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    European Regulatory Roundup: UK to Increase Regulatory Oversight of Antibiotics (22 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Plans Significant Increase in Regulatory Oversight of Antibiotics The United Kingdom government expects regulatory oversight of veterinary antibiotics to increase significantly in the future. Ministers singled out the enactment of legislation that restricts or bans the veterinary use of antibiotics that are of critical importance to people as one of the ...
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    EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection

    A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators. Pfizer decided to temporarily suspend operations at the site earlier this month and MHRA is now calling on EU member states’ National Competent Authorities to evaluate how ...
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    Woodcock: Antibiotics Pipeline is 'Fragile and Weak'

    At a congressional hearing in Washington, DC on Tuesday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that current incentives are not enough to overcome the challenges of developing new drugs to fight bacterial infections. Antimicrobial resistance (AMR) is increasingly being recognized as a global threat to public health. In its 2014 Antimicrobial Resistance: Global Report on Surveilla...
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    European Regulatory Roundup: Parliament Seeks More Responsible Use of Antibiotics (10 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. European Parliament Endorses Plan to Encourage Responsible use of Antibiotics The European Parliament has endorsed a draft law intended to encourage the responsible use of antibiotics in animals. Under the terms of the proposal, the European Commission will monitor the use of animal antibiotics in member states and report the data regularly, while veterinarians will be made...
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    Health Canada to Require Precautionary Statements in Antimicrobial Labels

    As part of efforts to encourage the more prudent prescribing and use of antimicrobials, Health Canada on Monday announced it will now require the inclusion of precautionary statements in antimicrobial product labelling. The proposal, which was announced alongside the kickoff of World Antibiotic Awareness Week , comes as bacteria are increasingly stronger, more resistant to antibiotics and therefore more lethal. As part of its federal action plan on antimicrobial resis...
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    European Regulatory Roundup: Dutch Regulator Revamps Drug Nomenclature Policy (22 October 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Dutch Regulator Overhauls Policy on Nomenclature of Medicines The Medicines Evaluation Board (MEB) in the Netherlands has completely revised its policy on nomenclature covering human medicinal products and is enforcing the changes with immediate effect. Out of all the revisions included in the new nomenclature policy, MEB has picked out six that it sees as the most importan...
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    EMA Draft Guidance Seeks to Speed New Antibiotics Development

    The European Medicines Agency (EMA) is seeking comment on a new draft guideline that could help industry use of pharmacokinetics (PK) and pharmacodynamics (PD) analyses to speed the development of novel antibiotics that target multidrug-resistant bacteria and address unmet medical needs. Background Like in the US, the growth of bacteria resistant to a range of antibiotics, along with the need for new antibiotics to treat patients with limited or no treatment options, sp...
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    FDA Finalizes Policy Meant to Limit Use of Antibiotics in Farm Animals

    The US Food and Drug Administration (FDA) has released a long-anticipated final rule meant to limit the use of antibiotics in food-producing animals in order to limit the spread of antibiotic-resistant bacteria. The rule, known as the Veterinary Feed Directive (VFD) , has been amended to require veterinary antibiotics to be prescribed by a veterinarian "within the context of a veterinarian-client-patient relationship (VCPR)," FDA explained in an accompanying press s...
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    Global Efforts to Combat Antimicrobial Resistance 'Lacking,' WHO Report Finds

    The World Health Organization (WHO) has completed the first global assessment of national strategies to counter the rise of antimicrobial resistance (AMR). Only a quarter to countries had plans in place to limit the use of antimicrobials, leaving "major gaps" in the struggle against AMR in every region of the world. Background The rise of AMR is tied to the overuse and misuse of antimicrobial medicines such as antibiotics. When microbes targeted by antimicrobial medicin...
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    Senators Call for New Limits on 'Medically Important' Antibiotics

    A new bill introduced this week in the US Senate would restrict the use of "medically important" antibiotics in agriculture in the hopes of reducing the risk of bacteria developing resistance to those drugs. Background The bill, the Preventing Antibiotic Resistance Act (PARN) ( PDF ), was introduced on 2 March 2015 by Sens. Dianne Feinstein (D-CA) and Susan Collins (R-ME), with support from Sens. Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA). The legisl...
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    Bill Seeks Creation of New Pathway for Antibiotic Drug Approvals

    New legislation would allow the US Food and Drug Administration (FDA) to approve some antibiotics through a special "limited use" regulatory pathway, all in the hope of bringing more antibiotics to market to help fight antibiotic-resistant bacteria. A Limited Population Pathway The bill, the Promise for Antibiotics and Therapeutics for Health (PATH) Act , was introduced on 10 December 2014 by Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT). At its core, the legis...
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    As US Falters in Fight Against Antibiotics Over-Prescribing, EU Makes Progress

    The European Union seems to be making substantial strides in something the US thus far has been unable to do: reducing the use of antibiotics in food-producing animals. In a new report issued on 15 October 2014, the European Medicines Agency (EMA)—the EU's version of the US Food and Drug Administration (FDA)—announced that between 2010 and 2012, the sales of antibiotics for use in animals fell 15% on average across 20 European countries. While some of those countries...