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    Stakeholders weigh in on big data at EMA forum

    Effective use of real-world data and other data gathered outside the clinical trial arena requires a unified, big-picture approach, according to a new report from the first-ever big data stakeholder forum held by the European Medicines Agency (EMA).   The regulator’s report on the 15 December 2020 forum highlighted the importance of collaboration in addressing some of the challenges of bringing real-world data (RWD) into the drug development process. Some of these incl...
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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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    Amid pandemic, EMA's 2020 authorizations ticked upward

    Despite the pandemic, the European Medicines Agency (EMA) issued many more positive recommendations for human medicines in 2020 than in the previous year, according to a new report from the agency highlighting the year’s regulatory activities.   In 2020, 97 new medicines were recommended for authorization by EMA; of these, 39 contain a new active substance (NAS). In 2019, EMA issued 66 positive opinions for medicines, 30 of which contained a NAS. The total numbers of n...
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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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    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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    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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    EMA okays Europe's second COVID vaccine

    The European Commission has authorized a second vaccine against COVID-19 following a favorable review by the European Medicines Agency’s human medicines committee (EMA’s CHMP). On Wednesday, the messenger RNA (mRNA) vaccine co-developed by Moderna and the US National Institutes of Health was given a conditional marketing authorization.   “With the Moderna vaccine, the second one now authorized in the EU, we will have a further 160 million doses. And more vaccines will ...
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    FDA details review timelines as facility assessment-related CRLs pile up

    In guidance released Monday, the US Food and Drug Administration (FDA) provides the timelines it will stick to when reviewing responses to complete response letters (CRLs) for drugs and biologics when a facility assessment or inspection is required in order for the agency to make a decision on the application.   FDA’s ability to conduct on-site inspections has been dramatically curtailed amid the COVID-19 pandemic due to public health concerns and travel restrictions. ...
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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...