The European Medicine Agency (EMA) has published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.
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.
In 2019, EMA recommended 66 medicines for marketing authorisation. Of these, 30 had a new active substance which had never been authorised in the EU before. The infographic includes a selection of medicines that represent significant progress in their therapeutic areas.
An overview of some of the most notable recommendations is also provided.