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    Asia Regulatory Roundup: Australia Scraps Target Date for Processing GMP Applications (25 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Scraps 15-day Target for Processing GMP Clearance Applications Australia’s Therapeutic Goods Administration (TGA) has scrapped its 15-day target timeframe for processing good manufacturing practice (GMP) clearance filings. The target is a long-standing part of TGA’s guidelines for overseas manufacturers, but has become progressively harder to achieve as the volum...
  • European Regulatory Roundup: UK Fines Pfizer for 2,600% Price Hike (8 December 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EC Appeases Some SMEs With Revised Advanced Therapy GMPs but Objections Remain The European Commission has received some favorable feedback on its draft good manufacturing practice (GMPs) guidelines for advanced therapy medicinal products (ATMPs). However, while small and medium-sized enterprises (SMEs) were broadly supportive of changes proposed in the draft, the commission...
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    FDA, EMA, PMDA Begin Push for New Antibacterials

    The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) met at EMA headquarters in London last week to discuss their role in promoting the development of new antibacterial products. Antimicrobial resistance (AMR) is increasingly being recognized as a global threat to public health, with the World Health Organization (WHO) calling AMR "so serious that it threatens the achievements of modern h...
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    FDA Finalizes Guidance on Microbiology Data for Antibacterials

    The US Food and Drug Administration (FDA) on Friday finalized guidance intended to help drugmakers prepare the data necessary to support the approval of new antibacterial drugs. Antimicrobial resistance (AMR) is increasingly being recognized as a global threat to public health, with the World Health Organization (WHO) calling AMR "so serious that it threatens the achievements of modern healthcare." The threat is compounded by the fact that while bacteria are becoming in...
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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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    Experts Call for New Regulatory Pathways for Antibiotics

    Faced with the increasing threat of antimicrobial resistance (AMR), experts are calling for more incentives to boost investment in new antibiotics. At the FDA/CMS Summit in Washington, DC today, representatives from several companies developing new antibiotic treatments said that while recent initiatives such as the Generating Antibiotics Now Act (GAIN Act) have helped revitalize investment in antibiotic development, more needs to be done to encourage research and deve...
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    European Regulatory Roundup: EMA Calls for More Research Into Autism Diagnostic Tools (10 December 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Review Calls on Regulators to Limit Levels of Antimicrobials in Production Plant Wastewater A review commissioned by the British government has called for regulators to limit the levels of antimicrobials in manufacturing plant wastewater. By capping the concentration of antimicrobials in wastewater, regulators may contribute to a stemming of the rise of drug-resistant s...
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    FDA Releases 18 Years of Isolate-Level Data for Common Gut Bacteria

    In a move to make its data more transparent and promote scientific research, the US Food and Drug Administration (FDA) is releasing 18 years of data on several bacteria, collected as part of the National Antimicrobial Resistance Monitoring System (NARMS). Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World Health Orga...
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    AmpliPhi Biosciences Gets First cGMP Certification for Bacteriophage Facility

    AmpliPhi Biosciences announced Wednesday it has received the first ever good manufacturing practices certification for its bacteriophage facility in Slovenia. Background Bacteriophages are naturally occurring viruses that are capable of fighting bacteria. Phage therapy has been around for nearly a century, following the co-discovery of bacteriophages by Frederick Twort and Felix d'Hérelle in 1915 and 1917, respectively. Shortly thereafter, scientists began developing...
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    World Health Assembly Adopts Action Plan on Antimicrobial Resistance

    In Geneva Monday, members of the World Health Assembly (WHA) endorsed a plan to fight antimicrobial resistance (AMR) on a global scale. Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World Health Organization (WHO) called AMR "so serious that it threatens the achievements of modern medicine." In recent years, health autho...
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    EU Parliament Calls for Measures to Combat Antimicrobial Resistance

    The European Parliament is calling for new measures to combat antimicrobial resistance (AMR) in Europe, where 25,000 die each year due to drug-resistant infections. Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World Health Organization (WHO) called AMR "so serious that it threatens the achievements of modern medicine." T...
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    To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

    A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species. The data is intended to help advance FDA's efforts to promote the "judicious use" of antibiotics as part of a broader initiative to stem the rise of antimicrobial resistance (AMR). Under the 2008 Animal Drug User Fee...