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by Emer Cooke

EMA Executive Director

2020 will be remembered as the year the COVID-19 pandemic took hold of the world, causing hardship for so many. As the scientific body in charge of the regulation of medicines, EMA had an essential part to play in ensuring treatments and vaccines would be authorised as quickly as possible to help fight this new disease, without compromising any of the EU standards for efficacy, safety and quality.

Looking back at 2020, we can be proud of how EMA and the European medicines regulatory network rose to the challenge. Just as EMA closed the chapter of its relocation and moved into its permanent headquarters in Amsterdam, the COVID-19 outbreak meant that the Agency had to shift its operations to work fully remotely and re-prioritise its plans immediately to respond to the public health need. EMA set up agile infrastructures and mobilised EU expertise to enable fast decision-making, especially through the EMA pandemic Task Force (COVID-ETF). It also launched rolling reviews as a key tool to accelerate assessments of COVID-19 vaccines and treatments.

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Emer Cooke

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Throughout the year, we tackled one by one the various issues presented by the pandemic. We led and coordinated EU action to prevent and mitigate shortages of medicines due to the pandemic. Our experts provided early guidance to sponsors of potential COVID-19 treatments and vaccines; they worked day and night to support fast-track approvals and prepared for effective post-marketing safety monitoring. While we did everything that was necessary to expedite our evaluation processes, we were guided by one priority: getting our recommendations right for the benefit of European citizens. With this objective in mind, we actively reached out to stakeholders and citizens to explain our work, ensured utmost transparency of our scientific assessment and conclusions, and led international collaboration efforts to streamline regulatory requirements for COVID-19 vaccines and treatments.

I took over at the helm of the Agency from my predecessor Guido Rasi on 16 November 2020, just a few weeks before EMA gave its first positive opinion for a COVID-19 vaccine. I would like to mark his tremendous contribution to shaping EMA into an organisation that was ready to support the development and approval of a vaccine against a new disease less than a year after it first emerged – a truly historic scientific achievement.

It was made possible by the extraordinary resilience of EMA staff and the tireless work behind the scenes of a high number of experts from all EU Member States. A chapter of this annual report is dedicated to EMA’s response to the pandemic.

Despite the strong focus on the response to the COVID-19 pandemic, the Agency performed its core activities to the highest standards in 2020, thanks to swift and rigorous re-prioritising of activities. Altogether, EMA recommended 97 new human medicines for approval, the highest number in over 10 years. EMA continued to closely monitor the safety of medicines on the market and took action when needed to protect patients.

On the veterinary side, the Agency recommended 20 medicines for approval. The fight against antimicrobial resistance remained a priority. In addition to the annual report on the sales of veterinary antibiotics, EMA’s key contribution in this area in 2020 was the publication of updated scientific advice on the categorisation of antibiotics used in people and animals. It also continued to prepare for the new EU veterinary legislation which will remain a key focus looking forward.

2020 was also the year Brexit became a reality. The meticulous preparation by EMA and the EU medicines regulatory network meant that everybody was ready to successfully transition into the new dynamic of the EU27.

In 2020, EMA celebrated its 25th anniversary. It certainly did not rest on its laurels but made sure that it was prepared for future challenges. It published its Regulatory Science Strategy to 2025, in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines. This fed into the overarching Network Strategy to 2025, which was developed together with the Heads of Medicines Agencies (HMA), to guide the work carried out by the European medicines regulatory network in the coming years.

2020 has put EMA and the regulation of medicines in the public spotlight. While the pandemic led us on a motivating but incredibly challenging journey, it has also been an opportunity for us to demonstrate the value to public health of decision-making that is based on science – and science only. I would like to thank all those who have been part of this journey and who are at the heart of EMA’s work: the members of its scientific committees, the working parties and scientific advisory groups, the Management Board and the national experts, our stakeholders and, of course, EMA’s staff.

March 2021