Main Article Content
Abstract
The Latin American (LATAM) pharmaceutical market is growing rapidly, driven by increasing demand for innovative medicines, biologics, and generics. However, the diversity of regulatory frameworks among LATAM countries presents significant challenges for pharmaceutical companies. This review summarizes the regulatory landscape of major LATAM nations, focusing on their respective health authorities, approval processes, and documentation requirements. A comparative table is provided to assist stakeholders in navigating the complexities of the region’s regulatory systems.
Keywords
LATAM, Regulatory Affairs, ANVISA, COFEPRIS, INVIMA, Pharmaceuticals, Drug Approval