College of Pharmacy, Department of Clinical Pharmacy, University of Hail, P.O. Box 6166, Hail, 81442, Saudi Arabia.
Medication Safety Research Chair, King Saud University, Riyadh, Saudi Arabia.
Drug Saf. 2019 Jul;42(7):849-868. doi: 10.1007/s40264-019-00807-4.
Pharmacovigilance has received much attention in Arab countries recently due to the development of new regulations. However, there are differences in the progression of pharmacovigilance systems by regulatory agencies in these countries because only some are able to meet the requirements for conducting pharmacovigilance activities. Only 45% of Arab countries are official members of the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. Countries such as Morocco, Tunisia, Saudi Arabia, Egypt, and Jordan are considered to be advanced pharmacovigilance countries, whereas other countries such as Libya, Yemen, and Palestine remain in the very early stages of implementing and developing pharmacovigilance systems. Countries such as Somalia, Djibouti, Mauritania, and Comoros Island have no pharmacovigilance system or culture. Asian Arab countries have some advantages over those in Africa because 50% of them are a part of the Gulf Cooperation Council (GCC), meaning that most of them can utilize similar approaches for the application of the majority of activities related to the healthcare system, including pharmacovigilance. Thus, participating in the GCC enables increased connections among these countries. However, one of the strengths in Africa is that Morocco is partnering with the WHO through the WHO Collaborating Center to enhance and strengthen pharmacovigilance across the Eastern Mediterranean Region and the Francophone and Arab countries. This partnership could have a role in enhancing the pharmacovigilance culture among African Arab countries. This review provides a general overview of the current situation regarding regulatory agencies related to pharmacovigilance in Arab countries.
药物警戒在阿拉伯国家最近受到了广泛关注，这是由于新法规的发展。然而，由于只有一些国家能够满足开展药物警戒活动的要求，这些国家的监管机构在药物警戒系统的进展方面存在差异。只有 45%的阿拉伯国家是世界卫生组织（WHO）药物监测合作中心的正式成员。摩洛哥、突尼斯、沙特阿拉伯、埃及和约旦等国被认为是先进的药物警戒国家，而利比亚、也门和巴勒斯坦等其他国家仍处于实施和发展药物警戒系统的早期阶段。索马里、吉布提、毛里塔尼亚和科摩罗群岛等国没有药物警戒系统或文化。亚洲阿拉伯国家比非洲国家具有一些优势，因为其中 50%是海湾合作委员会（GCC）的成员，这意味着它们中的大多数国家可以采用类似的方法来应用与医疗保健系统相关的大多数活动，包括药物警戒。因此，参与 GCC 可以加强这些国家之间的联系。然而，非洲的一个优势是摩洛哥通过世界卫生组织合作中心与世界卫生组织合作，加强和加强东地中海区域以及法语和阿拉伯国家的药物警戒。这种伙伴关系可能在增强非洲阿拉伯国家的药物警戒文化方面发挥作用。本文综述了阿拉伯国家与药物警戒相关的监管机构的现状。
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