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by Christa Wirthumer-Hoche

Chair of EMA Management Board

I am pleased to introduce EMA’s annual report for 2020, a year in which the Agency was at the forefront of the largest public health emergency in modern times.

As everybody struggled with the COVID-19 pandemic around the world, the Management Board also had to get to grips with meeting in a virtual environment. We did this by adopting changes to the Board’s rules of procedure so that in 2020 all our decision-making meetings with the Member States could be held virtually.

The pandemic started just as EMA was completing its relocation to the Netherlands and setting up in its new office in Amsterdam. Once again, EMA and the European medicines regulatory network worked swiftly to adapt their activities and processes to ensure a rapid response to the pandemic whilst maintaining their core activities to protect public and animal health.

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Christa Wirthumer-Hoche

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The pandemic has underlined the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the EU and globally. I am incredibly impressed by the endurance and rigour shown by all experts in the network, as well as EMA’s staff and the Board, in facilitating the development and approval of COVID-19 vaccines and therapies at an unprecedented pace, without compromising on our high standards of safety, quality and efficacy.

Amid this public health crisis of unprecedented scale, there was a change at the head of EMA. Guido Rasi’s mandate as EMA’s Executive Director came to an end after nine years and Emer Cooke took over leadership of the Agency on 16 November 2020, following her nomination by the Board in June 2020. This change came at a time of tremendous pressure on the Agency, but thanks to their excellent cooperation, there was a seamless transition between the outgoing and the new Executive Director. The Board has full confidence that Emer will continue to lead the Agency successfully in the years to come, as we implement our network strategy to 2025, in alignment with the European Commission’s pharmaceutical strategy for Europe.

On behalf of the Board, I would like to thank Guido for his remarkable leadership during an exceptionally challenging period for EMA.

We have all felt the strain of the pandemic, yet despite the immense challenges of 2020, the network and EMA have made progress in important areas. The independent audit of the future clinical trials information system began as scheduled in December 2020, with the system on track to go live, and the new EU clinical trials regulation to become applicable, in early 2022. A review of EMA’s working party activities continued in 2020, with COVID-19 giving us an opportunity to reflect further on how we can serve the expertise needs of the network in an agile and sustainable way and respond to future scientific and technological challenges.

Implementation of the new veterinary regulation has progressed considerably, both in terms of new procedures and IT systems at the Agency and of delegated and implementing acts by the Commission based on the EMA’s scientific opinions. We are on track to meet the legal deadline of January 2022 and, in parallel, the network has been preparing training and information materials for stakeholders to learn and adapt to the new framework.

On behalf of the Board, I wish to thank colleagues across the network, the Commission and EMA staff for all they have achieved during what was the most unusual and challenging year in EMA’s history.

March 2021