The overview of key recommendations in 2021 includes figures on the authorisation of medicines and a selection of new treatments, as well as safety monitoring of veterinary medicines.
In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance which had never been authorised in the European Union (EU) before. This is a 35% increase compared to the 39 medicines with a new active substance that were authorised in 2020.
COVID-19 was a key priority for EMA in 2021: The Agency recommended four vaccines and five treatments for COVID-19. A lot of effort was dedicated to scaling up vaccine manufacturing capacity and supply. Throughout the year, EMA approved 33 new manufacturing sites for COVID-19 vaccines, leading to a substantial increase in vaccine manufacturing capacity and supply.
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 recommendations, including safety recommendations for COVID-19 vaccines that received global public attention, is also included in the document.
EMA has published an overview of its key recommendations of 2021 regarding the authorisation and safety monitoring of veterinary medicines.
In 2021, EMA recommended 12 medicines for marketing authorisation. Of these, seven had a new active substance. Five are vaccines, including four new biotechnological vaccines.
A selection of these recommendations can be found in the veterinary medicines highlights document.