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.

Background The Kuwaiti drug regulatory authority (DRA) lack a structured classification system for the assessment of imported herbal medicines (HMs), which leads to ambiguity in the registration process. This study aimed to examine the policy development and implementation process in an established HM registration system (Bahrain) and harness lessons to inform recommendations for a suitable HM classification system and explore implementation readiness in Kuwait. Methods A sequential study design was chosen, with data collected in Bahrain (case 1), recommendations formed and readiness for implementation explored subsequently in Kuwait (case 2). With ethics and DRA approval in place, data sources were documentary review of regulatory policies, direct observations of HMs registration processes, and semi-structured interviews with twenty three key officials involved in the HMs registration processes. Data from all three sources were analysed thematically and findings triangulated. Results The classification policy in Bahrain was found to be based on evidence and extensive stakeholder engagement, resulting in a clear and organised HM registration process. The availability of HMs classification policies in other DRAs, officials’ dedication and teamwork, and support by higher authority, were identified as the main facilitators in policy development and successful implementation. Barriers were the diversity of HM classifications worldwide, a lack of staff and resultant workload, and lack of training. Proposed recommendations for Kuwait were to adopt a clear definition of what constituted HMs, and to introduce a Traditional Herbal Registration based on this definition and the product’s characteristics. Interviews in Kuwait showed that almost all participants were in favour of the proposed recommendations and were in support of timely implementation. Interviewees anticipated that consistency in the HM registration process would be the main benefit, increasing reviewer’s confidence in making regulatory decisions. Interviewees also identified potential challenges which may impede successful implementation, including staff shortages, resistance to change by internal and external stakeholders, and the impact of cultural and traditional ways of working. Conclusions Insights into the HM policy development and implementation process in Bahrain, and exploration of Kuwait’s readiness to implement resultant recommendations informed an effective implementation process for a well-designed HMs policy for Kuwait and other Arab countries.

Conflict of Interest: This is an independent research undertaken as part of a Ph.D., and the authors were not asked nor commissioned to inform a herbal medicine registration system for the Kuwaiti drug regulatory authority (DRA). However, it is projected that the recommendations listed in this manuscript will be proposed to the Kuwaiti DRA for consideration.