Despite competition from both local and international players, the Latin American pharmaceutical market has experienced a steady growth in recent years. The regulatory landscape in Latin America presents a blend of challenges and opportunities for pharmaceutical investment and expansion. Despite variations in regulatory systems across the region, concerted efforts have been made to fortify regulatory frameworks, establish quality review mechanisms, and adopt risk-based approaches. Initiatives like the EU-Mercosur agreement and the development of a Latin American Technical Core Dossier are geared towards simplifying regulatory procedures and fostering harmonisation, which in turn, benefits both pharmaceutical companies, national health authorities and patients.