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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...
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    Asia Regulatory Roundup: TGA Creates Guidance on Device Standards for Quality Management Systems

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Creates Guidance on Device Standards for Quality Management Systems   The Therapeutic Goods Administration (TGA) has created guidance to help companies comply with a medical device law passed in Australia earlier this year. The law covers medical device standards for quality management systems (QMS) and medical devices intended to be supplied in a sterile state. ...
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    EU Regulatory Roundup: EMA, Running Two Years Behind Schedule, Gears up for Clinical Trial Portal Audit

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EMA, Running Two Years Behind Schedule, Gears up for Clinical Trial Portal Audit   The European Medicines Agency (EMA) has begun preparing its Clinical Trials Information System (CTIS) for audit. EMA performed testing and bug fixing of the single entry point for clinical trial information earlier in the year, positioning it to now enter “a phase of agile, iterative ...
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    Asia Regulatory Roundup: Australia Extends GMP Clearance Filing Review Timelines to up to 120 Days

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Extends GMP Clearance Filing Review Timelines to up to 120 Days   Australia’s Therapeutic Goods Administration (TGA) has extended its target processing timelines for good manufacturing practice (GMP) clearance applications. TGA will now take up to 120 working days to process compliance verification for sterile and biotech finished products.   GMP cleara...
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    EU Regulatory Roundup: MHRA Offers Advice on use of Brand Names to Prescribe Drugs

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Offers Advice on use of Brand Names to Prescribe Drugs   The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guideline on the naming of medicinal products. MHRA’s most substantive change is the addition of a new section that provides general recommendations for brand naming and prescribing.   In some cases, products are appro...
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    Asia Regulatory Roundup: China Tightens Genetic Material Rules, Places Extra Restrictions on Foreigners

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Tightens Genetic Material Rules, Places Extra Restrictions on Foreigners   China is set to tighten restrictions on the use of human materials including DNA, organs, blood and tissues. The rules require foreign organizations to team up with local partners to use human genetic materials and otherwise place extra limits on their access to samples taken in China. ...