To address the complex challenges in the global regulatory environment and the growing demand for patient access to new medicines, regulatory agencies in Latin America are actively engaging in regulatorystrengthening and capacity-building initiatives, including the use of priority pathways, reliance on the prior reviews of trusted authorities and work sharing to facilitate better utilisation of resources. This R&D Briefing focuses on the trends observed in 4 countries in Latin America region for 136 new active substances (NASs) approved from 2009 to 2017 (with subset analyses of various years). The briefing explores the changes over the decade and their reasons and suggest best practices for these agencies to maximise the value-added activities they can contribute to the medicines’ review process.
