Drug Evaluation Committee Developing a Drug Risk Management Plan: An Introduction Minimum required preparation for communication between companies and PMDA
Pharmacovigilance Subcommittee
December 2016
The number of pharmaceutical risk management plans (J-RMPs) published on the PMDA website exceeds 200 products, and while the number of companies with experience in preparing J-RMPs is increasing, there are many companies that are just beginning to prepare J-RMPs.
We have compiled this document as an introductory Explanation to help those who are 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 result in a high quality J-RMP with both the PMDA and the company satisfied.
We hope that you will use this document as a checklist, and that the use of the tables to summarize your thinking will lead to more scientifically omitted discussions, more efficient communication with other departments, and help to create a higher quality J-RMP.
Notes
- For details on how to describe the J-RMP, please refer to the white book "Guidance for Developing a Drug Risk Management Plan (RMP) - Tentative Version (revised August 2014)" published by the PMS Subcommittee TF1.
- 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.
Drug Evaluation Committee PMS Subcommittee Continuing Issues Team 1 (KT1)