{"title":"Regulatory Review Process in the Gulf Cooperation Council States: Similarities and Differences","authors":"R. Al-Essa, S. Salek, S. Walker","doi":"10.1177/0092861511427674","DOIUrl":null,"url":null,"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.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"329 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"6","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug information journal : DIJ / Drug Information Association","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/0092861511427674","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 6
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.