Drug Evaluation Committee General introduction of RMP (including the latest information on the revision of medical fees, etc.) (November 3, 2024, Japan Society of Medical Pharmacy Slide)
December 2024
This document consists of lecture slides at the following symposium.
- The 34th Annual Meeting of the Japanese Association for Medical and Pharmaceutical Sciences (November 3, 2024)
- Symposium 32 How should we use a drug risk management plan (RMP) for the benefit of patients?
More than 10 years have passed since the formulation of RMPs for new drugs and other products began with the Pharmaceutical Risk Management Plan (hereinafter referred to as "RMP") Guidelines issued in 2012. The purpose of this RMP is to ensure post-marketing safety by evaluating the balance between the benefits and risks of a drug and planning and implementing necessary safety measures. Therefore, RMPs play an important role in drug safety measures. Healthcare professionals who have daily contact with patients are also expected to fully understand the RMP, use RMP materials, and collect drug information on safety issues to consider how to respond to them in the medical field, which has been the focus of attention in the 2024 revision of medical fees. However, some issues have been pointed out, such as insufficient understanding by healthcare professionals and varying granularity of RMPs among pharmaceutical companies. Therefore, he gave a lecture from the viewpoint of a pharmaceutical company as he reconsidered what the RMP should be for patients from the standpoint of each stakeholder.
December 2024
PV Subcommittee of the Committee on Drug Evaluation, Continuing Issues Response Team 1 (KT1)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables