Latin America is increasingly raising interest from pharmaceutical companies in other regions. It is noticed that there is very little knowledge about the region, not only regarding sanitary affairs. Because we detected this gap, we decided to write a little about it.<\/p>\n
Latin America includes the countries and territories in which the romanic languages are predominantly spoken: Portuguese, Spanish and French. This region is often regarded as a set of countries with similar characteristics and are grouped by the industry for strategy and business definitions.<\/p>\n
Geographically, this region consists of countries from the northern Mexican border to the southernmost point of South America, including Caribbean countries.<\/p>\n
Although they are always considered together from a business point of view, from a sanitary point of view, the region is very diverse. Each country has its own sanitary regulations and authorities, and there is no regulatory harmonization among them all. Some initiatives can be pointed out in subregions that are moving towards some harmonization, such as within the Mercosur, Andean Community and Comieco (continental Central America) economic blocs.<\/p>\n
Unlike the European Union, there is not an authority to centralize and harmonize sanitary regulation across the entire region.<\/p>\n
The following drug products regulatory health authorities may be cited as being the main ones in the region.<\/p>\n
Argentina: <\/strong>Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica<\/em> \/ National Administration of Drug Products, Food and Medical Technology (ANMAT)<\/p>\n Brazil: <\/strong>Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria<\/em> \/ National Health Surveillance Agency (ANVISA)<\/p>\n Chile: <\/strong>Agencia Nacional de Medicamentos – Instituto de Salud P\u00fablica<\/em> \/ National Medicines Agency – Public Health Institute (ANAMED – ISP)<\/p>\n Cuba:<\/strong> Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos M\u00e9dicos<\/em> \/ Center for State Control of Medicines, Equipment and Medical Devices (CECMED)<\/p>\n Colombia: <\/strong>Instituto Nacional de Vigilancia de Medicamentos y Alimentos<\/em> \/ National Institute for Food and Medicine Surveillance (INVIMA)<\/p>\n Mexico: <\/strong>Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios<\/em> \/ Federal Commission for Protection against Health Risks\u00a0 (COFEPRIS)<\/p>\n Peru: <\/strong>Direcci\u00f3n General de Medicamentos, Insumos y Drogas<\/em> \/ General Directorate of Medicines, Supplies and Drugs (DIGEMID)<\/p>\n Bolivia: <\/strong>Unidad de Medicamentos y Tecnolog\u00eda en Salud<\/em> \/ Medicines and Health Technology Unit (UNIMED)<\/p>\n Venezuela: <\/strong>Instituto Nacional de Higiene Rafael Rangel<\/em> \/ National Institute of Hygiene Rafael Rangel (INH-RR)<\/p>\n Paraguay:<\/strong> Direcci\u00f3n Nacional de Vigilancia Sanitaria<\/em> \/ National Directorate of Health Surveillance<\/p>\n Uruguay: <\/strong>Ministerio de Salud P\u00fablica<\/em> \/ Ministry of Public Health<\/p>\n Costa Rica:<\/strong> Ministerio de Salud<\/em> \/ Ministry of Health<\/p>\n El Salvador: <\/strong>Direcci\u00f3n Nacional de Medicamentos<\/em> \/ National Directorate of Medicines (DNM)<\/p>\n Guatemala: <\/strong>Departamento de Regulaci\u00f3n y Control de Productos Farmac\u00e9uticos y Afines<\/em> \/ Department of Regulation and Control of Pharmaceutical and Related Products<\/p>\n Honduras:<\/strong> Agencia de Regulaci\u00f3n Sanitaria<\/em> \/ Sanitary Regulation Agency (ARSA)<\/p>\n Nicaragua:<\/strong> Direcci\u00f3n General de Regulaci\u00f3n Sanitaria<\/em> \/ General Directorate of Sanitary Regulation<\/p>\n Panama:<\/strong> Direcci\u00f3n Nacional de Farmacia y Drogas<\/em> \/ National Pharmacy and Drug Directorate<\/p>\n \n The Pan American Health Organization (PAHO) has a system for evaluating National Regulatory Authorities for Drug Products, which is based on the recommendations of the World Health Organization (WHO) for strengthening regulatory bodies.<\/p>\n Four levels of regulatory development (from 1 to 4) are defined, and authorities considered as Regional Reference Authorities by PAHO are those classified as Level 4.<\/p>\n