Drug Evaluation Committee Guidance for Preparation of "Infectious Disease Evaluation Report" (2026 Edition)
Pharmacovigilance Subcommittee
April 2026
In accordance with the revision of the Pharmaceutical Affairs Law in May 2025, the periodic reporting required as "Periodic Reporting of Infectious Diseases" for regenerative medical products or biological products was changed to "Infectious Disease Evaluation Report", which requires reporting within 30 days from the date of knowledge of a high risk, such as when there is a risk of serious physical or life threatening consequences, in addition to the existing reporting within 6 months. In addition to the conventional six-monthly reports, a report is now required within 30 days of learning of a high-risk case, such as a case that may have serious physical or life threatening effects.
In accordance with the revised Pharmaceutical Affairs Law of 2025 and related notifications, we have prepared a guide for the preparation of "Infectious Disease Evaluation Reports" (edition of 2026).
We hope that this guide will be of some help to those companies involved in the preparation of the Infectious Disease Evaluation Report.
Please note that the periodic report on infectious diseases also applies to regenerative medical products and medical devices, but this guidebook has been edited for pharmaceutical products only. Please keep in mind that there are parts of regenerative medical products and medical devices that have not been fully examined.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Pharmacovigilance Subcommittee Continuing Issues Team 8
Guidance for Preparation of "Infectious Disease Evaluation Report" (2026 Edition)