【摘要】 中国特殊医学用途配方食品(简称“特医食品”)的注册管理制度已初步建立，但相较于其他发达国家，中国特医食品行业起步较晚，相关制度还有待补充与完善。文章简要叙述中国特医食品的注册管理模式，分析目前面临的问题与挑战，梳理欧盟、美国、日本等国家的特医食品管理制度，并从产品研发、产品准入、审批流程3个角度提出建议，以期为人们的健康保障提供更多选择，推动中国特医食品行业的可持续发展。更多还原

【Abstract】 The registration management system of food for special medical purposes(FSMP) in China has been initially established. But compared with other developed countries, China’s FSMP industry started late, and its system needs to be supplemented and improved. This research briefly describes the registration management mode of FSMP in our countries, analyzes the problems and challenges faced at present, sorts out the registration management system of FSMP in the European Union, the United States and Japan. Suggestions are put forward from three perspectives: product research and development, product access, and approval process, In order to provide more choices for people’s health security and promote the sustainable development of China’s FSMP industry.更多还原