Barriers to Autoimmune Cell Therapy Lowered... Medical Data Use Regulations Eased

Government announces measures to rationalize bio-sector regulations
Preliminary clinical research waived for cell therapies with proven safety
Pseudonymized medical information exempt from IRB review

The 2-3 years of preliminary clinical research previously required before receiving autoimmune cell therapy will be waived in some cases. The review burden for studies using medical data will also be reduced, and researchers will have more opportunities to use data collected in existing clinical studies for other research. The government plans to lower barriers to advanced regenerative medicine treatments and revise regulations on the use of medical data to strengthen the competitiveness of new drug development and the medical artificial intelligence (AI) industry.

The government held the second plenary meeting of the Regulatory Rationalization Committee jointly with relevant ministries on October 23 and announced a set of measures titled "Regulatory Rationalization Measures to Match the Level of Bio-Sector Competitors." The key goals are to improve Korea's rigid domestic bio-regulatory framework in comparison with major competitors such as the United States, the European Union (EU) and Japan, and to improve patients' access to treatment and the use of medical data.

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First, the risk classification for autoimmune cell therapies with proven safety will be lowered from "medium risk" to "low risk." Until now, treatment using immune cells extracted from and cultured from a patient's own blood or other sources required preliminary clinical research that took 2-3 years. Going forward, when safety has been confirmed through domestic and international literature and clinical data, patients will be able to receive treatment after review of a treatment plan by the Advanced Regenerative Bio Review Committee, without separate preliminary clinical research.

Regulations on securing source cells will also be eased. Cell processing facilities are currently required to collect source cells themselves. The government will amend the relevant laws to allow them to obtain umbilical cord blood and embryonic stem cells stored at other institutions, such as cord blood banks, for use in research and treatment.

The government will also pursue government-led clinical research to promote the use of autologous stem cell therapies. It plans to conduct a two-year clinical study involving 330 participants with conditions including knee osteoarthritis and chronic pain to assess safety and efficacy and support the use of these therapies in treatment. The Advanced Regenerative Medicine Review Committee will operate separate review processes based on risk level and introduce expedited reviews for identical or repeated treatment plans.

Regulations on medical data research will also be substantially revised. Studies using medical information that has been securely pseudonymized to prevent individuals from being identified will be exempt from review by an Institutional Review Board (IRB). To this end, the government plans to amend the Enforcement Rules of the Bioethics and Safety Act to exclude such studies from the scope of "human subjects research." The government expects that the time required for data research needed for medical AI and new drug development will be shortened, as researchers will not need to undergo separate IRB review.

The government will also introduce a broad consent system so that medical data collected in existing research can be used in other studies. It plans to amend the Bioethics and Safety Act to allow researchers to use data without obtaining individual consent again for each new study, provided certain requirements are met, including ensuring that research participants retain the right to refuse.

Standards for pseudonymization, which have varied among medical institutions, will also be unified. The government plans to establish common national standards for pseudonymizing structured medical data and expand their scope to cover all medical data. It will also establish standards for cloud-based remote analysis environments so researchers can analyze data without having to visit secure analysis rooms inside hospitals in person.

Minister of Health and Welfare Jeong Eun-kyeong said, "These measures lower barriers to advanced regenerative medicine treatments by one step to ensure that the public has timely access to treatment, and redesign regulations to match the level of competing countries so that Korean medical data can serve as a key growth driver for the advanced bioindustry. We will continue to listen to feedback from the field and pursue institutional improvements to help Korea become a leading biohealth nation."

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