The Ministry of Food and Drug Safety and the Ministry of Health and Welfare announced on the 25th that the enactment of the Enforcement Decree of ‘The Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals' has passed the cabinet meeting.
The Advanced Regenerative Bio Act is a bill created to more systematically manage biopharmaceuticals made by culturing or editing living cells, and to support the development of innovative medicines that cure diseases that have not been curable.
This decree divided the scope of advanced regenerative medicine into four categories: cell therapy, gene therapy, tissue engineering therapy, and convergence therapy.
In addition, it stipulated the procedure for establishing an annual implementation plan, the operation of the policy review committee, which is a government-wide public-private partnership, and the basic plan for advanced renewable bio, which is scheduled to be established every five years.
Also, this decree stated specific procedures and methods necessary for the creation of a research plan for regenerative medical institutions and application for deliberation for the conduct of advanced regenerative medicine clinical research.
The Ministry of Health and Welfare said, "In a situation where it is difficult to carry out work due to the COVID-19, we have focused on preparing the subordinate laws, essential organizations, and budgets necessary for the enforcement of the law.”
In response, stem cell treatment-related bio companies are regrettable that the enforcement decree was enacted later than expected, but it certainly had an encouraging aspect since the regulatory uncertainty was resolved.