Abstract This narrative review examines how regulatory authorities across Arab countries are adopting novel regulatory tools to streamline review and approval pathways, including expedited review mechanisms, reliance on assessments conducted by stringent regulatory authorities, conditional approvals, priority designations, emergency use authorizations, and digital submission systems such as the electronic Common Technical Document. A structured search of publicly available regulatory guidance, peer-reviewed literature, government publications, and regional policy documents from 2017 to December 2025 was conducted to compare the evolution and implementation of these frameworks across the region. The findings indicate that Saudi Arabia has integrated a comprehensive suite of regulatory tools—such as verification and abridged review pathways, priority review, conditional approval routes, and breakthrough designations—into a cohesive system that formally aims to shorten assessment timelines. Comparable reliance-based and accelerated pathways have been introduced in Egypt, Jordan, Kuwait, the United Arab Emirates, Bahrain, Qatar, and Oman, with the Gulf Cooperation Council–centralized procedure providing an additional mechanism for regional work-sharing. Despite these developments, regulatory heterogeneity, limited capacity, restrictive pricing and reimbursement structures, insufficient real-world evidence (RWE) guidance, and evolving intellectual property considerations continue to present operational challenges. Potential solutions include harmonizing regulatory standards, strengthening institutional capacity, developing clear RWE frameworks, expanding digitalization efforts, integrating artificial intelligence (AI) tools where appropriate, and aligning pricing policies with accelerated approval objectives. Early AI initiatives in several Gulf countries—such as national AI authorities and automated dossier-screening technologies—suggest further opportunities to enhance regulatory efficiency. Continued cooperation among regulatory agencies, supported by the principles of the World Health Organization Good Regulatory Practices and Good Reliance Practices, will be essential to sustaining progress and improving timely, equitable access to medicines across the region.
Mohammad Nammas (Fri,) studied this question.