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    EU Regulatory Roundup: UK Confirms US Sites Can Batch Test Drugs in Event of a No-Deal Brexit

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Confirms US Sites Can Batch Test Drugs in Event of a No-Deal Brexit   The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed it will accept results from batch testing performed in the United States in the event of a no-deal Brexit.   MHRA published the original list of countries authorized to perform batch testing weeks be...
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    Asia Regulatory Roundup: China Approves Gilead HIV Drug Within 18 Months of EMA and FDA

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Analysis of Paclitaxel-Coated Device Data Finds no Safety Signal   The Therapeutic Goods Administration (TGA) has analyzed Australian adverse event data on patients with paclitaxel-coated devices in light of a meta-analysis published last year. The meta-analysis found a link between the devices and increased risk of death, but no safety signal was seen in the TGA...
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    EU Regulatory Roundup: MHRA Drops Statement That Avoiding No-Deal Brexit is the ‘Top Priority’

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news. MHRA Drops Statement That Avoiding No-Deal Brexit is the ‘Top Priority’   The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has indicated a shift in the government’s willingness to countenance a no-deal Brexit in an update to its guidance on exiting the EU.  No-deal Brexit guidances published by MHRA and other parts of the UK government ...
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    Asia Regulatory Roundup: China Expands Medical Device Registration Pilot to Cover Multiple Regions

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Expands Medical Device Registration Pilot to Cover Multiple Regions   China’s National Medical Products Administration (NMPA) has expanded a medical device registration pilot project. The pilot project, which began in a free trade zone, will now cover 21 provinces to help NMPA accrue more experience of the medical device registration system.   NMPA is running ...
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    EU Regulatory Roundup: Regulatory Action Against Fresenius Kabi's Calea Affects UK Product Supply

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news. The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has found fault with the manufacturing process at a Calea facility. MHRA warned that Calea has cut its output while it works to resolve the problems, creating the risk of disruption to the supply of total parenteral nutrition (TPN) bags in the UK. Calea, a Fresenius Kabi subsidiary, received...
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    Asia Regulatory Roundup: India Forms Medical Device Technical Advisory Group to Help CDSCO

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Reveals Recently Passed Order Faced Strong Industry Opposition   Australia’s Therapeutic Goods Administration (TGA) has revealed that parts of the medicines industry objected strongly to its recently adopted standard for tablets and capsules. The legislation came into effect in March despite big pharma trade group Medicines Australia arguing that, “It is unclear ...
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    EU Regulatory Roundup: MHRA Finances Hit by Brexit-Triggered Drop in Income From EMA

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Finances Hit by Brexit-Triggered Drop in Income From EMA   The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) suffered a £5.7 million ($7.1 million) drop in its income from external customers last year. MHRA attributed the 5.6% decline to the fall off in work from the European Medicines Agency (EMA) ahead of Brexit.   In the 201...
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    Asia Regulatory Roundup: TGA Updates Guidance on the Testing of Biological Medicines

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Updates Guidance on the Testing of Biological Medicines   Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on testing biological medicines. Version 2.0 of the guidance features new details on the use of TGA in-house orthogonal testing methods and other changes.   TGA published the first, and until this week only, version of the guid...
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    EU Regulatory Roundup: UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation   Committees of British politicians have pushed back against the government’s attempts to adopt new drug and medical device legislation without holding debates in Parliament.   Last month, the UK government proposed changes to legislation intended to ensure the rules covering dru...
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    Asia Regulatory Roundup: TGA Proposes Ban on Certain Breast Implants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Proposes Ban on Certain Breast Implants After Safety Review   Australia’s Therapeutic Goods Administration (TGA) is planning to cancel the licenses of nine Natrelle textured breast implants made by Allergan. TGA proposed the action, plus the suspension of 16 other devices, after reviewing evidence of links between breast implants and a form of lymphoma.   Ove...
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    EU Regulatory Roundup: Danish Regulator Bans Staff From Owning Shares in Pharma, Device Companies

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Updates Guidance in Light of Lack of 2D Barcodes in Greece and Italy   The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has updated its falsified medicine guidance in light of the situation in Greece and Italy, neither of which has set up a 2D barcode unique identifier system.   MHRA’s revised guidance states that organizations...
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    Asia Regulatory Roundup: China Reports Sharp Increase in Applications to Drug Review Center

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Reports Sharp Increase in Applications to Drug Review Center   China’s Center for Drug Evaluation (CDE) has reported a sharp increase in the number of applications it receives. In 2018, CDE received 5,574 applications for technical review, an increase of 47% over the previous year.   The increase is one of many double-digit rises detailed in CDE’s 2018 drug...