Human medicines

EMA is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 41 had a new active substance which had never been authorised in the EU before. EMA continued to closely monitor the safety of medicines on the market and take action when needed. The product information for 467 centrally authorised medicines was updated on the basis of new safety data in 2022. Here are some key figures on the authorisation and safety monitoring of medicines for human use in 2022. For more detailed information, download the full annual report 2022 (PDF version).