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Author Archives: Maria I. Guaia
Top 10 Pharma – products in the pipeline
Did you know that you can consult which new innovations are in the pipelines of the top 10 pharma companies directly from their websites? Have a look! 1- Johnson&Johnson 2- Pfizer 3- Novartis 4- Sanofi 5- Merck&Co 6- GlaxoSmithKline 7- Abbott … Continue reading
Anvisa Approves Track and Trace System
Anvisa Approves Track and Trace System.
Posted in Brazil
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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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Brazil makes proposed outsourcing regulations available for comment
Brazil makes proposed outsourcing regulations available for comment.
Puerto Rico to ‘opportunistically pursue’ biologics to regenerate industry
Puerto Rico to ‘opportunistically pursue’ biologics to regenerate industry.
Posted in Uncategorized
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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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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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Brazil: Overview of API registration
In Brazil, the health authority (ANVISA) will require that all Active Pharmaceutical Ingredients (APIs) manufactured in Brazil, imported for manufacturing of drug products, or included in imported finished products, are registered with the agency. This regulation has been put in … Continue reading
Posted in Brazil
Tagged Active Pharmaceutical Ingredients, anvisa, API, brazil, import, Latin America, manufacturing, registration
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Regulatory Affairs in Latin America 