Human medicines highlights 2022

In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 411 had a new active substance which had never been authorised in the European Union (EU) before. The Human medicines highlights 2022 of the 2022 key recommendations published today includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.

Public health emergencies remained a key priority for EMA in 2022. The highlights document summarises the most important recommendations on vaccines and treatments for COVID-19 and for mpox (monkeypox).

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 safety-related recommendations is also included in the document.

1 This news was updated to accurately reflect the number of medicines with a new active substance recommended for marketing authorisation.

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