International Comparison of Five Herbal Medicine Registration Systems to Inform Regulation Development: United Kingdom, Germany, United States of America, United Arab Emirates and Kingdom of Bahrain

Abstract

BackgroundHerbal medicine (HM) regulation is less developed than that of allopathic medicines, with some countries lacking specific regulations.ObjectiveFor 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.MethodsThe 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.ResultsThere 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.ConclusionsOwing 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.

Herbal Medicine Classification: Policy Recommendations

“…Findings from comparing the HM registration laws in five countries (1) revealed that all comparative authorities state in their HMs definitions that the product must consist of plant materials, with Germany, UK (under European Union Directive 2004/24/EC), Bahrain and UAE having the highest similarity in defining a HM. These four countries' definitions are consistent with the recommended World Health Organization (WHO) definition of an "authorized industrially manufactured therapeutic herbal product for registration" (13).…”

“…Herbal medicines (HMs) have been defined as "preparations manufactured industrially consisting of active ingredient(s) which is/are purely and naturally original, not chemically altered plant substance(s), and is/are responsible for the overall therapeutic effect of the product" (1). Due to a belief that as "natural" products, HMs are "safe" or "safer" than conventional medicines, consumers have turned to plant-derived preparations (2).…”

Regulatory compliance of herbal medicines – A review

“…The MCA differentiated a product as medicine or food or cosmetics based on the product claims and had to comply as the Directive 65/65/EEC way back in 1995. (Alostad et al, 2018).…”

“…Companies which opt to register under the THR scheme will have to provide evidence of quality as per the GMP standards and evidence of safety and ef icacy based on long traditional use of 30 years overall and 15 years in EU, the label should carry that the THR certi ication mark and a statement that the product is "exclusively based on long term use". For major health claims, or the products that calls for a medical prescription, a market authorisation is required, and in addition to the above requirements, clinical studies, along with toxicological studies are to be provided (Alostad et al, 2018).…”

Herbal-induced Stevens-Johnson syndrome with oral involvement and management in an HIV patient

“…In SJS patients suspected of suffering from herbal medicine-induced etiology, it is very difficult to identify the specific medicine causing the hypersensitivity because most patients consume a mixture of herbal medicines. 11,[17][18][19][20][21] A diagnosis of herbal medicine-induced SJS in HIVpatients is reported here in addition to a literature-based description of SJS related to the characteristics and criteria used in both its diagnosis and oral treatment.…”