Drug Evaluation Committee Guidance for Preparation of a Drug Risk Management Plan (J-RMP) -January 2023 Edition
Pharmacovigilance Subcommittee
January 2023
Many companies have already prepared and published the Drug Risk Management Plan (J-RMP), which became law in October 2014. However, the regulations and notices related to RMPs are diverse, including preparation guidelines, version control, and publication procedures, and it is difficult to keep track of all these notices, etc. Therefore, we have prepared this document to provide an easy-to-understand summary of related notices, descriptions, examples, etc. Therefore, we published the first edition of this guide in May 2008 as a pamphlet (Green Book) that summarizes related notices, descriptions, examples, etc. in an easy-to-understand manner.
In April 2021, the booklet was revised to reflect the handling of RMPs after reexamination and the posting of materials associated with RMPs on the website, etc. In March 2012, a notice regarding RMPs was issued, and the booklet was revised to reflect the consistency between the submitted and published versions of RMPs, the addition of new forms for submission notification/replacement requests, etc., and the electronic submission of J-RMPs, etc. The revised version of the J-RMP has been prepared to reflect the new format and the electronic submission of the J-RMP.
We hope it will be of assistance to those involved in RMP development in their business operations and in the preparation of documents.
January 2023
KT1 (Continuing Issues Team 1), PV Subcommittee of the Drug Evaluation Committee
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Guidance for Preparation of a Drug Risk Management Plan (J-RMP) - January 2023 Version - (13MB)
(Note: The latest version was released in January 2025.
The above contents contain outdated information, so please be sure to refer to the latest version.
Reference materials (see table below for details)
Table List of contents of Reference Material Zip
| Number | Document name | File Format |
|---|---|---|
| 1 | Example of Checklist for Drug Risk Management Plan | WORD |
| 2 | Key Points of the March 2022 Notification on RMP | PPT |
| 3 | Collection of Q&As for Notification on RMP for March 2022 | PPT |
| 4 | Creation of RMP link for publication - Example Word file with bookmarks and bookmarks | WORD |
(Supplementary information)
A document summarizing the key points of the March 2022 RMP Notice is also attached as Reference Material 2.
Deliverables of the Drug Evaluation Committee Return to list of all deliverables