An evaluation of the review process for marketing pharmaceutical products in the Gulf states and its impact on patients' access to medicines

• Main Author: Hashan, Hajed M. H.
• Published: Cardiff University 2005
• Subjects: 340
• Online Access: http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.526748

Today's pharmaceutical regulatory environment, where regulatory authorities assess medicines for safety, quality and efficacy before licensing them for sale in the marketplace, has been shaped by events over the last century. The responsibility of all regulatory authorities to safeguard the patient population is common, however the structures, strategies, practices and processes vary considerably worldwide. Using questionnaires to collect data on the regulatory processes in the Gulf Cooperation Council (GCC) States, this study aimed to describe and evaluate the regulatory environment, its impact on patients' access to medicines and the degree of harmonisation between authorities. In addition, it was hoped to make recommendations towards greater harmonisation in the interests of efficiency and quality. Regulatory practices including the review process, approval time and quality of review were compared in the six Gulf countries (Saudi, Kuwait, Bahrain, Oman, UEA and Qatar). The approval time in the KSA showed a significant (p<0.001) downward trend from two to one year during the period of the study (1998- 2003) and it was found that there were a significant difference in the time required for each milestone (p<0.001), with the analytical step being the longest (60% of total approval time). There was a significant difference (p<0.001), in approval times between the six Gulf authorities KSA, Kuwait, Bahrain, Oman, UAE and Qatar. These differences may be due to an internal non-published policy within some authorities in the region. However, there are many other factors that could potentially affect the approval time, including whether parts of the regulatory review procedure are conducted in parallel or sequentially, the geographical location of a company, and the communication within a company. Since increased efficiency must not be at the expense of quality, the quality control measures incorporated into each review process were also assessed and compared. Although all authorities studied believed systematic QA, staff training and transparency are important elements of quality review, none had any such processes in place. Recommendations were made for the thorough review and monitoring of the steps and milestones involved in the approval process. Furthermore, assessment of dossiers should be carried out by highly qualified and trained personnel. Finally, recommendations for improvement and harmonisation were made based on the experience of the International Conference on Harmonisation (ICH). The Gulf Registration System (GCR), set up to increase harmonisation, has produced striking results in terms of reducing approval time for registration of new drugs by local manufacturers. Although international pharmaceutical companies have not yet used the GCR system actively and continue to submit for registration at the national level, the clear evidence of the efficiency of the GCR system should encourage these companies to use the centralised system. Also, It is hoped that the GCR model encourages further regional harmonisation, such as the Arab Central Registration system.