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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...
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    Asia Regulatory Roundup: India Offers Fast-Track Approvals to HIV, Hepatitis Combo Products (28 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Offers Fast-Track Approvals to HIV, Hepatitis Combination Products The Drug Controller General of India (DCGI) is offering fast-track approvals to combination products to treat HIV and hepatitis B and C. DCGI Dr GN Singh is prepared to waive the need to run clinical trials and truncate the regulatory submission process to cut the time it takes for sponsors to br...
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    GAO: Drugmakers Want More Clarity on Antibiotic Incentives

    Despite some improvements, drugmakers say the US Food and Drug Administration (FDA) has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office (GAO). Specifically, GAO says that FDA has issued 14 updated or new guidances focused on antibiotics since the Generating Antibiotic Incentives Now (GAIN) Act was passed as part of the Food and Drug Admi...
  • 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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    European Regulatory Roundup: EMA Plans Ways to Curb Antibiotic Resistance (2 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Proposes Restricting Use of Colistin to Curb Rise of Antibiotic Resistance The European Medicines Agency (EMA) is proposing to restrict the use of colistin to curb the rise of antibiotic resistance. Under the plan, use of colistin in animals would be limited to last-resort cases, a constraint intended to quell concerns that an emerging resistant mutation will spread quic...
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    European Regulatory Roundup: Brexit Could Lead to New Regulatory Burdens (25 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Industry Leaders Warn Brexit Would Lead to Significant Regulatory Burdens More than 50 leaders of the British biopharmaceutical industry have warned of the regulatory and business upheaval that could result from the United Kingdom leaving the European Union, an event dubbed “Brexit.” In a letter in The Financial Times , the executives argue leaving the EU would result in “s...
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    EMA to Investigate Use of Last-Resort Antibiotic

    The European Medicines Agency (EMA) announced Monday that it will investigate the use of a last-resort antibiotic after the discovery of a gene in the EU that causes bacteria, such as E. coli , to become resistant to the drug. Background In November, scientists published a study in The Lancet on the gene, known as MCR-1, which was found to cause bacteria to become resistant to the last-resort antibiotic, known as colistin, which is of the polymyxin class and can be...
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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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    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...