Drug Evaluation Committee Guidance for Conformity Surveillance of Reexamination etc.
Pharmacovigilance Subcommittee
October 2025
The Pharmacovigilance Subcommittee has published the "Guide to Conformity Surveillance for Reexamination Applications" in response to system changes and revised notices in order for each company to accurately conduct investigations and confirm that materials related to reexamination applications conform to the GPSP Ministerial Ordinance and standards for reliability of application materials (so-called conformity surveys).
For the implementation of reexamination and other conformity investigations, the "Implementation Guidelines for Documentary Conformity Surveillance of Application Materials for Approval of New Drugs and On-site Investigation of GPSP for Drugs" (Notification No. 0831-4 of August 31, 2020, Director, Drug Evaluation and Management Division, Pharmaceuticals and Pharmaceutical Affairs Bureau, MHLW) and the "Implementation Guidelines for Documentary Conformity Surveillance of Application Materials for Approval of Drugs and GCP On-site Investigation of GPSP for Drugs" (Notification No. 0831-4 of August 31, 2020, Director, Drug Evaluation and Management Division, Pharmaceutical Affairs and Consumer Health Bureau, MHLW) are available for download. (Notification of the Director-General of the Pharmaceuticals and Medical Devices Agency, dated August 31, 2020) and "Procedures for Conforming Document Surveillance and On-site GCP Surveillance for Drug Application Materials, and Procedures for Conforming Document Surveillance and On-site GPSP Surveillance for Interim Evaluation, Re-Evaluation and Re-evaluation Application Materials of Pharmaceuticals" (Notification of the President of the Pharmaceuticals and Medical Devices Agency, dated August 31, 2020) were issued, and following the partial amendment of the Pharmaceutical Affairs Law in 2022 Following the revision of the Pharmaceutical Affairs Law in 2004, the law was revised in July 2023 to more effectively implement the procedures according to the risks involved. In response to the revision, we prepared Version 2.0 of this document in December 2023, which was followed by a reminder for smooth implementation of conformity assessment, as well as the "Operational Procedure for Changing the Scope of Conformity Assessment of Pharmaceuticals and Regenerative Medicine Products According to the Risk" (Notification of the Director-General of the Evaluation Center for Pharmaceuticals and Medical Devices Agency, dated January 31, 2025). In addition, the "Notice of the Director of the Evaluation Center of the Pharmaceuticals and Medical Devices Agency (January 31, 2025)" was issued, which requires more efficient and effective preparation and operation of conformity investigations.
In light of the above circumstances, we are pleased to publish a revised edition of the "Guide to Conformity Surveillance for Reexaminations and Other Conformity Assessments". We hope that this document will help those involved in reexamination conformity assessment operations to operate more efficiently and to prepare documents.
Created in October 2025 (ver. 2.1)
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
PV Subcommittee Continuing Issues Team 3
Guidance for Conformity Surveillance of Reexamination, etc., October 2025 (Ver. 2.1) (1,713KB)
Reference materials (see table below for details)
Forms, etc. related to Conformity Surveys
Download all forms (Japanese only) (pmda.go.jp)
(1) "8) Adverse drug reaction reports (including those derived from the drug use-results survey)" in the documents to be submitted for the written conformity survey and the on-site survey of GPSP. Please confirm that the file* to be submitted in "8) List of reports of adverse drug reactions (including those derived from the drug use-results survey) and list of literature/conference reports" has been updated.