Drug Evaluation Committee Pharmaceutical Risk Management Plan (RMP) Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials)
June 2021
With the introduction of the RMP system in 2013, comprehensive and systematic visualization of drug safety monitoring and risk minimization according to the characteristics of pharmaceutical products, as well as timely and appropriate evaluation and review, has started in Japan.
In this context, the evaluation of the effectiveness of additional risk minimization measures has not progressed very well. It is of great interest to manufacturers 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.
Therefore, in this issue, we have prepared a document that summarizes the parts of the guidance related to RMPs that have already been published domestically and internationally that can be used as a reference when evaluating the effectiveness of additional risk minimization activities, as well as providing examples of actual cases in which the effectiveness of additional risk minimization measures in Japan and overseas have been evaluated.
We hope that this document will be of assistance to those involved in the development of RMPs and the evaluation of the effectiveness of additional risk minimization measures.
Drug Evaluation Committee PV Subcommittee Continuing Issues Response Team 1 (KT1)