Drug Evaluation Committee Current Status of Post-Marketing Surveillance under the Japanese GPSP Ordinance: Questionnaire Survey on GPSP
Pharmacovigilance Subcommittee
May 2026
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
2025 Pharmacovigilance Subcommittee
Continuing Issues Team 3
The Current State of Regulatory Post-Marketing Studies in Japan: A Questionnaire Survey on Good Post-Marketing Studies Practice
Shoko TSUKUBE， Hiroaki SASA, Takafumi KASAHARA, Yuichiro SAKAMOTO, Masaya TANAKA, Yuki AIKAWA, Etsuko TANAKA, Toshio KITERA, Kazuma KOIZUMI, Makoto MIYAZAKI
Link to the article (J-STAGE link)
Release date: 2026/4/24 (Early release)
The Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee, FY2025 Pharmacovigilance Subcommittee, Continuing Issues Team 3 (KT3), has released the July 18, 2024 notice "How to proceed with the study on the formulation of a post-marketing surveillance plan for pharmaceutical products" and "Q&A on the use-results survey of ethical drugs by the all-case surveillance method In addition, a questionnaire survey on the current status of post-marketing surveillance (PMS) under the GPSP Ordinance will be conducted in FY2024 in order to organize and record the current status of post-marketing surveillance at a turning point as the environment surrounding post-marketing safety enters a period of further change. The results of the survey are presented in this report.
This report introduces the results of the survey and discusses the impact of the notification and the current status and issues of post-marketing surveillance. The results of the survey revealed an increase in the number of approved items for which PMS is no longer required, a decrease in the percentage of items requiring an all-case surveillance, and an increase in the percentage of items for which a post-marketing database survey is conducted.
It was also confirmed that the results of many use-results surveys are being used for conference presentations, article submissions, and provision of information to medical professionals. Pharmaceutical companies are expected to select appropriate safety surveillance activities based on research questions and contribute to safety management and proper use of their products by providing useful information to the medical community.