Drug Evaluation Committee Guidance for Preparation of a Drug Risk Management Plan (J-RMP) April 2021 edition
April 2021
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 compiled this guide, which includes related notices, descriptions, examples, etc., in an easy-to-understand format. Therefore, in May 2008, we published a pamphlet (Green Book) summarizing related notices, case studies, and other information in an easy-to-understand format.
Three years have passed since the publication of the Green Book, and there have been changes in notifications regarding RMPs, such as the handling of RMPs after reexamination and the posting of materials tied to RMPs on the website, so we have prepared a revised version of this guide.
In addition, since various ways of working, including telecommuting, have advanced at a rapid pace over the past year, and in light of requests for online publication of the Green Book, we have made this revision an online version instead of a booklet version.
We hope this will help those involved in RMP development in their business operations and in the preparation of materials.
April 2021
Drug Evaluation Committee PV Subcommittee Continuing Issues Team 1 (KT1)
Click here for the main body
Guidance for Preparation of the Drug Risk Management Plan (J-RMP) - April 2021 version - (9.3 MB)
(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The above contents contain outdated information, so please be sure to refer to the latest version.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 Materials Zip
| Number | Name of document | File Format |
|---|---|---|
| 1 | Example of Checklist for Drug Risk Management Plan | WORD |
| 2 | Submission of Risk Management Plan (Prior Communication) | WORD |
| 3 | replacement request | WORD |
(Note)
The file was changed as follows in August 2021.
- Combined examples of RMP descriptions in the Reference Material Zip into the main body of the Guide.
- Revised the structure of the Reference Material Zip and deleted the White Book.