Tag Archives: National Regulatory Agency of Regional Reference

Americas Health Authorities Meeting

On the 20th and 21st of February of 2014, representatives of the five Latin-American Health Authorities of Regional Reference recognized by the Pan American Health Organization, plus those of the FDA, Health Canada, and El Salvador’s regulatory agency met in … Continue reading

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Argentina: Site Master File now required by ANMAT for national sites

Starting on November 19th, 2o13, sites in Argentina approved by ANMAT to manufacture or package, in own or contract facility, or import or export, both drug products and APIs, have to submit their Site Master Files (SMF) annually. This is … Continue reading

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Mexico and Costa Rica sign cooperation agreement on drugs and vaccines

On the 17th of October 2013, COFEPRIS issued a press release informing on a new agreement of cooperation between the health authorities of Mexico and Costa Rica that will allow the recognition of drug registrations approved by COFEPRIS, by Costa … Continue reading

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