王进博, 施沅坤, 陈广耀. 基于国内外经验的我国保健食品上市后的技术评价[J]. 上海预防医学, 2022, 34(12): 1261-1266. DOI: 10.19428/j.cnki.sjpm.2022.22143
引用本文: 王进博, 施沅坤, 陈广耀. 基于国内外经验的我国保健食品上市后的技术评价[J]. 上海预防医学, 2022, 34(12): 1261-1266. DOI: 10.19428/j.cnki.sjpm.2022.22143
WANG Jinbo, SHI Yuankun, CHEN Guangyao. Post-market technical evaluation of dietary supplements based on domestic and foreign experiences[J]. Shanghai Journal of Preventive Medicine, 2022, 34(12): 1261-1266. DOI: 10.19428/j.cnki.sjpm.2022.22143
Citation: WANG Jinbo, SHI Yuankun, CHEN Guangyao. Post-market technical evaluation of dietary supplements based on domestic and foreign experiences[J]. Shanghai Journal of Preventive Medicine, 2022, 34(12): 1261-1266. DOI: 10.19428/j.cnki.sjpm.2022.22143

基于国内外经验的我国保健食品上市后的技术评价

Post-market technical evaluation of dietary supplements based on domestic and foreign experiences

  • 摘要: 借鉴国内外相关领域经验,探讨我国保健食品上市后技术评价工作如何开展,系统梳理主要国家和地区在保健食品类似产品以及我国药品等领域产品上市后评价工作方面的有益经验,结合我国保健食品行业实际对我国开展保健食品上市后技术评价工作提出建议。发现美国的企业强制报告责任,欧盟设立专门的科学委员会长期提供技术支持,澳大利亚的以企业为上市后监测的责任主体,我国台湾地区的相关监测系统建设,药品和医疗器械领域相对成熟的法规体系、评价体系和管理体系,化妆品领域创设不良反应监测基地,特医食品赋予医疗机构上市后不良反应监测责任,各领域上市后管理均优先侧重于安全性方面等都是值得借鉴的有益经验。结合我国保健食品行业现状,提出了推动法规建设等具体建议。

     

    Abstract: The paper is to explore how to carry out post-market technical evaluation of dietary supplements in China by referring to the experiences at home and abroad. Experiences of major countries and regions in the post-market evaluation of similar products of dietary supplements and China’s experience in drugs were systematically reviewed. Combined with the actual situation of the health food industry in China, suggestions were put forward for the post-market technical evaluation of health foods in China. There are many useful experiences worth learning from, such as the mandatory reporting responsibility of enterprises in the United States, a special scientific committee which provides long-term technical support in the European Union, post-market monitoring by enterprises in Australia, the establishment of relevant monitoring systems in Taiwan, the relatively mature regulatory system, evaluation system and management system in the field of drugs and medical devices, and the establishment of adverse reaction monitoring bases in the field of cosmetics, the responsibility of post-mark adverse reaction monitoring of food for special medical purposes by medical institutions, and the post-market management in various fields giving priority to safety. In combination with the current situation of China’s health food industry, five specific suggestions, such as promoting the construction of laws and regulations, are put forward.

     

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