Evaluation of the regulatory review process of the GCC centralised procedure : development of a model for improving the approval 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 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 results of the Omani regulatory system showed no significant increase (p>0.05) in the total number of registered pharmaceutical products from 2006 to 2010. The approval time in Oman showed that there was a significant increase in approval times for pharmaceutical products from 2006 to 2010 (p<0.001). The findings show that although there was an increase in the approval time for all pharmaceutical company products, the median approval time for the five year period was 117 days. This was within the time limit (4 months) fixed by the health authority for the overall registration time. The comparative study of the GCC States showed a downward trend in the median approval time for most of the GCC States, during 2008 to 2010. However, the approval time for all approved products in the GCC States during this period varied from 60 days in Qatar and Oman (2009 and 2010) to 609 days in Saudi Arabia (2008). The main reasons for the decrease in approval time in the Gulf States were due to the positive effect of the Gulf Central Registration, the rise in the number of reviewers in some GCC drug authorities, and the parallel procedure used in the regulatory approval review process. The study of the regulatory review process of the GCC central registration showed that a total of 413 products (96 NASs and 317 EASs) were approved during the period 2006-2010 with an overall significant increase in the EASs (p<0.001). The approval times increased from 107 calendar days in 2006 to 265 in 2010 (p<0.001). The lowest approval time was for EASs submitted by the Gulf companies (134 days) and the longest for NASs submitted by international companies (346 days) (p<0.001). VI Both the regulatory authorities and the pharmaceutical companies agreed that the centralised procedure is an effective system for authorising medicinal products in all seven GCC countries in one procedure and is the way forward in the future but there is room for improvement in the procedure and the follow ups. They also agreed that clear guidelines, transparency of procedures, effective interactions between authorities and companies, increase in the number of the committee meetings per year, use of electronic on-line submissions will improve approval time for registration of new medicines, enhance the quality of review practice and encourage the pharmaceutical companies to use the GCC central registration system. This research has enabled development of a new model of the GCC central registration procedure to be proposed for the GCC Health Authorities which could improve patient access to medicines in the GCC states.