ANNUAL REPORT 2021 (europa.eu)

In the annual report 2021 EMA summarized activities, achievements, and future plans. Despite the fact that pandemic situation was the number one priority for EMA and the whole European medicines regulatory network, EMA still managed to recommend 92 human and 12 veterinary medicines for marketing authorization. Additionally, EMA prepared for the implementation of the Veterinary Medicines Regulation and for the launch of the new Clinical Trials Information System (CTIS) supporting the go-live of the Clinical Trials Regulation, which entered into application in January 2022.

Moreover, efforts to address the public health threat of antimicrobial resistance (AMR), activities to strengthen IT security following a cyberattack on EMA in December 2020, several digital change initiatives, projects strengthen scientific advice for products under development, provide support to marketing authorization assessments and introduce new data analysis methodologies and tools to strengthen the scientific assessment of medicines are also highlighted in the report.

This report presented statistics and trends illustrating the EMA activities in the regulation of medicines as well.

Look into future for EMA shows close monitoring and mitigating shortages of medicines and medical devices during major events and public health emergencies and facilitate faster approval of medicines for the treatment or prevention of diseases causing a public health crisis.