美国食品药品监督管理局（FDA）于2025年5月发布了“降低人体细胞、组织以及基于细胞和组织的产品（HCT/Ps）传播结核分枝杆菌（Mtb）风险建议的供企业用的指导原则草案”并要求立即实施。该指导原则在目前还没有特异的检测供体Mtb感染的筛查供体的情况下，根据大量文献提出了用综合措施筛查Mtb感染供体的建议，以降低HCT/Ps传播Mtb风险，包括筛查供体是否存在Mtb感染的风险因素和条件；筛查供体是否有Mtb感染的临床证据；筛查供体是否有Mtb感染的身体证据；检测供体是否有Mtb感染的证据以及其他风险降低措施。而我国目前还没有类似指导原则。详细介绍FDA该指导原则，以引起我国HCT/Ps研究和生产单位以及监管部门对筛查并排除Mtb感染的HCT/Ps供体的重视。

In May 2025, the FDA issued“Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft Guidance for Industry”and mandated immediate implementation.In the absence of specific screening methods for detecting Mtb infection in donors, this guidance provides evidencebased recommendations using comprehensive donor screening measures to mitigate transmission risk through HCT/Ps. Key recommendations include: Screening a donor for risk factors and conditions for Mtb infection; Screening a donor for clinical evidence of Mtb infection; Screening a donor for physical evidence of Mtb infection; testing a donor for evidence of Mtb infection and additional risk reduction measures. While, no analogous guidance currently exists in China. This paper offers an exhaustive introduction of the FDA guidance, aiming to raise awareness among Chinese HCT/Ps research institutions, production units, and regulatory authorities regarding the critical importance of screening and excluding HCT/Ps donors with Mtb infection.

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中国中医科学院中药研究所“使命导向改革” 重点专项（ CI2023E001TS01）