Advanced Regenerative Medicine Targets 150 Clinical Research and Treatment Plans by 2030; Annual R&D Investment to Exceed KRW 200 Billion

Government-led clinical research to proceed for four conditions, including knee osteoarthritis and blood cancer
Reclassify autologous immune cell therapies as lower risk and strengthen post-designation oversight of institutions

The government is accelerating regulatory improvements and research and development (R&D) support to expand advanced regenerative medicine beyond research and into actual patient treatment and commercialization. It aims to approve at least 150 clinical research and treatment plans for advanced regenerative medicine and develop at least five advanced biopharmaceuticals by 2030, while increasing annual national R&D investment to at least KRW 200 billion.

At the 2026 Advanced Regenerative Medicine Annual Symposium held on October 27, the Ministry of Health and Welfare outlined the current status of policies and initiatives for advanced regenerative medicine. Based on the Second Basic Plan for Advanced Regenerative Medicine and Advanced Biopharmaceuticals (2026–2030), the government is pursuing three strategic priorities: expanding patient access, rationalizing regulations and strengthening safety management, and enhancing technological and industrial competitiveness.

Advanced regenerative medicine comprises medical technologies that use cells, genes, and other materials to regenerate or restore damaged structures and functions of the human body, or to treat disease. It can offer a new treatment option for patients with serious, rare, or intractable diseases who may not benefit sufficiently from existing treatments. However, an institutional framework connecting clinical research, which verifies safety and efficacy, with actual treatment is essential.

The government will first establish a domestic treatment infrastructure for diseases with high patient demand. It will pursue government-led clinical research into four conditions: knee osteoarthritis, intractable chronic pain, blood cancer, and recurrent glioblastoma. The plan is to verify safety and efficacy and then, following a review of treatment plans, enable patients to receive treatment in Korea.

The government is pursuing a plan to reclassify technologies using cultured autologous immune cells, for which safety evidence has accumulated, from the existing moderate-risk category to the low-risk category. Low-risk classification would allow applications for treatment-plan review without prior clinical research, reducing the time it takes for patients to receive treatment. However, reclassification does not mean that safety verification will be waived for all treatments.

The review system will also be revised to address growing demand for clinical research. The government plans to establish subcommittees within the review committee and reorganize the areas covered by expert committees to improve expertise and predictability. It will develop guidelines for clinical research and treatment plans based on accumulated review cases, and establish review procedures for identical or repeat treatment plans involving moderate- and low-risk treatments.

The government also plans to strengthen oversight of medical institutions by introducing a system requiring regenerative medicine institutions to renew their designation every three years, and by reviewing their safety management standards and records of clinical research and treatment. Institutions will be required to submit a clinical research plan or treatment plan within one year of designation; failure to do so may result in measures such as revocation of their designation. The government will also continue monitoring false or misleading advertising that promotes advanced regenerative medicine to prevent harm to patients.

The government has also set a goal of increasing annual national R&D investment from about KRW 90 billion last year to at least KRW 200 billion by 2030, and expanding the number of regenerative medicine institutions from 183 to 400 over the same period. It aims to develop at least five advanced biopharmaceuticals by 2030.

A total of KRW 58.5 billion will be invested in the 2025–2028 program to support the growth of clinical research in advanced regenerative medicine. The program will support clinical research in advanced regenerative medicine, as well as research to meet overseas demand by conducting studies in Korea. It will also support technology valuation and the development of industrial infrastructure so that technologies established at the research stage can progress to clinical trials, product development, manufacturing, and production.

In addition, the government is pursuing legal and regulatory improvements to promote research, including expanding the scope of advanced regenerative medicine and the sources of raw cells, and revising requirements for cell-processing facilities regarding the sourcing and supply routes of human cells and their authorization. Expanding the scope of covered technologies to include in-vivo(In-vivo) gene therapy is also a key priority.

Choi Gyeongil, director of the Advanced Medical Support Bureau at the Ministry of Health and Welfare, said, "This year has been significant in bringing advanced regenerative medicine closer to the public: the first treatment plan for advanced regenerative medicine was approved, and an amended law is set to take effect that will also enable in-vivo gene therapy. We will expand support and continue improving the system to increase access to treatment and promote the development of innovative technologies."

This content was produced with the assistance of AI translation services.