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    EU Regulatory Roundup: Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply   Ireland’s Health Products Regulatory Authority (HPRA) has shared details of its work to mitigate the risk that a no-deal Brexit will disrupt the supply of medical devices. HPRA wants companies to consider their stocking levels and make arrangements to ensure they can replenish their supp...
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    MHRA Updates No-Deal Brexit Device Guidance

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday updated its no-deal Brexit guidance for medical devices, adding a new section on the role of the “UK Responsible Person.” According to the guidance, the UK Responsible Person, who must be established in the UK, acts on behalf of a non-UK manufacturer to carry out tasks for the manufacturer, which include registering with the  MHRA  before a device is placed on the UK market. “Only a manu...
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    UK Warns Again: No-Deal Brexit Could Disrupt Medicine Supplies

    The UK government on Wednesday published a previously sensitive document explaining how a no-deal Brexit beginning on 31 October could strain trade across the English Channel for up to six months. “The reliance of medicines and medical products’ supply chains on the short straits crossing make them particularly vulnerable to severe extended delays; three-quarters of medicines come via the short straits,” the document, first drafted in August and dubbed “Operation Yellow...
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    No-Deal Brexit: How Medicines and Devices Will be Regulated in the UK

    Although there may be another extension to Brexit day, the prospect for a no-deal Brexit at the end of October still looms large and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday reiterated guidance on what will happen to drug and medical device regulations if such a no-deal path moves forward. On the side of minimal disruption, MHRA notes that transitional legislation will ensure that all currently granted Centrally Authorised Products ...
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    EU Regulatory Roundup: AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit   The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has added the active pharmaceutical ingredient (API) in AstraZeneca’s Calquence to the list of materials cleared for export to the European Union in the event of a no-deal Brexit.   If the UK leaves without a deal the E...
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    EU Regulatory Roundup: MHRA Expands Guidance on Assistive Technology to Help Device Industry

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Expands Guidance on Assistive Technology to Help Device Industry   The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has revised its guidance on assistive technologies, products that support people with disabilities, restricted mobility or other impairments.   MHRA published guidance on the definition and safe use of assistive te...
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    MHRA to Land a New Interim Chief Executive Ahead of Brexit

    Beginning 20 September, June Raine will be the new interim Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA). Raine will replace Ian Hudson, who will step down after 18 years with MHRA, including six years as chief executive. In addition to Hudson, John Wilkinson, director of devices at MHRA, will step down at the end of October. In June, Wilkinson discussed with Focus several initiatives that MHRA is working on, including how to de...
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    RoundupsRoundups

    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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    MHRA Consults on Analytical Quality by Design Principles

    The UK’s Medicines and Health care products Regulatory Agency (MHRA) on Tuesday opened a three-month public consultation on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeial standards.   “Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management,” MHRA writes.   Th...
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    House Appropriators Target Areas for FDA Improvement

    The House Appropriations Committee on Tuesday voted to send its FY 2020 spending bill for the US Food and Drug Administration (FDA) to the House floor, in addition to releasing a report explaining areas where FDA needs to focus its efforts. The funding bill would provide FDA with $3.26 billion in non-user fee funding, an increase of $184 million (6%) above the FY 2019 enacted level. According to the Alliance for a Stronger FDA, the bill is expected to be taken up on the...
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    House Committee Proposes 6% Increase in FDA Funding for FY 2020

    The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the US Food and Drug Administration (FDA), calling for a $184 million increase in discretionary funding over 2019’s enacted level.   Total funding for FDA, including revenue from user fees, is $5.86 billion, according to the bill. That total is slightly less than the $6.1 billion requested by the Trump Administration for FDA.   “Within this total, the Committee prov...
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    MHRA’s Director of Devices to Step Down

    After more than seven years with the agency, John Wilkinson, director of devices at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will step down from his position at the end of October. A champion of the new EU regulations on medical devices and IVDs, Wilkinson worked to investigate reports of device problems and to advise health professionals and companies on the safe use of devices. Wilkinson also chaired the Competent Authorities Medical Devices...