www.ema.europa.eu Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting.The committee recommended granting a conditional marketing authorisation for Casgevy* (exagamglogene autotemcel), an...

www.ema.europa.eu The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have published the first version of the Union list of critical medicines. It contains more than 200 active substances of medicines for human use considered critical for healthcare systems across...

www.ema.europa.eu The Committee adopted by consensus a positive opinion for a variation requiring assessment for Bravecto (fluralaner) concerning the addition of a new pharmaceutical form, 150 mg/ml powder and solvent for suspension for injection, for dogs.The Committee adopted by consensus...

www.ema.europa.eu Close collaboration between medicines regulators worldwide is paving the way towards the development of a global Pharmaceutical Quality Knowledge Management System (PQ KMS). The goal is to ensure patients can benefit from a continuous supply of life-saving medicines in a...

www.ema.europa.eu Availability of contentThe content from the previous version of this website is still available, including EMA’s bank of information on medicines.Former addresses (URLs) - such as links to pages and documents – also still work. These are either unchanged or, for the small...

www.ema.europa.eu The European Medicines Regulatory Network (EMRN) has been at the forefront of the fight against COVID-19 with its crucial role in the evaluation and monitoring of medicines, including vaccines. A joint report issued by the European Medicines Agency (EMA) and the Heads of...