Latin America Annual Meeting

The rapid development of innovative medicines requires regulatory frameworks and processes that enable timely access for patients worldwide. For regulators in Latin America, conducting reviews efficiently is a key priority to address unmet medical needs without compromising safety. At the same time, regulatory agencies in the region face recurring challenges in securing the resources needed to rapidly review clinical studies and marketing authorization applications for pharmaceutical and medical products. This session will explore regulatory strategies to accelerate clinical and registration approval timelines in the region, including expedited development and review pathways, as well as approaches to reduce the backlog of submissions. Presentations will examine the landscape of expedited development and review pathways, especially for products addressing high unmet medical needs and rare diseases. By sharing country-specific examples, this session will identify how various regulatory groups in LatAm are working to accelerate approvals and opportunities that can be explored in the region.