South Korean biotechnology and medical industry developments

The South Korean government has announced plans to ease regulations within the biotechnology sector to enhance industrial competitiveness. Specifically, the risk level for advanced regenerative medicine using cultured autoimmune cells will be downgraded from ‘medium-risk’ to ‘low-risk’. This change permits immediate treatment following a review of the treatment plan, removing the previous requirement for two to three years of preliminary clinical research. Other reforms include expanding the supply of raw cells through external institutions and exempting pseudonymized medical data research from certain Institutional Review Board deliberations to accelerate medical AI development.

While intended to assist patients with rare diseases, some healthcare organizations have expressed concern that the deregulation prioritizes industry growth over patient safety, citing potential unforeseen side effects from skipping verification procedures.

Concurrently, the medical device industry is focusing on global regulatory compliance to facilitate international expansion. Industry leaders at the KIMES BUSAN exhibition emphasized the need for proactive planning to navigate requirements in markets such as the United States, China, Japan, and Europe. Support initiatives, including seminars on ISO certifications and the introduction of the AI-based ‘G2M’ platform for market intelligence, aim to help domestic firms enter diverse global markets more efficiently.