我国保健食品的市场准入制度及对未来产品研发的启示和展望

Enlightenment and prospect of market access system of China's dietary supplement for future product research and development

中文关键词:  保健食品  注册  备案  研发

英文关键词:health food  registration  filing  research and develop

中文摘要:

      近年来我国社会经济持续稳定发展, 国民收入水平不断提升, 随着居民健康意识不断增强, 人们对保健食品的期待也越来越高。人们对能够提高自身免疫力等的保健功能产品越来越青睐, 保健食品生产企业也应根据近几年更新较快的法规调整新产品的上市模式。目前我国对于保健食品的重要市场准入制度包括注册和备案, 虽然2种制度在申报途径上不同, 但注册和备案的产品在安全性、功能性和质量控制方面的要求是一致的。本文分析解读了现行的法规文件, 同时深入分析了近期保健食品注册技术审评中发现的申请注册保健食品常见问题, 并对未来研发保健食品的申请者提出建议, 以期研发出更多满足人民日益增长对健康品质需求的产品, 为促进大健康产业创新发展、提高上市产品质量提供监管依据。

英文摘要:

      In recent years, the social and economic development in China has been sustained and stable, the national income level is constantly improving, the residents' health awareness is constantly enhanced, and people's expectation for health food is also becoming stronger and stronger. There is a growing interest in functional health products such as those that boost the immune system, and dietary supplement manufacturers should adjust the marketing model of new products in line with the faster changing regulations of recent years. At present, the important market access system for health food in China includes registration and filing. Although the 2 systems differ in the way they are declared, the requirements for safety, functionality and quality control for registered and registered products are the same. This paper analyzed and interpreted the current laws and regulations. At the same time, according to the recent health food technology review, the paper analyzed the common problems deeply, and put forward suggestions for the applicants of health food research and development. In order to develop more products to meet people's growing demand for healthy quality, and to provide regulatory basis for promoting the innovation and development of the big health industry and improving the quality of listed products.