A Comparative Perspective of the Regulatory Review Process in Gulf Cooperation Council (GCC) Countries

Abstract

The Gulf Cooperation Council (GCC) countries have significant growth in the pharmaceutical and medical device industries. This review aims to provide an overview of the current regulatory landscape in GCC countries, highlighting challenges, opportunities, and best practices. This study evaluates the regulatory submission review timeline in GCC countries. Although their structures, approaches, and procedures differ significantly, regulatory bodies in industrialized and developing nations ensure patients have access to safe and effective medications. To provide a unified approach, the study's objective was to assess the regulatory frameworks of the Gulf Cooperation Council (GCC), which includes Saudi Arabia, the United Arab Emirates (UAE), Bahrain, Kuwait, Oman, Qatar, and Yemen. The analysis encompasses the three regulatory review phases: submission, evaluation, and authorization. This review explores each GCC country's regulatory frameworks and processes, highlighting regulatory submission requirements, timelines, and authorization processes. The analysis also includes critical tasks and requirements like good manufacturing practices (GMP) status verification, analysis of samples, validation procedures, patent protection considerations, applicant response time, regulatory fees, and pricing procedures. This review also examines the interactions between sponsors and regulatory authorities. To enable more effective and efficient navigation of these intricate systems, this thorough research attempts to offer a deeper understanding of the regulatory review procedures in the GCC nations.