One Health
One Health: joint framework for action launched by five EU Agencies

How to enable EU to prevent and respond to health threats

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Human medicines committee meeting: April 2024 highlights

CHMP recommends 8 new medicines for approval in the EU

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Confidentiality arrangement between EU and Republic of Korea
Confidentiality arrangement between EU and Republic of Korea

EU and Korean regulators can now exchange confidential information on medicinal products

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hand picking a medicine from the shelf
Medicine shortages: new recommendations to strengthen supply chains of critical medicines

How to address vulnerabilities in production and delivery of critical medicines in the EU

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Covid-19 sesen at microscope
Report on COVID-19 vaccine strain updates: global regulators agree on timing and data requirements

International Coalition of Medicines Regulatory Authorities and World Health Organization workshop

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Latest news

EMA closed 9-10 May

The European Medicines Agency's (EMA) office is closed from 18:00 on Wednesday 8 May 2024 to 07:30 on Monday 13 May 2024. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.

NewsCorporate
One Health initiative
One Health: a joint framework for action published by five EU agencies

Today, the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda...

NewsHumanVeterinaryCorporate
EMA closed 1 May

The European Medicines Agency's (EMA) office is closed from 18:00 on Tuesday 30 April 2024 to 07:30 on Thursday 2 May 2024. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.

NewsCorporate
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Events

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system

EudraVigilance is the EU's system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA) and supports the reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of...

Online
Start date: 13 May 2024
End date: 17 May 2024
EventHumanClinical trials
Clinical Trials Information System (CTIS): Walk-in clinic - May 2024

This walk-in clinic on CTIS functionalities provides an opportunity for sponsors to receive practical information about the Clinical Trials Information System by asking questions to CTIS experts in real time.

Online
European Medicines Agency, Amsterdam, the Netherlands
Live Broadcast
Start date: 15 May 2024, 16:00 (CEST)
End date: 15 May 2024, 17:00 (CEST)
EventHumanClinical trials
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