Tech & ScienceHuman medicines: highlights of 2022 In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 411 had a new active substance wh...2023.03.17Tech & Science
Tech & ScienceEdgio Strengthens Security Offering with WAAP Enhancements and DDoS Scrubbing Solution Upgrades Boost Edgio’s Ability to Mitigate Sophisticated Threats and Safeguard Applications and Data2023.03.01Tech & Science
Tech & ScienceVeterinary medicines: highlights of 2022 EMA has published an overview of its key recommendations of 2022 regarding the authorisation and...2023.02.21Tech & Science
Tech & ScienceActions 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...2023.02.09Tech & Science
Tech & ScienceUse 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...2023.02.03Tech & Science
Tech & ScienceMandatory 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...2023.01.25Tech & Science
Tech & ScienceAssessment 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...2023.01.22Tech & Science
Tech & ScienceFacilitating Decentralised Clinical Trials in the EU The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have publish...2023.01.13Tech & Science
Tech & ScienceEMA 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...2023.01.10Tech & Science
Tech & ScienceEnd-of-year message from EMA’s Executive Director List item News: End-of-year message from EMA’s Executive Director (n...2023.01.07Tech & Science
Tech & ScienceBest practices to fight antimicrobial resistance The International Coalition of Medicines Regulatory Authorities (ICMRA) highlights successful regulatory and non-regulat...2023.01.01Tech & Science
Tech & ScienceNew 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...2022.12.29Tech & Science
Tech & ScienceETF 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...2022.12.23Tech & Science
Tech & ScienceETF 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...2022.12.20Tech & Science
Tech & ScienceFirst gene therapy to treat haemophilia B EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Hemgenix (etranacogene...2022.12.17Tech & Science