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Events

  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2020, PRAC, 10/07/2020

    At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of...

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  • International regulators align positions on phase 3 COVID-19 vaccine trials, , 09/07/2020

    Medicines regulatory authorities from around the world have published a report  today highlighting the outcomes of the second workshop on COVID-19...

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  • EMA finalises opinion on presence of nitrosamines in medicines, , 09/07/2020

    EMA’s human medicines committee (CHMP) has issued an opinion requiring companies to take measures to limit the presence of nitrosamines in human...

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  • Workshop: safe use of medicines during pregnancy and breastfeeding, , 08/07/2020

    EMA is hosting a virtual workshop with its Patient and Consumers’ Working Party (PCWP) and Healthcare Professionals’ Working Party (HCPWP) on Tuesday ...

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  • Launch of public consultation on joint network strategy to 2025, , 06/07/2020

    EMA and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years that is released for a two-month public...

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  • International regulators provide guiding principles for COVID-19 clinical trials, , 01/07/2020

    EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory...

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  • EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information, , 30/06/2020

    EMA and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have signed an agreement that allows them to share confidential...

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  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020, CHMP, 26/06/2020

    Eight new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its June 2020 meeting....

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  • New medicine for cystic fibrosis patients, CHMP, 26/06/2020

    EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Kaftrio, the first triple combination...

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  • New treatment to enable kidney transplant in highly sensitised patients, CHMP, 26/06/2020

    EMA has recommended granting a conditional marketing authorisation in the European Union for Idefirix (imlifidase), the first treatment for adult...

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  • First COVID-19 treatment recommended for EU authorisation, , 25/06/2020

    EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-...

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  • Emer Cooke nominated as new EMA Executive Director, MB, 25/06/2020

     The EMA Management Board has nominated Emer Cooke as the new Executive Director of the Agency. At an extraordinary virtual session on 25 June, the Board...

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  • Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines, , 24/06/2020

    Under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed COVID-19 vaccine...

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  • European regulators make recommendations drawing on lessons learnt from presence of nitrosamines in sartan medicines, , 23/06/2020

    The European medicines regulatory network has issued recommendations on impurities in medicines following the conclusion of an exercise to draw on...

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  • Academia developing medicines for rare diseases to receive free EMA scientific advice, , 23/06/2020

    To further encourage the development of treatments for rare diseases, EMA will waive all fees for scientific advice for academia developing orphan...

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  • European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines, , 22/06/2020

    Senior officials from the European Commission (EC - DG SANTE), EMA and the United States Food and Drug Administration (FDA) held their 2020 bilateral...

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  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020, CVMP, 19/06/2020

    CVMP adopts a draft strategy on antimicrobials 2021-2025CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive...

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  • International regulators stress value of safe and effective vaccines, , 18/06/2020

    EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the International Coalition of Medicines...

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  • Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4, , 15/06/2020

    The International Coalition of Medicines Regulatory Authorities (ICMRA) convened its regular virtual meeting of regulators from around the world on 12...

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  • Annual report 2019 published, , 15/06/2020

    EMA released its annual report that showcases the Agency’s efforts to protect and promote human and animal health in Europe and highlights the...

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