Drug Evaluation Committee Guidance for the Preparation of Defect Reports for Combination Products (2025 Edition)
Pharmacovigilance Subcommittee
July 2025
The Pharmacovigilance Subcommittee has prepared the "Guidance on Reporting Failure pertaining to Drug Combination Products (2025 Edition)" regarding the reporting of failures in the parts related to machinery and equipment, etc. of combination products that are approved to be manufactured and sold together with machinery and equipment, etc., which is mandatory under the revised Pharmaceutical and Medical Device Law that came into force on November 25, 2014. In addition, as reporting by electronic data processing system became possible from April 1, 2020, the revised edition (2021 edition) was published.
The revised edition (2021 edition) was issued in response to the revision of the Enforcement Regulations of the Pharmaceuticals and Medical Devices Law in 2021, which changed the reporting frequency of periodic reports of medical device unknown non-serious failures from "every year" to "within one year," as well as to changes in terminology and other descriptions along with related notices, etc. The revised edition was issued after the publication of the 2021 edition of the guide. We have now begun work on a revised edition of the guide that reflects the revisions and notifications issued after the publication of the 2021 edition, and are pleased to announce its publication.
We hope that this guide will be of some help in preparing "Defect Reports on Drug Combination Products".
Drug Evaluation Committee
Pharmacovigilance Subcommittee Continuing Issues Response Team 2
Guidance for the Preparation of Defect Reports for Combination Products (2025 Edition)