市场监管总局发布肝病、胃肠道吸收障碍特医食品临床研究指南

Core Viewpoint - The State Administration for Market Regulation has released two technical guidance documents aimed at standardizing the clinical trial processes for specific total nutritional formula foods related to liver disease and gastrointestinal absorption disorders, ensuring scientific, truthful, and reliable data and results, improving registration review and approval efficiency, and protecting the safety and rights of participants and consumers [1] Group 1 - The documents are intended to guide enterprises and clinical trial institutions in the clinical trial processes for specific total nutritional formula foods [1] - The guidance aims to ensure the safety, nutritional adequacy, and clinical effectiveness of the products [1] - The initiative is expected to enhance the efficiency of registration review and approval processes [1]