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PAHO recognizes COFEPRIS as a National Regulatory Authority of Regional Reference

Washington, DC, 2 July 2012 (PAHO/WHO) — Mexico's Federal Commission for Protection against Sanitary Risks (COFEPRlS) was recognized as a National Regulatory Authority of Regional Reference of medicines and Biological products by the Pan American Health Organization/World Health Organization (PAHO/WHO) at a meeting held in Mexico City on 18-22 June as a part of the technical cooperation program to strengthen national regulatory authorities for medicines and biological products.


From left to right: José Parisi (PAHO), Eva Dalidet (ANAMED, Chile), Patricia Andreotti (ANVISA, Brazil), Maria Luz Pombo (PAHO), Biorkys Yañez (CECMED, Cuba), José Peña (PAHO), Ileana Herrera (Costa Rica), Phillipe Lamy (PAHO Mexico), Salomón Chertorivsky (Mexico's Health Secretary), Mikel Arriola Peñalosa (Comisionado Federal para la Protección contra Riesgos Sanitarios).


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.

Following the recognition, COFEPRIS expressed its commitment to support efforts to strengthen other regulatory agencies, based on its own experience, by promoting exchange and cooperation among countries, and by actively participating in regulatory harmonization efforts within the framework of the Pan American Network for Drug Regulatory Harmonization (PANDRH).

COFEPRIS was evaluated by a group of experts from PAHO/WHO and the national regulatory authorities of Brazil, Chile, Costa Rica, Cuba, who verified the commission's performance in product registration, licensing of producers and establishments, inspection of good manufacturing practices, authorization and monitoring of clinical trials, and activities for quality control and batch release. The results of the evaluation led to PAHO/WHO's designated of COFEPRIS as a National Regulatory Authority of Regional Reference.

To date, five national regulatory authorities have been 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), the Center for State Control of Drug Quality Cuba (CECMED) and the Federal Commission for Protection against Sanitary Risks of the United Mexican States (COFEPRlS).

More information regarding the qualifying process for national regulatory authorities.


Contacts:

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