Regulatory Update
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30 July 2012
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Brazilian consumers will not be able to purchase over-the-counter drug products at pharmacies according to new rules published 17 July 2012 by Brazilian health regulator Anvisa.Under the new rules,
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Latest News
Regulatory Update
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25 July 2012
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Brazilian government officials, including those at the regulatory agency Anvisa, have gone on strike, leaving the agency critically under-staffed and scrambling to make sure its basic operational
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Latest News
Regulatory Update
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12 July 2012
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Brazilian regulatory authorities are looking to keep newly-won authority to deny the grant of patents for medical products—authority won in 2012 as the result of patent reforms.Speaking at a 10 July
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Regulatory Update
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9 July 2012
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Brazil’s National Health Surveillance Agency (Anvisa) has opened a public consultation on proposed amendments (41/2012) to the regulation of biological products in Brazil. The proposed changes,
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Regulatory Update
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25 June 2012
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Brazil’s National Health Surveillance Agency (ANVISA) published a new proposed rule on medicines used as reference products for generic equivalents (RDC No. 35/12) on 19 June 2012.According to the
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Regulatory Update
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18 June 2012
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Brazil’s national regulatory agency, Anvisa, and the Ministry of health have announced the joint recognition of regulation as a benefit for social and economic development under a new Memorandum of
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Regulatory Update
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11 June 2012
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The Board of Anvisa, the national regulatory authority of Brazil, is scheduled to review new regulations governing the format of “non-print” instructions for use of health products and the criteria
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Regulatory Update
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11 June 2012
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Brazil’s national regulatory agency, Anvisa, has published a new guide for pharmaceutical companies and local inspectors on the good manufacturing practices (GMP) principles and practices mandated
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Regulatory Update
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4 June 2012
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As the result of a new patent review process, Brazilian regulatory authority Anvisa is being given the authority to deny the grant of a patent for a medical product.The agency can make deny a decision
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Regulatory Update
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4 June 2012
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Brazil’s national regulator, Anvisa, will open a public consultation on establishing quality requirements for pharmaceutical excipients used in the manufacture of medicinal products. Excipients
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