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    UK Seeks to Increase Clinical Trials Transparency

    The UK government issued a policy paper to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report offered in 2018. “Research findings must be communicated in ways that are timely, meaningful and relevant to evidence users,” Parliamentary Under-Secretary of State for Health Baroness Blackwood said, welcoming the chance to address the October 2018 report . “Only with a system which values transpar...
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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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    UK Looks to Ensure Pharma Submissions Can Continue Under No Deal Brexit

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to ensure that if the UK leaves the EU without a deal, pharmaceutical companies can continue to submit regulatory and notification information to the UK. “If the UK leaves the EU with no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. Submissions related to human medicines would need to be submitted directly to the MHRA,” the agency said. ...
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    Falsified Medicines Directive: MHRA Responds to Comments, Addresses Brexit Impact

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) last month responded to comments on its proposal to implement packaging safety features under the EU Falsified Medicines Directive (FMD) .   The safety features, which include requiring a unique identifier comprised of a 2D data matrix code and human readable information and an anti-tampering device on the packaging of certain medicines, are detailed under Commission Delegated Regulation (EU) 2016/16...
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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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    European Regulatory Roundup: MHRA Rolls Out Online Portal to Streamline Medical Device Regulatory Services (18 January 2018)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Calls for HES Solutions to be Pulled From Market Over Kidney Injuries Europe looks set to suspend  the marketing authorizations for hydroxyethyl-starch (HES) solutions for infusion. The Pharmacovigilance Risk Assessment Committee (PRAC) recommended the suspension after a review found restrictions it imposed in 2013 had failed to stop the use of the drugs in patien...
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    ICH Transparency: New Info on Funding, Expert Working Groups

    The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded. "While these experts represent the regulatory and industry association parties that nominate them, this new level of transparency will bring a novel understanding of who contributes to the development of guidelines as well as the roles they play," ICH said. Accord...
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    UK’s MHRA Unveils Human Factors Guidance for Medical Devices

    As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers. The guidance, intended not just for manufacturers of all device classes and drug-device combination products but notified bodies too, offers a look at the UK’s regulatory framework, comparisons of different ...
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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 Triggers Brexit: What’s Next for the UK, MHRA and EMA?

    UK Prime Minister Teresa May on Wednesday set in motion the UK’s departure from the EU over the next two years, guaranteeing the European Medicines Agency (EMA) will see some significant changes over the next few years. One of the biggest changes due to Brexit will be the departure of the EMA’s headquarters from London to another country in the EU ( member states will decide the new location), though it’s still unknown where the headquarters will go and how UK’s Medicin...
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    MHRA: UK an Active Member of EU Networks ‘Until we Left the EU’

    In its annual accountability review, the UK’s Medicines & Healthcare products Regulatory Agency told the Parliamentary Under Secretary of State for Health that the UK “remained an active member of EU regulatory networks until we left the EU.” MHRA work with the EMA has been extensive, and according to the minutes of the meeting on 20 October, “was highly valued. The MHRA was working closely with stakeholders, including industry, to fully consider all the options for reg...
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    A ‘Cures’ Revival? Congress Looks to Lame Duck Session to Pass Bill Overhauling FDA, NIH

    With the election just eight days away, House and Senate Republicans are working hard to re-shape a wide-ranging bill lingering for more than two years that would overhaul the way the US Food and Drug Administration (FDA) reviews medical devices and significantly increase (to the tune of almost $9 billion over five years) funding for the National Institutes of Health (NIH), among other major changes. Last month, Senate Majority Leader Mitch McConnell (R-KY) and House Spe...