미국, 유럽, 일본, 한국의 융복합 의료제품에 대한 규제 프레임워크 비교 연구

Combination products (CPs) combine two or more product types such as drugs, devices, and/or biological products for increased safety and clinical effectiveness. The emergence of innovative CPs poses new challenges for regulatory agencies to assign jurisdiction for pre-market review and oversight. The United States (US) Food and Drug Administration has formulated regulations and guidance documents, including regulatory pathways. The 1990 Safe Medical Devices Act (SMDA) defines and provides classification criteria for CPs; the US government has also developed a regulatory process by multiple acts, including the 21st Century Cures Act of 2016. Regulators in the European Union (EU) and Republic of Korea (Korea) have recently recognized the importance of premarket pathways for combination products. The European Medicines Agency (EMA) has issued guidelines/explanations on compliance issues related to Medical Devices Regulations for drug-device CPs. Unlike in the US, drug-device CPs are currently not regulated as CPs but are categorized as drugs or medical devices according to the relevant regulatory framework. In Japan, like the EU, there are no specific laws for combination products, but the guidelines distributed in 2014 include the definition, types, classification, approval, and post market surveillance of combination products. This study aims to comprehensively summarize the regulatory oversight of CPs by presenting an analysis of the regulatory policy and legal framework in the US, EU, and Korea. The regulatory challenges faced when developing CPs are also discussed.