Regulatory landscape of dietary supplements and herbal medicines from a global perspective
Shraddha Thakkar, Elke Anklam, Alexander M. Xu, Franz Ulberth, Jing Li, Bo Li, Marta Hugas, Nandakumara Sarma, Scott Crerar, Sibyl N. Swift, Takashi Hakamatsuka, Valeriu Curtui, William Yan, Xingchao Geng, William Slikker, Weida Tong
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.