Drug Evaluation Committee Internal Process Flow for Utilization of the Registry in Drug Approval Applications, etc. (From Internal Proposal to Registry Modification)
Clinical Evaluation Subcommittee
December 2022
In the utilization of disease registries for drug approval applications, etc., various notifications have been issued by regulatory authorities and guidelines have been developed, and related organizations have provided support for the establishment of registries, the release of registry search systems, and support for matching registry users and registry holders.
The FY2021/2022 Clinical Evaluation Subcommittee and Ongoing Issues Team10 focused on the internal process when companies utilize the registry for applications for approval, etc., and summarized the points to keep in mind and issues to be addressed in each situation. We hope that this report will help companies with no experience to take the first step to utilize the registry.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Clinical Evaluation Subcommittee, Continuing Issues Response Team 10
- Appendix (96KB)
- Support Tool #1: Timeline from the proposal to the agreement on the use of the registry (reference example)
- Support Tool #2 Steps to identify candidate registries and key initial assessment points
- Support Tool #3 Example of a Risk Management Plan
- Support Tool #4 Checklist for Registry Appropriateness and Reliability Assessment
- Reference List
Deliverables of the Drug Evaluation Committee Return to list of all deliverables