의료제품의 장기추적조사 관련 제도현황과 중장기 추진방향

Legal Basis Review for the Establishment of Long Term Follow-up of Medical Products in Korea and Mid-Term, Long-Term Plan for Introduction of new Regulation

As the safety issues of medical products have been continuously generated, the need for long-term safety management, 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 of safety management of medical products in Korea to propose future plan for establishing medical products LTFU system in Korea. We review the laws and regulations for safe use of medical products and compare regulations, definitions and processes in the following laws: Pharmaceutical Affair Act, Medical Device Act, Act on Safety and Support for Advanced Regenerative 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 Affair Act. In Medical Devices Act, there is no legal basis for conducting LTFU. Thus, establishing safety management regulation for LTFU in medical devices is essential. On the other hand, LTFU on advanced biopharmaceutical has implemented since this August with the new law. In order to conduct a LTFU and registry management, the regulatory science center should have a systematic process and manpower. Furthermore, to establish a LTFU system for all medical products, running pilot project is essential to evaluate feasibility. Public relations activities and training expertise to induce stakeholder participation is indispensable for successful implementation of LTFU.