Drug Evaluation Committee Explanation Materials on the New RMP System (October 2026) – JPMA Briefing Materials and Other Resources
October 2026
Following the enactment of the RMP legislation, notifications and administrative circulars regarding the new RMP were issued on September 30, 2026.This time, the revisions to the new RMP system are wide-ranging—including the mandatory evaluation of the effectiveness of additional risk minimization activities and changes to the approach for safety considerations to be included in the RMP—and it is anticipated that it will be difficult to fully grasp all of these notifications and other documents.For this reason, we have compiled relevant notifications and examples of required entries in an easy-to-understand format and released a video at a briefing session hosted by the Japan Pharmaceutical Manufacturers Association (JPMA). We are making the materials used in this briefing session available below and hope they will assist those involved in RMP development in their daily operations. We also plan to continue compiling and publishing relevant materials regarding the new RMP system on this website.
Explanation Materials, etc.
- Japan Pharmaceutical Federation Briefing Slides [Summary Version] ← Approximately 10 slides. Please review this first to get an overview.
- Japan Pharmaceutical Association Briefing Slides [Detailed Version] ← Approximately 60 slides. We strongly encourage those involved in RMP creation, such as pharmacovigilance (PV) staff, to review these.
- Sample Text for a Request to Lift Approval Conditions ←These are examples of how to draft a Request for Waiver of Approval Conditions regarding the RMP (content that has already been discussed with regulatory authorities)
Looking Ahead
As operational challenges are anticipated leading up to the system’s implementation on May 20, 2027, we are also considering holding additional briefing sessions. While this content and any future updates will be reflected in the Green Book at a later date, we will compile detailed information on this page to provide timely updates in the meantime.Therefore,
① Please bookmark this page and refer to it as needed.
② The Japan Pharmaceutical Manufacturers Association (JPMA) is conducting a survey regarding any questions or requests you may have. Your responses will be reflected in future briefing materials, so please complete the survey via the link. (Survey period: Through December 31, 2026)
Reference Information
- Link to the Japan Pharmaceutical Manufacturers Association (JPMA) Website ←Click here to view videos from the JPMA briefing sessions (featuring regulatory authorities and the JPMA). (Available until December 31, 2026)
- Link to the PMDA Website (RMP) ←Click here to view notifications, administrative notices, and sample RMP submissions
