COFEPRIS stands for Comisión Federal para la Protección contra Riesgos Sanitarios: Federal Commission for Protection against Sanitary Risks and is the authority with competence to control and regulate drug products in Mexico.
In addition to drug products, the COFEPRIS is in charge of food and beverages, tobacco products, other healthcare supplies (medical devices, vaccines, blood and tissues, etc.), healthcare services, cosmetics and other consumer goods, pesticides, plant nutrients and toxic substances, national health emergencies, occupational health and environmental risks. Put all together, all these products and sectors represent around 10% of the Mexican GDP, and a 92 billion dollar market.
COFEPRIS has responsibility over all activities related to these products and services: production, distribution, commercialization, imports and exports, advertisement, sales and supply, etc.
In July 2012, the World Health Organization, through the Pan American Health Organization, designated COFEPRIS as National Regulatory Authority of Regional Reference of medicines and biological products. (see official PAHO press release) The recognition follows an evaluation of the commission’s performance of basic functions, recommended by WHO, for ensuring the quality, safety and efficacy of medicines in the country.
COFEPRIS then joined other four national regulatory authorities already recognized by PAHO/WHO as National Regulatory Authorities of Regional Reference: Brazil’s National Health Surveillance Agency (ANVISA), Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT), the National Institute of Food and Drug Monitory of Colombia (INVIMA), and the Center for State Control of Drug Quality Cuba (CECMED).
Last update: October 2013