Regulatory Strategy Center for Combination Products (RSCP), Ajou University, Suwon, 16499, Republic of Korea.
Ther Innov Regul Sci. 2024 Sep;58(5):796-806. doi: 10.1007/s43441-024-00661-2. Epub 2024 May 8.
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 in assigning jurisdiction for premarket review and oversight. In US, the 1990 Safe Medical Devices Act defines and provides classification criteria for CPs, and the US government has developed a regulatory process through multiple acts, including the 21st Century Cures Act of 2016. Meanwhile, regulators in the European Union (EU) and the Republic of Korea have recently recognized the importance of premarket pathways for CPs. The European Medicines Agency (EMA) has issued guidelines and explanations on compliance issues related to drug-device CPs under MDR. EMA doesn't have the definitions of CPs, but uses the term drug-device combination products (drug-device CPs). CPs are categorized as drugs or medical devices, which follow their relevant regulatory framework. The Ministry of Food and Drug Safety (MFDS) in Korea has legal definitions of CPs under the Notice of the MFDS. CPs are designated as drugs or medical devices according to their primary mode of actions (PMOA) and follow regulatory processes through the framework of drugs or medical devices. This study aims to comprehensively summarize the regulatory oversight of CPs by analyzing the regulatory policies and legal frameworks in the US, the EU, and Korea. The regulatory challenges encountered when developing CPs are also discussed. With specific emphasis on the combination of drugs and devices, this study provides in-depth insights into the regulatory landscape, shedding light on the unique challenges associated with the development of CPs for this particular intersection of drugs and devices.
组合产品（CPs）将两种或多种产品类型（如药物、器械和/或生物制品）组合在一起，以提高安全性和临床效果。创新型 CPs 的出现给监管机构在分配上市前审查和监督的管辖权方面带来了新的挑战。在美国，1990 年《安全医疗器械法案》定义并提供了 CPs 的分类标准，美国政府通过多项法案制定了监管流程，包括 2016 年的《21 世纪治愈法案》。与此同时，欧盟和韩国的监管机构最近认识到 CPs 上市前途径的重要性。欧洲药品管理局（EMA）发布了关于《医疗器械条例》下药物-器械 CPs 合规问题的指南和解释。EMA 没有 CPs 的定义，但使用“药物-器械组合产品”一词。CPs 被归类为药物或医疗器械，遵循各自的监管框架。韩国食品药品安全部（MFDS）根据 MFDS 通知，对 CPs 有法律定义。CPs 根据其主要作用模式（PMOA）被指定为药物或医疗器械，并通过药物或医疗器械的框架遵循监管流程。本研究旨在通过分析美国、欧盟和韩国的监管政策和法律框架，全面总结 CPs 的监管监督情况。还讨论了开发 CPs 时遇到的监管挑战。本研究特别强调了药物和器械的组合，深入探讨了监管领域的独特挑战，为这一特定的药物和器械交叉点的 CPs 开发提供了深入的见解。
