On February 21, 2025, Korea introduced the Regenerative Medicine Law, which will enable patients suffering from serious, rare, or untreatable diseases to gain access to cell and gene therapies that are not yet fully approved for marketing. The law’s full title is – The Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products. It introduces a strict regulatory system designed to protect patient safety while opening up new healthcare options.
Key points from the law include:
- Patients can be treated with new regenerative therapies when no approved treatments are available.
- Treatments should have established safety and efficacy in clinical trials.
- Only 112 authorized hospitals and clinics with regenerative medicine specialties can utilize these therapies.
- A national review panel of a maximum of 21 experts will issue approvals.
- Tight quality control procedures, long-term follow-up of patients, and conflict-of-interest protection are required.
- These treatments will not be covered by health insurance, so patients will have to pay out-of-pocket.
Korea is different from the U.S. and EU because it excludes minimally manipulated cells, like umbilical cord blood, which continue to be subject to distinct laws. The program has also been compared to Japan’s framework for regenerative medicine, but Korea’s program is stricter, with centralized approval via a single committee versus a multi-tiered risk-based review.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.