Technical Guidance on Quality, Nonclinical, and Clinical Studies for Regenerative Medical Products (Human Cell-Based Products)
Date: June 27, 2016
Issued by: Ministry of Health, Labour and Welfare, Japan
Subject: Notification to Pharmaceutical Affairs Divisions of Prefectural Health Departments
In reference to the above subject, the Pharmaceuticals and Medical Devices Agency (PMDA) has submitted a report, as attached, which is to serve as a reference for future operations. Please disseminate this information to relevant businesses under your jurisdiction.
Attachment
Date: June 14, 2016
Document No.: Yakuki-Hatsu 0614043
From: Director, Office of Medical Devices and Regenerative Medicine Products Review, Minister's Secretariat, MHLW
To: President, Pharmaceuticals and Medical Devices Agency
While the handling of regenerative medical products is already addressed in existing documents, such as the notice titled "Points to Consider in Applying for Manufacturing and Marketing Authorization of Regenerative Medical Products" (issued on August 12, 2014, Document No. Yakushokukisan-Hatsu 0812 No. 5), the PMDA has now compiled technical guidance specific to the development of human cell-based regenerative medical products.
This guidance outlines key considerations and scientific perspectives necessary for the development process of human cell-based products, covering quality evaluation, nonclinical safety studies, and clinical trial implementation.
Please note that this guidance represents the basic principles based on the latest scientific knowledge available at the time of publication. It is subject to regular review and revision. Compliance with the specific methods described in this guidance is not mandatory; other scientifically justified approaches may be acceptable.