Drug Evaluation Committee Maintenance of J-RMP as Seen from Company Case Studies -Proposals for Appropriate Drug Risk Management- (March 2022 version)

The Drug Risk Management Plan (J-RMP), which became law in October 2014, is currently being prepared by many pharmaceutical companies for use in risk management.

In 2020, KT1 proposed the ideal operation of "RMP Evaluation" and "Method of Dissemination after Revision of J-RMP" in " Maintenance of J-RMP as Seen from Company Case Studies (February 2020 Edition) ".

Two years have passed since then, and some J-RMPs have reached the end of their reexamination period, and there have been many cases of J-RMPs being terminated after evaluation of safety considerations through preparation of reexamination application materials. On the other hand, there are no clear guidelines on the procedures for completing the J-RMP, handling RMP materials, signal evaluation procedures, etc., and each company is still searching for a way to complete the J-RMP. Therefore, we conducted another questionnaire survey of the 16 companies participating in KT-1 in FY2021, and prepared the March 2022 version, which includes additional information on the actual status of J-RMP management at the time of reexamination application and after the completion of reexamination, as well as maintenance at the time of J-RMP termination.

In addition, additional risk minimization activities must also be evaluated when applying for reexamination. Please also refer to " Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials) in the Drug Risk Management Plan (RMP) " prepared by KT-1 in June 2021 for the considerations.

We hope that this document will help those who are involved in the operation of the J-RMP to resolve day-to-day problems and questions.