EMA’s annual report 2021 published today provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU) and highlights EMA’s most significant achievements. These include the Agency’s activities to tackle the COVID-19 pandemic but also its work related to the scientific assessment and supervision of medicines in the EU.

The digital report features main outcomes regarding the evaluation and monitoring of human and veterinary medicines and the European medicines regulatory network’s response to COVID-19, and includes a selection of key figures. It also contains an interactive timeline of important milestones in 2021, allowing readers to explore each topic in more depth through additional documents, audio-visual materials and infographics.

The efficient and timely response to the COVID-19 pandemic remained the number one priority for EMA and the European medicines regulatory network in 2021. EMA recommended four vaccines and five treatments for COVID-19 for marketing authorisation in the EU. The Agency was also successful in supporting the scaling up of vaccine manufacturing capacity that led to a substantial increase in vaccine supply in the EU and globally. In addition, the annual report highlights key lessons learnt during the public health crisis.

In light of the experience accrued by EMA while dealing with the public health crisis, EU institutions took first steps towards extending EMA’s role in crisis preparedness and management of medicinal products and medical devices. In future, EMA will also closely monitor and mitigate 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. An overview of the Agency’s activities to prepare for its new legal mandate is provided in the report.

The report also showcases how EMA continued to address public and animal health needs beyond the pandemic. EMA recommended 92 human medicines for marketing authorisation in 2021. Of these, 54 had a new active substance which had never been authorised in the EU before. This is a 38% increase compared to 2020, by far the highest number in the last five years.

EMA also recommended 12 veterinary medicines for marketing authorisation, including a new vaccine for pigs which has the potential to reduce the need for antimicrobial treatment in animals and could limit the development of antimicrobial resistance (AMR).

Additionally, the report shows how the Agency 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.

The annual report also draws attention to other major achievements of the Agency, high-impact activities and challenges in 2021. These include efforts to address the public health threat of AMR, activities to reinforce IT security following a cyberattack on EMA in December 2020, as well as digital change initiatives. A number of projects that will strengthen scientific advice for products under development, provide support to marketing authorisation assessments and introduce new data analysis methodologies and tools to strengthen the scientific assessment of medicines are also highlighted in the report.

As in previous editions, the second chapter of the report is dedicated to core statistics and trends illustrating the Agency’s activities in the regulation of medicines. More detailed statistical information about EMA can be found in a traditional print-ready version that is published in a PDF format alongside the digital annual report.