摘要
目的:梳理特殊医学用途配方食品(Food for Special Medical Purpose,FSMP)的法规标准,汇总分析已获批产品的相关信息,为产品研发、申请注册、临床使用等提供参考。方法:从管理和应用的角度,对与FSMP密切相关的法律法规、标准进行汇总、解读和说明;从产品数量、产品类型、适用人群等方面对已批复特殊医学用途配方食品进行总结分析。结果:特殊医学用途配方食品已形成相对完善的标准和法律法规体系;截至2024年3月,特殊医学用途配方食品已注册181个产品。结论:特殊医学用途配方食品标准和法律法规是产品研发生产、注册审批及临床使用的依据,FSMP的批复信息是产品研发、临床应用的重要参考信息,应加强了解和掌握,促进FSMP的研究开发和临床应用。
Objective:To sort out the regulations and standards of food for special medical purposes(FSMP),summarize and analyze the relevant information of approved products,so as to provide reference for product research and development,application for registration and clinical use.Method:To summarize,interpret and explain the laws,regulations and standards closely related to FSMP from the perspectives of management and application;to summarize and analyze the approved FSMP in terms of the number of products,types of products,and applicable populations.Result:A relatively complete system of standards and laws and regulations has been formed for FSMP;As of March 2024,181 products have been registered for FSMP.Conclusion:The standards and laws and regulations of FSMP are the basis for product research and development,production,registration and approval,and clinical use;the information on the approval of FSMP is an important reference information for product research and development and clinical application,and it should be enhanced to be understood and prehended in order to promote research as well as clinical use of FSMP.
作者
王萍
WANG Ping(Guangdong Province Institute of Biological Products and Materia Medica,Guangzhou 510440,China)
出处
《食品安全导刊》
2024年第10期114-117,共4页
China Food Safety Magazine
关键词
特殊医学用途配方食品
标准
法律法规
food for special medical purpose
standards
laws and regulations
