Registration,Review and Approval of Tablets Functional Food in China

JIANG Yu; TONG Na

doi:10.13422/j.cnki.syfjx.2014180225

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Registration,Review and Approval of Tablets Functional Food in China

更新时间：2024-01-04

- Registration,Review and Approval of Tablets Functional Food in China
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 20, Issue 18, Pages: 225-227(2014)
- 作者机构：
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.2014180225
  CLC： R95;TS218
- Published：2014
- 稿件说明：
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JIANG Yu, TONG Na. Registration,Review and Approval of Tablets Functional Food in China[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(18): 225-227.
DOI：

JIANG Yu, TONG Na. Registration,Review and Approval of Tablets Functional Food in China[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(18): 225-227. DOI： 10.13422/j.cnki.syfjx.2014180225.

摘要

通过系统调查分析片剂保健食品审批情况，考察其原料、原料提取物及常用辅料的使用频次，总结近年来片剂保健食品注册、变更及审评中存在的问题，为片剂保健食品的研发、监管、申报提供数据参考。以国家食品药品监督管理总局保健食品审评中心后台数据库为数据来源，对2005—2013年注册和批准的保健食品进行统计汇总，分析其中涉及的片剂保健食品，考察其原料、原料提取物及常用辅料的使用频次。2005—2013年共审批保健食品6 560件，其中片剂保健食品1 755件，国产产品批准数占总批准数的97.6%。最主要营养素声称为补充多种维生素及矿物质，最主要功能声称为增强免疫力，常见原料为碳酸钙及维生素C。结果发现片剂固然具有诸多优点，但并非所有的原料都适合制成片剂。

Abstract

Through investigation and analysis for approval of tablets health foods

to investigate its frequency of usage of raw materials

extracts of raw materials and auxiliary materials

summarize problems existed in registration

alteration and evaluation of tablets health foods in recent years

in order to provide data reference for research and development

supervision

reporting of tablets health foods.Taking database of center for health food evaluation of state food and drug administration as data source

statistical summary(6 560 pieces) of registration and approval of health foods during 2005—2013

then involving tablets health foods(1 755 pieces) were analyzed

which domestic products accounted for 97.6% of the total number.Main nutriment claims is added vitamins and minerals

their main function claim is enhance immunity

main raw materials are calcium carbonate and vitamin C.Despite tablets have many advantages

but not all of raw materials are suitable for making into this formulation.

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Related Author

CHEN Guangyao

SUN Mingxia

WANG Yun

TIAN Jixiang

WANG Dan

DU Peng

Gan XU

Shuang-cheng MA

Related Institution

Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences

China Nutrition and Health Food Association

Center for Food Evaluation，State Administration for Market Regulation

Center for Drug Evaluation，National Medical Products Administration

National Institutes for Food and Drug Control

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