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    EU Regulatory Roundup: Denmark Teams With WHO to Help Build Regulatory Capacity in Poorer Countries

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Government Holds off Backlash Against ‘Extraordinary Power Grab’ on Drug Shortages   The United Kingdom government has resisted an attempt to revoke changes to the handling of drug shortages. An opposition politician called the serious shortage protocol reforms an “extraordinary power grab” but was unable to rally enough support in parliament to get the changes r...
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    Asia Regulatory Roundup: Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository   Singapore’s Health Sciences Authority (HSA) has apologized to blood donors after a vendor stored their information in a vulnerable database. HSA learned the database lacked adequate safeguards from a cybersecurity expert and does not think other unauthorized people accessed the information...
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    EU Regulatory Roundup: UK Industry and Lords Criticize No-Deal Preparations

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Industry and Lords Criticize No-Deal Preparations as Potential Hard Split Nears   Members of the House of Lords have strongly criticized the United Kingdom government’s attempts to lessen the effect of a no-deal Brexit on the biopharma industry. Citing feedback from industry and the government’s own impact assessment, the Lords warned the mitigating actions riske...
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    Asia Regulatory Roundup: India Expands Cost Controls for Cancer Drugs

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Expands Cost Controls for Cancer Drugs, Cutting Prices by up to 87%   India’s National Pharmaceutical Pricing Authority (NPPA) has brought 390 brands of non-scheduled cancer medicines under tougher price controls. The changes impose a 30% trade margin cap on the products, resulting in price cuts of up to 87% on certain products.   NPPA outlined plans to cha...
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    EU Regulatory Roundup: UK Talks Up Prospect of No-Deal Brexit Accelerating Access to New Medicines

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Talks Up Prospect of No-Deal Brexit Accelerating Access to New Medicines   The British health minister has talked up the prospect of a no-deal Brexit accelerating access to new medicines.   After receiving clear feedback from industry about the importance of harmonization, the government largely stopped talking about adopting a divergent, lighter medicine reg...
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    Asia Regulatory Roundup: China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal   China is planning to introduce a risk-based regulatory system for cell and gene therapies in the wake of the germline modification scandal. The system would require developers of high-risk therapies to get state-level clearance for clinical trials, while leaving local authorities to sign o...
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    EU Regulatory Roundup: UK Sets up Logistics Hub in Belgium to Support Post-Brexit Drug Shipments

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Sets up Logistics Hub in Belgium to Support Post-Brexit Drug Shipments   The United Kingdom has created a logistics hub and bought tickets from ferry operators to mitigate the risk that a no-deal Brexit will disrupt the supply of drugs and medical devices.   In the event of a no-deal Brexit, preferred shipping routes between Dover, Calais and other towns and ...
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    Asia Regulatory Roundup: Sanofi’s ‘Brazen Defiance’ Prompts Philippines to Pull Dengue Vaccine License

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Sanofi’s ‘Brazen Defiance’ Prompts Philippines to Pull Dengue Vaccine License   The Philippines Food and Drug Administration (FDA) has revoked the registration of Sanofi’s dengue vaccine Dengvaxia. FDA took the action in response to Sanofi’s “complete disregard” for its rules and regulations.   Sanofi’s landmark, but controversial, vaccine ran into trouble in 201...
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    EU Regulatory Roundup: Germany Warns Brexit Could Cause the Suspension of 1,300 Clinical Trials

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   Germany Warns Brexit Could Cause the Suspension of 1,300 Clinical Trials   Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has warned that it could suspend 1,300 clinical trials in the event of a no-deal Brexit. The warning reflects the fact that the sponsors of many studies are still registered in the UK and there are stipulations in the Medicinal ...
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    Asia Regulatory Roundup: TGA Mulls Disclosing Drug Approval Filings to Further Transparency Agenda

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Mulls Disclosing Drug Approval Filings to Further Transparency Agenda   Australia’s Therapeutic Goods Administration (TGA) is considering disclosing when it is evaluating a filing for approval of a prescription drug. TGA currently only shares details of submissions once it has finished evaluating them, but is open to changing its position to make the process more...
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    Asia Regulatory Roundup: India to Treat Implants and Imaging Equipment as Drugs From April 2020

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India to Treat Implants and Imaging Equipment as Drugs From April 2020   India is pushing ahead with previously discussed plans to categorize certain classes of medical device as drugs. The change will mean implants and imaging equipment are subject to more burdensome regulatory requirements than in the past.   The Drugs Technical Advisory Board (DTAB) floated t...
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    EU Regulatory Roundup: Ireland Asks Companies to Proactively Discuss Possible Effects of Brexit

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   Ireland Asks Companies to Proactively Discuss Possible Effects of Brexit to Avoid Disruptions   The Irish Health Products Regulatory Authority (HPRA) has asked companies to contact it with details of disruptions that may occur in the event of a no-deal Brexit. HPRA wants to learn of Brexit-related product withdrawals and clinical supply problems ahead of time so it ...