美國食品藥品監(jiān)督管理局（FDA）于2025年5月發(fā)布了“降低人體細(xì)胞、組織以及基于細(xì)胞和組織的產(chǎn)品（HCT/Ps）傳播結(jié)核分枝桿菌（Mtb）風(fēng)險建議的供企業(yè)用的指導(dǎo)原則草案”并要求立即實施。該指導(dǎo)原則在目前還沒有特異的檢測供體Mtb感染的篩查供體的情況下，根據(jù)大量文獻(xiàn)提出了用綜合措施篩查Mtb感染供體的建議，以降低HCT/Ps傳播Mtb風(fēng)險，包括篩查供體是否存在Mtb感染的風(fēng)險因素和條件；篩查供體是否有Mtb感染的臨床證據(jù)；篩查供體是否有Mtb感染的身體證據(jù)；檢測供體是否有Mtb感染的證據(jù)以及其他風(fēng)險降低措施。而我國目前還沒有類似指導(dǎo)原則。詳細(xì)介紹FDA該指導(dǎo)原則，以引起我國HCT/Ps研究和生產(chǎn)單位以及監(jiān)管部門對篩查并排除Mtb感染的HCT/Ps供體的重視。

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of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft Guidance for Industry”and mandated immediate implementation.In the absence of specific screening methods for detecting Mtb infection in donors, this guidance provides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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中國中醫(yī)科學(xué)院中藥研究所“使命導(dǎo)向改革” 重點專項（ CI2023E001TS01）