摘要
标识交叉引用类组合产品是美国特有的一类组合产品监管方法,其保障了独立包装和不同厂家的药品和医疗器械联用时的安全性和有效性。本文从产品定义、监管主体、上市许可路径及程序、相关法规等角度综述了美国FDA对标识交叉引用类组合产品的监管框架,并以美国FDA批准的10款光动力产品为代表,结合其他相关案例分析了美国FDA对标识交叉引用类组合产品的上市许可监管现状。
Cross-labeled combination product is a unique type of regulatory approach in the United States for combination products,ensuring the clinical safety and effectiveness of the independently packaged drugs and medical devices when used together.This article provides an overview of the FDA's regulatory framework for cross-labeled combination products from the perspectives of product definition,regulatory bodies,premarket pathways and procedures,as well as relevant regulations.It also analyzes the current status of the FDA's premarket regulation for cross-labeled combination products,using ten FDA-approved photodynamic products as examples,along with other relative cases.
作者
蒋剑平
邵颖
JIANG Jian-ping;SHAO Ying(Shenyang Pharmaceutical University,Shenyang 110016,China;Shanghai Fudanzhangjiang Biopharmaceutical Co.,Ltd.,Shanghai 201210,China;Shanghai Engineering Research Center of Photodynamic Drugs,Shanghai 201210,China)
出处
《中国新药杂志》
北大核心
2025年第9期922-932,共11页
Chinese Journal of New Drugs
关键词
组合产品
标识
标识交叉引用
组件
上市许可
监管
光动力产品
combination products
labeling
cross-labeling
constituent part
premarket approval
regulation
photodynamic product
