The 2022 Annual Report of the European Medicines Agency (EMA) highlights the agency's key activities in the protection and promotion of public and animal health in the European Union (EU). This includes the evaluation and approval of human and veterinary medicines, with a special focus on the response to public health emergencies such as the COVID-19 pandemic and the mpox virus outbreak. In addition, the report highlights the authorization of numerous innovative medicines, as well as important changes in the regulation of veterinary medicines. Also mentioned is the successful implementation of the Clinical Trials Regulation and the initiatives that are transforming the way clinical trials are conducted in Europe. Taken together, the report reflects the EMA's achievements and challenges in 2022, with a focus on the response to public health emergencies and advances in medicines regulation in the EU.