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  • Regulatory NewsRegulatory News

    UK grants early access to remdesivir for COVID-19

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued a positive early access to medicines scheme (EAMS) opinion for Gilead Sciences’ remdesivir to provide the drug via the National Health Service to certain hospitalized patients with severe cases of coronavirus disease (COVID-19).   “For the time being and due to limited supplies, treatment will be prioritised for patients who have the greatest likelihood of deriving the most benefit,” ...
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    EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020

    The European Commission (EC) said recently that all marketing authorization holders (MAHs) need to ensure that all work at batch testing facilities in the UK is transferred to EU facilities and that all the necessary regulatory submissions are completed by 1 January 2020. The reminder announcement follows a letter sent last February that said drugmakers under certain circumstances would be allowed to continue batch testing in the UK even after the UK departed from the...
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    EU Committee Urges No-deal Brexit Transition Period for Medical Devices

    The European Commission (EC) should act in the “best interest of citizens” and establish a transition period to allow manufacturers to keep placing medical devices certified by a UK Notified Body (NB) on the EU market under a no-deal Brexit, trade association COCIR urged Wednesday in an open letter. The European Coordination Committee of the Radiological Electromedical and Healthcare IT Industry—otherwise known as COCIR—expressed its concerns around the increasingly lik...
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    MHRA Sets No-Deal Brexit Process for Pharma Submissions

    Pharmaceutical companies and clinical trial sponsors were directed to follow new guidelines for regulatory submissions that would have to be directly submitted to the UK’s Medicines and Health products Agency (MHRA) if Britain leaves the EU without reaching an agreement by the end of this month. The guidance, posted Monday, describes the steps applicants and sponsors need to follow for access to the new MHRA gateway for UK submissions from day one post-Brexit in a no-de...
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    MHRA Spells Out Post-Brexit Regulation of Medical Devices Under No-deal Scenario

    With just about a month left until Brexit, the UK regulatory authority for medical products issued updated guidance on what the medical device industry needs to know about the future device regulation under the increasingly likely scenario of Britain leaving the EU without a deal on continuing resolutions. From requiring a new role as a UK Responsible Person and additional importing and distributing obligations to a slew of new registration and classification requiremen...
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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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    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 ...