摘要
美国食品药品监督管理局(FDA)的"供企业用对药品中的谷蛋白及其相关标示建议的指导原则(草案)",详细分析了口服药品中谷蛋白的来源和含量并建议在有证据的情况下,在口服药品说明书和标签中列入"不含由含谷蛋白谷物(小麦、大麦或黑麦)制成的成分"的声明,以确保乳糜泻患者的用药安全。详细介绍该指导原则,期望引起我国药品上市许可持有人和药品监管部门对谷蛋白危害的重视。
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.
作者
萧惠来
XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《药物评价研究》
CAS
2020年第10期1932-1938,共7页
Drug Evaluation Research
