[Press Release, Aug. 25 / Unofficial translation] Enforcement Decree of“Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act”passes cabinet meeting - Concrete procedures and details have been prepared for the enforcement of the Act - The Designation of regenerative medicine institutions, which had been delayed amid COVID-19 responses, is planned to be completed by the end of 2020 □ The Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-Kyung) and the Ministry of Health and Welfare (MoHW, Minister Park Neung-Hu) announced that the draft Enforcement Decree of the “Advanced Regenerative Bio Act”* (promulgated on Aug. 27, 2019 and to be enforced on Aug. 28, 2020) passed the cabinet meeting on Aug. 25. * “Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act” (jointly legislated by the MFDS and the MoHW) □ The Decree was recently legislated to stipulate the detailed authority delegated by the law to enforce the “Advanced Regenerative Bio Act,” and the main contents of the legislated Enforcement Decree are as follows. [1] Definitions including the scope of advanced regenerative medicine and human cells (Article 2 through 4 of the draft) ○ (Scope of advanced regenerative medicine) Classified into four therapy types comprised of cell therapy, gene therapy, tissue engineering and fusion therapy ○ (Scope of human cells) Cells and tissues originated from humans or animals, or those treated with methods such as cell manipulation, cell processing, and cell manufacturing ○ (Risks of clinical studies) Provide medical institutions with standards for self-assessment of risks to refer to when devising research plans. [2] Establishment of Basic Plan (Article 5 through 9 of the draft) ○ (Basic plan) Outlines the first quintennial Basic Plan for Advanced Regenerative Medicine and Advanced Biopharmaceuticals and procedures for the establishment of its annual implementation plan, related government departments*, operation of a policy review committee for cross-governmental public-private cooperation in governance, among others * (led by the MFDS, MoHW) joined by the Ministry of Economy and Finance; the Minitry of Education; Ministry of Science and ICT; the Ministry of Agriculture, Food and Rural Affairs; the Ministry of Trade, Industry and Energy; the Ministry of Oceans and Fisheries; and the Ministry of SMEs and Startups [3] Launching clinical studies in the advanced regenerative medicine (Article 10 through 25 of the draft) ○ (Institutions for regenerative medicine) Specifies research plan documentation, submission methods, and required documents among other matters in regard to application procedures and methods for research plan reviews *Advanced regenerative medicine institutions: medical institutions designated by the Minister of Health and Welfare which meet the standards on facilities, equipment and human resources and is capable of providing advanced regenerative medical services. Medical institutions can conduct clinical trials only after they are designated as regenerative medicine institutions and obtain approval on research plans. ○ (Reviews by the Review Committee*) Prescribes review process for research plans submitted by regenerative medicine institutions *Advanced regenerative medicine and advanced biopharmaceuticals review committee (Article 13): comprised of 20 or less experts from the private sectors include medical professionals, experts in relevant fields, representative of patients. The committee will review and determine the legitimacy of the research plans submitted by regenerative medicine institutions. .(Establishment of expert subcommittee under the review committee) To conduct reviews in a more professional manner, 4 expert subcommittees will be established for each of the four treatment types. The subcommittees will be in charge of writing review reports on the efficacy, safety, and ethical legitimacy of research plans for advanced regenerative medicine. * comprised of 12 or less experts from the private sector for every subcommittee .. (Establishment of review committee secretariat) general management of review committee affairs including the registration of research plans, organization of review committee meetings, and announcement of review results ○ (Cell processing facilities*) specify requirements for facilities, equipment and human resources for the approval as cell processing facilities and rules such as obligation to record and report during cell processing * Business that was newly created to supply human cells as ingredients for advanced regenerative medicine to regenerative medicine institutions. (Article 15) Such facilities specialize only in cell processing. ○ (Safety management institutions*) the establishment and operation of information system for a systematic and collection and management of clinical trial data generated by regenerative medicine institutions and the establishment of plans for patient(test subjects) safety management and long-term follow-up surveys * Safety management institutions designate the National Institute of Health under Korea Centers for Disease Control and Prevention as the safety management institution for advanced regenerative medicine (draft Enforcement Rules) [4] Strengthening of management system suited for the characteristics of advanced biopharmaceuticals (Article 26 through 36 of the draft) ○ (Standards for advanced biopharmaceutical manufacturing and importing facilities) define standards for facilities such as establishments, storage, laboratories, and record rooms needed for approval and reporting. ○ (Requirements for the approval of human cell management business*) provide requirements on facilities, equipment, human resources set out for the approval and define the elements of quality management system. * A new type of business that supply human cells and other matters intended to be used as ingredients for Advanced biopharmaceuticals (Article 28 of the Act) ○ (Long-term follow-up investigation on advanced biopharmaceuticals) set out procedures for selecting products* that need to be monitored through long-term follow-up investigations, for reporting adverse cases, and for registering dosage records. * Products eligible for designation: stem cell therapy products, medicines that contain animal tissue or cells, gene therapy products, etc. □ In line with the planned promotion and restructuring of Korea Centers for Disease Control to an administrative organization in September aimed at strengthening COVID-19 responses, essential organizations* related to advanced regenerative medicine will be launched. * Regenerative medicine policy Task Force and the Review Committee Secretariat (under the MoHW) / Division of Safety Management for Advance Regenerative Medicine at Korea National Institute of Health (under Korea Centers for Disease Control) ○ The Task Force will take lead in the preparation of all necessary measures including the designation of regenerative medicine institutions so that the law can be implemented this year. ※ The beginning of application period for designation as regenerative medicine institutions will be informed as soon as it is ready. □ The representative of the MoHW’s Division of Healthcare Technology Development said that it “finished the preparation of necessary subordinate statutes, essential government organizations, and budget in accordance with the enforcement date and that it will swiftly take additional measures to see smooth implementation of the law.” * 2.8 billion Korean won to be injected in the Pharmaceutical, Bio, and Regenerative medicine sectors during the next 10 years (refer to the news from Jul. 3, 2020) □ The Biopharmaceutical Policy Division of the MFDS stated that “the recent legislation of the Enforcement Decree served as an opportunity to build a foundation for safety management by setting standards for the facilities needed in the manufacturing of advanced biopharmaceuticals and by defining procedures and methods for long-term follow-up investigations.” ○ and also that “administrative rules that specify matters delegated by the Act will enter into force as soon as possible.”