For the period 2025–2029, we have identified four themes that will guide our scientific activities. These themes align with the strategic direction outlined in our Strategic Business Plan 2024–2028 (SBP). They also build on the science policy of 2020–2024.
The 4 scientific themes
In recent years, many changes have occurred, affecting medicines authorities, healthcare providers, patients, and the pharmaceutical industry alike. These developments are expected to continue in the years ahead. In our science policy for the coming years, we are responding to these developments by focusing on four main themes:
Animal testing is used in the development of medicines. We believe this should only be done when truly necessary. Animal studies do not always provide reliable information about how a medicine will affect humans. That’s why we critically assess whether animal testing genuinely adds value.
We are committed to replacing, reducing, and refining animal testing. We conduct scientific research into better methods for evaluating medicines - such as organoids (mini-organs), computer models, or research using human cells. We advise researchers on how to minimise animal testing, and we adapt regulations for medicine studies wherever possible. In doing so, we work towards a situation where animal testing is only used when it provides truly valuable information.
In addition to results from clinical trials, we are increasingly collecting real-world data - information gathered from everyday healthcare settings. These data help us better understand how medicines perform in practice. We are exploring how best to use this information in the approval and monitoring of medicines.
To ensure that new medicines better meet the needs of patients, it is essential to understand what matters most to them. That’s why we are increasingly incorporating patients’ experiences and preferences into our work. We collaborate with patient organisations and researchers to achieve this.
We are also developing a public database containing clear and reliable information about medicines approved in Europe. This will make such information easier to find and use for everyone.
In addition, we are investigating how artificial intelligence can contribute to faster and more accurate assessments of medicines. At the same time, we ensure this technology is used responsibly, with close attention to the quality and reliability of the data.
We are working to make innovative medicines available to patients more quickly and effectively. This includes cell and gene therapies (ATMPs) for rare diseases. These treatments are often complex to develop. That’s why we share knowledge, conduct research, and collaborate with other (international) partners to make regulations clearer and easier to apply.
New technologies - such as 3D printing and gene editing - can help make medicine production faster and more cost-effective. We investigate how these techniques can be used safely and contribute to updating relevant regulations.
We are also exploring the use of biomarkers - measurable indicators in the body that can help doctors choose the right treatment for individual patients. Improved understanding of biomarkers allows medicines to be better tailored to each patient’s unique situation.
For rare diseases, where no treatments may yet exist, we research how existing medicines can be repurposed - a process known as drug repurposing.
The European Commission aims to modernise medicines legislation to better respond to emerging technologies and unmet medical needs.
The proposed legislation includes concepts such as platform technologies, regulatory sandboxes, and rules to support the repurposing of existing medicines (drug repurposing). There will also be increased focus on the environment, for example through stricter requirements regarding the environmental impact of medicines.
In addition, the way medicine evaluation is organised in Europe is undergoing major changes - including digital dossier submissions and a reallocation of tasks within the European Medicines Agency (EMA).
Many of the proposed rules still need to be further developed. That’s why we are conducting research into how these new regulations can be implemented effectively in practice. The results of this research will contribute to European discussions on shaping the new legislation, starting from 2026.