Drug Evaluation Committee Guidance for Preparation of a Drug Risk Management Plan (J-RMP) -January 2025 Edition- (in Japanese)

Many companies have already prepared and published the Drug Risk Management Plan (J-RMP), which became law in October 2014. However, the regulations and notifications related to RMPs are diverse, including preparation guidelines, version control, and publication procedures, and it is difficult to keep track of all of these notifications, etc. Therefore, this document provides an easy-to-understand guide to preparing RMPs, including related notifications, descriptions, and examples. Therefore, the first edition of this guide was published in May 2008 as a pamphlet (Green Book), which summarizes related notices, descriptions, examples, etc. in an easy-to-understand manner.
The first edition of this guide was published as a booklet (Green Book) in May 2008, and was subsequently revised in April 2008 (handling of RMPs after reexamination, commencement of online posting of RMP materials, etc.) and January 2023 (consistency between the submitted and published versions of RMPs, addition of new forms for submission notification/replacement requests, etc., and electronic submission of J-RMPs, etc.). The revised version has been prepared to reflect the following

We hope that this will be of assistance to those involved in the RMP development process in their operations and documentation.