Drug Evaluation Committee Guidance for Re-Evaluation Applications - Gateway System Use
Pharmacovigilance Subcommittee
March 2024
The reexamination system is a system for reconfirming the quality, efficacy, and safety of new drugs. 40 years have already passed since it was established based on the revision of the Pharmaceutical Affairs Law in 1980, and it is now widely used as one of the pillars of Japan's post-marketing safety measures.
In light of the "streamlining of reexamination application materials" in the Plan for the Implementation of Regulatory Reform, the "Materials to be attached to an application for reexamination of a new prescription drug" was partially revised (March 25, 2020, Pharmaceutical Affairs Bureau of Japan, No. 0325-10), and in order to make the reexamination process more transparent and contribute to proper use of pharmaceutical products, the "reexamination report for confirmation of reexamination of new pharmaceutical products" was revised (March 25, 2020, Pharmaceutical Affairs Bureau of Japan, No. 0325-10). In addition, the "Publication of Reexamination Reports, etc. Concerning Confirmation of Reexamination of New Drugs" was revised (November 30, 2020, Pharmaceutical and Food Safety Agency Bulletin No. 1019, No. 3) to make reexaminations more transparent and to contribute to the proper use of pharmaceuticals. In addition, in July 2022, based on the jointly issued notice by the heads of the four divisions of the Pharmaceutical Affairs Bureau (No. 0519, dated May 19, 2022, et al), "Handling of Online Submission of Applications, etc.", it became possible to submit reexamination applications for new drugs using the electronic application data system (gateway system), and this manual, "Application Guide for Use of the Gateway System", was published. This manual, "Application for New Drugs Using the Gateway System," has been published in response to this change.
This guide is intended to serve as a reference for companies that wish to apply for reexamination of new drugs using the gateway system, and includes examples of how to respond to points to keep in mind and questions that arise when applying for reexamination. We hope that it will be of assistance to companies involved in reexamination applications and reexamination/compliance investigations.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
PV Subcommittee, Continuing Issues Team 3
Reference materials (see table below for details)
Electronic files of Appendix Forms, etc. related to reexamination application (205KB)
Table List of contents of reference material Zip
| File name | Document name | File Format |
|---|---|---|
| Reexamination_Appendix Form 1 | Attachment Form 1: Summary of the item(s) for which reexamination is applied for | Word |
| Reexamination_Appendix Form 2 | Adverse drug reactions and infections up to the time of approval | Excel file |
| Reexamination_Appendix Form 3 | History of revision of precautions for use | Word |
| Reexamination_Appendix Form 4 | Status of implementation of drug risk management plan | Word |
| Reexamination_Appendix Form 5 | Appendix Form 5 Summary of Outcome Surveillance | Word |
| Reexamination_Appendix Form 6 | Summary of Post-Marketing Database Survey | Word |
| Reexamination_Appendix Form 7 | Attachment Form 7 Summary of Post-Manufacturing and Sales Clinical Study | Word |
| Reexamination_Appendix Form 8 | Exhibit Form 8 Summary of Additional Risk Minimization Activities | Word |
| Reexamination_Appendix Form 9 | Exhibit Form 9: Incidence of Adverse Reactions and Infectious Diseases Not Predictable from "Precautions for Use | Excel file |
| Reexamination_Appendix Form 10 | Reexamination_Appendix Form 10 Incidence of Adverse Reactions/Infectious Diseases in Case Reports | Excel file |
| Reexamination_Appendix Form 11 | Table of Contents of Adverse Reaction/Infectious Disease Case Reports | Word |
| Reexamination_Appendix Form 12 | Additional Drug Safety Monitoring Plan for Adverse Reaction/Infectious Disease | Excel file |
| Reexamination_Appendix Form 13 | Appendix Form 13 Status of Report of Foreign Measures | Word |
| Reexamination_Appendix Form 14 | Status of Research Report (Appendix Form 14) | Word |
| Re-Examination_Appendix Form 15 | Adverse drug reactions and infections in post-marketing surveillance, etc. | Excel file |
| Reexamination_Appendix Form 16 | Appendix Form 16 Summary of cases in post-marketing surveillance, etc. | Excel file |
| Reexamination_Statement_Example | Statement (Example) | Word |
Please refer to the following link for the checklist file ("Items to be checked when submitting electronic files of documents for release of information").
(Summary of Examination Report and Application Materials "4. Submission of Electronic Media for Information Release")
Guidance for Reexamination Application - Created in October 2021 (ver. 1.0)(2.1MB)
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