Tech & Science
Tech & ScienceTech & Science
Tech & ScienceHuman medicines: highlights of 2022
In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 411 had a new active substance wh...
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 Data
Tech & ScienceVeterinary medicines: highlights of 2022
EMA has published an overview of its key recommendations of 2022 regarding the authorisation and...
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...
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...
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...
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...
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...
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...
Tech & ScienceEnd-of-year message from EMA’s Executive Director
List item News: End-of-year message from EMA’s Executive Director (n...
Tech & ScienceBest practices to fight antimicrobial resistance
The International Coalition of Medicines Regulatory Authorities (ICMRA) highlights successful regulatory and non-regulat...
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...
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...
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...
Tech & ScienceFirst gene therapy to treat haemophilia B
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Hemgenix (etranacogene...