Innovative pharmaceuticals and medical devices are transforming patients’ lives and spurring economic growth across the region, requiring a responsive regulatory environment for timely market access. This Forum will demonstrate the distinct regulatory frameworks and international references for pharmaceuticals and medical devices, including best practices, use of AI to streamline processes, digitalization for transparency and efficiency, and recommendations on regulatory convergence and reliance models. The Forum will explore direct case studies, opening discussions for international challenges and proposed approaches to address them.