Interview: Science as the Foundation for Regulatory Innovation
Science underpins all activities at the Medicines Evaluation Board (MEB). Enhancements to our assessment system also stem from scientific research, with the ultimate aim of improving evaluations and thereby increasing trust in medicines. Eric Boersma, Marjon Pasmooij, and Aimad Torqui speak about the importance of scientific research within the MEB.
With its Science Policy 2025-2029, the MEB outlines the organisation’s strategic choices regarding science for the coming years. While the previous policy encompassed eight central themes, the new policy opts for a more in-depth focus on four core themes (see Box 1).
Why is science integral to our mission? “Our primary responsibility is to ensure that medicines are safe and effective. This inherently ties science to our operations. It's no coincidence that science is one of our organisation's core values,” says Marjon Pasmooij, Head of the Science Department. “Gaining knowledge through scientific research enables us to make better assessments and, consequently, fulfil our role more effectively.”
Eric Boersma, Board Member and Chair of the Science Committee at the MEB (see Box 2), concurs. “Determining the balance between the risks and benefits of a medicine is central to the MEB's role. This can only be done effectively on the basis of scientific research. It's essential not only to evaluate individual assessments or developments but also to critically assess our own evaluation processes. This encompasses both scientific innovation and process improvement.”
“Our Strategic Business Plan (SBP) 2024–2028 clearly articulates our intention to concentrate our efforts—enhancing what we excel at and making deliberate choices,” Marjon continues. “This science policy aligns with that vision. The foundation—what we do and how we do it—remains consistent with the previous science policy. However, the decision to streamline to four themes was intentional, providing focus while retaining the flexibility to respond to questions arising from the assessment process or our national and international networks.”
Focus and flexibility
Eric views the updated science policy as a clear roadmap for the future. “The flexibility Marjon mentions is important. These themes allow us to concentrate our efforts while providing sufficient scope to adapt to emerging developments, such as the new pharmaceutical legislation.”
"It is vital for the MEB to continue learning, innovating, and reflecting."
New developments are undoubtedly forthcoming. “Technological advancements and societal changes are rapidly evolving. Therefore, it is vital for us as an organisation to continue learning, innovating, and reflecting,” says Marjon. Major themes like data-driven assessment and personalised medicine align well with this approach.
EMRD
Eric highlights a concrete example related to data-driven assessment: “One of the tangible outcomes of the MEB's science policy is the European Medicines Regulatory Database (EMRD), developed in collaboration with Utrecht University. This database and dashboard encompass a vast array of data on medicines authorised in Europe. Previously fragmented information is now more accessible to researchers, patients, and other stakeholders. It's commendable that such data is available following the FAIR principles (Findable, Accessible, Interoperable, Reusable).”
Three of the four themes were already part of the 2020–2024 science policy. Due to societal developments in Europe, a new fourth theme has been introduced, focusing on the new pharmaceutical legislation in Europe. “We've deliberately included this legislation as a theme because it will significantly impact our operations and the processes within the MEB, other European medicines authorities, and the EMA,” explains Aimad Torqui. As Division Head for Europe, Better Use of Medicines, and Veterinary, he is closely involved in international developments, including the new European pharmaceutical legislation.
Preparing for the Future
“This fourth scientific theme aids in adequately preparing for the future,” Aimad continues. “The new legislation will alter many regulatory processes. This necessitates a critical examination of the system and how we allocate personnel and resources to maintain operational feasibility. Currently, the European network faces increasing pressure. Dossiers are becoming more complex, placing greater demands on medicines authorities and assessors, making it even more pertinent to explore process improvements.”
This perspective is shared beyond the Netherlands. “Regulatory Science has now been incorporated into the Network Strategy of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) for the first time. This establishes a link at the European level between scientific research and its practical application in regulatory decision-making. We should look closely at what we can contribute from the Netherlands. The inclusion of regulatory science in the European network strategy aligns seamlessly with our scientific programme. Previously, we provided input on guidelines; now, we also provide input on the system as a whole.”
Importance of Collaboration
These changes in legislation and processes transcend national boundaries, making collaboration within Europe even more crucial. “And there is already substantial collaboration,” says Marjon. “Consider the EMA, the European committees and working parties in which we participate, collaborations with EMA and other agencies, and various chain partners. Where we can avoid duplication, we should of course do so.”
This collaborative spirit is also evident in the European Platform on Regulatory Science Research (EPRSR), where Marjon serves as co-chair on behalf of the MEB. “With this platform, we explicitly seek to establish connections,” she says. “We hold three meetings annually on specific topics. The first is scheduled for this month. These platform meetings aim to strengthen the bond between regulators and academics—together with the EMA, national medicines authorities, and non-profit organisations.”
"Acquiring knowledge is essential to keep pace with ongoing developments, underscoring the importance of collaboration."
Staying Up to Date
Acquiring knowledge is essential to keep pace with ongoing developments, underscoring the importance of collaboration. Aimad: “We need to demonstrate that we're a relevant knowledge partner—for academic institutions, industry, and patients. Operating within a network ensures we have access to the necessary knowledge to perform our duties as efficiently and effectively as possible.”
Marjon concludes with a concrete example illustrating the importance of science: “Consider the progress in reducing animal studies, where we focus on research into replacement, reduction, and refinement—the 3Rs. This has been one of our themes and continues to be so. We've advocated for this issue in Europe, leading to new insights being incorporated into international guidelines. With our strategy for 2025–2029, we aim to continue making such impactful contributions in the coming years.”
Read more about the MEB’s scientific strategy in ‘From Expertise to Impact: Science as the Foundation for Regulatory Innovation’ – Science Policy 2025–2029.