Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Office of Safety I, Pharmaceuticals and Medical Devices Agency
Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Office of Safety I, Pharmaceuticals and Medical Devices Agency
Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Office of Safety I, Pharmaceuticals and Medical Devices Agency
Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency
This English version is intended to be a reference material to provide convenience for users. In the event
of inconsistency between the Japanese original and this English translation, the former shall prevail.
In regard to Risk Management Plan, the Ministry of Health, Labour and Welfare (MHLW)
previously issued notifications entitled Risk Management Plan Guidance PFSB/SD Notification
No. 0411-1 and PFSB/ELD Notification No. 0411-2 dated April 11, 2012 issued jointly by the
Director of Evaluation and Licensing Division and the Director of Safety Division, Pharmaceutical
and Food Safety Bureau, Ministry of Health, Labour and Welfare and provided its guidelines. This
notification sets up the specific templates for Risk Management Plan and the handling of the
submission, etc, as described below. Please inform Marketing Authorization Holders (MAHs) under
your jurisdiction of this notification.
2. Submission of a draft of Risk Management Plan at the time of application for approval
a) When a new drug application is filed, the applicants for marketing authorization shall file a
draft of Post-Marketing Surveillance/Clinical study Plan based on the 3-1-1-(11) and the
attachment 2-11 of the notification entitled Points of preparation for the data to be
attached for application form in the new drug application (PFSB/ELD Notification No.
899 dated June 21, 2001 issued by the Director of Evaluation and Licensing Division,
Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare).
However, when the applicants for marketing authorization submit approval applications on
and after April 1, 2013, a draft of Risk Management Plan should be submitted instead of a
draft of Post-Marketing Surveillance/Clinical study Plan. In addition, after the notice day of
this notification, the applicants for marketing authorization may submit a draft of Risk
Management Plan as data to be attached to the new drug application instead of a draft of
Post-Marketing Surveillance/Clinical study Plan.
b) In terms of biosimilars/follow-on biologics, the applicants for marketing authorization shall
file specific methods and plans of post-marketing surveillance and risk management based
on the annex 9. of the Guidelines for ensuring the quality, safety and efficacy of
biosimilars/follow-on biologics (PFSB/ELD Notification No. 0304007 dated March 4,
2009 issued by the Director of Evaluation and Licensing Division, Pharmaceutical and
Food Safety Bureau, Ministry of Health, Labour and Welfare). However, when the
applicants for marketing authorization for biosimilars/follow-on biologics submit approval
applications on and after April 1, 2013, a draft of Risk Management Plan should be
submitted instead of a draft of the specific methods and plans of post-marketing
surveillance and risk management. In addition, after this notification, the applicants for
marketing authorization may submit a draft of Risk Management Plan instead of the draft
of the specific methods and plans of the post-marketing surveillance and risk management.
4. Submission of Risk Management Plan when new safety concerns have been identified in the
post-marketing phase.
When new safety concerns have been identified in the post-marketing phase and the MAHs
might want to develop or change Risk Management Plan, contact the Pharmaceuticals and
Medical Devices Agency (PMDA) regarding the timing of submission and the content of the
plan.
5. Others
a) When the MAHs change Risk Management Plan including the case of above 4, except for
the minor change, the Risk Management Plan should be submitted to the PMDA. In addition,
the author should underline the changed parts and put down with the latest contents.
b) The MHLW will issue notification regarding the form of periodic reports based on the
implementation of Risk Management Plan later.
[Appended form]
Risk Management Plan
DD/MM/YY
Brand name
Active ingredient
Indication
Conditions for
approval
Remark
Change history
The contents of pharmacovigilance activities and the reasons why they are chosen
The contents of risk minimization activities and the reasons why they are chosen :
The contents of pharmacovigilance activities and the reasons why they are chosen
The contents of risk minimization activity and the reasons why they are chosen :
The contents of pharmacovigilance activities and the reasons why they are chosen
The contents of risk minimization activity and the reasons why they are chosen :
The contents of pharmacovigilance activities and the reasons why they are chosen
The contents of risk minimization activity and the reasons why they are chosen :
The contents of pharmacovigilance activities and the reasons why they are chosen
The contents of riskminimization activity and the reasons why they are chosen :
The contents of pharmacovigilance activities and the reasons why they are chosen
The contents of risk minimization activity and the reasons why they are chosen :
The contents of pharmacovigilance activities and the reasons why they are chosen
The contents of risk minimization activity and the reasons why they are chosen :
The contents of pharmacovigilance activities and the reasons why they are chosen
The contents of risk minimization activity and the reasons why they are chosen :
The contents of pharmacovigilance activities and the reasons why they are chosen
The contents of risk minimization activity and the reasons why they are chosen :
1.2 Concerns for efficacy
Objective, summary of the content and method of the surveillance and studies and the reasons
why the surveillance and/or studies are chosen
6. Organizational structure for Risk management plan
6.1 Responsible persons
Safety management
supervisor
Chief administrator of
Post-Marketing
Surveillance/Clinical study
Plan, etc.
7. Background information
Guide for developing Risk Management Plan
1. General
The text should be laid out for Japanese Industrial standards A4 paper.
A submitter may attach a separate sheet with describing as the attached document in the
column if all of the statement cannot describe within each column.
For every particular items in the plan, if there is no statement to be included in the column,
the author may put N/A in the space.
If a submitter files a draft of Risk Management Plan as part of applications for new drugs,
biosimilars/follow on biologics, generics and partial changes, it is recommended that the
document should be submitted along with outline of the draft of Post-Marketing
Surveillance/Clinical study Plan and the draft of the materials of Risk minimization plan at
the time.
If a submitter files a draft of Risk Management Plan other than a point of drug application,
the draft of Post-Marketing Surveillance/Clinical study Plan and materials for additional
phamacovigilance activities and additional risk minimization activities should be submitted
at the time of submission.
2. Summary of products
If a submitter files a draft of Risk Management Plan as part of drug application, the
submitter should leave the undecided items such as approval date, approval number and
conditions for approval, etc., blank. For the items of therapeutic category, dosage and
administration, indication, etc., the author should describe the same content as the
marketing application form and put planned on each item
In the remarks column, the followings should be stated
The status of re-examination period or after the period, and the information of generic drug,
etc.
The name of the person in charge, affiliation and telephone number, etc.
The name of the product and the company name in the case of a joint development
product.
If a Risk Management Plan is submitted to the PMDA by joint names of the relevant
parties for their products, description of a joint development product is not required.
9. Background information
Make a list for the attached the documents to the Risk Management Plan
As background information, the submitter should attach the outline of document (for the
Pharmaceutical Affairs and Food Sanitation Council) attached with the application form at
the time of the new drug application, the review report, the review result report for the
Pharmaceutical Affairs and Food Sanitation Council and the draft version of package insert.