Tech & Science

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Human medicines: highlights of 2022

In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 411 had a new active substance wh...
EdgioTech & Science

Edgio Strengthens Security Offering with WAAP Enhancements and DDoS Scrubbing Solution

Upgrades Boost Edgio’s Ability to Mitigate Sophisticated Threats and Safeguard Applications and Data
Tech & Science

Veterinary medicines: highlights of 2022

EMA has published an overview of its key recommendations of 2022 regarding the authorisation and...
Actions to support the development of medicines for childrenTech & Science

Actions to support the development of medicines for children

Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency o...
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 becomes mandatory for ne...
Tech & Science

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 for all new clinical tr...
Tech & Science

Assessment of human dietary exposure to residues of veterinary medicines in the EU

EMA and the European Food Safety Authority (EFSA) have published a joint report on the development of a harmonised appro...
Tech & Science

Facilitating Decentralised Clinical Trials in the EU

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have publish...
Tech & Science

EMA business hours over holiday period

The European Medicines Agency's (EMA) office is closed from 18:30 on Thursday 22 December 2022 to 07:30 on Wednesday 4 J...
Tech & Science

End-of-year message from EMA’s Executive Director

List item News: End-of-year message from EMA’s Executive Director (n...
Tech & Science

Best practices to fight antimicrobial resistance

The International Coalition of Medicines Regulatory Authorities (ICMRA) highlights successful regulatory and non-regulat...
Tech & Science

New Quality Innovation Expert Group (QIG) supports medicine innovation

EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufa...
Tech & Science

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 bivalent vaccines targeting the original strain and Omicron...
Tech & Science

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 monoclonal antibodies currently authorised for COVID-19 are unlikely...
Tech & Science

First gene therapy to treat haemophilia B

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Hemgenix (etranacogene...
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