Suppr超能文献

全球视角下的膳食补充剂和草药的监管格局。

Regulatory landscape of dietary supplements and herbal medicines from a global perspective.

机构信息

National Center for Toxicological Research (NCTR), Food and Drug Administration (FDA), USA.

European Commission, Joint Research Centre (JRC), Belgium.

出版信息

Regul Toxicol Pharmacol. 2020 Jul;114:104647. doi: 10.1016/j.yrtph.2020.104647. Epub 2020 Apr 16.

Abstract

The number of Individuals that use dietary supplements and herbal medicine products are continuous to increase in many countries. The context of usage of a dietary supplement varies widely from country-to-country; in some countries supplement use is just limited to general health and well-being while others permit use for medicinal purposes. To date, there is little consensus from country to country on the scope, requirements, definition, or even the terminology in which dietary supplement and herbal medicines categories could be classified. Transparent science-based quality standards for the ingredients across these regulatory frameworks/definitions becomes even more important given the international supply chain. Meanwhile, there has been a rapid advancement in emerging technologies and data science applied to the field. This review was conceived at the Global Summit on Regulatory Sciences that took place in Beijing on September 2018 (GSRS2018) which is organized by Global Coalition for Regulatory Science Research (GCRSR) that consists of the global regulatory agencies from over ten countries including the European Union. This review summarizes a significant portion of discussions relating to a longitudinal comparison of the status for dietary supplements and herbal medicines among the different national jurisdictions and to the extent of how new tools and methodologies can improve the regulatory application.

摘要

在许多国家,使用膳食补充剂和草药产品的人数不断增加。膳食补充剂的使用背景因国家而异;在一些国家,补充剂的使用仅限于一般的健康和福祉,而其他国家则允许将其用于医疗目的。迄今为止,各国之间在膳食补充剂和草药类别的范围、要求、定义,甚至术语方面几乎没有达成共识。鉴于国际供应链的存在,这些监管框架/定义中对成分的透明、基于科学的质量标准变得更加重要。同时,新兴技术和数据科学在该领域的应用也取得了快速进展。本次审查是在 2018 年 9 月于北京举行的全球监管科学峰会(GSRS2018)上构思的,该峰会由全球监管科学研究联盟(GCRSR)组织,该联盟由来自包括欧盟在内的十个以上国家的全球监管机构组成。本次审查总结了大量与不同国家司法管辖区的膳食补充剂和草药的现状进行纵向比较以及新工具和方法学在多大程度上可以改进监管应用的讨论。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验