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  • Linking the Pharmacopeias of Argentina and Brazil

    Wednesday, July 8th, 2009

    Brazil’s National Sanitary Vigilance Agency (Anvisa) today issued a regulation (Resolution RDC 37) permitting reference chemical substances certified by either the Argentine Pharmacopeia or the World Health Organization’s (WHO) International Pharmacopeia to be used for evaluating the quality of pharmaceutical raw materials (active ingredients and excipients) and medicines produced in Brazil.
    Anvisa already allowed that, where […]

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    New Pharmaceutical Labeling Rules Proposed in Brazil

    Friday, April 10th, 2009

    Brazil’s National Sanitary Vigilance Agency (ANVISA) is proposing changes in package labeling rules for pharmaceuticals sold in that country (as set out in ANVISA Resolution RDC 333/03) with a view to making pack labels more informative to consumers.  For example, the proposals released for public consultation (until 11 May) would make medicines with a sedative […]

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    Important LAC Developments on Clinical Trials

    Monday, March 23rd, 2009

    Argentina and Brazil are creating national registries for clinical trials. Clinical trials are research studies that prospectively assign human participants or groups of humans to one or more health-related interventions (pharmaceuticals, vaccines, surgical procedures, radiological procedures, medical devices, etc.) to evaluate the effects on health outcomes, often undertaken with a view to seeking regulatory approval. […]

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    Gates Foundation Funds WHO/UNICEF Research on Children’s Medicines

    Wednesday, January 21st, 2009

    From the World Health Organization (WHO):
    WHO receives funds for children’s medicines research with UNICEF

    US$ 9.7 million grant from Gates Foundation to help crucial research on children’s medicines

    WHO has received US$ 9.7 million in grant from the Bill & Melinda Gates Foundation to work with UNICEF to conduct crucial research in children’s medicines, with the aim […]

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    MERCOSUR Adopts Guidelines on Promotion, Advertising & Marketing of Pharmaceuticals

    Tuesday, December 30th, 2008

    I’ve said here many times that Latin American and Caribbean (LAC) nations tend to take seriously the recommendations, guidelines and other soft norms of the World Health Organization (WHO) on any issue involving public health and/or the environment, and I’ve tried to provide a few examples where WHO work has translated into national laws and […]

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    New Brazilian Rules on Pharmaceutical Marketing

    Wednesday, December 24th, 2008

    Brazil’s Health Minister, José Gomes Temporão, and the head of the National Health Surveillance Agency (Anvisa), Dirceu Raposo, recently announced new rules on pharmaceutical marketing in that country to replace less ambitious ones adopted in 2000.  The new rules aim at substantially changing how medicines are promoted in Latin America’s largest pharma market, and may […]

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