我国特殊医学用途配方食品批准情况分析与开发建议

Approval Status Analysis of Formula Food for Special Medical Use in China and Its Development Proposal

简述我国特医食品分类与注册管理制度,分析我国特医食品批准情况与开发难点。特医食品的开发建议首选不需要进行临床试验的全营养配方食品和非全营养配方食品;次选住院治疗病例多、营养不良发生比率高的肿瘤与肾病特定全营养配方食品;适时开发老年人全营养配方食品。针对发病率高、住院比例低的糖尿病与肥胖人群,建议开发辅助降血糖与减肥保健食品。

The classification and registration management system of formula food for special medical use(special medical food in short) in China are introduced in this paper, and the approval status and development difficulty of the special medical food are also analyzed. We propose that for the development of special medical food, the full nutrition formula food and non full nutrition formula food that need not undergo clinical trials are preferred;the specific full nutrition formula food for patients with tumor or kidney diseases of high hospitalization rate and high incidence of malnutrition is also proposed. The full nutrition formula food for the elderly should be developed in good time. For the people with diabetes and obesity of high incidence and low hospitalization rate, it is proposed to develop auxiliary hypoglycemic and weight reducing health foods.