Drug Evaluation Committee Reference Manual for Clinical Development of Regenerative Medicine Products
Clinical Evaluation Subcommittee
May 2025
The development of regenerative medical products differs from conventional drug development in terms of development methods, clinical evaluation methods, safety evaluation/monitoring, and legal regulations, as well as in some aspects that require unique responses in Japan. As a result, pharmaceutical companies that are developing regenerative medical products for the first time face a time-consuming and burdensome information gathering process. In the hope of promoting understanding of the overall picture of the development of regenerative medical products and enabling the prompt and high-quality implementation of clinical trials, we have prepared a reference document that summarizes the results of a survey of laws and notices related to regenerative medical products, as well as the results of an analysis of information on previously approved regenerative medical products and a questionnaire targeting medical professionals working on development of such products. This document is a reference document that summarizes the results of the survey on laws and notices related to regenerative medical products.
This document summarizes information on domestic regulations regarding regenerative medical products, consultation with PMDA before starting a clinical trial, points to keep in mind when conducting a clinical trial, as well as information on how to apply for approval and what to do after application for approval. Please note that the development environment surrounding regenerative medical products is changing significantly, so it is necessary to keep yourself up-to-date with the latest information by referring to this document. We hope you will find this document useful as a compass for your research and development activities and as a reference material for solving practical issues.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Clinical Evaluation Subcommittee 2024 Task Force 3
Deliverables of the Drug Evaluation Committee Return to list of all deliverables