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    MHRA Clarifies Medical Devices Policies for Users

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a new guidance document on Monday to clarify existing policies and procedures around the use of medical devices. The agency’s guidance provides information that ranges from the definition of a medical device and CE marking to information on buying devices for personal use, as well as problems associated with device use and troubleshooting. For those interested in buying a medical device for pe...
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    EU Lists First Notified Body Under MDR

    BSI United Kingdom (UK) became the first notified body (NB) to be officially designated as an NB under the Europe Union’s (EU) medical device regulation (MDR). The new NB designation—the first-of-its-kind to be listed in the European Commission’s New Approach Notified and Designated Organizations (NANDO) database—comes months before the timeline the Notified Bodies Operations Group had estimated in 2017 guidance for NB designation and notification. The scope of B...
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    MHRA Expands on ‘No-Deal’ Brexit Preparations for Drugs, Medical Devices

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidance on Thursday to propose and further clarify certain regulatory positions in case of a “no-deal” scenario as Brexit looms around the corner. The 14-page guidance document covers the current and possible future regulatory space for medicines and medical devices brought into the UK market, as well as clinical trials conducted in the UK. It was developed based on responses to MHRA’s Octob...
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    Half of Clinical Trials Fail to Publish Results, UK Report Finds

    Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.   “Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.   Based on these findin...
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    European Regulatory Roundup: UK Hurries Drug Pricing Bill Ahead of Election (4 May 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Hurries Through Drug Pricing Bill Before Parliament Closes for Snap Election Politicians in the UK have hurried through drug pricing legislation before Parliament closed ahead of a snap general election. The calling of the surprise election created a deadline for resolving a dispute between the two houses of the UK Parliament, prompting politicians to create a compr...
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    EMA to Pharma Companies: Prepare for UK to EU Shift

    Setting the stage for a likely exodus from the UK for pharmaceutical manufacturers and staff, the European Medicines Agency (EMA) on Tuesday notified marketing authorization holders (MAHs) that for centrally authorized products, EU law requires them to be established in the EU or European Economic Area, which includes Iceland, Liechtenstein and Norway. EMA also notified MAHs that some of their activities must be performed in the EU (or EEA), related for example to ...
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    MHRA Plans for the Future of Drug, Device Regulation Post-Brexit

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU. MHRA is pushing for a more international strategy that focuses on collaboration and engagement with key partners and stakeholders and continuing to partici...
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    UK on Brexit Implications: ‘Significant Benefits’ to Remain Part of EMA

    The UK government’s EU External Affairs Subcommittee on Tuesday published a report on the implications of Brexit on trade, noting that there may be “significant benefits” in continuing UK participation in the European Medicines Agency (EMA). However, the report also notes that it “is unclear how the UK could co-operate with the EMA after Brexit, and whether the UK would be able to influence decisions taken by the EMA.” How the UK is able to maintain its influence at th...
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    NICE Halts Plans to Charge for Appraisals

    The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy. The controversial plan to charge for appraisals, first unveiled in October , would see companies pay fees of up to £282,000 for each cost-effectiveness assessment. NICE’s chief executive, Sir Andrew Dillon, said...
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    European Regulatory Roundup: UK Advances Bill to Stop Price Spikes on Generic Drugs (27 October 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Politicians Advance Bill to Close Drug Pricing ‘Loophole’ Legislation intended to close a drug pricing loophole in the United Kingdom has taken another step forward. The bill is designed to align two medicine price regulation schemes and, in doing so, give the government the power to stop companies from exploiting monopolies on generic drugs.   The UK runs paralle...
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    Japan’s Ministry of Foreign Affairs: Don’t Move EMA Headquarters From London

    If the European Medicines Agency (EMA) transfers its headquarters to another EU member state, which is all but certain following the Brexit vote, Japan’s Ministry of Foreign Affairs is warning that the “appeal of London as an environment for the development of pharmaceuticals would be lost.” The harsh critique comes as the EMA, which has 890 employees of various nationalities at its headquarters in London, has said the decision on where to move from its current locale...
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    Brexit Rejig: UK Taps Three Leaders to Helm Office for Life Sciences

    The UK’s Office for Life Sciences, which will continue to be a joint unit across the Department of Health (DH) and the newly formed Department for Business, Energy, and Industrial Strategy (BEIS), on Thursday selected three new ministers to lead. In the DH, two ministers will be jointly responsible for life sciences, including: Lord Prior of Brampton, Parliamentary Under Secretary of State for Health and former adviser to the health authority of Abu Dhabi, who will lea...