Forewordby Lorraine Nolan
Chair of EMA Management Board
Welcome to the 2024 EMA annual report, which highlights milestones and achievements of the past year, and our regulatory network's commitment to bringing value to public and animal health in the European Union (EU).
As I reflect on another big year of change and progress for the European medicines regulatory network, several highlights that will help shape the future direction of our work over the next few years really stand out.
Last year marked a significant milestone in our strategic planning as EMA and the Heads of Medicines Agencies (HMA) started to update the European medicines agencies network strategy (EMANS), extending our vision to 2028. Titled 'Seizing opportunities in a changing medicines landscape', this comprehensive update to the original EMANS strategy to 2025 responds to the rapid changes we are seeing on the regulatory and technological landscape.
Our vision is to have a well-resourced, competitive network that leverages technological advances to increase productivity. By setting measurable goals and objectives, the EMANS to 2028 will keep the network aligned with the evolving healthcare needs within the EU and accountable for the part that it plays.
In 2024, the network continued to take a proactive approach on its broader sustainability. The EU Network Training Centre plays an important role in supporting capacity development. Its comprehensive training courses have continued to offer high-quality scientific regulatory training opportunities. This has led to continuous sharing of expertise across Member States and contributes to improving capacity to handle complex assessments.
Progress on clinical trials and use of artificial intelligence in medicines regulation
In 2024, we saw continued progress in the implementation of the Clinical Trials Information System (CTIS) with increasing adoption across the EU and more sponsors transitioning their trials to this harmonised platform. Though work continues, the system is delivering on enhancing transparency and efficiency in clinical trials across Europe.
As a network it is important for us to examine how technologies such as AI can be deployed in a practical, safe and secure way and the AI work plan to 2028 does just that: setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks. The ongoing AI pilots running at EMA are very encouraging – and I can see how AI will further boost our network without sacrificing our core public health principles of safety, quality and efficacy
Medicines availability remained a pressing concern of the Board. Throughout 2024, our network continued to work closely with all stakeholders to address shortages and ensure continuity of supply across the EU.
Transparencyand collaboration
The strength of this network lies in its willingness to collaborate. Throughout the year, I have witnessed first hand the exceptional commitment of national competent authorities, working together with unwavering dedication to advance public health across Europe. I am confident that our initiatives will continue to enhance our ability to fulfil our mission in the coming years.
I am always aware of the important twin pillars of transparency and trust in medicines regulation. They are fundamental and remain at the heart of this network. In 2024, the Management Board endorsed EMA's updated policies on managing competing interests among our scientific committee members, experts and Management Board members. These revised policies respond to recent Court of Justice judgments while maintaining our commitment to robust and balanced governance – demonstrating our ongoing commitment to ensuring the highest standards of independence in our scientific decision-making processes.
I extend my heartfelt thanks to my fellow board members, particularly our new vice chair, Rui Santos Ivo, and our dedicated topic coordinators who provide invaluable expertise and leadership. The Board's newly established audits and risks group (MBARG) deserves special recognition for its contributions in 2024. The group's strategic insights significantly strengthened our governance framework during last year.
I am also grateful to the European Commission for their partnership, support and trust throughout 2024. I would also like to thank my colleagues in our network, whose hard work and dedication to public health is reflected in this report. I look forward to our continued collaboration to support the EU's public health goals in 2025. Let the achievements documented here remind us of the immense value that science brings to our world.
Thank you all for your continued support.