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    Asia Regulatory Roundup: China’s Communist Party Expels Former Senior Vaccine Regulator for Corruption

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Seeks Input on How to Regulate Fecal Microbiota Transplantation   Australia’s Therapeutic Goods Administration (TGA) is seeking industry feedback on the regulation of materials used for fecal microbiota transplants. TGA initiated the consultation to answer fundamental questions about fecal transplant materials, such as whether they are biologicals, to help...
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    EU Regulatory Roundup: UK to Prioritize Medicines Over Food if No-Deal Brexit Occurs

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   UK Will Prioritize Shipments of Medicines Over Food if No-Deal Brexit Disrupts Trade   The British government has said it will prioritize medicines over food if a no-deal Brexit renders the country unable to import sufficient supplies of both. Government officials think their preparations will ensure they never need to make the decision but are clear what they will ...
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    Asia Regulatory Roundup: Leading Drugmakers Pressure Australian Government to Commit Resources to Regulatory Reforms

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Leading Drugmakers Pressure Australian Government to Commit Resources to Regulatory Reforms   A trade group representing leading drugmakers has called for the Australian government to commit more resources to the implementation of regulatory reforms agreed to in 2017. The reforms cover the development of revised pathways and doubling of access to early advice on new ...
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    EU Regulatory Roundup: Shire Raises ‘Substantial Concerns’ About ICH Guidelines

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   UK Drafts Legislation to Empower Pharmacists to Mitigate Drug Shortages   The United Kingdom is set to give pharmacists more power to substitute drugs in the event of serious shortages. Once enacted, the law will enable politicians to give pharmacists the flexibility to dispense a different drug than is specified on a prescription to ensure patients can access suita...
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    Asia Regulatory Roundup: TGA Brings 6 Guidance Documents in Line With PIC/S Guide to GMP

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Prohibits 80 FDCs After Prolonged Legal Dispute   India has published legislation banning the production of 80 fixed-dose combinations (FDCs) it thinks are likely to pose a threat to humans. The action is the latest salvo in a long-running fight over the rationality and legal status of hundreds of FDCs sold in India.   A subcommittee formed by the the Drugs...
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    EU Regulatory Roundup: UK Plans to Add Refrigerated Storage to Mitigate Hard Brexit

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   UK Plans to Add 5,000 Pallets of Refrigerated Storage to Mitigate Hard Brexit   The United Kingdom government expects to expand cold chain storage capacity ahead of a potential no-deal Brexit with refrigerated space for 5,000 pallets. Government officials also expect to add 53,000 pallets of ambient storage and 850 pallets of controlled drug storage.   Efforts t...
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    Asia Regulatory Roundup: TGA Plans GCP Inspection Program

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Plans GCP Inspection Program to Ensure Global Recognition of Australian Data   Australia’s Therapeutic Goods Administration (TGA) is planning to run a good clinical practice (GCP) inspection pilot program. TGA sees the pilot as a stepping stone to a permanent, routine inspection program designed to mitigate the risk that recognition of the quality and integrity o...
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    EU Regulatory Roundup: UK NHS Calls for Changes to Pricing Legislation

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   UK NHS Calls for Changes to Pricing Legislation to Lessen Focus on Fostering Competition   The United Kingdom National Health Service (NHS) has called for legislative changes to the rules and processes covering pricing and procurement. NHS officials think the law currently favors fostering competition at the expense of their ability to make decisions about pricing a...
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    Asia Regulatory Roundup: China Releases Guidelines on Overseas Inspections of Device Companies

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Planned Overhaul of Australian Medical Device Regulations   Australia’s Therapeutic Goods Administration (TGA) has begun consultations on proposed changes to several aspects of its regulation of medical devices. The consultations cover the planned introduction of a unique device identification (UDI) setup and other changes stemming from the Euro...
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    EU Regulatory Roundup: Denmark Outlines Process for Handling Alarms Triggered by Anti-Counterfeiting System

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news. Denmark Outlines Process for Handling Alarms Triggered by Anti-Counterfeiting System   The Danish Medicines Agency (DKMA) has posted guidance on the handling of alarms triggered by anti-counterfeiting systems. DKMA’s document details what it will expect of manufacturers and other organizations when the Falsified Medicines Directive comes into force next month.   Th...
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    Asia Regulatory Roundup: China Approves First Locally Developed Anti-PD-1 Checkpoint Inhibitor

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   New Zealand Seeks Feedback on Replacement for ‘Inflexible’ Therapeutic Legislation   The New Zealand government is planning to replace decades-old legislation that it thinks is “dated, inflexible and prescriptive.” In replacing the legislation, New Zealand is seeking to expand the range of products it covers, harmonize with global standards and facilitate easy update...
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    EU Regulatory Roundup: France to Create Trial Fast Track for Cell and Gene Therapies

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   Ireland Releases Guide to Wholesale Distribution Authorization Process   Ireland’s regulator has released a guide to help wholesale distributors make authorization application and variation requests. The Health Products Regulatory Authority (HPRA) guidance runs through all the information companies need to include on the regulatory forms covering distributor request...