Gu Xiaofang, Hou Yuanyuan, Lin Kai, Pan Juenan
Hainan Service Center for Drug and Medical Device Evaluation, Haikou, 570216.
Hainan Medical Products Administration, Haikou, 570216.
Zhongguo Yi Liao Qi Xie Za Zhi. 2025 Jul 30;49(4):460-465. doi: 10.12455/j.issn.1671-7104.240522.
In recent years, with the development of big data application technology, the real-world data and the corresponding generated real-world evidence have attracted the attention of healthcare regulatory authorities around the world. Regulators recognize that real-world research with specific purposes using real-world data can provide important evidence for regulatory decisions. A total of 90 instances of publicly released on the application of real-world evidence to support regulatory decisions of U. S. Food and Drug Administration are explored, and the positioning and value of real-world evidence in U. S. Food and Drug Administration regulatory decisions are summarized and analyzed, providing references for the use of real-world data and real-world evidence to promote medical devices whole cycle regulation in China.
近年来，随着大数据应用技术的发展，真实世界数据及相应产生的真实世界证据受到了全球医疗监管机构的关注。监管机构认识到，利用真实世界数据进行有特定目的的真实世界研究可为监管决策提供重要证据。本文探讨了美国食品药品监督管理局（FDA）公开的90例应用真实世界证据支持监管决策的案例，并对真实世界证据在美国食品药品监督管理局监管决策中的定位和价值进行了总结分析，为我国利用真实世界数据和真实世界证据推动医疗器械全周期监管提供参考。
