The aim of this study was to evaluate seven GCC regulatory authorities and pharmaceutical companies active in the region in order to identify the strengths and weakness of the current GCC centralised procedure. The GCC regulatory authorities and the pharmaceutical companies who had registered their products through the GCC centralized registration procedure and the national registration systems were recruited into the study and asked to complete the questionnaires specifically designed for this study. The regulatory review process in Oman was evaluated to identify areas for improvement in the system. Information on the total application numbers and approval dates were obtained directly from the Oman Ministry of Health archives. Another study was conducted to evaluate the regulatory review process and approval times of the remaining six GCC countries (Bahrain, Kuwait, Qatar, Saudi Arabia, UAE and Yemen) and the GCC central registration, with respect to review time for new and existing substances, to identify the strengths and weaknesses of the process and to propose strategies that could help the policy maker in the GCC to enhance the review process.

The aim of this study was to evaluate seven GCC regulatory authorities and pharmaceutical companies active in the region in order to identify the strengths and weakness of the current GCC centralised procedure. The GCC regulatory authorities and the pharmaceutical companies who had registered their ...