Latin American countries have been reviewing clinical research regulations, profiling a new horizon for clinical trial development in the region. It is expected that changes made by local governments will increase the contribution of Latin America to the global development of new therapeutic treatments. The increased alignment among countries in terms of processes and requirements, the reduction of regulatory approval timelines, the simplification of some importation processes and the increased understanding of specific country requirements, while maintaining patients’ safety, are already leading to a greater number of clinical trials in the region. This article provides a review of the regulatory changes in Argentina, Brazil, Chile, Colombia, Mexico and Peru, as well as the impact noted since the legislative changes, based on bibliographic information and recent practical experience. It is expected to take time to alter the preconceptions of lengthy timelines and inconsistent requirements that have contributed to the decline of clinical research across Latin America. It is therefore important to continue to review trends and opportunities during clinical trial feasibility and country selection discussions for multinational trials. Assuming that the improved predictability and shorter regulatory review timelines continue, it is anticipated there will be a steady increase in clinical research across the region over the next two years.