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Since joining the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in 2017, China has gradually strengthened the research on the extrapolation of overseas clinical trial data. Standardization of bridging studies and international multi-center clinical trials will become the trend of the times. Extrapolation of overseas clinical trial data is particularly important in the registration process of drugs that have been listed overseas and not listed in China. Usually, the Center for Drug Evaluation of NMPA needs to consider the completeness of clinical trial packages to determine whether a drug is racially sensitive and whether bridging studies are needed. At present, to investigate the influence of ethnic factors on the acceptability of overseas clinical trials, the ICH E5 (R1) Guidelines are generally followed internationally. In addition, the United States, Japan, the European Union, and other ICH member states have issued their own relevant regulations or guidelines. This article introduces the basis and key points of current review of overseas clinical trial data in China, summarizes and analyzes the design of bridging studies based on international experience, and finally puts forward reasonable suggestions for extrapolation of overseas clinical trial data in China.

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自2017年我国加入国际人用药品注册技术协调会（ICH）之后，逐渐加强了境外临床试验数据衔接方面的研究，桥接研究的规范化和国际多中心临床试验将成为大势所趋。在境外已上市境内未上市药品注册过程中，境外临床试验数据的外推与衔接尤为重要。通常国家药品监督管理局药品审评中心（CDE）需要考量临床试验数据包的完整性，判断该药物是否具有种族敏感性、是否需要进行桥接研究。目前针对种族因素对境外临床试验可接受性的影响研究，国际上普遍遵循ICH E5（R1）技术指导原则，另外美国、日本、欧盟等已出台各自有关的法规或指南文件。本文介绍了我国当前对于境外临床试验数据审查的依据和要点，根据国际经验对桥接研究的要点进行了汇总分析，最终对我国境外临床试验数据衔接提出合理性建议。

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贾国舒，女，硕士研究生，研究方向：医药政策与法规。E-mail: guoshu1051525069@163.com。

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贾国舒，女，硕士研究生，研究方向：医药政策与法规。E-mail: guoshu1051525069@163.com。

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