End-of-year message from EMA’s Executive Director

News 21/12/2022

Emer's Cooke end-of-year message 2022

We are rapidly approaching the end of 2022 and the festive season, which for many of us is one of the most wonderful times of the year – mainly because we reunite with family and friends from near and far to celebrate, to embrace.

This has become all the more poignant as last year, due to the COVID-19 pandemic, we couldn’t all enjoy these things we had previously taken for granted. Some of us were in lockdown or travelling was difficult with restrictions still in place to limit the spread of Omicron. 

Today we are in a much better place with COVID-19. We have seven COVID-19 vaccines and four vaccines tailored to specific strains of the SARS-CoV-2 virus authorised for use in the EU. Thanks to the rapid pace of scientific progress, and to EMA’s and the regulatory network’s ability to adapt during these times of crisis, we are able to experience some return to normality again. The knowledge we gained with COVID-19 also helped us mount a rapid response to mpox (monkeypox), declared a public health emergency by the World Health Organization (WHO) in the middle of the year.

Beyond our work on these public health crises, we have recommended 89 human medicines for approval. Under the EU Medicines for all (EU-M4All) procedure, EMA evaluated a new vaccine against dengue and two diabetes treatments that address important public health issues outside the European Union (EU). In the veterinary area, we recommended ten new medicines for approval. 

The festive season is also a time for reflection. For EMA, 2022 was a year of profound changes. We were adapting and improving, learning and adjusting.

The Agency became stronger thanks to the European Commission’s decision to extend our mandate. This is a recognition of EMA’s efforts and successes during the pandemic. The extended mandate formalises some of our existing procedures, but also provides us with new tools to respond effectively to future public health crises, tackle medicine shortages and improve the monitoring of medical devices and their authorisation procedures. This requires adjustments and transformation, such as becoming more digital and more agile.

We progressed the implementation of two new major pieces of legislation, with profound effects and changes in the way clinical trials are regulated and veterinary medicines are supervised in the EU.

The Clinical Trials Regulation that entered into force in January 2022 and the Clinical Trials Information System, or CTIS, launched at the same time, aim to reinvigorate clinical research in the EU. It is a major change management initiative, a move from an entirely national system to a system with a single EU submission, coordinated assessment between the Member States and high levels of transparency never seen before for clinical trials. We are working hard to deliver the next CTIS milestone: the mandatory use of the system as of 31 January 2023.

The Veterinary Medicines Products Regulation aims to ensure wider access to information about medicines for animals, a better monitoring of suspected side effects, and new measures to limit the development of antimicrobial resistance. As part of the implementation, EMA successfully launched the Veterinary Medicines information website at the beginning of the year.

2023 is around the corner. Like 2022, it will bring adjustments and change. Over the course of next year, we are planning to lift the business continuity status that was invoked in 2020 to cope with the COVID-19 pandemic. It will be necessary to establish a new, post-pandemic way of working in cooperation with our partners and stakeholders.

EMA will carry out its work on more flexible regulatory processes while maintaining high standards for quality, safety and efficacy of medicines. As real-world data are critical for regulatory decisions on medicines, we will invest in generating better, stronger data by using tools such as ACT EU or DARWIN EU. We will further strengthen the collaboration between regulators, governments, industry, science, and also plan to communicate more with you, the EU citizens, to share fact-based information, to actively listen, to engage.

We will continue to support a work environment that prevents burnout and promotes the wellbeing of our staff. During these times of intense change, listening directly to staff feedback, personal challenges and struggles helps us to find and implement the best tailored approaches.

Despite the many challenges and changes we face and the still ongoing COVID-19 pandemic, I am embracing the New Year with optimism. Together we can make a difference. With EMA’s staff, I look forward to continuing to work together with our partners and stakeholders to further promote public and animal health.

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