Trends in Saudi FDA drug approvals and GMP inspections: an observational study

The Saudi Food and Drug Authority's (SFDA) pharmaceutical products approval and regulation procedures have changed and become more sophisticated over the course of the past ten years. Although medical advances give patients more therapeutic options, issues can arise if the promotion of pharmaceuticals prompts medications that were approved on the basis of limited evidence to be used in patients for whom there is little evidence of benefit or to replace tried-and-true therapies with better-known risks and comparable or superior effectiveness. These flaws in the market can lead to costs that might not be justified by enhanced therapeutic effectiveness because new medicines are sometimes more expensive than the existing forms. As the top regulatory body in the Middle East and North Africa (MENA) region, the SFDA's long-term objective is to establish itself as a global hub of regulatory excellence and hasten patient access to medications. In this paper, we discuss the most prevalent product review gaps (Common Technical Documents (CTD) deficiencies), good manufacturing practices (GMP) inspection deficiencies noted, explore the evolution of laws and standards that impact drug regulation, examine the use of new approval programmes and standards, delineate the changes in the number of drugs approved from 2011 to 2020, and expand the role and authority of the Saudi FDA.