Latin America – Regulatory Agencies

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.

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.

Geographically, this region consists of countries from the northern Mexican border to the southernmost point of South America, including Caribbean countries.

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.

Unlike the European Union, there is not an authority to centralize and harmonize sanitary regulation across the entire region.

The following drug products regulatory health authorities may be cited as being the main ones in the region.

Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica / National Administration of Drug Products, Food and Medical Technology (ANMAT)

Brazil: Agência Nacional de Vigilância Sanitária / National Health Surveillance Agency (ANVISA)

Chile: Agencia Nacional de Medicamentos – Instituto de Salud Pública / National Medicines Agency – Public Health Institute (ANAMED – ISP)

Cuba: Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos / Center for State Control of Medicines, Equipment and Medical Devices (CECMED)

Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos / National Institute for Food and Medicine Surveillance (INVIMA)

Mexico: Comisión Federal para la Protección contra Riesgos Sanitarios / Federal Commission for Protection against Health Risks  (COFEPRIS)

Peru: Dirección General de Medicamentos, Insumos y Drogas / General Directorate of Medicines, Supplies and Drugs (DIGEMID)

Bolivia: Unidad de Medicamentos y Tecnología en Salud / Medicines and Health Technology Unit (UNIMED)

Venezuela: Instituto Nacional de Higiene Rafael Rangel / National Institute of Hygiene Rafael Rangel (INH-RR)

Paraguay: Dirección Nacional de Vigilancia Sanitaria / National Directorate of Health Surveillance

Uruguay: Ministerio de Salud Pública / Ministry of Public Health

Costa Rica: Ministerio de Salud / Ministry of Health

El Salvador: Dirección Nacional de Medicamentos / National Directorate of Medicines (DNM)

Guatemala: Departamento de Regulación y Control de Productos Farmacéuticos y Afines / Department of Regulation and Control of Pharmaceutical and Related Products

Honduras: Agencia de Regulación Sanitaria / Sanitary Regulation Agency (ARSA)

Nicaragua: Dirección General de Regulación Sanitaria / General Directorate of Sanitary Regulation

Panama: Dirección Nacional de Farmacia y Drogas / National Pharmacy and Drug Directorate

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.

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.

Currently, in Latin America, the National Regulatory Authorities considered competent and efficient to carry out the health regulatory functions recommended by PAHO / WHO to ensure the efficacy, safety, and quality of drug products, that is, Level 4, are: ANMAT, ANVISA, Public Health Institute of Chile, INVIMA, CECMED and COFEPRIS.

Further information about the sanitary authorities in the Americas and their classification in the development level may be found in PAHO website through the link: https://bit.ly/2L0WlQe.

Note: In addition to these, the authorities of the United States of America (FDA) and Canada (Health Canada), are also classified as Level 4, within the Americas.