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Risk Management Plan (RMP)

Summary of Risk Management Plan (RMP)

In order to ensure the safety of drugs, it is important to assess measures for appropriate management of the risks of drugs at any time from the development phase to the regulatory review and the post-marketing phase. The RMP is a document which is shown the consistent risk management of drug from the development phase to the post-marketing phase. And the RMP aims to be made evaluate the risk management at regular intervals or in response to the progress of post-marketing surveillance and a set of pharmacovigilance activities to minimize the risks of drugs. Sharing the published information among medical professionals is meant to ensure further enhancements of post-marketing safety measures.

Outline of the RMP

The RMP consists of the following three elements for individual drugs. 1) Safety specification: Important adverse drug reactions, which are clarified or suspected to the association with the drug, and important missing information. 2) Pharmacovigilance activities: Activities for collecting information which are performed in post-marketing. 3) Risk minimization activities: Activities for safety measures taken to minimize the risks, which consists of information provision for healthcare professionals and setting of the terms of use, etc.
With regard to pharmacovigilance and risk minimization activities, there are two types of activities such as "routine" and "additional" activities. Routine activities are activities for being commonly conducted for all drugs by Marketing Authorization Holders (MAHs), specifically collecting information on adverse drug reactions and information provision by package inserts of drugs, etc. Additional activities are activities for being conducted individually based on the individual properties, such as "Early post-marketing Phase Vigilance" of new drugs or "use-results surveys", "post-marketing clinical studies" and "distributing of materials to ensure the proper use of drugs that require caution", etc.
When PMDA concludes the necessity of the additional activities on the process of approval, etc., PMDA will publish the RMP in PMDA web site after MAHs submit the RMP including the contents of additional activities to PMDA.
Detail of the RMP is shown at the following related notice and Pharmaceuticals and Medicals Devices Safety Information No.300 .

Related notice
Notification number, etc Title
PSEHB/ELD Notification No.1205-1
PSEHB/SD Notification No.1205-1
December 5, 2017
(Partial amendment of PFSB/ELD Notification No.0426-2
PFSB/SD Notification No.0426-1
April 26, 2012)
Partial amendment of "Risk Management Plan templates and instructions"
(Reference) Risk Management Plan templates and instructions
PFSB/ELD Notification No.0426-2 PFSB/SD Notification No.0426-1 April 26, 2012
(As partially revised by PFSB/ELD Notification No.0304-1 and PFSB/SD Notification No.0304-1 dated March 4)
Risk Management Plan templates and instructions for authors
PFSB/ELD Notification No.0304-1
PFSB/SD Notification No.0304-1
March 4, 2013
Publication of Risk Management Plans

PFSB/ELD Notification No.0411-1
PFSB/ELD Notification No.0411-2
April 11, 2012
Risk Management Plan Guidance
August 2, 2011 Risk Management Plan (RMP) Guidance (Draft)


To healthcare professionals

Publishing RMP will help healthcare professionals to understand what types of risks are known for individual drugs at present. Healthcare professionals are required to know what kind of surveillance / studies which are asked for your cooperation as safety measures by MAHs are being conducted.
In order for appropriate use with drugs based on the results derived from implementation of post-marketing surveillance / studies scheduled in RMP, understanding and cooperation of healthcare professionals is necessary.

Risk Management Plan

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Risk Management Plan (RMP)