美國(guó)食品藥品監(jiān)督管理局（FDA）的"供企業(yè)用對(duì)藥品中的谷蛋白及其相關(guān)標(biāo)示建議的指導(dǎo)原則（草案）"，詳細(xì)分析了口服藥品中谷蛋白的來(lái)源和含量并建議在有證據(jù)的情況下，在口服藥品說(shuō)明書(shū)和標(biāo)簽中列入"不含由含谷蛋白谷物（小麥、大麥或黑麥）制成的成分"的聲明，以確保乳糜瀉患者的用藥安全。詳細(xì)介紹該指導(dǎo)原則，期望引起我國(guó)藥品上市許可持有人和藥品監(jiān)管部門對(duì)谷蛋白危害的重視。

FDA's gluten in drug products and associated labeling recommendations guidance for industry (draft) analyzed the sources and amounts of gluten in oral drug products in detail, and suggests that if there is evidence, the statement Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye) should be included in the some prescribing information and labelings in oral drug products,so as to ensure the medication safety of celiac patients. This paper introduces the guidance in detail, expecting to attract the attention of drug marketing license holders and drug regulatory authorities to the harm of gluten in China.

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