Expansion of the "Advanced Regenerative Medicine Law" in 2026
As of early 2026, South Korea has fully activated the expanded Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products.
This landmark legislation now allows patients with "severe, rare, or incurable" conditions to receive gene therapies that have demonstrated safety but have not yet achieved full market approval. Unlike previous frameworks, this 2026 update permits designated medical institutions—currently numbering over 110 nationwide—to initiate treatment plans directly under the supervision of a centralized national review committee. This "hospital-exemption-style" pathway has turned South Korean hospitals into real-world laboratories, collecting critical long-term safety and efficacy data (Real-World Evidence) that is used to accelerate formal global approvals.