Regulatory aspects of xenotransplantation in Korea.

ABSTRACT

BACKGROUND: The xenotransplant clinical trial with human subjects seems to be technically feasible, however, it needs the strict regulatory framework from the domestic as well as the international level to make sure the safety of the human subject and the general public. METHODS: The authors reviewed and introduced the current regulations regarding the xenotransplant clinical trial in Korea focusing on the recently stipulated act (Advanced Regenerative Medicine and Biopharmacology Act, ARMBA) and the role of the related government agencies and health institutions. RESULTS AND CONCLUSION: Korea is ready to conduct the xenotransplant clinical trial with human subjects in the current regulatory framework satisfying the requirements of the international guidance. The responsible governmental agencies would collaborate in control the xenotransplant clinical trial under the ARMBA and other related acts and guidance.