浅析我国特殊医学用途配方食品监管概况
Analysis of the regulation of foods for special medical purpose in China
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摘要: 长期以来,我国特殊医学用途配方食品一直采用药品审批制度,严重制约了该类产品的使用与发展,不能满足临床需要。2015年颁布的《食品安全法》将特殊医学用途配方食品列为特殊食品,2016年3月7日《特殊医学用途配方食品注册管理办法》出台,表明我国特殊医学用途配方食品由"药品"正式转为"食品"进行监管。本文归纳国内外对特殊医学用途配方食品的管理现状,对容易混淆的两类特殊食品"特殊医学用途配方食品"与"保健食品"比较区分,并分析制约我国特殊医学用途配方食品发展的因素,展望我国特殊医学用途配方食品发展趋势。随《特殊医学用途配方食品注册管理办法》的实施,我国特殊医学用途配方食品产业必将飞速发展。Abstract: For a long time,foods for special medical purpose( FSMPs) have been evaluated and approved as drugs in China.It seriously restricted the use and development of FSMPs,and made FSMPs unable to meet the clinical needs.Recently,measure for the registration and management of FSMPs has been promulgated. FSMPs were also classified as special foods in food safety law promulgated in 2015.It showed that FSMPs began to be supervised and administrated as foods in China. In this article,the regulatory policies for FSMPs at oversea and domestic and the differences between FSMPs and health foods were concluded. It also analysed the factors of restricting the development of the FSMPs and looked forward to the development trend of FSMPs in China.With the implementation of measure for the registration and management of FSMPs,FSMPs is bound to rapid development in China.
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