Drug Evaluation Committee Outline of the Drug Risk Management Plan (RMP) Study on Preparation and Utilization
May 2015
With the introduction of the RMP system in 2013, RMPs have been published on the PMDA website, and the use of RMPs has begun in the medical field as well. On the other hand, RMPs are not well recognized in the medical field, and even when they are used, some say they are difficult to understand and use.
In order to deepen the understanding of RMPs among healthcare professionals and to help promote their utilization, we examined the creation and utilization of an RMP outline. In preparing this document, we exchanged opinions in advance with the Japan Hospital Pharmacists Association, which issued the above-mentioned proposal for the utilization of RMPs.
Since the implementation of the RMP system itself has just begun, we will continue to deepen discussions with regulatory authorities and related organizations and review this outline as appropriate. We will continue to review this outline as necessary.
Drug Evaluation Committee PMS Subcommittee Task Force 1
(Note: The format was changed to match the notice issued on March 31, 2016 (September 13, 2016) regarding the preparation and publication of RMP outlines.)
For the latest RMP outline, please refer to the following (July 16, 2025)
Guidance for Preparation of a Pharmaceutical Risk Management Plan (J-RMP) - January 2025 Edition - (Green Book)
[Reference material] Creating RMP links for publication - Word file example (with bookmark and bookmark) - (53 .6 KB)word
https://www.jpma.or.jp/information/evaluation/results/allotment/PV_202501_j-rmp.html
| Notification No. etc. | Title |
|---|---|
| April 11, 2008
Pharmaceutical Safety and Health Safety Agency No. 0411001 To: Chairperson of the Safety Committee of the Federation of Pharmaceutical Manufacturers' Associations of Japan |
Partial Revision of "Points to Consider When Submitting Published Documents, etc. for Drug Risk Management Plans" (Repealed) |
| March 31, 2008
Pharmaceutical Safety and Health Affairs Agency No. 0331001 To: Chairperson of the Safety Committee of the Federation of Pharmaceutical Manufacturers' Associations of Japan |
Points to keep in mind when submitting published materials, etc. for drug risk management plans (repealed) |
| March 31, 2008
Pharmaceutical Affairs Agency Announcement No. 0331-13 Pharmaceutical Safety Agency No. 0331-13 To the Director-General of each Prefectural Health Administration Department (Bureau) |
Preparation and Publication of Summary of Drug Risk Management Plan (Repealed) |