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Tag Archives: regulatory affairs
COFEPRIS+MercadoLibre: agreement to regulate advertisement
On the 22nd of March, 2014, the COFEPRIS, representing the Mexican Secretariat of Health, has signed a collaboration agreement with the e-commerce company “Mercado Libre” of México. The agreement, signed by the COFEPRIS Federal Commissioner Mikel Arriola, and the general director of … Continue reading
Posted in Mexico
Tagged advertisement, agreement, COFEPRIS, collaboration, drug products, e-commerce, health authority, health supplies, MercadoLibre, Mexico, regulatory affairs
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Mexico and S. Korea: pharma cooperation agreement
On Tuesday 11th March 2014, the COFEPRIS, Mexico’s regulatory authority, and the South Korean Ministry of Health and Wellbeing, through their representatives, signed a collaboration agreement on matters of regulatory affairs for drug products, cosmetic products and medical devices. The … Continue reading
Posted in Mexico, South Korea
Tagged COFEPRIS, Cooperation, drug products, health supplies, Mexico, Mikel Arriola, regulatory affairs, South Korea, South-South Cooperation
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Clinical Trial Applications in Mexico: decentralization and acceleration of protocol approval
With the goals of accelerating the development of new molecules that improve the healthcare and quality of life of Mexicans, and of stimulating clinical investigation, pharmaceutical innovation and foreign investment in the country, on the 5th of March 2014, the … Continue reading
Posted in Mexico
Tagged Clinical Investigation, clinical trials, COFEPRIS, CTA, Decentralization, regulatory affairs
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Generic Market in Mexico up to 84%
The volume of generic drug products consumed by the Mexican population grew from 54% to 84% in the last three years, was announced by Mikel Arriola, Commissioner for the COFEPRIS, the Mexican regulatory agency. The announcement was made at the … Continue reading
Posted in Mexico
Tagged COFEPRIS, drug products, generics, health authority, Mexico, Mikel Arriola, regulatory affairs
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Movies for regulatory professionals: Dallas Buyers Club (2013)
This is a movie I found especially interesting and enjoyable as a regulatory affairs professional, both because of the historical perspective, and because of the ethical and philosophical exercise of thought it brings. Dallas Buyers Club is a 2013 American biographical … Continue reading
Posted in Mexico, RA in Popular Culture, USA
Tagged AIDS, clinical trials, ethics, FDA, movie, popular culture, regulatory affairs
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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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List of FDA Advisory Committees
The FDA Advisory Committees for drugs and other healthcare products receive requests for technical and clinical evaluation of new drugs by the U.S. Food and Drug Administration. The committees, consisting of members from academic and clinical settings, the general public, … Continue reading
Posted in USA
Tagged Advisory Committee, drug products, FDA, regulatory affairs, USA
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Mexico at the vanguard with new combination drug
In the past days, COFEPRIS granted approval for the combination drug containing fluticasone furoate and vilanterol, indicated for treatment of chronic obstructive pulmonary disease (COPD) and asthma. Although the product had already been approved in the US by the FDA in … Continue reading
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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Regulatory Affairs in Latin America 