Government to Expand Government-Led Clinical Research in Advanced Regenerative Medicine... Lowering Barriers to Treatment for Rare and Intractable Diseases

‘2nd Basic Plan for Advanced Regenerative Medicine and Biopharmaceuticals’ Approved
Goal Set for 150 Treatment Approvals, Including Knee Osteoarthritis, by 2030
Replacing Overseas Medical Trips with Domestic Treatments... Risk Assessment Rationa

Patients with serious, rare, and intractable diseases—such as knee osteoarthritis—who previously relied on overseas treatments, will soon have access to advanced regenerative medicine therapies within Korea. The government plans to expand clinical research in cell and gene therapy, streamline regulations to broaden domestic treatment opportunities for patients, and simultaneously enhance the competitiveness of the advanced regenerative bio industry.

On July 21, the Ministry of Health and Welfare, under the leadership of Minister Jeong Eun-kyeong, convened the '1st Policy Committee on Advanced Regenerative Medicine and Advanced Biopharmaceuticals for 2026' and deliberated and approved the '2nd Basic Plan for Advanced Regenerative Medicine and Advanced Biopharmaceuticals (2026~2030)'. The committee also discussed strengthened post-management measures for designated institutions and regulatory streamlining strategies.

This basic plan envisions 'overcoming serious, rare, and intractable diseases through advanced regenerative biotechnology.' The plan will be promoted based on three major strategies: ▲ expanding patient access ▲ rationalizing scientific regulations and strengthening safety management ▲ enhancing technological and industrial competitiveness.

First, the government will spearhead multicenter clinical trials for four diseases with high demand for overseas treatment: knee osteoarthritis, intractable chronic pain, hematologic cancers, and recurrent glioblastoma. Based on the research findings, a comprehensive evaluation of safety, efficacy, and treatment costs will determine whether domestic treatment will be implemented. For ultra-rare diseases, a model for developing personalized therapies using platform technologies will also be established.

Infrastructure to facilitate clinical research will be expanded. Unlike in the past—when researchers had to directly operate cell processing facilities or outsource to contract manufacturers—from now on, clinical trial samples and process development will be supported by jointly utilizing the facilities, personnel, and equipment of high-quality cell processing centers. In addition, a 'K-Cell Bank and Library' will be established to secure and supply GMP-grade clinical cell lines, and a system for standardized electronic case report forms (eCRF) for clinical research and treatment data will be set up.

The data collected from clinical research and treatment will be standardized to create a robust infrastructure for utilization. Information on approved treatments, designated institutions, and treatment costs will be made available via the Advanced Regenerative Medicine Portal so that patients can easily access relevant data; the government is also considering providing financial support for treatment costs.

To streamline regulations, there are plans to lower the risk classification of cultured autologous immune cell therapies from moderate to low if sufficient safety evidence has been accumulated. This means that, with the lower risk designation, it will be possible to apply for treatment plan review without prior clinical research, reducing the normal two- to three-year process timeline.

Cell processing facilities will also have broader access to source cell supply channels. Previously, facilities were only permitted to process cells they collected themselves; going forward, legal amendments will allow them to use source cells collected and stored by other institutions, such as cord blood banks or human cell managers. To address rising demand for reviews, subcommittees will be established within the main review committee, and review guidelines will be developed to increase both efficiency and predictability in the process.

Stricter Post-Management and Implementation of Renewal System for Regenerative Medicine Institutions

Management of regenerative medicine institutions will also become more rigorous. As of June 2026, the number of designated institutions rose to 223, but actual participation in clinical research and treatment remains low, while some institutions have been found to misuse their designation for promotional purposes.

The government will revise the law to require designated regenerative medicine institutions to submit a clinical research or treatment plan within one year of designation; failure to comply may result in loss of designation. A renewal system will be introduced every three years, comprehensively evaluating research and treatment results and compliance with relevant laws. Onsite inspections of in-hospital cell processing and treatment procedures will be enhanced to ensure safety during the treatment process. Monitoring will also be strengthened for misleading or exaggerated advertising, with new advertising guidelines for regenerative medicine institutions.

Technological and industrial competitiveness will be enhanced throughout the entire lifecycle, from fundamental technology development to clinical translation, manufacturing innovation, and commercialization. Support will be provided for next-generation technologies, including bioprinting, cell-based artificial tissue, gene editing and delivery, and anti-aging. Research and development utilizing AI and bio big data will be expanded. Automation of manufacturing processes using AI and robotics, as well as the development of domestic materials, components, and equipment, will increase productivity and strengthen supply chain stability. The government will also promote venture business commercialization, workforce development, and international cooperation.

Through these efforts, the government aims to surpass 150 cumulative approvals for clinical research and treatment plans by 2030, and to secure at least five domestically developed advanced biopharmaceuticals. The number of regenerative medicine institutions will increase from 183 currently to 400, and annual national R&D investment is projected to rise from 90 billion won to over 200 billion won.

With this basic plan, the government’s strategy is to move beyond symptom management and expand 'fundamental therapies' that correct the root cause of disease at the cellular and genetic level, thus enhancing the global competitiveness of Korea's advanced regenerative bio industry. The global regenerative medicine market is projected to grow from USD 23.2 billion in 2024 to USD 62.1 billion in 2030, with major countries accelerating regulatory innovation and support for manufacturing and commercialization.

Minister Jeong Eun-kyeong of the Ministry of Health and Welfare stated, "Through the 2nd Basic Plan, we expect real progress in expanding safe domestic treatment opportunities for patients and overcoming serious, rare, and intractable diseases. We will continue with evidence-based regulatory streamlining and strengthen comprehensive safety management, so that patients can receive treatment with peace of mind while promoting active clinical research and therapies in advanced regenerative medicine."

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