Emer Cooke, EMA’s Executive Director: 2024 achievements in medicine regulation

17 December 2024

EMA's Executive Director shares her end-of-year message and takes stock of EMA's work in 2024

We are getting closer to the end of another year - usually this time gets very busy for everyone, as we still have goals, deadlines, and ambitious plans for what we want to achieve before we take a well-deserved rest. Despite the end-of-year pressure, I do try to stop for a moment, reflect and take stock of what the year has brought to EMA, to its network and to public and animal health.

The numbers speak for themselves - 2024 is marked by high performance, steady innovation and unshakable collaboration within the network.

In 2024, we recommended 114 new medicines for human use, of which 48 contain a completely new active substance and 16 are for the treatment of rare diseases. It is the first time since 2009 that we have been able to deliver more than 100 positive opinions.

This is good news for patients, but also a very encouraging indication of the competitiveness of the European pharmaceutical sector. The situation is similarly positive in the veterinary medicines area, with 23 recommendations for new medicines for animals, of which 12 are vaccines.

I also want to emphasise a few notable “firsts”: the Agency issued a positive opinion for marketing authorisation in the European Union (EU) for the first medicine shown to slow the progression of Alzheimer's disease in certain patients, as well as for the first vaccine to protect adults from Chikungunya, a virus transmitted to people by mosquitoes. In addition, EMA released the first certificate for a vaccine platform technology master file which will support and accelerate the development and authorisation of new veterinary vaccines in the EU.

As antimicrobial resistance (AMR) continues to be one of the biggest threats to public health, estimated to cause 35,000 deaths in the EU every year, it is worth mentioning EMA’s recommendation for marketing authorisation for a new antibiotic to fight infections caused by multidrug-resistant bacteria. On the veterinary side, we launched a new platform for collection of sales and use data of antimicrobials in animals, which supports us in tackling AMR in both human and animals.

In 2024, collaboration with our partners continued to be essential in the way EMA works. With EU Member States, we continued the efforts to encourage the transition of all ongoing clinical trials to the Clinical Trials Information System, which needs to be finalised by 30 January 2025. Ten thousand applications have been submitted in the system since January 2022. This marks the end of a three-year transition period that began when the Clinical Trials Regulation became applicable.

2024 was the first year of our efforts to support the establishment of the African Medicines Agency, in close collaboration with African and European regulators. Under this initiative, EMA has been sharing its learnings and experiences gained from working together as a network of thousands of experts from across Europe. This work included support to a continental pilot to test procedures for joint evaluation of medicines in Africa.

We are keenly aware that shortages of medicines put pressure on patients, pharmacists, doctors and EU healthcare systems in general. In 2024, together with EU Member States, we have done a lot to ensure that medicines are available to patients when and where they need them most.

• We issued recommendations to marketing authorisation holders to facilitate the availability and supply of critical human medicines for which vulnerabilities in the supply chain have been identified;
• We increased our communication and interaction efforts with key actors on glucagon-like peptide-1 (GLP-1) receptor agonists – critical medicines for patients living with diabetes and obesity. We engaged directly with patients and healthcare professionals, as well as with journalists across Europe;
• We launched the core set of functionalities of the European Shortages Monitoring Platform (ESMP) to enable a quick and efficient exchange of information between regulators and pharmaceutical companies on shortages of medicines.

This year also marks the conclusion of the work carried out by the Task Force on Availability of Authorised Medicines for Human and Veterinary Use. This groundbreaking work was established in 2016 by the Heads of Medicines Agencies (HMA) and EMA as a voluntary initiative. Fast forward to today, and one pandemic later, the activities started by the group have been enshrined in law and added to our public health mandate. The Task Force can be incredibly proud of what it has achieved, including the just published second version of the Union list of critical medicines.

In 2025, EMA will continue its mission to protect public and animal health – with determination, with enthusiasm and passion. We are tirelessly working on reinventing and improving ourselves. Next year, the Agency will maintain its focus on accelerating and optimising the assessment of key medicines, improving both accessibility and availability of medicines, as well as working on approaches to future-proofing medicines regulation in the EU in preparation for the new pharmaceutical legislation.

I am expecting 2025 to be another exciting year for medicines regulation.