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    Brexit, medicine availability top EMA stakeholder report

    Brexit readiness, regulatory science strategic planning, and medicine availability topped the list of big-picture areas of engagement between the European Medicines Agency (EMA) and industry stakeholders in a newly released biennial report.   The EMA report , released Friday and covering the 2018-19 biennium, was presented to EMA’s Management Board in December 2020. It provides a high-level look at interaction between the European regulator and the pharmaceutical indu...
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    Recon: Record-shattering 2020 healthcare investment; BIO layoffs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Who’s who in Biden’s health care team ( Medical Economics ) Biden begins presidency with aggressive healthcare agenda ( Healthcare IT News ) Biden Inherits a Vaccine Supply Unlikely to Grow Before April ( NYT ) Biden administration is trying to figure out what’s delaying Covid vaccine shots, CDC says ( CNBC ) How To Fix The Covid-19 Vaccine Rollout ( Forbes )...
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    Cyberattack: EMA says leaked documents ‘manipulated’

    Documents related to COVID-19 vaccines that were unlawfully accessed in a cyberattack against the European Medicines Agency (EMA) and subsequently leaked online were intentionally manipulated, the agency said on Friday.   EMA first disclosed the hack in December and said at the time it had launched a full investigation in cooperation with law enforcement and other authorities. Since then, vaccine frontrunners Pfizer and BioNTech and Moderna have released statements ack...
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    EMA offers parallel Article 58, centralized authorization reviews

    The European Medicines Agency (EMA) on Thursday issued a draft guidance for consultation explaining how sponsors can pursue a parallel Article 58 (EU-M4all) opinion and centralized marketing authorization for medicines they intend to market in the EU and abroad.   The Article 58 procedure allows EMA’s Committee for Medicinal Products for Human Use (CHMP) to give opinions in cooperation with the World Health Organization (WHO) on medicines intended to be used in low- an...
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    European Commission appoints members to MDR/IVDR expert panels

    The European Commission this week released the names of members appointed to its 12 expert panels on medical devices and in vitro diagnostics (IVDs).   The expert panels, established under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will provide scientific, technical and clinical input to the Commission, its Medical Device Coordination Group (MDCG), member states, notified bodies and manufacturers. In particular, notified bodies ...
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    EMA considers AstraZeneca vax; Swissmedic okays Moderna's

    The European Medicines Agency (EMA) could issue an opinion on the COVID-19 vaccine co-developed by AstraZeneca and the University of Oxford as early as 29 January, according to a press release the agency issued on Tuesday.   The agency announced that it has received the full application packet for conditional marketing authorization of the chimpanzee adenovirus vector vaccine following a rolling review that began 1 October.   The AstraZeneca vaccine, already author...
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    EC clears path for remote audits by notified bodies

    Remote audits will be an option during the pandemic for some European medical device and in vitro diagnostic manufacturers, following an announcement from the European Commission (EC).   The temporary step takes into account the “exceptional and unforeseen circumstances caused by the COVID-19 crisis,” according a notice issued by the EC on Monday. Both industry and notified bodies had felt hamstrung by the complete stall in inspections caused by the coronavirus pande...
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    Updated: Documents leaked to the internet in wake of EMA cyberattack

    Editor's note: This article was updated 12 January 2021 to include information provided in EMA's fourth update on this cyberattack.  Some of the COVID vaccine-related documents obtained during an early December 2020 cyberattack on the European Medicines Agency (EMA) made their way to the internet, according to the agency's fourth update on the matter. EMA's ongoing investigation has shown that "some of the unlawfully accessed documents related to COVID-19 medicines an...
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    Euro Roundup: Onslaught of Brexit guidances from MHRA; Swissmedic's adverse event reporting challenges

    MHRA publishes 48 guidance documents on new regulatory regime   The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published 48 guidance documents on the processes that will apply now that the Brexit transition period has ended. Throughout 2020, MHRA published guidance on how drugs and medical devices would be regulated in the UK after Brexit. In the days before and after the transition period ended on 31 December, the agency released a flurry o...
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    What’s in the Brexit trade deal for the pharmaceutical and medical device industries?

    After years of painstaking negotiations, the UK parted ways with the EU on 1 January after an 11-month transition period with a 1,200-plus page trade deal in hand, narrowly avoiding a no-deal scenario.   The trade deal, which was reached on 24 December, avoids tariffs and quotas on goods traded between the EU and UK and sets forth some provisions for cooperation and alignment on a range of issues from transportation to environmental protection but avoids major topics...
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    COVID antigen testing framework laid out by EC

    The European Commission is purchasing more than 20 million rapid antigen tests for SARS-CoV-2, the virus that causes COVID-19, and making them available to member states. At the same time, EC is also proposing a framework for a common approach for use, validation and mutual recognition of the tests across the European Union’s member states.   Rapid antigen tests are a tool “to further strengthen countries’ overall testing capacity, particularly as testing remains a key...
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    EU authorizes Pfizer-BioNTech COVID vaccine

    The European Commission on Monday conditionally authorized Pfizer and BioNTech’s COVID-19 vaccine after receiving a recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use earlier in the day.   The fast-tracked decision shortened what is usually a two-month procedure to a matter of hours, spotlighting the dire need for a vaccine as much of Europe faces lockdowns and restrictions amid a winter resurgence of the virus. The c...