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The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.
The European Medicines Agency published its Annual Report 2022 on May 15, 2023, outlining some of the agency’s milestones achieved in 2022 and highlights from its evaluation and monitoring of medicines. The new digital report also features advanced functionalities so readers can better explore documents and audio-visual materials.
COVID-19 and other health emergencies, such as the monkeypox outbreak, were a focus for the agency in 2022, with new vaccines and treatments approved. The report details activities EMA performed to reinforce its crisis preparedness and management as a result of these emergencies.
According to the report, EMA authorized 89 medicines in 2022 that included 41 new APIs. There were also 269 orphan drug applications received by the agency with 176 given the designation. There were also 51 requests for advanced therapy medicinal products, of which six were recommended for authorization.
“EMA’s annual report also draws attention to other major achievements of the [a]gency, 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 remodeling 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,” the agency stated in a press release.
Check out the report for more on EMA’s accomplishments in 2022.