Drug Evaluation Committee A review of the first 10 years since the introduction of the RMP system from the perspective of the pharmaceutical industry
Pharmacovigilance Subcommittee
December 2025
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Pharmacovigilance Subcommittee
Continuing Issues Response Team 1 (KT1)
Pharmaceutical and Medical Device Regulatory Science, PMDRS, 55(3), 172-178 (2024)
Special Feature: Considering Safety Practice by Utilizing RMP
A review of 10 years after the introduction of RMP system from the viewpoint of pharmaceutical industry
Nagahama, Takaki, Emiko Iida, Kazuhiko Ishida, Tomoko Yamada, Shinya Takemoto
Link to the article (J-STAGE link)
In April 2012, the Ministry of Health, Labour and Welfare (MHLW) issued the "Guidelines for Drug Risk Management Plans" based on the "Final Recommendations" of the Hepatitis Medication Verification and Review Management Committee. The year 2023 marks the 10th anniversary of the application of the RMP (Risk Management Plan) to new drugs and biologics for which marketing authorization applications have been submitted since April 2013.
On this occasion, the Regulatory Science Foundation of Japan (RSPF) planned a "Special Program: Considering the Practical Application of Safety Measures through the Use of RMPs" in its magazine.
The Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA), Pharmacovigilance Subcommittee, Continuing Issues Team 1 (KT1), has organized a special feature entitled "Considering the Practical Application of Safety Measures through the Use of RMPs" to review how the RMP system has contributed to safety measures in the past 10 years and to discuss the three components of RMPs: "Safety Considerations," "Safety Considerations," and "Safety Measures for RMPs. The team discussed issues for the next 10 years in each of the three components of the RMP: "Safety Considerations," "Drug Safety Surveillance Activities," and "Risk Minimization Activities.