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Title: Registration requirements for herbal medicines in Kuwait and internationally
Author: Alostad, Azhar
ISNI:       0000 0004 8504 3279
Awarding Body: University of Manchester
Current Institution: University of Manchester
Date of Award: 2019
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Background Industrially manufactured herbal medicines (HMs) are historically popular and their consumption continues to increase. As HMs use increases, identification of adverse effects occur more frequently. In some countries' national drug regulatory authorities (DRAs), clear premarketing legislative controls were developed and implemented to ensure the safe use of HMs. In other countries, Kuwait specifically, the premarketing quality, safety and efficacy evaluation of imported HMs is performed with some ambiguity since the DRA does not have a structured classification system in place. This thesis aimed to make recommendations of policy design and implementation of a suitable definition and classification for imported HMs into Kuwait, and explore implementation readiness there. Methods The policymaking cycle by Anderson was used to frame this programme of research which was conducted in four stages. Stage one and two consisted of documentary analysis and comparisons of HM registration systems in five countries: United Kingdom (UK), Germany, United States (US), United Arab Emirates (UAE) and Bahrain, and a review of published empirical evidence on factors that may facilitate or impede medicine policy implementation. With University ethics and relevant DRAs' approval, stage three and four consisted of thematic analysis of observations and document review of the registration process, and semi-structured interviews with stakeholders in Bahrain as a country which has recently introduced HM regulations. Evaluation of the Bahraini HM registration system, together with findings from stage one allowed policy recommendations for Kuwait, which were followed with further observations, document review and interviews on the Kuwaiti DRA's readiness for implementation, using the Theory of Organisational Readiness for Change. Results Findings from stage one demonstrated that while there is a diversity in how the five countries define and register HMs, UK, Germany, UAE and Bahrain offer adequate classification and sufficient evaluation procedure based on long standing traditional-use plausible efficacy of HMs. The US, however, offer an unevaluated passage of HMs into the market under the classification of dietary supplements. Findings from stage two revealed that literature on implementation experiences concerning HMs policies in DRAs is lacking and the existing policy implementation research on medicines require a more reliable methodological underpinning. Findings from stage three revealed that the implementation of the classification policy in Bahrain encountered several barriers but ultimately resulted in a more consistent and clearer HM registration process. This allowed recommendations based on the traditional-use classification to be proposed for Kuwait. Findings from stage four revealed that almost all interviewed officials welcomed the proposed recommendations, however the culture of how work is conducted in the authority may impede a successful implementation. Conclusions Using experiences and insights from stages 1-4, the final policy recommendations consisted of adoption of a universal harmonised HM definition and implementation of the traditional-use registration. An implementation roadmap involving planning for human and technical resources and promoting a professional organisational culture were proposed. Additional research with regards to the evaluation of the HM classification policy would be beneficial to contribute to the currently composed insights.
Supervisor: Schafheutle, Ellen ; Steinke, Douglas Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available
Keywords: International ; Registration system ; Policy analysis ; Bahrain ; Imported herbal medicines ; Drug regulatory authority ; Policy implementation ; Regulations ; Herbal medicine ; Kuwait