Drug Evaluation Committee Guidance for Preparation of "Periodic Report of Infectious Diseases" (2025 Revision)
Pharmacovigilance Subcommittee
March 2025
The Pharmacovigilance Subcommittee has published a guide for preparing "Periodic Reporting of Infectious Diseases" regarding the periodic reporting system for infectious diseases related to biological products, which came into effect on July 30, 2003.
In 2021, the period of investigation for reporting was changed to "within 6 months," and in 2023, online submission using the electronic data system for application became possible. In addition, in 2024, the Director-General's Notification Attachments 2 through 7 allowed for the partial simplification of the contents of periodic reports on infectious diseases when there is no new information to be reported during the period covered by the investigation of the report.
The Pharmacovigilance Subcommittee has started to prepare a revised version of the guide to reflect these notifications issued after the publication of the revised guide in 2008, and has now decided to publish a new version.
The periodic reporting of infectious diseases also applies to regenerative medical products and medical devices, but this guide has been edited to cover pharmaceutical products only. Please keep in mind that there are parts of regenerative medical products and medical devices that have not yet been fully examined.
We hope that this guide will be of assistance in the preparation of the "Periodic Report of Infectious Diseases".
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Pharmacovigilance Subcommittee, Continuing Issues Response Team 2
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