Current Status of RMP Evaluation in PMDA

Abstract

The Risk Management Plan (RMP) is a document which is shown the consistent risk management of drug from the development phase to the post-marketing phase. RMP mainly consists of safety specifications, pharmacovigilance plans and risk minimization plans. The guidance for RMP was implemented on April 1, 2013. About 3 years have been passed since RMP preparation started to be required, our experience of RMP evaluation is being accumulated. In this paper, we introduce RMP outlines and current status of RMP evaluation in Pharmaceuticals and Medical Devices Agency based on our experience of the RMP review process. Also, we discuss the future directions of RMP, including the promotion of healthcare professionals’ awareness and active use of RMP.