The 「Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biological Products」 was enacted in 2019 and has been implemented since 2020 to unify biopharmaceuticals-related regulations scattered in the National Assembly's Pharmacy Act and Bioethics Act, introduce an expedited approval system, and establish a safety management system. Since then, three years after the implementation of the Advanced Regenerative Medicine Act, the government is preparing a plan to improve the system with the goal of deregulation, and the regenerative medicine market is expected to open in earnest in Korea. Under the current law, advanced regenerative medicine could only be applied to clinical studies on severe, rare, and intractable patients. However, through the amendment to the Advanced Regenerative Medicine Act, it is expected that it will be applicable to general patients, and the scope of applied diseases will be expanded to include regeneration and recovery of body structure and function. In overseas countries such as Japan and Taiwan, the government is also actively investing in R&D and supporting clinical research to foster regenerative medicine technology. In particular, we would like to share the changes in the regenerative medicine industry at home and abroad since the implementation of the legal system, and seek ways to overcome regulatory hurdles to promote commercialization, revitalize the domestic industrial ecosystem, and advance into the global market.