美国食品药品监督管理局（FDA）于2023年4月发布了“评估简化新药申请仿制透皮和局部给药系统可能的刺激性和致敏性的供企业用的指导原则草案”，全面而又具体地阐明FDA对仿制透皮和局部给药系统（TDS）可能的刺激性和致敏性人体内研究的设计和实施的建议。其中包括一般原则（一般考虑）、研究设计和实施、统计分析（刺激性分析和致敏性分析）、辅料TDS和阳性对照TDS以及部分（切割）TDS等。而中国目前还没有类似的指导原则，详细介绍FDA该指导原则主要内容，期望对中国仿制TDS刺激性和致敏性人体内研究与监管有所裨益。

The Assessing the Irritation and Sensitization Potential of Generic Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry released by the FDA in April 2023, comprehensively and specifically clarified the FDA's recommendations for the design and conduct of in vivo studies on the potential irritation and sensitization of generic transdermal and local drug delivery systems. This includes general principles (general considerations), study design and conduct, statistical analyses (irritation analysis and sensitization analysis), vehicle TDS and positive control TDS, as well as partial (Cut) TDS. However, there is currently no similar guidance in China. This article provides a detailed introduction to the FDA's guidance, with the expectation of being beneficial for the study and regulation of the irritation and sensitization of generic transdermal and local drug delivery systems in China.

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