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. The overview of key recommendations in 2021 includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.
![EMA, International , Healthcare, Biotechnology, Pharma, European Medicines Agency, regulatory science, Research](https://chemrobotics.in/wp-content/uploads/2021/12/WhatsApp-Image-2021-12-16-at-10.03.48-PM.jpeg)
EMA
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.
For further information, please download:
Human medicines highlights 2021 (PDF/1.17 MB)