의료제품의 장기추적조사 관련 제도현황과 중장기 추진방향

Abstract

As the safety issues of medical products have been continuously generated, the need for long-term safetymanagement, such as long term follow-up (LTFU), has been emerged. Current laws and regulations in Korea, however,have limitations to implement LTFU and track medical products immediately. This review examines the current status ofsafety management of medical products in Korea to propose future plan for establishing medical products LTFU systemin Korea. We review the laws and regulations for safe use of medical products and compare regulations, definitions andprocesses in the following laws: Pharmaceutical Affair Act, Medical Device Act, Act on Safety and Support for AdvancedRegenerative Medicine and Advanced Biopharmaceuticals. In case of medicinal products except Advanced Biopharmaceuticals,regulations are needed to be developed and enforced even though there is legal basis for LTFU in Pharmaceutical AffairAct. In Medical Devices Act, there is no legal basis for conducting LTFU. Thus, establishing safety management regulationfor LTFU in medical devices is essential. On the other hand, LTFU on advanced biopharmaceutical has implemented sincethis August with the new law. In order to conduct a LTFU and registry management, the regulatory science center shouldhave a systematic process and manpower. Furthermore, to establish a LTFU system for all medical products, running pilotproject is essential to evaluate feasibility. Public relations activities and training expertise to induce stakeholder participationis indispensable for successful implementation of LTFU.