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  • Regulatory NewsRegulatory News

    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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    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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    UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges. “Users of Accu-Chek Insight insulin pump system with NovoRapid PumpCart cartridges, can check for any leaked insulin in the cartridge compartment...
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    European Regulatory Roundup: MHRA, UK Biopharma Industry Warn Against Brexit (12 May 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA Chairman Signs Letter Warning of ‘Complexity and Uncertainty’ of Brexit The chairman of the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has signed a letter warning of the “complexity and uncertainty” that could follow Britain’s exit from the European Union (EU). MHRA Chairman Sir Michael Rawlins joined with more than 90 other members of the...
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    European Regulatory Roundup: EMA to Allow Patient-Reported Outcomes in Oncology Trials (28 April 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Finalizes Guidelines on Using Patient-Reported Outcomes in Oncology Trials The European Medicines Agency (EMA) has finalized its guidelines on the use of patient-reported outcomes (PRO) in oncology clinical trials. EMA created the document to help sponsors incorporate patient perspectives and quality-of-life measures into their clinical trial datasets. Once the document...
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    Cash-Strapped MHRA Looks to Stay Flexible

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released its business plan for 2016-17, warning of serious financial troubles, particularly as funding for the regulation of medical devices has declined over the past decade and as it's losing revenue from industry because of changes at the EU level. “Funding for devices regulation is at half the level of what it was in 2003 in real terms; and while a number of efficiency measures have been t...