特殊医学用途配方食品产品配方研发注册常见问题及解决建议研究
作者:
作者单位:

国家市场监督管理总局食品审评中心,北京 100070

作者简介:

王星 女 副主任药师 研究方向为特殊医学用途配方食品 E-mail:ymwangxing@163.com

通讯作者:

中图分类号:

R155

基金项目:


Research on common problems and solutions for formula design and the registration of formula food for special medical purposes
Author:
Affiliation:

Center for Food Evaluation, State Administration for Market Regulation, Beijing 100070, China

Fund Project:

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    摘要:

    目的 通过探讨分析特殊医学用途配方食品产品配方研发注册存在的问题及解决建议,为该类产品研发、注册管理、临床使用等提供参考。方法 从产品注册申请和技术审评的角度,对特殊医学用途配方食品的含义和组成要求、研发设计原则及重点内容、注册申请材料关注重点等进行分析总结。结果 特殊医学用途配方食品的产品配方设计应以标准和法规为基础,整体观是产品配方设计的重点,临床使用是产品配方设计的主导,同时应关注注册申请材料的完整性和统一性。结论 产品配方设计是特殊医学用途配方食品研发的重中之重,应关注其科学性、合理性和临床适用性,相关部门也应进一步完善相关标准法规。

    Abstract:

    Objective This paper discusses the development and design of food formulations for special medical purposes to provide a reference for product development and design, registration management, and the clinical use of such products.Methods We summarized and analyzed the formulations of formula food for special medical purposes, determined the important aspects of formula development and design, and identified key points for evaluating registration applications.Results The formulation design of formula food for special medical purposes should be based on standards and regulations. The most important thing is to think the formula design as a whole, clinical use shuold be the leading of the formulation design, and attention should be paid to the registration dossiers.Conclusion Formulation design is the most important aspect in the research and development of formula foods for special medical purposes. Attention should be paid to the scientific, rational, and clinical applications of these foods. The administrative department should improve its standards and regulations to ensure they are widely used in clinical practice.

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引用本文

王星,吴娜.特殊医学用途配方食品产品配方研发注册常见问题及解决建议研究[J].中国食品卫生杂志,2023,35(10):1529-1532.

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  • 收稿日期:2022-08-17
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  • 在线发布日期: 2024-02-04
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