EMA: Human medicines highlights of 2021

EMAIn 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.

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)

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