美國食品藥品管理局（FDA）于2022年2月發(fā)布了“人用處方藥治療性蛋白質(zhì)和選擇藥品說明書的免疫原性信息——內(nèi)容和格式”供企業(yè)用的指導(dǎo)原則草案，提出了對這類藥物說明書中免疫原性信息內(nèi)容和格式的新要求。該指導(dǎo)原則提出將這類藥物臨床相關(guān)免疫原性信息納入說明書，建議在“臨床藥理學(xué)”項下設(shè)“免疫原性”專用小項，概述免疫原性主要信息，而不是像以往那樣將其置于“不良反應(yīng)”項下；用主要篇幅對說明書“免疫原性”小項、“不良反應(yīng)”“臨床研究”以及“警告和注意事項”項目的免疫原性信息內(nèi)容和格式的撰寫要求，做了詳細(xì)說明。中國目前還沒有類似指導(dǎo)原則，詳細(xì)介紹FDA的該指導(dǎo)原則，期望對我國這類藥物的免疫原性信息的規(guī)范撰寫和監(jiān)管有幫助，并促進這類藥品臨床安全有效地使用。

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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