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Evaluation of the regulatory review processes, quality of decision-making and strategic planning in the Gulf Cooperation Council (GCC) states

Al-Essa, Reem 2011. Evaluation of the regulatory review processes, quality of decision-making and strategic planning in the Gulf Cooperation Council (GCC) states. PhD Thesis, Cardiff University.

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Regulatory authorities in both developed and developing countries share the responsibility of ensuring the access of safe and effective medicines to patients however their structures, strategies, and practices vary significantly. The aim of this study was to evaluate the Gulf Cooperation Council (GCC) regulatory systems (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates (UAE) and Yemen) in order to develop a harmonised strategy. A questionnaire was designed and completed by the seven GCC authorities to provide details of their review process and the quality measures used to improve their assessment procedures. The Kuwait Drug and Food Control (KDFC) authority was assessed to identify areas for improvement in the system. Metrics for medicines approved for the private and government sectors were collected together with their patients' access time using data obtained from the authority's archives. Another questionnaire was developed to assess and compare the strategic planning processes of the regulatory authorities in the seven Gulf States. Both questionnaires were tested for applicability and practicality in the GCC region and a pilot study was conducted with two selected authorities, after which they were distributed for completion by senior managers in each of the seven GCC authorities. The results of the Kuwaiti regulatory system showed a significant decline (p < 0.001) in the number of medicines approved for the private sector from 180 to 129 products (2006 to 2009). In contrast, there was an increase in the number of medicines approved for the government sector from 22 to 48 products over the same period, but did not reach statistical significance (p > 0.05). Further analysis showed a significant decline (p < 0.001) in the patients' access time for New Active Substances (NASs) (26 to 11 months) and Existing Active Substances (EASs) (28 to 14 months) due to the enhanced political conditions and the improved performance of the authority. Furthermore, there was a significant decline in the registration time for government health supply (GHS) medicines from 10 to 7 months (p < 0.05) and for private sector medicines from 28 to 14 months (p < 0.001) over the same period. The comparative study of the seven Gulf States showed that Kuwait and Yemen carry out a verification assessment for all applications. Bahrain and Oman conduct an abridged review while Saudi Arabia and UAE perform a full review for the majority of their applications. Furthermore, the speed of the approval process in the GCC States depends on the types of products being registered (NASs or EASs), the quality of the submitted data, the level of interaction between the sponsor and the authority and whether parts of the review process are carried out in parallel or sequentially. Several GCC authorities lack the essential measures for conducting a quality review process such as Good Review Practice, assessment templates, Standard Operating Procedures and peer reviews. Finally, comparisons of the GCC strategic planning processes showed that the seven Gulf States shared common strategic parameters that can form a harmonised strategy, namely, the guidelines, SOPs, resources and Post-Marketing Surveillance (PMS). It is hoped that the findings of this study will help the GCC authorities to improve approval time for the registration of new medicines by fully engaging in the quality review practices. Such improvements will fulfil the GCC central drug registration goals and encourage the pharmaceutical industry to use the GCC centralised system which is a step towards successful harmonisation of the regional regulatory systems.

Item Type: Thesis (PhD)
Status: Unpublished
Schools: Pharmacy
Subjects: R Medicine > RS Pharmacy and materia medica
ISBN: 9781303196072
Date of First Compliant Deposit: 30 March 2016
Last Modified: 09 Aug 2023 11:16

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