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In 2022, EMA recommended 89 medicines for marketing authorisation

In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 41 had a new active substance that had never been authorized in the European Union (EU) before. There r PDF icon overviewkey recommendations The 2022 data released today includes drug authorization data and a selection of new treatments that represent significant advances in their therapeutic areas.

Public health emergencies remained a key priority for EMA in 2022. The featured paper summarizes the most important recommendations on vaccines and treatments for COVID-19 and for mpox (monkey pox).

Once a medicine is authorized by the European Commission and prescribed to patients, EMA and EU Member States constantly monitor its quality and benefit-risk balance and take regulatory action when necessary. The measures may include a change to the product information, suspension or withdrawal of a medicine or the recall of a limited number of batches. Also included in the document is an overview of some of the most important security recommendations.

EMA press release – 16 February 2023

EMA. Human Medicines Highlights 2022

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco