Drug Evaluation Committee Guidance for "Periodic Safety Reporting" -Gateway System Use- (Japanese only)
Pharmacovigilance Subcommittee
May 2024
Based on the "streamlining of reexamination application materials" in the "Regulatory Reform Implementation Plan" approved by the Cabinet on June 15, 2008, the "Partial Revision of "Materials to be Attached to Reexamination Applications for New Ethical Drugs" (Notification of the Director, Drug Evaluation and Management Division, Pharmaceuticals and Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare No. 0325-10 dated March 25, 2020) was issued. (Notification of the Director, Drug Evaluation and Management Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare dated March 25, 2020). In accordance with this amendment, the latest PBRER (Periodic Benefit-Risk Evaluation Report) can be additionally submitted as a reference after the time of reexamination application. In addition, in accordance with the revision of the Ordinance for Enforcement of the Pharmaceutical Affairs Law (Ordinance of the Ministry of Health, Labour and Welfare No. 155 of August 31, 2020), the "Periodic Safety Reporting System for New Ethical Drugs" (Notice No. 0831-5 of August 31, 2020, issued by the Director-General of the Pharmaceutical Affairs and Consumer Health Bureau, Ministry of Health, Labour and Welfare) was also issued, and if the contents of the periodic safety report are appropriately described in the reexamination application materials, the last periodic safety report can be submitted. The new regulation allows the last periodic safety report to be substituted for the reexamination application, as long as the contents of the periodic safety report are appropriately described in the reexamination application materials. In addition, it is now possible to flexibly operate the investigation unit period in accordance with the PBRER period.
In addition, since January 2023, it has been possible to submit periodic safety reports using the electronic application data system (gateway system) in accordance with the notice jointly issued by the heads of the four divisions of the Pharmaceutical Affairs Bureau (November 11, 2022) entitled "Handling of Online Submission of Application Forms, etc." (Pharmaceutical and Medical Substance Control Agency Bulletin No. 1111, No. 1, et al).
Based on the above background, we are pleased to publish this document, which corresponds to the related notices issued up to FY2023. This document is a revised version of the Periodic Safety Reporting System, which is linked to the reexamination system, and aims for consistency between the reexamination application materials and the Periodic Safety Reporting Forms, incorporating the concept of a drug risk management plan (RMP). We hope that this document will be of assistance to companies involved in the preparation of periodic safety reports.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
PV Subcommittee, Continuing Issues Team 3
Guidance for Periodic Safety Reporting - Gateway System Usage Edition - (Ver 2.2) (3.7MB)
Reference materials (see table below for details)
Electronic file of the attached forms, etc. related to periodic safety reports (125KB)
Table List of contents of reference material Zip
| File name | Document name | File Format |
|---|---|---|
| Periodic Safety Report _Appendix Form 1 | Appendix Form 1 Periodic Safety Report on New Ethical Drugs | Word |
| Periodic Safety Report _Appendix Form 1 | Attachment Form 1 Summary of Implementation Status of Drug Risk Management Plan | Word |
| Periodic Safety Report _Appendix Form 1-2 | Adverse drug reactions and infections up to the time of approval | Excel file |
| Periodic Safety Report _Appendix Form 2 | Adverse drug reactions and infections in post-marketing surveillance, etc. | Excel file |
| Periodic Safety Report _Appendix Form 3 | Adverse Reactions and Infectious Diseases in Post-Marketing Surveillance, etc. | Excel file |
| Periodic Safety Report _Appendix Form 4 | Table of Contents of Adverse Reaction/Infectious Disease Case Report | Word |
| Periodic Safety Report_Replacement Request_Example | Application for Replacement <Example | Word |
| International Date of Birth of the Drug for which Approval is Scheduled_Example | International Date of Birth of the drug for the proposed approval_Example | Word |
Guidance for "Periodic Safety Reporting" prepared in September 2021 (2.7MB)
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