BRIEF—EMA approved 89 new medicines in 2022

In 2022, the European Medicines Agency (EMA) recommended 89 medicines for marketing authorization.

Of these, 40 had a new active substance which had never been authorized in the European Union (EU) before.

The  overview of the 2022 key recommendations published today includes figures on the authorization 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 summarizes the most important recommendations on vaccines and treatments for COVID-19 and for mpox (monkeypox).

Once a medicine is authorized by the European Commission and prescribed to patients, the 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.