Drug Evaluation Committee Pharmaceutical Risk Management Plan (RMP) Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials) Version 2
Pharmacovigilance Subcommittee
April 2022
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 and the implementation of timely and appropriate evaluation and review have started in Japan.
In this context, the evaluation of the effectiveness of additional risk minimization measures has not progressed very well. It would be of great interest to manufacturers, distributors, and healthcare professionals to know how many people actually read and understand the information materials prepared for healthcare professionals and patients, and whether these materials are useful in changing behavior for risk minimization. In June 2021, we prepared the first edition of this report as a reference for evaluating the effectiveness of additional risk minimization activities based on the guidance related to RMPs that has already been published in Japan and overseas, as well as to introduce actual cases in which the effectiveness of additional risk minimization measures in Japan and overseas was evaluated.
This second edition has been revised to include additional information necessary for actually evaluating the effectiveness of additional risk minimization measures in Japan under the current regulatory framework.
We hope that this document will be of assistance to those who are involved in the development of RMPs and the evaluation of the effectiveness of additional risk minimization measures.
Pharmaceutical Evaluation Committee
PV Subcommittee Continuing Issues Response Team 1 (KT1)
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