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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...
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    EU Regulatory Roundup: EMA Settles Dispute Over London Lease

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Settles Dispute Over Canary Wharf Office   The European Medicines Agency (EMA) says it has settled its dispute against Canary Wharf Ltd over its former headquarters at 30 Churchill Place in London.   When EMA entered into the lease, it expected to be in London for years, leading it to sign up to stay at the offices until 2039. Brexit forced EMA to change its p...
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    Asia Regulatory Roundup: TGA Details How Manufacturers Can Seek GMP Clearance Prioritization

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Details How Manufacturers Can Seek GMP Clearance Prioritization   Australia’s Therapeutic Goods Administration (TGA) has provided guidance on how manufacturers can request the prioritization of their good manufacturing practice (GMP) clearance requests.   In recent years, the sharp increase in the number of requests to TGA to establish the compliance of over...
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    EU Regulatory Roundup: Trade Group Warns Preparing UK for October No-Deal Brexit is ‘Impossible’

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Trade Group Warns Preparing UK for October No-Deal Brexit is ‘Impossible’   A biopharma trade group has warned it will be “impossible” to prepare the UK medicine supply chain to withstand the impact of a no-deal Brexit by October. The warning comes as the leading candidate to take over as Prime Minister committed to take the UK out of the EU on 31 October, “do or di...