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 shows the consistent risk management of drug from the development phase to the post-marketing phase. The RMP aims that the risks of drugs are evaluated 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.
RMP lists already confirmed ADRs (important identified risks). It also lists adverse events for which a relationship to the administered drug is suspected but not thoroughly verified (important potential risks) and identifies the information considered insufficient (important missing information) for predicting the post-marketing safety of the drug. In addition, to address these risks or missing information, collection of the missing information, examination of risk factors for important identified risks and causality assessment of important potential risks (the pharmacovigilance activities) or post marketing activities such as information provision for risk minimization (the risk minimization activities) are described. In the risk minimization activities, besides the routine risk minimization activities such as providing information through electronic package inserts, materials (the RMP Materials) may be prepared intended for medical professionals and patients as additional risk minimization activities. Such materials are prepared for drugs for which additional information provided by materials and other means was considered necessary in the process of marketing authorization review. Contents of RMP and RMP Materials were confirmed at PMDA and the RMP Marking is affixed to these materials to indicate that they are materials prepared in line with RMP.
PMDA has made efforts to promote utilization of RMP and RMP Materials in clinical settings. RMP and RMP Materials have been posted on the PMDA website, information has been provided through the PMDA Medi-navi, and “Learn about RMP in 3 Minutes,” an RMP made-easy material, as well as “Simple Enough to Start Today! How to use RMP,” have been prepared and released.
PMDA, in collaboration with the Japanese Society of Drug Informatics and with the intention of enhancing the promotion of utilization of RMP in clinical settings, has developed an e-learning video set titled “Simple Enough to Start today! How to use RMP” as an easy-to-understand guide. The set has been available since March 2020 on the PMDA’s YouTube channel and on its website. (Videos are available only in Japanese.)
The YouTube videos are available directly from the QR code below.
< e-learning content page > (only in Japanese)
The RMP consists of the following three elements for individual drugs. 1) Safety specification 2) Pharmacovigilance activities 3) Risk minimization activities. 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.
Details of the RMP is shown at the following related notifications and Pharmaceuticals and Medicals Devices Safety Information No.378.
|Notification number, etc||Title|
|March 18, 2022
|Questions and Answers (Qs and As) on Risk Management Plan|
|March 18, 2022
PSEHB/PED Notification No. 0318-2
PSEHB/PSD Notification No. 0318-1
|Risk Management Plan templates, instructions and publication|
|December 5, 2017
PSEHB/ELD Notification No.1205-1
PSEHB/SD Notification No.1205-1
(April 26, 2012
Partial amendment of PFSB/ELD Notification No.0426-2
PFSB/SD Notification No.0426-1)
|Partial amendment of "Risk Management Plan templates and instructions"
(Reference) Risk Management Plan templates and instructions
|April 26, 2012
PFSB/ELD Notification No.0426-2 PFSB/SD Notification No.0426-1
(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|
|March 4, 2013
PFSB/ELD Notification No.0304-1
PFSB/SD Notification No.0304-1
|Publication of Risk Management Plans
|April 11, 2012
PFSB/ELD Notification No.0411-1
PFSB/ELD Notification No.0411-2
|Risk Management Plan Guidance|
|August 2, 2011||Risk Management Plan (RMP) Guidance (Draft)|
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.