Drug Evaluation Committee Guidance for Conformity Surveillance of Reexamination etc.
December 2023
To ensure that companies accurately implement the re-examination system, the Pharmacovigilance Subcommittee has periodically revised and published the “Guidance for Re-examination Applications” in response to system changes and revisions to notifications.Since the publication of the “Heisei 30 Revised Edition,” regarding re-examination and other compliance inspections, the “Implementation Guidelines Concerning Documentary Compliance Reviews of New Drug Approval Applications, On-site GCP Inspections of Drugs, and On-site GPSP Inspections of Drugs, etc.”(Notice No. 0831-4 dated August 31, Reiwa 2, issued by the Director of the Pharmaceutical Review and Management Division, Pharmaceutical and Living Environment Bureau, Ministry of Health, Labor and Welfare), as well as the “Procedures for Conducting Documentary Compliance Reviews and GCP On-Site Inspections of Drug Approval Application Documents, and Procedures for Conducting Documentary Compliance Reviews and GPSP On-Site Inspections of Application Documents for Interim Evaluation, Re-examination, and Re-evaluation of Drugs” (Notice from the President of the Pharmaceuticals and Medical Devices Agency, dated August 31, Reiwa 2,hereinafter referred to as the “Procedures Notice”), document compliance reviews, GCP on-site inspections, GPSP on-site inspections, and GLP compliance inspections were consolidated into a single notice. The revisions were made to align GPSP more closely with GCP, and an interim evaluation system for conditionally approved pharmaceuticals was also introduced.Furthermore, to conduct compliance inspections for clinical trials, post-marketing clinical trials, and post-marketing surveillance utilizing EDC more effectively and efficiently, the “Methods for Verifying EDC Management Status in Compliance Inspections of Pharmaceuticals and Regenerative Medicine Products” (Notice from the Director of the Review Center, PMDA, dated Reiwa 2, November 16) and,Following a pilot launch during the COVID-19 pandemic, specific inspection methods were codified in the “Guidelines on the Implementation of Remote Inspections in Conformity Inspections of Pharmaceuticals and Regenerative Medicine Products” (Notice from the Director of the Review Center, PMDA, dated November 16, Reiwa 2), and since then, the operation of conformity inspections has been reformed to be more efficient and effective.Consequently, we have extracted relevant sections from the previous “Guidance on Applications for Re-examination” and published this “Guidance on Re-examination and Other Conformity Surveys,” which is specifically tailored to re-examination and other conformity surveys.
Since the publication of the first edition, various related notices—including the aforementioned procedural notice—have been revised; consequently, we have decided to publish this revised edition. We hope this guide will be of assistance to all companies involved in re-examination operations in their day-to-day operations and the preparation of documentation.
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.