Alostad Azhar H, Steinke Douglas T, Schafheutle Ellen I
Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Stopford Building, Oxford Road, Manchester, M13 9PT UK.
Pharmaceut Med. 2018;32(1):39-49. doi: 10.1007/s40290-018-0223-0. Epub 2018 Jan 20.
Herbal medicine (HM) regulation is less developed than that of allopathic medicines, with some countries lacking specific regulations.
For the purpose of informing a registration system for HMs in Kuwait, which does not manufacture but imports all HMs, this study compared the similarities and differences between the current HM registration systems of five countries.
The five countries were selected as major source countries of HM in Kuwait (United Kingdom (UK), Germany and United States of America (USA)) or because of geographical proximity or size and approach (United Arab Emirates (UAE) and Kingdom of Bahrain). Documentary analysis of HM classification systems was performed by reviewing the regulatory and law documentation of these countries' drug regulatory authority websites. Data on HM definition, classification and the main requirements for registration were extracted and analysed for similarities and differences.
There was diversity in the classification of HMs across all five countries including terms used, definitions, type of law, requirements, restrictions and preparation type. The regulatory authorities of the UK, Germany, UAE and Kingdom of Bahrain offer simplified registration for HMs, where plausible efficacy as a result of established traditional use is sufficient. In USA, the concept of traditional use does not exist, instead, the product can be categorised as a dietary supplement where no assessment or evaluation is required prior to marketing.
Owing to the inconsistencies in how drug regulatory authorities define HMs, it will be important to design a clear definition of what constitutes a HM in Kuwait, which is a country that does not produce and register its own products but assesses products registered elsewhere.
草药（HM）监管的发展程度低于对抗疗法药物的监管，一些国家缺乏具体的监管规定。
为了给科威特的草药注册系统提供信息（科威特不生产草药，但进口所有草药），本研究比较了五个国家现行草药注册系统之间的异同。
选择这五个国家，是因为它们是科威特草药的主要来源国（英国、德国和美国），或者是由于地理位置接近、规模和管理方式（阿拉伯联合酋长国和巴林王国）。通过查阅这些国家药品监管机构网站的监管和法律文件，对草药分类系统进行文献分析。提取并分析有关草药定义、分类和注册主要要求的数据，以找出异同。
所有五个国家的草药分类都存在差异，包括使用的术语、定义、法律类型、要求、限制和制剂类型。英国、德国、阿联酋和巴林王国药管局为草药提供简化注册，只要传统使用确立的合理疗效就足够了。在美国，不存在传统使用的概念，相反，该产品可归类为膳食补充剂，上市前无需评估。
由于药品监管机构对草药的定义不一致，对于不生产和注册本国产品但评估其他地方注册产品的科威特来说，设计一个明确的草药构成定义非常重要。
