Drug Evaluation Committee Considerations for the Development of Additional Risk Minimization Activities in the Pharmaceutical Risk Management Plan (RMP)
October 2019
With the introduction of the RMP system in 2013, the visualization of comprehensive and systematic drug safety monitoring and risk minimization according to the characteristics of pharmaceutical products, as well as the implementation of timely and appropriate evaluation and review, has started in Japan.
In this context, as there is no document that summarizes the points to be considered in establishing additional risk minimization activities for the J-RMP, we have prepared a document that summarizes the parts that may be helpful in establishing additional risk minimization activities based on published domestic and foreign guidance related to the RMP and examples of such activities established in Japan. We have therefore prepared a document that summarizes the parts that may be helpful in formulating additional risk minimization activities based on published domestic and foreign guidance related to RMPs and domestic examples.
We hope that this document will be used as a reference material and help those involved in the development of additional risk minimization activities for the J-RMP in their work operations and in the preparation of the document.
Notes
- Please refer to the "Guidance for Preparation of Drug Risk Management Plan (J-RMP) (May 2008 edition)" issued by the Pharmacovigilance Subcommittee of the Drug Evaluation Committee for information on how to describe the J-RMP.
- The parts quoted from each guidance, etc. are excerpted from the original documents and partially summarized, so please check the original documents when referring to them in the actual formulation.
Drug Evaluation Committee, Pharmacovigilance Subcommittee, Continuing Issues Response Team 1 (KT1)