早产/低出生体重婴儿特殊医学用途配方食品注册相关问题的考虑

Consideration of Issues Related to the Registration of Foods for Special Medical Purposes for Preterm or Low-Birth-Weight Infants

世界卫生组织,欧洲儿科胃肠病学、肝病学和营养学学会,美国儿科学会及国内的多个指南及专家共识就早产/低出生体重婴儿的肠内营养需求提供了推荐意见和相应的循证医学证据,相关临床营养研究也取得了较大进展。根据早产/低出生体重婴儿营养需求设计的特殊医学用途配方食品为肠内营养支持提供了必要时的选择。本文综述早产/低出生体重婴儿营养需求相关研究进展以及主要类别产品的临床使用,分析存在的问题,并基于当前共识情况,探讨早产/低出生体重婴儿的特殊医学用途配方食品注册上市需充分考虑的产品科学、安全相关问题,为产品研发和注册提供参考。

Several guidelines and expert consensuses issued by the World Health Organization(WTO),the European Society for Pediatric Gastroenterology,Hepatology and Nutrition(ESPGHAN),the American Academy of Pediatrics(AAP)and relevant Chinese associations provide recommendations and corresponding evidence-based medical evidence for the enteral nutritional requirements of preterm or low-birth-weight infants.Relevant clinical nutrition research has greatly progressed.Foods for special medical purposes(FSMPs)designed to meet the nutritional requirements of preterm or low-birth-weight infants provide an option for enteral nutrition support when necessary.This review article summarizes progress in research on the nutritional requirements of preterm or low-birth-weight infants and the clinical application of the major categories of FSMP products,and analyzes the existing problems.Based on the current consensus,this article discusses science and safety issues that need adequate consideration when FSMPs for preterm or low-birth-weight infants are registered for sale,so as to provide a reference for the development and registration of relevant products.