Regulatory Landscape: The 2026 "Compassionate Access" Milestone
The defining event of 2026 is the maturity of the Act on the Safety and Support of Advanced Regenerative Medicine. As of early 2026, South Korea has designated over 160 "Implementation Institutions" (up from 112 in 2024), ranging from tertiary hospitals like Seoul National University to specialized clinics.
Approval Breakthrough: For the first time, patients with "severe, rare, or incurable" conditions can access non-approved gene therapies directly through these institutions if safety has been demonstrated in clinical research.
Data Governance: All treatments are now linked to a mandatory 15-year Long-Term Follow-Up digital registry, making South Korea the world’s most robust provider of real-world evidence (RWE) for genomic safety.
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