Foreword by Lorraine Nolan
Chair of EMA Management Board
Welcome to the European Medicines Agency’s (EMA) annual report for 2023. On behalf of the Management Board, I invite you to explore the wealth of information in the following pages, which details the Agency’s important work to promote public health in the European Union (EU).
In 2023, the World Health Organization declared the end of the COVID-19 public health emergency. Over these three years we as a network collaborated, pooled our scientific and regulatory expertise across Europe, and together dealt with a crisis of gargantuan proportions. They were difficult times for health systems and while there are many lessons to learn – covered in the joint report issued by EMA and the Heads of Medicines Agencies (HMA) – our network is more robust and our mission more relevant than ever.
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Midterm report: lessons beyond COVID-19
Alongside the COVID-19 lessons, we also published the midterm report of the European Medicines Agencies Network Strategy (EMANS). Adopted in 2020, the EMANS identified shared challenges, goals, and priorities for a five-year period, to give strategic direction to the work of the European medicines regulatory network (EMRN).
The pandemic and its unprecedented challenges absorbed large amounts of resources from the medicines regulatory network, but it strengthened the network and supported transformative change in the European system across key strategic areas.
Today, we are on course and in good shape for the next challenges to come. For example, the structures, processes, and new technologies built throughout the COVID-19 pandemic will help implement the upcoming revision of the EU’s pharmaceutical legislation.
Systemic challenges in 2023
The Management Board’s oversight role covers the full range of EMA programmes and activities, making sure that the Agency works effectively and co-operates successfully with partner organisations across the EU and beyond. In 2023, our attention was focused on ongoing initiatives to address medicines shortages and the implementation of the Clinical Trials Information System (CTIS).
The CTIS was made mandatory on 31 January and, over the course of the year, the Board was pleased to see the number of clinical trial submissions grow from 100 new initial clinical trials in February 2023 to over 190 in October 2023. This is a testament to the hard work done to improve the performance of the system and enhance user experience.
On shortages, the Board noted the significant progress made to strengthen the existing framework. There are now a range of tools and measures available to Member States, including EMA Medicines Shortages Steering Group (MSSG) Toolkit, which sets out a wide range of actions Member States can take to manage medicine supply issues. We also welcomed the first version of the Union list of critical medicines.
Launching the audits and risks group
In 2023, we launched the Management Board Audits and Risks Group (MBRG) as a new subgroup of the Management Board. Its role is to provide objective and independent review, advice, impact assessment and oversight of EMA’s strategic processes in relation to risk, internal control and governance.
Transformation across the Network
The pace of development of Artificial Intelligence (AI) also sent ripples through the network in 2023. The Board fully supported EMA’s public consultation on its draft AI Reflection Paper, which sets out the parameters for this technology in the context of medicines regulation. I believe we have a responsibility as a network to leverage digital innovation where it can help improve our processes and get safe medicines to the patient faster. I also welcome EMA and HMA's AI workplan to 2028 that sets out a collaborative and coordinated strategy to make the most of the benefits of AI to stakeholders, while managing the risks.
Our work in medicines regulation relies on scientific talent and purposeful collaboration across 27 Member States. This is in the DNA of the EMRN and the cornerstone of EMA’s work and success and I welcome all of the effort and progress made by EMA in partnership with the network to ensure it is prepared and ready for new health challenges, as well as the constant demands of technological change and transformation.
On that note, I would like to thank all my colleagues and fellow Board members for their enthusiasm and support in 2023. I appreciate the great effort and participation of members of the various topic coordination groups that enrich the thinking of the Management Board, and indeed all aspects of our work.
Thank you all for your dedication and the trust you place in me as Chair.