Regulatory Review Process in the Gulf Cooperation Council States: Similarities and Differences
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Regulatory Review Process in the Gulf Cooperation Council States: Similarities and Differences
Drug Information Journal 46(1) 65-72 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861511427674 http://dij.sagepub.com
Reem Al-Essa, MBA, PhD1, Sam Salek, PhD, RPh, FFPM, MRPSGB2, and Stuart Walker, PhD, MFPM, FIBiol, FRSC, FRCPath3
Abstract This study compared the assessment models and the regulatory review processes conducted in the Gulf Cooperation Council (GCC) region. A questionnaire was completed by the 7 GCC regulatory authorities (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates [UAE], and Yemen) providing details of the regulatory review processes and timelines in the region. The results showed that Kuwait, Qatar, and Yemen use the verification model; Bahrain and Oman use an abridged review; and Saudi Arabia and UAE conduct a full review. There were 3 common phases in the GCC regulatory review process: submission, evaluation, and authorization. Key milestones within each phase were also common—receipt and validation, queuing, scientific assessment, sample analysis, sponsors’ interaction, pricing, and decision making—but target approval times and the order of some activities were different among the member states as some processes are performed in parallel rather than sequentially. The resulting similarities and differences provided an opportunity to propose a standardized regulatory review process for the GCC region. Keywords general review process, GRP, regulatory decision making, key milestones
Introduction Modern-day licensing began in the 1940s with the formation of the World Health Organization (WHO) recommending global standards to be established in relation to the safety and efficacy of medicinal products, as well as their labeling and advertising.1 However, there is little conformity between countries worldwide as to how the review is conducted, including what stages comprise the process, who carries out each stage, what criteria are employed, how long it takes, or, indeed, whether there is a formal review process at all. About 30% of WHO member states have only a very rudimentary drug regulatory authority or none at all, whereas only 20% are thought to have a well-developed drug registration system.2 Since the establishment of the Gulf Cooperation Council (GCC) in 1981, the Gulf states have experienced major challenges in view of the rapid change in the regulatory environment around the world. However, because of their strategic importance and rich oil resources, they present significant potential for the growth of the pharmaceutical market, which
encouraged the GCC authorities to establish their regulatory systems to cope with the pace of development in their individual markets. The 7 GCC states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates [UAE], and Yemen) have encountered the need for regulatory reforms during the past 10 years to improve patients’ access to high-quality medicines throughout the region. Ther
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