Drug Evaluation Committee Presentation Slides: “Reflections on the Impact of the Study Group on Pharmaceutical Regulatory Framework on Post-Marketing Surveys and Other Activities” (July 11, 2026, 28th Assembly and Academic Conference of the Japanese Society for Pharmaceutical Information)
August 2026
This document contains the presentation slides from the following general session (oral presentation).
The 28th Assembly and Academic Conference of the Japanese Society for Pharmaceutical Information (July 11, 2026)
General Presentation (Oral) 2: Patient Safety and Community Healthcare (O-09)
“Reflections on the Impact of the Study Group on the Future of Pharmaceutical Regulations on Post-Marketing Surveys and Related Activities”
Purpose
Following discussions by the “Study Group on the Future of Pharmaceutical Regulations for Strengthening Drug Discovery Capabilities and Ensuring Stable Supply” (hereinafter referred to as the “Study Group”) and other bodies, revisions to relevant notifications and the streamlining of post-marketing surveys and other activities (hereinafter referred to as “surveys, etc.”) are progressing.The objective of this study was to quantitatively analyze the impact of this series of changes in the regulatory environment on the actual configuration of post-marketing surveillance and other activities at the time of new drug approval.
Method
The study focused on products approved between January 2024 and December 2025, and examined the Risk Management Plans (RMPs) and review reports published on the PMDA website. Data were compiled and analyzed regarding the presence or absence of post-marketing surveillance during each period, the types of surveillance (such as case-by-case surveys and database surveys), and trends in safety review items.
Result
A total of 259 approved products had an RMP during the study period.The analysis revealed that, following the publication of the review committee’s report, the proportion of cases where no surveys or other activities were conducted increased significantly (January–March 2024: 4.8%; April–December 2024: 51.1%; January–December 2025: 67.5%).Even in cases where surveys were conducted, the proportion of post-marketing surveillance and all-case surveys decreased. While the total number of safety review items identified through post-marketing surveillance and other means decreased, there was a trend toward placing greater emphasis on evaluations focused on significant potential risks and critical information gaps.
Discussion
Reflecting discussions at the review committee (final report issued in April 2024), efforts to streamline survey design were progressing in accordance with the revised notification.This is believed to be the result of the policy—that “case-serial studies will not be conducted solely on the grounds of a small number of cases”—and the importance of selecting the scientifically optimal methodology based on research questions becoming widely accepted by both industry and government; this suggests a shift toward more efficient and scientifically grounded safety monitoring activities.
Conclusion
Through the rationalization of pharmaceutical regulations, a transformation is underway from one-size-fits-all investigations to post-marketing safety measures that are individually optimized based on scientific evidence. Going forward, as the implementation of RMPs under the revised Pharmaceutical and Medical Devices Act gains full momentum, it will be crucial to continue and further develop high-quality safety measures.
