不同国家保健品注册程序的比较研究

Hiteksha J. Dobariya, Urvi J. Chotaliya
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摘要

营养保健品被定义为对健康有益的任何食品或食品成分,如预防或治疗疾病的能力,对发达国家和发展中国家的消费者来说都是必不可少的。由于生活方式的改变,维生素、矿物质和其他营养物质等功能性元素变得越来越重要。这一类现在包括益生菌、氨基酸和脂肪酸等。鉴于这些产品是供人类消费的,世界各地的监管机构都在关注产品质量和安全。本文研究了不同国家的营养药品注册过程。印度制定了特殊膳食用途食品注册程序,美国制定了膳食补充剂注册程序,日本制定了特定膳食用途食品(FOSHU)注册程序,而中国制定了保健食品注册程序。它还包括市场上销售的营养品配方。本文的目的是比较不同国家之间的监管过程。
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A Comparative Study of Registration Process of Nutraceuticals in different countries
Nutraceuticals, which are defined as any food or component of food that has health benefits, such as the ability to prevent or treat disease, have become essential for consumers in both developed and developing nations. Functional elements like vitamins, minerals, and other nutrients are becoming more important due to the changing lifestyle. This category now includes things like probiotics, amino acids, and fatty acids, among others. In light of the fact that these items are intended for human consumption, regulatory bodies worldwide are concentrating on the Product Quality and Safety. This paper looks into the nutraceutical registration processes in different countries. The India have developed the Food for special dietary use registration process whereas the USA have put into place Dietary supplement registration process and the Japan have developed registration process for Foods for specified dietary use (FOSHU) whereas the China have developed registration process for Health foods. It also includes the marketed formulation of nutraceuticals. The aim of this paper is to compare the regulation processes between the different countries.
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