– states The Medical Council of Thailand (Oct 31 ’24-Press Conference)

Review Mechanisms for Advanced Medical Therapies in Japan and Thailand

Advanced therapies like stem cell and gene therapies, as well as xenotransplantation, pose significant regulatory and ethical challenges. Major drug agencies in the U.S., India, and Europe require local ethics reviews, following strict approval standards. However, unapproved stem cell clinics continue to thrive, highlighting gaps in patient protection.

Japan has implemented a system requiring local approvals for all regenerative medical procedures and expedited processes for promising interventions. Nonetheless, this approach is criticized for lacking a balance between early access and thorough safety assessments.

In smaller countries like Thailand, limited expertise hampers the evaluation of these therapies. This article suggests that countries restrict the early adoption of advanced therapies to specialized clinics with the necessary scientific and ethical expertise, focusing evaluations on the clinical benefits for patients, regardless of whether treatments are classified as research or therapy.

References

Matsui, K., Israsena, N., Kaewkungwal, J. et al. Review Mechanisms for Advanced Medical Therapies in Japan and Thailand: A Proposal for the Use of Expert Clinical Benefit Assessments at Designated Institutions. ABR 17, 101–115 (2025). https://doi.org/10.1007/s41649-024-00301-9