Human medicines: highlights of 2023
In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs.
The Agency recommended two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV), and the first advanced therapy medicinal product using a ground-breaking gene-editing technology known as CRISPR/Cas9 to treat two rare blood disorders. EMA also adopted two positive opinions for medicines for use in countries outside the EU.
The overview of the 2023 key recommendations published today includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.
Once a medicine is authorised by the European Commission and prescribed to patients, EMA and the EU Member States continuously monitor its quality and benefit-risk balance and take regulatory action when needed. Measures can include a change to the product information, the suspension or withdrawal of a medicine, or a recall of a limited number of batches. An overview of some of the most notable safety-related recommendations is also included in the document.