Expedited Approval of Orphan Drugs in Latin America Not Yet a Reality

Latin America lacks harmonization in practically all areas of drug regulation, from clinical trials to new drug registrations and postregistration requirements. As an example, harmonized drug labeling in the region is extremely difficult to implement because of the diversity of national requirements. This is somewhat unexpected in a region that, despite its vastness and differences, has only two major and relatively similar languages (Portuguese and Spanish), many cultural commonalities, powerful regional associations (such as Mercosur) and an Intergovernmental Commission on Drug Policy (CIPM) that meets regularly. However, in the absence of one regional Latin American medicines agency able to align national agencies (e.g., as the European Medicines Agency does in Europe), each country´s agency continues to develop its regulations quite independently from those of neighboring countries.