Foreword
by Lorraine Nolan
Chair of EMA Management Board
Welcome to EMA’s annual report for 2022. In here you will find details about EMA’s achievements and milestones during another transformative year for the Agency, the regulatory network and European healthcare systems as a whole.
This is my first year as Chair of the Management Board, a role I took over from Christa Wirthumer-Hoche in March. I would like to start by thanking Christa for her valuable support. Her tenure as EMA Chair coincided with a series of crises and organisational challenges – Brexit, EMA’s move to Amsterdam and the COVID-19 emergency. Throughout this challenging period, Christa’s steadfast advocacy, commitment and dedication as chair of EMA’s Management Board was exemplary.
In 2022, people began to live with COVID-19 in the community. The pandemic did not end, but it did evolve during the year with different phases requiring new vaccination campaigns for Member States. A key focus for EMA was on the approval of new and the development of existing vaccines and therapeutics to support this public health response collaborating across the regulatory network to pool the best scientific expertise from across the EU.
In March, EMA started operating under a new extended mandate which recognised the role the Agency played during the pandemic. One of my responsibilities as Chair of the Management Board is to ensure that the Agency has the resources to deliver efficiently on this new mandate.
During the course of the year, we also saw significant enhancements to the medicines regulatory system with the implementation of two new regulations, which are transforming human and animal medicines regulation in the EU – the Clinical Trials Regulation, which includes the Clinical Trials Information System, for which EMA is responsible, and the Veterinary Medicines Products Regulation. These regulatory changes will strengthen our system and provide better outcomes for patients and animal health and health system delivery.
I would like to acknowledge the forward steps we have been making to bring data and analytics into our work in 2022 more specifically. Digital innovation has disrupted all industries, and the work of a medicines regulator is not beyond its influence. By embracing new technologies, we can further develop new approaches to the way we assess and approve treatments and therapies in the EU. For example, the Data Analysis and Real World Interrogation Network (DARWIN EU) will deliver timely and reliable evidence from across Europe on diseases, populations and the uses and performance of medicines.
At the organisational level, the Management Board saw the benefits of continued investment in IT to improve processes and efficiency in EMA. Our organisation has to make sure that our ways of working meet the needs of the European medicines regulatory network in a fashion that is streamlined, efficient and reliable. We will continue to ensure that EMA’s processes, systems and approaches are progressive and fit for a world leading public health agency.
Our achievements, as outlined in this report, give multiple examples of the true value of partnership across the EU regulatory network. Most of EMA’s work relies heavily on collaboration between regulators, organisations, people and Member States. Looking ahead, as Chair of the Management Board I would like to see continued investment in the sustainability of our network to ensure we have the resourcing and capacity to meet the regulatory needs of the EU population, both in normal times, and in a crisis.
Finally, I would like to thank my fellow Board members for putting their trust in me as Chair, and to all of my colleagues across the regulatory network and the European Commission. I would also like to express my deep gratitude to EMA’s staff whose scientific excellence in the evaluation and supervision of medicines supports all European citizens and animals alike. As we continue to navigate our way out of the pandemic, let us all continue to work closely together, share our ideas and expertise and make sure the medicines regulatory network that emerges from this crisis is stronger, bolder and ready for current and emerging challenges.