministry of Health, Labour and Welfare (MHLW). The content of the survey included the status of drug approvals, the status of implementation of surveys, etc., including all case surveillance and database surveys, and the detailed status of each individual survey.
The number of companies that did not conduct surveys or other actions (annualized) for the periods from April 2020 to March 2023, from April 2023 to July 17, 2024, and from July 18, 2024 to July 18, 2024, was higher in the period from July 18, 2024 to July 17, 2023. After July 18, 2024, the percentage of items requiring an all-case surveillance tended to decrease. The percentage of items requiring a post-marketing database survey increased during each period.
The "Partial Revision of "How to Proceed with the Examination of the Formulation of Implementation Plans for Post-Marketing Surveillance of Pharmaceuticals" and "Partial Revision of "Q&A on Investigations of Usage Results for Ethical Drugs Using the All-Patient Surveillance Method"" were issued on July 18, 2024, and although it was soon after the issuance of the notifications, the percentage of new drugs requiring an all-case surveillance has been decreasing. Although it has only been a short period of time since the issuance of the notice, the trend of review results for new drugs was considered to be changing. It is hoped that these trends will lead to more effective implementation of surveys, etc. in the future.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
PV Subcommittee, Continuing Issues Team 3
Deliverables of the Drug Evaluation Committee Return to list of all deliverables