EMA published its annual report 2022 today. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU).

The digital report outlines the most important highlights regarding the evaluation and monitoring of human and veterinary medicines and a selection of key figures. It also contains an interactive timeline of important milestones in 2022, with advanced functionalities that allow readers to explore each topic in more depth by accessing additional documents, audio-visual materials and infographics.

Ongoing and newly emerging public health emergencies remained a key focus area of EMA and its partners within the European medicines regulatory network in 2022. Based on EMA’s scientific assessments, new vaccines and treatment options were added to the EU’s arsenal in the fight against COVID-19. When an outbreak of the mpox (monkeypox) virus brought an additional challenge to public health, the crisis preparedness tools established in the context of the Agency’s extended mandate were put to use, ensuring a coordinated EU response. The report includes an overview of EMA’s recommendations on vaccines and treatments for COVID-19 and for mpox. In addition, it highlights the Agency’s activities carried out to implement the EU regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices.

The report also showcases how EMA continued to address public and animal health needs beyond the ongoing public health emergencies. In 2022, EMA recommended the authorisation of 89 medicines for human use, including 41 with a new active substance. Many represented significant progress in their therapeutic areas.

In the area of veterinary medicines, EMA recommended ten medicines for marketing authorisation. On 28 January 2022, the Veterinary Medicinal Products Regulation became applicable, bringing important changes in the regulation of medicines for animals. An overview of these is provided in the report.

EMA’s annual report also draws attention to other major achievements of the Agency, high-impact activities and challenges in 2022. These include the implementation of the Clinical Trials Regulation, which entered into application in January 2022, as well as the successful launches of the Clinical Trials Information System (CTIS) and the Accelerating Clinical Trials in the EU (ACT EU) initiative, which are remodelling the way clinical trials in Europe are initiated, designed and run. Additionally, the report presents EMA’s initiatives aimed at driving transformation in regulatory decision-making by building capability and capacity in the analysis and use of data and real-world evidence.

As in previous editions, the second chapter of the report presents a selection of figures and interesting trends illustrating more broadly the Agency’s activities in the regulation of medicines in the EU. More detailed statistical information about EMA can be found in the print-ready version that is published alongside the digital annual report in PDF format.