《特殊医学用途配方食品临床试验质量管理规范(试行)》解析

摘要

Food for Special Medical Purpose is a type of food that is used by people in the state of a disease or a particular disease,It is important to standardize its clinical trials .On November 1, 2016, China Food and Drug Administration issued "Food for special medical purpose Clinical Practice (Trial draft)", we interpreted the main draft.%特殊医学用途配方食品是一类针对疾病或特定疾病状态下人群使用的食品,规范其临床试验具有重要意义.2016年11月1日,国家食品药品监督管理总局发布《特殊医学用途配方食品临床试验质量管理规范(试行)》,本文对该规范的主要内容进行解析.