Regulatory Update
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11 April 2013
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Brazil’s National Health Surveillance Agency (Anvisa) has signed a technical cooperation agreement with two other Brazilian agencies designed to sustain the country’s economic growth and health by
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Regulatory Update
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22 January 2013
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Brazil's national regulatory authority, Anvisa, has opened a Public Consultation on proposed revisions to the criteria for the technical requirements for quality, safety and efficacy needed to support
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4 December 2012
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The US Food and Drug Administration (FDA) is delaying by two weeks the implementation of its facility registration requirements under the Generic Drug User Fee Act (GDUFA), a subset of a recently
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23 October 2012
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A new guidance for industry published by the US Food and Drug Administration (FDA) includes information about new registration requirements established under the Food Safety Modernization Act (FSMA),
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15 October 2012
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Australia's Therapeutic Goods Administration (TGA) is reminding all biologics manufacturers that, per a new regulatory framework for biological medicines, that they must re-register their products
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23 August 2012
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Two new draft guidance documents published by the US Food and Drug Administration (FDA) instruct owners of manufacturing facilities that produce generic drug products on how to comply with the terms
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1 August 2012
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The US Food and Drug Administration (FDA) has issued a final rule regarding electronic device registration and listing requirements, putting into practice a long-awaited rule combining the
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10 July 2012
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European Commissioner for Health and Consumers John Dalli plans to introduce new clinical trials legislation as early as 17 July 2012, reports Reuters.The legislation, previewed at a 27 June meeting
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6 June 2012
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The US Food and Drug Administration (FDA) sent eight warning letters to foreign-based pharmaceutical manufacturers between January 2012 and May 2012 after finding the companies were exporting
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Regulatory Update
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24 April 2012
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The Public Consultation - CP No. 26 - on proposed new criteria for establishing the priority review for registration of medicines opened on April 20 and comments may be submitted within 30 days. The
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