The Regulatory Architecture of the "Advanced Regeneration Bio Act"
The primary legal framework governing gene therapy in South Korea in 2026 is the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act.
This legislation categorizes gene therapy as one of the four pillars of regenerative medicine (alongside cell therapy, tissue engineering, and fusion therapy). By 2026, the Ministry of Food and Drug Safety (MFDS) has streamlined the "fast-track" approval process for gene therapies targeting life-threatening diseases with no existing treatment. Key to this framework is a mandatory Long-Term Follow-Up system, requiring patients to be monitored for up to 15 years to track the safety and efficacy of the genetic modifications.
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