[关键词]
[摘要]
美国食品药品管理局(FDA)的“供企业用药-械和生物制品-器械组合产品的桥接指导原则(草案)”详细描述了药-械组合产品注册申请人,利用另外的开发方案产生的信息,作为拟开发产品的注册资料(即桥接),替代试验研究资料的方法,支持拟申报产品的批准;推荐渐进式5步骤法,确定桥接策略和信息需求并列举了3个示例予以解读。详细介绍该指导原则的内容,期望为中国药-械组合产品研发和监管开辟新思路,建议在合适的条件下可考虑利用“桥接”方法减少试验研究,加速研究进程,缩短研究周期,节省研究经费,促进药-械组合产品的开发。
[Key word]
[Abstract]
The FDA's Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry (Draft) described in detail that the applicant for registration of drug-device combination products can use the information developed by another development program as the registration information of the product to be developed (i. e. bridging) and replace the experimental research data to support the approval of the product to be applied for. That is to say, the stepwise five step approach is recommended to determine the bridging strategy and information requirements are determined, and three examples are given to interpret. This paper introduces the guidance in detail, hoping to open up new ideas for the research and development as well as supervision of drug-device combination products in China. In suitable conditions, it can be considered to use "bridging" method to reduce experimental research, speed up the research process, shorten the research cycle, save research funds, and promote the development of drug-device combination products.
[中图分类号]
R951
[基金项目]