Regulatory perspectives of combination products.
Regulatory perspectives of combination products.
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DOI：
10.1016/j.bioactmat.2021.09.002
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发表时间：
2022-04
影响因子：
18.9
通讯作者：
Zhang X
中科院分区：
文献类型：
--
作者：
Tian J;Song X;Wang Y;Cheng M;Lu S;Xu W;Gao G;Sun L;Tang Z;Wang M;Zhang X
具有广泛临床应用的组合产品代表了一类独特的医疗产品，这些产品不仅仅由单一的医疗设备或药物/生物制品组成。联合产品的产品研发、临床翻译以及监管评估是复杂和具有挑战性的。本文首先介绍了组合产品的起源、定义和名称。然后介绍了对设备引导/监督组合产品的安全性和有效性进行系统监管审查的关键领域。讨论了联合产品的临床前和临床评价。最后对组合产品监管科学的研究前景进行了展望。计算建模和模拟的新工具、人工智能等新技术、开发新标准的需求、循证研究方法、包括设计创新或突破性医疗产品的新方法都已开发出来，并可用于评估组合产品的安全性、有效性、质量和性能。综上所述，医疗保健领域潜力巨大的组合产品的快速发展为监管审查和监管科学的推进提供了新的机遇。组合产品的起源、定义和名称的完整概述。对联合产品的安全性和有效性进行监管审查和评估。监管科学及其对组合产品的未来展望。
Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological product. The product research and development, clinical translation as well as regulatory evaluation of combination products are complex and challenging. This review firstly introduced the origin, definition and designation of combination products. Key areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then presented. Preclinical and clinical evaluation of combination products was discussed. Lastly, the research prospect of regulatory science for combination products was described. New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality and performance of combination products. Taken together, the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science. Full overview of the origin, definition and designation of combination products. Regulatory review and evaluation of the safety and efficacy of combination products. Regulatory science and its future perspectives of combination products.
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