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Events

  • EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines, , 09/04/2020

    As part of its health threat plan activated to fight COVID-19, the Agency has finalised and published the composition and objectives of its COVID...

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  • Global regulators stress need for robust evidence on COVID-19 treatments, , 09/04/2020

    International regulators have published a report today highlighting their considerations on the development of potential COVID-19 therapeutics, clinical...

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  • Global regulators discuss observational studies of real world data for COVID-19 medicines, , 07/04/2020

    In a dedicated COVID-19 workshop, organised by the European Medicines Agency (EMA) under the umbrella of the International Coalition of Medicines...

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  • EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic, , 06/04/2020

    The continued availability of medicines, in particular those used for patients with COVID-19, is of critical concern for EMA and its partners in the ...

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  • EMA provides recommendations on compassionate use of remdesivir for COVID-19, CHMP, 03/04/2020

    During an extraordinary virtual meeting held on 2 April 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the investigational...

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  • International regulators discuss available knowledge supporting COVID-19 medicine development , , 03/04/2020

    On 2 April, regulators from around the world joined the second workshop on COVID-19 organised by the European Medicines Agency (EMA) under the umbrella...

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  • COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes, , 01/04/2020

    Chloroquine and hydroxychloroquine, two medicines currently authorised for malaria and certain autoimmune diseases, are being investigated worldwide...

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  • Regulatory information - 1.6% increase in fees from 1 April 2020, , 01/04/2020

    General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.6% on 1 April 2020.Full details...

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  • EU recommendations for 2020/2021 seasonal flu vaccine composition, CHMP, 01/04/2020

    EMA has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal...

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  • Advancing regulatory science in the EU – new strategy adopted, , 31/03/2020

    EMA has published its Regulatory Science Strategy to 2025  today. The strategy provides a plan for advancing regulatory science over the next...

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  • Update on treatments and vaccines against COVID-19 under development , , 31/03/2020

    Supporting the rapid development and approval of effective and safe treatments for and vaccines against COVID-19 is EMA’s top priority to help save...

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  • EMA to issue electronic certificates for medicines, , 30/03/2020

    EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. As of today, the Agency will no longer provide...

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  • EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic, , 27/03/2020

    EMA is aware of recent media reports and publications which question whether some medicines, for instance angiotensin converting enzyme (ACE) inhibitors...

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  • No change to product information for breast cancer medicine Tyverb following re-assessment of data, CHMP, 27/03/2020

    The product information for Tyverb, a breast cancer medicine, will continue to state that no data are available on the effectiveness of Tyverb used...

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  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020, CHMP, 27/03/2020

    Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its March 2020 meeting. In...

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  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated), CHMP, 27/03/2020

    Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its March 2020 meeting. In...

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  • New gene therapy to treat spinal muscular atrophy, , 27/03/2020

    EMA has recommended granting a conditional marketing authorisation in the European Union for the gene therapy Zolgensma (onasemnogene abeparvovec) to...

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  • Restrictions in use of cyproterone due to meningioma risk, CMDh, 27/03/2020

    On 13 February 2020, EMA’s safety committee (PRAC) recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for...

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  • Recommendations to restrict use of fosfomycin antibiotics, CHMP, 27/03/2020

    EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic...

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  • No change is needed in use of direct oral anticoagulants following EMA-funded study, CHMP, 27/03/2020

    No change to the conditions of use of the direct oral anticoagulants Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban) is...

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