Navigating barriers to real-world evidence utilization for drug regulatory affairs and market access in Saudi Arabia

This study reveals critical barriers to RWE generation and utilization in Saudi Arabia. Having clear governance, policies, and guidelines for the collection, standardization, sharing, and utilization of real-world data is crucial for overcoming these barriers and challenges. A multifaceted policy approach characterized by stakeholder engagement, collaboration, and coordinated implementation efforts could help build a robust, unified RWE system that aligns with the Saudi Vision 2030 objectives for a sustainable, data-driven healthcare ecosystem.