Creating an Advanced Regenerative Medicine Treatment Environment... Introducing Regulatory Exceptions for Bio Mega Clusters

Ministry of Health and Welfare Marks One Year of K-Bio Regulatory Reform
Paradigm Shift Toward Support and Fostering
Promoting the Use of Deceased Patients’ Medical Data and Health Insurance Big Data

The Ministry of Health and Welfare announced on June 1 that, over the past year, it has revised longstanding regulations and shifted its policy framework toward support and fostering, aiming to accelerate the growth of new industries in the K-bio sector and secure leadership in the global market.

President Lee Jae-myung is speaking at the first plenary meeting of the Regulatory Rationalization Committee held at the Blue House on April 15. Photo by Yonhap News

Previously, the Ministry has identified key regulatory rationalization tasks and pursued system improvements that reflect on-the-ground feedback through the "2nd Core Regulatory Rationalization Strategy Meeting" presided over by President Lee Jae-myung in October last year, and the "1st Plenary Meeting of the Regulatory Rationalization Committee" held in April this year.

First, regulations on stem cell therapy, which were previously limited to serious, rare, and intractable diseases and demanded excessive non-clinical data, have been eased. To allow more flexible evaluation of intractable diseases, the Ministry provided a list of 82 example conditions and relaxed the guidelines so that, in medium- and low-risk research, high-risk-level non-clinical data is not required in principle.

Additionally, clinical research using autologous stem cells for conditions frequently treated overseas, such as chronic pain and musculoskeletal diseases, has begun, making practical treatment possible in Korea. The Ministry has also permitted the use of verified overseas clinical trial and research results for treatment, even if there are no domestic research outcomes. With these changes, advanced regenerative medicine will now be available domestically, creating an environment where patients no longer need to travel abroad for treatment.

The Ministry of Health and Welfare has also clarified the procedures for using deceased patients’ medical data and health insurance big data to enhance the efficiency of new drug development.

Until now, even though deceased patients’ medical data is a key indicator for verifying drug efficacy, its use was limited at the field level due to difficulties in determining whether the data was pseudonymized. In response, the Ministry, together with the Personal Information Protection Commission, has clarified guidelines for the use of deceased patients’ information and developed a "low-risk pseudonymous dataset" with strengthened measures to prevent individual identification. In principle, deceased patients’ medical data, as long as it does not contain information related to bereaved families, is not subject to the Personal Information Protection Act, but it must be pseudonymized to prevent patient identification when used.

For the industry, the method of analyzing health insurance big data—which had previously caused inefficiencies in research—will be improved. The government is promoting a remote analysis safety evaluation pilot project to allow online analysis of data from the National Health Insurance Service and the Health Insurance Review & Assessment Service. The first pilot, which permits online remote access by industry players while minimizing concerns about personal information re-identification, will run until the end of this month. After evaluation, a second pilot will be conducted in the second half of the year. This is expected to improve the efficiency of medical AI research and new drug development for public benefit.

In connection with the national balanced development strategy of the "Five Regions, Three Special Districts" (the Seoul Metropolitan Area, Southeast Region, Daegu-Gyeongbuk Region, Central Region, Honam Region, and the Special Self-Governing Provinces of Jeju, Gangwon, and Jeonbuk), an environment will be created within the Bio Mega Clusters where resident companies and local governments can easily select the regulatory relaxation measures they need.

Previously, decentralized clinical trials (where blood collection, data gathering, etc., are conducted outside clinical institutions, such as at home), which were difficult to implement due to legal and institutional restrictions, will now be allowed within the special zones. Through a regulatory exception for decentralized clinical trials utilizing approved and safe pharmaceuticals, activities such as direct medication logging by participants and data transmission via wearable devices will be recognized as legitimate clinical procedures.

The limit on the size of pharmaceutical and medical device production facilities within advanced medical complexes will be significantly relaxed, from the former cap of 5,000 square meters to up to 15,000 square meters. In addition, the installation of health functional food and functional cosmetics production facilities, which was previously not permitted within the complexes, will now be allowed, thereby promoting large-scale investment and collaboration among companies in the special zones.

Furthermore, within the Bio Mega Clusters, the current uniform procedures of the central deliberation committee will be replaced by allowing the operation of "regional advanced regenerative bio review committees" and separate safety management institutions, easing the deliberation process. In addition, when reviewing treatment plans within the special zones, not only existing domestic clinical research results but also domestic and international clinical trial data will be recognized.

Minister of Health and Welfare Chung Eun-kyung emphasized, "We will lower the barriers to advanced regenerative medicine treatments, expanding treatment opportunities for patients with serious, rare, and intractable diseases. By enabling the safe use of medical data and granting regulatory exceptions within the Bio Mega Clusters, we aim to stimulate proactive investment by companies."

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