摘要
保健食品上市后技术评价作为保健食品全生命周期管理的重要一环,与上市前评价同等重要。随着《保健食品注册与备案管理办法》及其配套文件将申请保健食品延续注册时提交“人群食用情况分析报告”作为保健食品上市后技术评价工作的抓手,保健食品上市后技术评价工作取得了初步成效,但也存在数据质量有待提高、试验设计有待优化、数据分析和结果解释需更严谨等问题,在一定程度上影响了保健食品上市后技术评价工作。本文从保健食品上市后技术评价工作开展的必要性、“人群食用情况分析报告”技术审评中发现的主要问题和原因分析及进一步做好保健食品上市后技术评价工作的对策探讨等方面进行分析,以期对保健食品上市后技术评价工作提供一定的帮助。
As an important part of the whole life cycle management of health food,post marketing technical evaluation of health food is as important as pre marketing evaluation.As Administrative Measures for Registration and Filing of Health Food and relevant documents requires the submission of“Analysis Report on Population Consumption”when applying for continued registration of health food as the starting point of post marketing technical evaluation of health food,the post marketing technical evaluation of health food has achieved initial results.However,there are still some problems,such as data quality to be improved,test design to be optimized,data analysis and result interpretation to be more rigorous,which have affected the post marketing technical evaluation of health food to a certain extent.This paper analyzes the necessity of post marketing technical evaluation of health food,the main problems and causes found in the technical evaluation of“Analysis Report on Population Consumption”and the countermeasures to further improve the post marketing technical evaluation of health food,in order to provide some help to the post marketing technical evaluation of health food.
作者
王进博
陈广耀
WANG Jin-bo;CHEN Guang-yao(Center for Food Evaluation,State Administration for Market Regulation(National Committee on the Assessment ofthe Protected Traditional Chinese Medicinal Products),Beijing 100070,China)
出处
《食品与药品》
CAS
2022年第4期369-372,共4页
Food and Drug
基金
保健食品上市后技术评价指导原则研究(编号:SSZX-2020-BJ-02)
保健食品上市后技术评价方法及示范研究(编号:SSZX-2020-BJ-03)
保健食品应用安全性、功能性情况调查及数据库建立(编号:ZBW-2017-BJSP-09)。
关键词
保健食品
人群食用情况分析报告
技术审评
上市后技术评价
health food
Analysis Report on Population Consumption
technical review
post marketing technology evaluation
