Tech & Science

Tech & Science

Veterinary medicines: highlights of 2022

EMA has published an overview of its key recommendations of ...
Actions to support the development of medicines for children Tech & Science

Actions to support the development of medicines for children

Regulators in the European Union (EU) have taken several ini...
Tech & Science

Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU

List item News: Use of Clinical Trials Information System be...
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Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications

List item News: Mandatory use of CTIS from 31 January 2023 f...
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Assessment of human dietary exposure to residues of veterinary medicines in the EU

EMA and the European Food Safety Authority (EFSA) have publi...
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Facilitating Decentralised Clinical Trials in the EU

The European Commission (EC), the Heads of Medicines Agencie...
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EMA business hours over holiday period

The European Medicines Agency's (EMA) office is closed from ...
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End-of-year message from EMA’s Executive Director

List item News: End-of-year message from EMA’s Executive Dir...
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Best practices to fight antimicrobial resistance

The International Coalition of Medicines Regulatory Authorit...
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New Quality Innovation Expert Group (QIG) supports medicine innovation

EMA has established a Quality Innovation Expert Group (QIG) ...
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ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination

EMA’s Emergency Task Force (ETF) considers that adapted mRNA...
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ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2

EMA’s Emergency Task Force (ETF) has cautioned that monoclon...
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First gene therapy to treat haemophilia B

EMA has recommended granting a conditional marketing authori...
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Call for expression of interest for civil society representatives to participate in the work of EMA’s Paediatric Committee

The European Commission has launched a call for expression o...
Tech & Science

EMA recommends approval of second adapted Spikevax vaccine

EMA’s human medicines committee (CHMP) has recommended autho...