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Regulatory review process in the Gulf Cooperation Council states: similarities and differences

Al-Essa, Reem, Salek, Mir-saeed and Walker, Stuart 2012. Regulatory review process in the Gulf Cooperation Council states: similarities and differences. Drug Information Journal 46 (1) , pp. 65-72. 10.1177/0092861511427674

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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.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Pharmacy
Subjects: R Medicine > RA Public aspects of medicine
R Medicine > RM Therapeutics. Pharmacology
Uncontrolled Keywords: general review process; GRP; regulatory decision making; key milestones
Publisher: SAGE Publications
ISSN: 2168-4790
Last Modified: 10 Oct 2017 15:31

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