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根据《中华人民共和国食品安全法》及其实施条例、《特殊医学用途配方食品注册管理办法》,日前,国家食品药品监督管理总局制定并公布了《特殊医学用途配方食品临床试验质量管理规范(试行)》(以下简称《规范》)。根据《规范》,特殊医学用途配方食品的临床试验机构应当为药物临床试验机构,具有营养科室和经
According to the “Food Safety Law of the People’s Republic of China” and its implementing regulations, the “Measures for the Administration of Recipe Foods for Special Medical Purposes”, recently, the State Food and Drug Administration formulated and promulgated the “Code of Practice for Clinical Trials of Special Medical Purposes ) ”(Hereinafter referred to as“ norms ”). According to the “norms”, clinical trials of special medical uses formula food should be a drug clinical trials agencies, with nutrition departments and