Drug Evaluation Committee Guidance for Conformity Surveillance of Reexamination etc.
December 2023
The Pharmacovigilance Subcommittee has been revising and publishing the "Guide to Application for Reexamination" as necessary in response to changes in the system and revisions of notices in order for each company to accurately administer the reexamination system. Since the publication of the "2008 Revised Edition," the "Implementation Guidelines for Conformity Surveillance of Application Documents for Approval of New Drugs, GCP On-Site Surveillance of Drugs, and GPSP On-Site Surveillance of Drugs" (Notification No. 4 of August 31, 2020 of the Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare, Pharmaceuticals and Life Health Bureau, Pharmaceutical Evaluation and Management Division) and the "Guidelines for Conformity Surveillance of New Drugs" (Notification No. 0831-4 of August 31, 2020 of the Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare). (Notification of the Director, Drug Evaluation and Management Division, Pharmaceuticals and Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare, dated August 31, 2020), and "Procedures for Conducting Documentary Conformity Surveillance and On-site GCP Surveillance for Drug Application Materials and for Conforming Documentary Conformity Surveillance and On-site GPSP Surveillance for Interim Evaluation, Re-Evaluation and Re-evaluation Application Materials of Pharmaceutical Products" (Notification of the Director, Pharmaceuticals and Medical Devices Agency, Japan, dated August 31, 2020, hereinafter Procedure Notice). The "Notice of the Director-General of the Pharmaceuticals and Medical Devices Agency" (hereinafter referred to as the "Procedure Notice") was revised to integrate the document review, GCP site survey, GPSP site survey, and GLP implementation survey into one notice, and to incorporate GPSP into GCP, as well as to introduce interim evaluation of conditionally approved drugs. In addition, in order to more effectively and efficiently conduct conformity investigations related to clinical trials, post-marketing clinical trials, and use-results surveys using EDC, the "Method of Confirming the Status of EDC Management in Conformity Surveillance of Drugs and Regenerative Medicine Products" (November 16, 2020 notice from the Director of the Evaluation Center of the Pharmaceuticals and Medical Devices Agency) and the "Corona Medical Devices Agency" (November 16, 2020 notice from the Director of the Evaluation Center of the Pharmaceuticals and Medical Devices Agency) were introduced. Since then, specific survey methods have been clarified in the "Notice of the Director of the Evaluation Center of the Pharmaceuticals and Medical Devices Agency" dated November 16, 2020) and the "Notice of the Director of the Evaluation Center of the Pharmaceuticals and Medical Devices Agency" dated November 16, 2020), which started on a trial basis with the Corona Disaster, and since then, the Since then, the method has been revised to ensure efficient and effective operation of the conformity survey. Therefore, we have decided to publish this document, "Guide to Conformity Surveillance for Reexamination, etc.", which is specialized for conformity survey for reexamination, etc., and is separated from the previous "Guide to Application for Reexamination".
Since the publication of the first edition of this guide, various notices have been revised, including the earlier Notice of Procedures, and we have decided to publish a revised edition of this guide. We hope that this document will be of assistance to companies involved in reexamination operations and the preparation of documents.
Created in December 2023 (ver. 2.0)
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
PV Subcommittee Continuing Issues Team 3
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.