Japan and South Korea regulate cell-based treatments through clinic plans, while approving products for specific diseases
Japan and South Korea regulate cell-based treatments through clinic plans, while approving products for specific diseases
On August 7, BioPharma APAC published an analysis of the legal pathways for cell-based interventions in the longevity market. It distinguished three forms: a clinical trial, a procedure conducted under an approved clinic plan, and a product approved for a specific disease.
The phrase “cell therapy for longevity” covers three distinct things. A clinical trial collects data. An approved plan allows a specific clinic to perform the procedure described in that plan. Product approval permits the use of a product for a particular disease or condition. These regulatory pathways assign responsibility for gathering evidence in different ways.
In Japan, the Act on the Safety of Regenerative Medicine regulates the provision of regenerative medicine involving cell products that have not been approved under the Pharmaceuticals and Medical Devices Act. An institution submits a procedure plan, which a certified committee reviews according to its risk class. Since May 31, 2025, the plan must specify criteria for scientific validity, including expected efficacy, and annual reports must compare treatment outcomes with those criteria.
In the spring, gerontologist Matt Kaeberlein described how clinics offer stem cells before comparable data become available. Japanese rules require a clinic to have a reviewed plan and to report outcomes annually. Approval of the cell product itself is governed by the Pharmaceuticals and Medical Devices Act.
In South Korea, an amendment effective since February 2025 created a separate pathway for treatment with regenerative methods. The Regenerative Medicine Acceleration Foundation guide states that only institutions designated by the Minister of Health may perform such procedures, and they must follow an approved plan. Low-risk methods are exempt. For all other methods, a clinical trial must first be completed, and the pathway is intended for serious, rare, or incurable diseases.
The same cell-based method may be used in a clinical trial, performed under a clinic plan, or approved as a product. These labels answer different questions: where data are collected, who is permitted to perform the procedure, and which product may be used for a specific disease.