South Korea to relax regulations on autoimmune cell therapy

The South Korean government has announced a plan to ease regulations in the biotechnology sector to bolster industrial competitiveness. Under the new measures, the risk level for advanced regenerative medicine using cultured autoimmune cells will be downgraded from ‘medium-risk’ to ‘low-risk’. This change allows for immediate treatment following a review of the treatment plan, bypassing the previous requirement for two to three years of preliminary clinical research.

Further reforms include expanding the supply of raw cells by allowing the use of cells stored in external institutions, such as umbilical cord blood banks. Additionally, the government aims to accelerate medical AI development by exempting pseudonymized medical data research from Institutional Review Board (IRB) deliberations.

While the government intends to lower barriers for patients seeking treatment for rare and incurable diseases, some healthcare organizations have criticized the move. Critics argue that the deregulation focuses more on fostering the bio-industry than ensuring patient safety, expressing concerns that skipping essential verification procedures could lead to unforeseen side effects.