Korea to ease rules on immune cell, stem cell therapies to cut need for medical trips abroad

The government plans to significantly ease regulations on advanced regenerative medicine, including scrapping a mandatory preliminary research requirement for autologous immune cell therapy.

It will also lead government-driven clinical research into stem cell treatments for conditions with high patient demand, such as knee osteoarthritis and chronic pain.

The measures aim to strengthen the biotech industry while allowing patients to receive immune cell and stem cell treatments domestically, without traveling abroad.

The Ministry of Health and Welfare announced the "Biotech Regulatory Rationalization Plan to Match Competing Nations' Standards" on Friday in a joint release with related ministries.

The government has overhauled regulations to allow autologous immune cell therapy to reach patients more quickly. Under the previous framework, such treatments — which involve extracting and culturing immune cells from a patient's own blood — were classified as "medium-risk," requiring mandatory preliminary clinical research that took two to three years before therapy could be administered. Many cancer patients seeking cell therapy faced years-long waits in Korea or traveled to countries such as Japan, where autologous immune cell culture treatments are available.

The government will now reclassify autologous immune cell therapy from "medium-risk" to "low-risk."

Under the low-risk designation, treatment can begin immediately upon review by the Advanced Regenerative Medicine and Biopharmaceuticals Deliberation Committee based solely on published literature, with no preliminary clinical research required. The government expects the change to relieve the burden of overseas medical trips and ensure patients receive timely treatment.

Going forward, researchers and clinicians will also be able to source raw cells from cord blood banks and other storage institutions rather than collecting them directly.

Current regulations require cell processing facilities to collect raw cells from scratch for any clinical research or treatment. Even when cord blood, embryonic stem cells, or other biological resources are held by other institutions, they cannot be used — a restriction that has limited both supply and research.

In response, the government will amend the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals to allow facilities to receive and use raw cells stored at other institutions without collecting them directly.

The plan also includes measures to promote stem cell therapy and strengthen the deliberation framework for advanced regenerative medicine.

The government will directly lead clinical research into stem cell treatments for knee osteoarthritis and chronic pain — conditions that see high public demand and frequent medical tourism. Government-led clinical trials involving 330 participants over the next two years will assess the safety and efficacy of stem cell therapy.

The government will also pursue a plan to split the deliberation committee for advanced regenerative medicine research and treatment into separate bodies by risk level.

The current single committee handles all cases together. Under the new structure, it will be divided into two bodies — one for high-risk cases and one for medium- and low-risk cases — to improve expertise. A fast-track review procedure will also be introduced for identical or repeated treatment plans.

The government will also significantly loosen regulations that have hampered the use of medical data.

Research using safely pseudonymized medical data will be exempted from institutional review board scrutiny.

Under current rules, even pseudonymized medical data must go through an IRB review before research can begin, causing delays due to paperwork and administrative procedures.

Researchers will now be able to use de-identified medical data without IRB review, reducing administrative burdens and significantly shortening research timelines.

The government will also open a path for previously collected medical data to be used in new research.

Previously, secondary use of medical data collected for research purposes required prior consent from research subjects. This meant that clinically gathered data often went unused or was discarded, and researchers had to re-recruit subjects and obtain fresh consent each time a new study was launched.

In response, the government plans to amend the Bioethics and Safety Act to introduce a broad consent procedure, allowing medical data to be used in secondary research.

The government will also establish national common standards for pseudonymizing medical data to ensure consistency across institutions, and will create an environment for remote analysis of medical data.

Currently, researchers must visit the institution holding the data in person to conduct any analysis, due to concerns about personal information leaks.

The government will set standards for a cloud-based remote analysis environment that allows researchers to securely access and analyze data from outside the holding institution. The change is expected to improve research efficiency by sparing researchers outside the Greater Seoul area from having to travel to major hospitals in the metropolitan area each time.

"This plan lowers the threshold for advanced regenerative medicine treatment to guarantee patients timely access to care, and redesigns the regulatory framework so that medical data can serve as a growth engine for the advanced biotech industry," Health and Welfare Minister Jeong Eun-kyeong said. "We will strictly enforce safety management and prevent misuse to minimize any safety concerns arising from regulatory rationalization."