The government is shifting the center of gravity of its advanced regenerative medicine policy from building a research base to actual treatment and industrialization. Stem cell treatments that people used to receive overseas at high cost will be made safely available in Korea through government-led clinical research, and treatments with confirmed safety will face lower barriers to enter clinical use. On the other hand, oversight will be strengthened so designations can be revoked for institutions that use their status as regenerative medicine providers for hospital promotion without any research or treatment performance.
The Ministry of Health and Welfare and the Ministery of Food and Drug Safety on the 21st held the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Policy Committee, co-chaired by Minister Jung Eun-kyeong and Ministery of Food and Drug Safety Commissioner Oh Yu-Kyoung, and reviewed and approved the Second Basic Plan for Advanced Regenerative Medicine and Advanced Biopharmaceuticals (2026–2030) containing these measures.
The government set goals of at least 150 cumulative approvals of clinical research and treatment plans by 2030 and five or more domestically developed advanced biopharmaceuticals. Lee Jun-mi, head of the Regenerative Medicine Policy Division at the Ministry of Health and Welfare, said in a pre-briefing the previous day, "The key is to bring treatments with demand for overseas medical trips into the national safety management system."
◇ First treatment approved, CAR-T cleared… signals of industrialization follow
Behind the government's policy shift is the view that research outcomes have begun to move into the actual treatment stage.
In April, Yeouido St. Mary's Hospital of the Catholic University received approval for Korea's first advanced regenerative medicine treatment: an autologous immune cell treatment plan for 15 patients with EBV-positive extranodal NK/T-cell lymphoma. The treatment cost was set at 76 million won, but a performance-linked model was applied in which the full amount is refunded if the disease relapses within five years after treatment. The government also plans to consider models that refund or adjust costs based on subsequent treatment effects.
Clinical research results are also emerging. Seoul National University Hospital built an in-hospital CAR-T production platform, cutting the production time from the previous 56 days to 12 days. Of eight pediatric and adolescent leukemia patients who received treatment, five showed complete remission one month after infusion.
In addition, Seoul St. Mary's Hospital succeeded in the world's first 3D bioprinted tracheal transplant using allogeneic adult stem cells, and Korea University Guro Hospital applied an Organoid-based treatment to patients with Behcet's disease.
The industry is also growing. Companies in the advanced regenerative medicine field increased about 80%, from 76 in 2023 to 138 last year. In April this year, the first domestically developed CAR-T Therapy received marketing authorization.
◇ Overseas treatment at home… "low risk" exempt from preliminary clinical trials
The government will promote government-led multicenter clinical research for knee osteoarthritis, intractable chronic pain, hematologic cancers, and recurrent glioblastoma, which have high demand for overseas medical trips.
These projects will run for about 21 months starting this month. Based on the results, and after review of treatment plans, a decision could come as early as the second half of 2028 on whether to offer the treatments domestically. A plan for National Health Insurance coverage has not yet been prepared.
Regulations will also be adjusted. By Oct., the government plans to issue a notice reclassifying the risk level of cultured autologous immune cell treatments with accumulated safety evidence from the current "medium risk" to "low risk."
The core is not shortening review times but streamlining steps to enter clinical use. Currently, medium-risk advanced regenerative medicine typically requires two to three years of clinical research before applying for a treatment plan, but if the risk level is adjusted to low, providers can immediately apply for treatment plan review based on accumulated literature and safety data.
However, cell culture will remain permissible only at authorized cell processing facilities even after the risk reclassification, with parallel legal revisions.
Sourcing raw cells will also get easier. Following the establishment in May of grounds to use overseas raw cells, the government will pursue legal revisions to allow the use in research and treatment of raw cells stored by other domestic institutions such as cord blood banks.
◇ Faster reviews and removal of "regenerative medicine in name only" institutions
The review system will be revamped in step with treatment expansion.
Applications for advanced regenerative medicine review increased from 51 in 2024 to 118 last year, and are expected to rise to 193 this year. Review periods have also lengthened from around 50 days to as many as 110 days.
The government will expand reviewers from the current 25 to 40 and establish subcommittees that separately assess high-risk and medium/low-risk cases. It will also develop review guidelines based on accumulated cases to improve consistency and predictability.
Alongside deregulation, post-management will be strengthened. As of June this year, the number of institutions carrying out advanced regenerative medicine increased to 223, but some have been criticized for using the designation for hospital promotion without any research or treatment performance.
The government will require regenerative medicine institutions to submit a clinical research or treatment plan within one year of designation, and will pursue legal revisions to allow cancellation of designation if they fail to comply. When renewing designation every three years, authorities will also evaluate participation in research and treatment, completion of required training, and any legal violations. Institutions suspected of unapproved procedures will undergo on-site inspections, and advertising guidelines tailored to advanced regenerative medicine will be prepared.
The government will also disclose approved treatments, implementing medical institutions, and treatment costs through the advanced regenerative medicine portal, and will provide information on support programs such as catastrophic medical expense aid. It said it will consider expanding performance-linked expense models that tie treatment effects to costs, but has no plan to make them mandatory.