Promoting Biohealth Commercialization Using Medical Data... Follow-up Measures for Regulatory Free Zone Special Cases

Prime Minister Holds 12th Regulatory Free Zone Committee Meeting
Two Projects with Completed Regulatory Improvements to Be Commercialized Immediately

The commercialization potential of biohealth using human-derived materials and medical information is expected to increase.

Prime Minister Han Duck-soo is delivering opening remarks at the Cabinet meeting held on the 21st at the Government Seoul Office in Jongno-gu, Seoul. Photo by Jo Yong-jun jun21@

On the 24th, the government announced on the 26th that the 12th Regulatory Free Zone Committee was held in writing under the chairmanship of Prime Minister Han Duck-soo, where they reviewed and approved the ‘Follow-up Measures Plan for Regulatory Free Zone Exceptions’ and other matters.

Two projects with completed regulatory improvements, including legal amendments, can be commercialized immediately, promoting rapid market entry.

First, in the Daejeon Biomedical Free Zone, a company-exclusive human-derived material bank will be jointly operated. Stability will be verified through a joint committee operation among human-derived material banks (Chungnam National University, Eulji University, and Konyang University hospitals). Until now, companies developing in vitro diagnostic devices needed clinical specimens, but they had to individually verify and apply for review at each hospital’s human-derived material bank, causing difficulties in time and procedures. Human-derived materials refer to human components collected or extracted from the body, such as tissues, cells, blood, bodily fluids, or separated components like serum, plasma, chromosomes, DNA, and proteins.

In the Daejeon Free Zone, breast cancer in vitro diagnostic kits and diagnostic products for autoimmune diseases such as diabetes have been developed and obtained domestic and international certifications. A government official explained, “As joint committee operations among human-derived material banks nationwide become possible in the future, positive impacts are expected on the rapidly growing simple and rapid in vitro diagnostic industry as well as the biohealth industry.”

In the Gangwon Precision Medicine Industry Free Zone, demonstration projects for precision medical technology development using medical data will be undertaken. Pseudonymized medical data has been provided and its safety verified. According to the Ministry of Health and Welfare’s interpretations of Article 37 of the Bioethics and Safety Act and Article 21 of the Medical Service Act, the use of health and medical data by third parties such as companies has become possible when conditions minimizing the risk of personal information identification are met. Previously, companies developing AI solutions for precision medical prediction and diagnosis required various medical data such as human-derived materials, lifestyle information, genetic information, and imaging data (MRI, CT), but faced difficulties due to the lack of legal grounds for third-party provision of medical data.

In the Gangwon Free Zone, an AI solution for diagnosing and predicting chronic liver disease has been developed and is undergoing clinical trials. Given the expected high growth of AI-based medical prediction and diagnostic services in the global medical AI market, there is growing anticipation for the development of extensive AI precision medical technologies using pseudonymized medical data.

Ten cases recognized for safety and other factors are undergoing regulatory improvements. Five cases, including medium-voltage direct current electricity demonstration in the Jeonnam New Energy Industry Free Zone, hydrogen fuel cell indoor logistics vehicles and hydrogen ship commercialization in the Ulsan Hydrogen Green Mobility Free Zone, have been converted to temporary permits. Additionally, the temporary permit periods for five cases, such as mobile LNG charging stations in Jeonbuk and electric vehicle charging infrastructure advancement in Jeju, have been extended.

Furthermore, eight demonstration exception cases have been extended to continuously prove the need for regulatory improvements.

A government official stated, “As the Regulatory Free Zone enters its fifth year, economic achievements such as attracting 11 trillion won in investment, increasing sales by 168 billion won, and creating 5,503 jobs have greatly expanded. Going forward, the government plans to focus more on post-management and spreading achievements, including regulatory improvements and commercialization support, to foster new industries and revitalize regional economies through the Regulatory Free Zones.”

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