Drug Evaluation Committee A Guide to Viewing the PMDA's "Video on Reexamination Compliance Surveillance
Pharmacovigilance Subcommittee
February 2025
In order to ensure that the reexamination compliance investigation of a pharmaceutical product is conducted without delay, the PMDA reminds you to check the relevant notices and the information on the PMDA website when you apply for reexamination in preparation.
In particular, the "Video on Conformity Surveillance at the Time of Application for Reexamination" posted on the PMDA website explains in detail how to prepare for and respond to a specific conformity survey at the time of application for reexamination, and we believe that viewing and understanding the video will facilitate the preparation of the reexamination application. However, some users have commented that it is difficult to confirm and grasp the information they want to know due to the large number of videos and the wide variety of content.
This document consists of a guide that summarizes which videos explain "what you want to know" when preparing for the conformity assessment at the time of reexamination application, and a document that summarizes the outline of each video. We hope that this guide will facilitate the viewing and understanding of the contents of the videos and help all companies involved in reexamination and other conformity assessment activities in their operations.
Created in February 2025 (ver. 1.0)
Committee on Evaluation of Pharmaceutical Products, Japan Pharmaceutical Manufacturers Association
PV Subcommittee Continuing Issues Response Team 3
*Please review this document first.
A Guide to Viewing the PMDA's "Video on Reexamination Compliance Surveillance
Electronic files listed in the Viewing Guide
- Video No. 3 This will help you understand! Procedures for Conformity Surveys from Application for Reexamination to Schedule Adjustment - Key Points for Preparation of Documents
- Video No.4 [Full-scale introduction] Next-generation GPSP management tool - How to describe GPSP
- Video No.5 [Full-scale version] DB survey management tool -How to describe
- Video No.6 Reduction of the Number of Questions in Reexamination Conformity Surveys - Improvement of the Efficiency of GPSP On-Site Surveys
- Video No.7 Project for Reducing the Number of Questions in Conformity Surveillance -Safety Management Information and Safety Database- (Japanese only)
- Video No.8 Project for reducing the number of questions in reexamination and other conformity assessment -Data management (use-results survey)
- Video No.9 Project for Reducing the Number of Questions in Conformity Surveillance -Data Management (Use-results Survey)- Examples of Presentations of Evidence
- Video No.10 Use of Consultation on Reexamination Compliance Surveillance for Succeeded Drugs
References
Information on the reexamination conformity survey (GPSP Gate)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables