Обзорная статья

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

Shraddha ThakkarNational Center for Toxicological Research (NCTR), Food and Drug Administration (FDA), USAElke AnklamEuropean Commission, Joint Research Centre (JRC), BelgiumAlexander M. XuCenter of Drug Evaluation (CDE), National Medical Products Administration (NMPA), ChinaFranz UlberthEuropean Commission, Joint Research Centre (JRC), BelgiumJing LiCenter for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), USABo LiNational Institutes for Food and Drug Control (NIFDC), National Medical Products Administration (NMPA), ChinaMarta HugasEuropean Food Safety Authority (EFSA), EU, ItalyNandakumara SarmaUS Pharmacopeia (USP), USAScott CrerarSibyl N. SwiftCenter for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA), USATakashi HakamatsukaNational Institute of Health Sciences (NIHS), JapanValeriu CurtuiEuropean Food Safety Authority (EFSA), EU, ItalyWilliam YanHealth Canada (HC), CanadaXingchao GengNational Institutes for Food and Drug Control (NIFDC), National Medical Products Administration (NMPA), ChinaWilliam SlikkerNational Center for Toxicological Research (NCTR), Food and Drug Administration (FDA), USA. Electronic address: [email protected]Weida TongNational Center for Toxicological Research (NCTR), Food and Drug Administration (FDA), USA. Electronic address: [email protected]

2020en

ABI

Аннотация

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.

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Идентификаторы

DOI: 10.1016/j.yrtph.2020.104647

Цитирования и источники

Цитирований: 3Использованных источников: 0

Показатели — AkademScholar