SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
National Bio Committee On 23 January 2025, South Korea launched the National Bio Committee, a presidential advisory body aimed at fostering the bio industry as a key driver of national economic growth. The com- mittee integrates cross-ministerial policies span- ning science, health, and industry while pro- moting public–private collaboration to enhance capabilities across all areas of biotechnology. Comprising 24 civilian experts and 12 govern- ment officials, the committee set an ambitious goal to position South Korea among the top five global bio powers by 2035. Key initiatives include establishing a “Korean-style bio cluster”, accelerating AI-driven drug discovery, and cre- ating a public–private fund worth KRW1 trillion. This strategic governance framework seeks to drive innovation and growth in the bio sector, laying the foundation for South Korea’s future economic leadership. Integrated Review and Assessment System South Korea’s Integrated Review and Assess- ment System (IRAS) for innovative digital medical devices, launched in October 2022, streamlines the evaluation process by conducting concurrent reviews for device designation, reimbursement eligibility, and technological innovation, reduc- ing the review period from up to 390 days to as little as 80 days. Under this system, digital and AI-based medical devices designated as inno- vative can receive temporary health insurance
coverage for up to three years, even before full clinical evidence is established. This provisional reimbursement allows the devices to be used in clinical settings and accumulate real-world evidence, after which a formal evaluation deter- mines their eligibility for permanent health insur- ance registration. The system aims to acceler- ate patient access to cutting-edge diagnostic and therapeutic technologies while supporting industry innovation and evidence generation. Promoting the Market Entry and Reimbursement of Digital Therapeutics (DTx) South Korea has taken major steps to promote the market entry and reimbursement of digital therapeutics (DTx), due to the Integrated Review and Assessment system launched in October 2022. In August 2023, revised health insurance guidelines enabled DTx to receive temporary reimbursement for up to three years, allowing coverage by national health insurance before full clinical evidence is established. This temporary status supports early clinical use and real-world evidence collection, with the potential for for- mal reimbursement upon proven effectiveness. Despite this progress, the DTx market in South Korea is still early stage and faces challenges such as unclear long-term reimbursement path- ways, regulatory uncertainties, and low aware- ness among providers and patients, underscor- ing the need for continued policy support and regulatory clarity.
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