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Category Archives: Argentina
INVIMA+ANMAT: inter-agency collaboration activities
During the last Summit of Regulatory Authorities of Regional Reference that took place in Acapulco, Mexico, on the 10th to 21st of February, the representatives of Colombia’s INVIMA and Argentina’s ANMAT, Dr. Blanca Elvira Cajigas de Acosta and Dr. Carlos A. Chiale, … Continue reading
Posted in Argentina, Colombia, Guatemala
Tagged ANMAT, Argentina, Colombia, Cooperation, Good Traceability Practices, Guatemala, INVIMA, Latin America, regulatory affairs
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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
Posted in Argentina, Brazil, Canada, Colombia, Cuba, Mexico, Uncategorized, USA
Tagged ANMAT, anvisa, Argentina, brazil, Canada, CECMED, COFEPRIS, Colombia, Cooperation, Cuba, drug products, FDA, health authority, Health Canada, Latin America, Mexican Health Agency, Mexico, Mikel Arriola, National Regulatory Agency of Regional Reference, PAHO, Pan American Health Authorization, regulatory affairs
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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
Posted in Argentina, Uncategorized
Tagged Active Pharmaceutical Ingredients, ANMAT, API, Argentina, drug products, electronic submission, GMP, Good Manufacturing Practices, inspections, Latin America, National Regulatory Agency of Regional Reference, new Disposition, regulatory affairs, Site Master File, SMF
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Argentina: checklist for GMP inspections of API facilities
On the 3rd of September 2013, ANMAT (regulatory agency in Argentina) issued a new Disposition establishing the guidelines and checklists that will be used by its inspectors for GMP inspections of sites of manufacturing, elaboration, fractionating, distribution, commercialization, exports and imports … Continue reading
Posted in Argentina, Uncategorized
Tagged Active Pharmaceutical Ingredients, ANMAT, API, Argentina, GMP, ICH guidelines, new Disposition
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ANMAT launches online platform to report drug adverse reactions
On July 10th, 2013, ANMAT implemented a system for electronic submission of reports on adverse reactions to drug products. The system consists on an online form accessible from the website of the National System of Pharmacovigilance. You can access the online … Continue reading
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