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The guidance on CMC study of in vivo gene therapy products was issued by the Center for Drug Evaluation, NMPA, on May 26, 2022, to encourage and promote the development of in vivo gene therapy products. This paper gives a detailed interpretation of the main contents and some important issues of the guidance and provides a reference for the market authorization application, combined with the drafting process of the guidance, so that the industry can better understand the technical requirements of the guidance during the development of in vivo gene therapy products.

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为鼓励和促进体内基因治疗产品的发展，国家药品监督管理局药品审评中心于2022年5月26日正式发布了《体内基因治疗产品药学研究与评价技术指导原则（试行）》。本文结合该指南的起草过程，对指南的主要内容和部分重点问题进行了详细解读，以便业界在开发和研究体内基因治疗产品时更好地理解和参考该指南技术的要求，促进体内基因治疗产品的上市申请。

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徐隆昌，男，博士，助理研究员，主要从事生物制品药学审评工作。联系电话：(010)85243067，E-mail: xulch@cde.org.cn。

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徐隆昌，男，博士，助理研究员，主要从事生物制品药学审评工作。联系电话：(010)85243067，E-mail: xulch@cde.org.cn。

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