构建保健食品上市后技术评价证据体的思考

Reflections on the construction of the evidence body of technical evaluation of functional foods after market introduction

基于动物实验和小样本量的人体试食试验很难在保健食品批准注册前准确地诠释保健食品的完整科学内涵,需要在上市后对商业规模生产的保健食品从安全性、保健功能等方面开展进一步的技术评价。从《保健食品注册与备案管理办法》实施3年多以来申请产品延续注册时提交的上市后人群食用情况分析报告来看,保健食品上市后评价报告尚缺乏系统完善的证据支持。本文借鉴循证医学和药品上市后评价的成功经验,对保健食品上市后评价内容、证据源构建、证据分类和分级进行分析,从点、线、面等多个角度出发,提出构建上市后保健食品安全性和保健功能技术评价证据体的初步思路,为今后该领域证据体系的研究提供思路。

Interpretation of the complete scientific connotation of functional foods accurately prior to approval and registration based on animal tests and small sample size human food tests is challenging.Further technical evaluation after market introduction should be carried out on safety,health function and other aspects of those widely used commercial scale production products.According to the analysis report on the consumption situation of postmarketing population submitted when applying for product registration extension since the implementation of the functional food registration and filing management measures more than 3 years ago,the post-marketing evaluation report of functional food still lacks systematic and perfect evidence support.Based on the successful experience of evidence-based medicine and post-marketing evaluation evidence,this paper analyzes the post-marketing evaluation content,evidence source construction,evidence classification and classification of functional food,and puts forward the preliminary idea of constructing post-marketing evaluation evidence body of functional food safety and health function technology from multiple view points,so as to provide insights into evidence system research in this field in the future.