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Author Archives: Maria I. Guaia
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
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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Mexico: new guidelines for the acceptance of GMP certificates
In October 2013, the Mexican health authority released a new document setting the criteria that will be used to accept GMP certificates as valid. This criteria applies to certificates of manufacturing facilities both of finished products and API. Summary of … Continue reading
Posted in Mexico
Tagged COFEPRIS, GMP, GMP certificate, Good Manufacturing Practices, health authority, inspecitions, Latin America, Mexico, regulatory affairs
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New domain!
Starting right now, we have a brand-new nice domain for our regulatory affairs information site and blog: LatAmPharmaRA.com So exciting! Come by anytime!
Posted in Uncategorized
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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
Labeling update Argentina: gluten-free/gluten-containing compulsory claim
Last month, after active lobbying by the Argentinian Association of Assistance to Celiacs, (ACELA) ANMAT decided to incorporate in the labeling texts of all drug products, information about their content of gluten. Celiac disease is a condition that damages the … Continue reading
Posted in Uncategorized
Tagged ANMAT, Argentina, celiac disease, labeling, Latin America, regulatory affairs
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Regulatory Affairs in Latin America 