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The rapid development of cell and gene therapy products carries the high expectations of industry, patients, and healthcare workers, and also poses a considerable challenge to drug regulatory authorities. In order to promote the development and marketing of these products with great therapeutic potential, the US and European drug regulatory authorities have adopted measures to adjust organizational structures, improve regulations and guidelines, and develop targeted accelerated procedures for cell and gene therapy products. China's regulatory policy for cell and gene therapy products is also constantly improving. By summarizing and analyzing the accelerated assessment and approval policies of the US and European drug regulatory agencies for cell and gene therapy products, this paper aims to provide reference for the optimization of the accelerated assessment and approval policies for these classes of products in China.

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细胞和基因治疗产品研发的快速发展，承载了产业界、患者和医疗工作者们的殷切期望，也给药品监管机构带来不小的挑战。为促进具有巨大治疗潜能的此类产品研发和上市，美国和欧洲药品监管机构专门针对细胞和基因治疗产品采取了调整组织结构、完善法规和指导原则、制定针对性的加速程序等措施。我国对细胞和基因治疗产品的监管政策也在不断完善中。本文拟通过概述和分析美国和欧洲药品监管机构细胞和基因治疗产品加快审评审批政策，为我国细胞和基因治疗产品加快审评审批政策优化提供借鉴。

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王晶，女，博士研究生，主要从事生物制品临床审评工作。联系电话：(010)80995660，E-mail: wangjing01@cde.org.cn。

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王晶，女，博士研究生，主要从事生物制品临床审评工作。联系电话：(010)80995660，E-mail: wangjing01@cde.org.cn。

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