国内外真实世界数据/证据的相关药械监管政策法规及指导原则比较研究

Comparative Study of Chinese and Foreign Policies,Regulations and Guidance for Real World Data/Evidence for Drugs and Devices Regulation

近年来,随着真实世界数据和真实世界证据的不断推广和应用,国内外药械监管机构针对用于药品和器械审评与监管的真实世界证据/数据,相继发布了相关的政策法规及指导原则。我国真实世界研究在药械审评、监管和决策方面较国际先进监管机构起步晚,研究体系、数据规范及标准仍存在一定差距。本文旨在梳理国内外主要药械监管机构已发布的有关真实世界证据/数据的政策法规及指导原则,比较国内外各主要药械监管机构现行针对真实世界数据的相关法规和指导原则。在此基础上,列举了我国学者真实世界数据用于药械监管的积极探索实践,为我国开展支持药械审评与监管的真实世界研究,完善数据及标准体系建设提供参考与借鉴。

In recent years,with the continuous promotion and application of real world data and real world evidence,domestic and foreign drugs and devices regulatory authorities have issued relevant policies,regulations and guidance on the real world evidence/real world data used in the evaluation and supervision of drugs and devices.China’s real world research started late compared with advanced international regulatory institutions in drugs and devices evaluation,supervision and decision-making,and there are still some gaps in the research system and data norms and standards.The purpose of this paper is to review the policies,regulations and guidance on real world evidence/data issued by major domestic and foreign regulatory bodies of drugs and devices,and to further compare the current regulations and guidance on real world data issued by them.We further summarized the active exploration and practice of Chinese scholars on the application of real world data in the regulation of drugs and devices,which provides reference for future real world research,data and standard system establishment to support the evaluation and regulation of drugs and devices in China.