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Tag Archives: drug products
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
2 Comments
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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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
2 Comments
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
2 Comments
Brazil: ANVISA bans Lorcaserin (Belviq)
Today ANVISA, the Brazilian health authority with competence on the control of pharmaceutical products and APIs, banned the manufacturing, import, commercialization, manipulation and use of the API Lorcaserin. Lorcaserin is the drug substance of Belviq, an innovative weight-loss product that … Continue reading
MoU between Mexican and Chinese health authorities
In the framework of the bilateral agreements recently signed by the presidents of Mexico and China, Enrique Peña Nieto and Xi Jinping, respectively, the representatives of both sanitary agencies, subscribed the first Memorandum of Understanding to strengthen cooperation in matters … Continue reading
Posted in China, Mexico, Uncategorized
Tagged CFDA, COFEPRIS, Cooperation, drug products, Harmonization, health supplies, Memorandum of Understanding, Mexico, Mikel Arriola
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Regulatory Affairs in Latin America 