Drug Evaluation Committee Developing a Drug Risk Management Plan: An Introductory Guide Minimum Preparation for Communication between Companies and PMDA
Pharmacovigilance Subcommittee
December 2016
More than 200 drug risk management plans (J-RMPs) have been published on the PMDA website, and while the number of companies with experience in preparing J-RMPs is increasing, many companies are still in the process of preparing their own J-RMPs.
We have compiled this manual as an introductory guide to help those in charge of identifying Safety Specification (SS) to consider what, when, and how to do so in a more practical manner.
By identifying SSs and preparing a J-RMP with reference to this document, we expect that the number of inquiries regarding basic matters will be reduced, and even if there are inquiries, we hope that by smoothly answering them from the prepared study materials, sufficient discussions will take place and a high-quality J-RMP will be created with the mutual understanding of both PMDA and the company. We hope that this will lead to a high quality J-RMP with the mutual consent of both PMDA and companies.
We hope that this document will be used as a checklist and that the use of the tables to summarize ideas will lead to more scientifically omitted discussions, efficient communication with other divisions, and help to create a higher quality J-RMP.
Notes
- Please refer to the white book "Guidance for Developing a Drug Risk Management Plan (RMP) - Provisional Version (revised August 2014)" published by the PMS Subcommittee TF1 for information on how to describe a J-RMP.
- Please note that the examples of inquiries and other information are limited and have been modified to make them easier to understand as examples, rather than actual cases themselves.
PMS Subcommittee of the Drug Evaluation Committee, Continuing Issues Response Team 1 (KT1)
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