Drug Evaluation Committee Reflections on the first 10 years since the introduction of the RMP system from the pharmaceutical industry's perspective
Pharmacovigilance Subcommittee
December, 2025
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
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 the RMP system from the standpoint of the 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 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.
In the "Special Feature: Considering the Practice of Safety Measures by Utilizing the RMP," Team 1 (KT1) of the Pharmacovigilance Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) reviewed how the RMP system has contributed to safety measures over the past 10 years and discussed the three components of the RMP: "Safety Consideration," "Safety Consideration," and "Safety Consideration. The paper looks back on how the RMP system has contributed to safety measures over the past 10 years, and discusses issues for the next 10 years for each of the three components of the RMP: "Safety Considerations," "Drug Safety Surveillance Activities," and "Risk Minimization Activities.
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