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ICMRA workshop on adapted COVID-19 vaccinesCOVID-19 |International collaboration
ICMRA workshop on adapted COVID-19 vaccines
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ICMRA workshop on adapted COVID-19 vaccinesCOVID-19 |International collaboration
ICMRA workshop on adapted COVID-19 vaccines
Global regulators agree on key principles to adapt COVID-19 vaccines to tackle virus variants
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Start of review for ImvanexMonkeypox |Vaccine
Start of review for Imvanex
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Start of review for ImvanexMonkeypox |Vaccine
Start of review for Imvanex
EMA reviews data to extend use of smallpox vaccine Imvanex against monkeypox and recommends importing US vaccine to the EU as temporary measure
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Call for companies to register their i-SPOCEXTENDED MANDATE |SHORTAGES
Call for companies to register their i-SPOC
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Call for companies to register their i-SPOCEXTENDED MANDATE |SHORTAGES
Call for companies to register their i-SPOC
Marketing authorisation holders are invited to register their Industry Single Point of Contact on shortages in EMA’s IRIS platform. Deadline for registration is 2 September 2022
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CHMP highlights: June 2022MEDICINES |COMMITTEES
CHMP highlights: June 2022
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CHMP highlights: June 2022MEDICINES |COMMITTEES
CHMP highlights: June 2022
EMA's human medicines committee (CHMP) recommended 9 new medicines for approval in the EU at its June 2022 meeting
Latest news
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List item01/07/2022 COVID-19
Global regulators agree on key principles on adapting vaccines to tackle virus variants
On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop co-chaired by the European Medicines Agency (EMA) and the US Food and...
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List item30/06/2022
Assessing dietary exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU
EMA and the European Food Safety Authority (EFSA) published a report on the development of a harmonised approach to the assessment of the dietary exposure of people to residues of veterinary medicines, feed additives and pesticides in food of animal...
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List item28/06/2022
Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability
Marketing authorisation holders (MAHs) can now register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major...
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List item28/06/2022
Monkeypox: EMA starts review for Imvanex
EMA’s human medicines committee (CHMP) has started a review of data to extend the use of the smallpox vaccine Imvanex to include protecting people from monkeypox disease. Imvanex is currently authorised in the EU for the prevention of smallpox in...
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List item24/06/2022 COVID-19
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022
Nine new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its June 2022 meeting. The CHMP recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated,...
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List item24/06/2022
First gene therapy to treat severe haemophilia A
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) for the treatment of severe haemophilia A in adults who do not have factor VIII inhibitors (auto-antibodies...
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