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A new European platform for advancing regulatory science research

Launching in 2025, the European Platform for Regulatory Science Research will bring together academia, regulators and other stakeholders to accelerate collaborative regulatory science research solutions.
By
  1. Liese Barbier

    1. European Medicines Agency, Amsterdam, the Netherlands; Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

  2. Pierpaolo Moscariello

    1. European Medicines Agency, Amsterdam, the Netherlands; Department of Synthesis of Macromolecules, Max Planck Institute for Polymer Research, Mainz, Germany.

  3. Hubert G Leufkens

    1. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.

  4. Ralf Herold

    1. European Medicines Agency, Amsterdam, the Netherlands. *These authors contributed equally.

  5. Anna Maria Gerdina Pasmooij

    1. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands; Dutch Medicines Evaluation Board, Utrecht, the Netherlands. *These authors contributed equally.

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Regulatory science is essential for addressing issues and gaps encountered by stakeholders in medicines research, development and evaluation1,2,3. Research in regulatory science delivers solutions by providing better methodologies for medicines research and development, and improved tools for evaluating medicines based on outcomes that better align with patients’ needs. It drives progress by identifying gaps in the evolving regulatory system and developing new approaches for generating evidence to support decision-making. Tangible impacts of regulatory science research include the revision or creation of new regulatory guidelines, or the qualification of novel methodologies such as biomarkers to support their use in medicines development.

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Nature Reviews Drug Discovery 24, 485-486 (2025)

doi: https://doi.org/10.1038/d41573-025-00024-y

Acknowledgements

We thank colleagues from EMA and the European regulatory network, as well as all the public, who contributed to and helped to shape the development of the Platform. The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agencies or organizations with which the authors are affiliated.

References

  1. EMA Regulatory Science to 2025: Strategic Reflection EMA/110706/2020 (EMA, 31 March 2020); https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf

  2. Seizing Opportunities in a Changing Medicines Landscape: The European Medicines Agencies Network Strategy 2028 (Draft) EMA/376542/2024 (HMA, EMA, 3 October 2024); https://www.ema.europa.eu/en/documents/other/seizing-opportunities-changing-medicines-landscape-european-medicines-agencies-network-strategy-2028-draft_en.pdf

  3. Hines, P. A. et al. A future for regulatory science in the European Union: The European Medicines Agency’s strategy. Nat. Rev. Drug Discov. 19, 293–294 (2020).

    Article  PubMed  Google Scholar 

  4. Pasmooij, A. M. G. et al. The evolution of drug regulatory sciences in the Netherlands: More than a country report. Clin. Pharmacol. Ther. 116, 64–71 (2024).

    Article  PubMed  Google Scholar 

  5. European Platform for Regulatory Science Research: Concept Paper — Draft EMA/530334/2024 (EMA, HMA, 14 November 2024); https://www.ema.europa.eu/en/documents/other/draft-concept-paper-european-platform-regulatory-science-research_en.pdf

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Supplementary Information

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Competing Interests

The authors declare no competing interests.

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