EMA annual report reviews actions in 2022 24 May 2023

The European Medicines Agency (EMA) has published its annual report for 2022, highlighting its challenges and successes in a year that saw it face ongoing and new public health emergencies.

The EMA’s decisions saw new vaccines and treatments approved for COVID-19, and its extended mandate in crisis preparedness was brought to bear on an outbreak of monkeypox.

Alongside this work, the agency recommended 89 medicines for human use, including 41 with a new active substance. Among these were the first authorised product worldwide for the prevention of respiratory syncytial virus (RSV) disease in newborns and infants, plus the first gene therapy for severe and moderately severe haemophilia B.

Under the EU Medicines for All (EU-M4All) procedure, EMA evaluated a new vaccine against dengue and two diabetes treatments, addressing public health issues outside the EU.

The year also saw the implementation of the Clinical Trials Regulation, that came into use in January 2022, as well as the launches of the Clinical Trials Information System (CTIS) and the Accelerating Clinical Trials in the EU (ACT EU) programme. In addition, the EMA put greater emphasis on use of data and real-world evidence to support regulatory decisions.

Read the digital edition of the report here.