美国食品药品管理局（FDA）于2022年2月发布了“人用处方药治疗性蛋白质和选择药品说明书的免疫原性信息——内容和格式”供企业用的指导原则草案，提出了对这类药物说明书中免疫原性信息内容和格式的新要求。该指导原则提出将这类药物临床相关免疫原性信息纳入说明书，建议在“临床药理学”项下设“免疫原性”专用小项，概述免疫原性主要信息，而不是像以往那样将其置于“不良反应”项下；用主要篇幅对说明书“免疫原性”小项、“不良反应”“临床研究”以及“警告和注意事项”项目的免疫原性信息内容和格式的撰写要求，做了详细说明。中国目前还没有类似指导原则，详细介绍FDA的该指导原则，期望对我国这类药物的免疫原性信息的规范撰写和监管有帮助，并促进这类药品临床安全有效地使用。

Food and Drug Administration (FDA) issued Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling-Content and Format Guidance for Industry (Draft) in February 2022. The guidance provides new requirements for the content and format of immunogenicity information in the Labelings of such drugs. This guidance proposes to incorporate the clinical related immunogenicity information of such drugs into product labeling. It is suggested to set up "immunogenicity" dedicated subsection under the "clinical pharmacology" section to summarize the main information of immunogenicity, instead of putting it under the "adverse reactions" section as before. This guidance has made a detailed description of the requirements for the content and format of immunogenicity information of the "immunogenicity" subsection, "adverse reactions", "clinical studies" and "warnings and precautions" sections in the Labelings in the main space. However, there is no similar guidance in China. This guidance of FDA is introduced in detail. It is expected to be helpful for the standard writing and supervision of immunogenicity information of such drugs in China, and promote the safe and effective clinical use of such drugs.

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