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  • COMMENT

Advancing pharmacogenomics in medicines regulation and clinical practice: a call for collaborative action

The full potential of pharmacogenomics to improve drug development and clinical practice has yet to be realized. Here, we present recommendations to address barriers to its implementation.
By
  1. Jasmine Gratton

    1. European Medicines Agency, Amsterdam, The Netherlands.

  2. Peter Arlett

    1. European Medicines Agency, Amsterdam, The Netherlands.

  3. Falk Ehmann

    1. European Medicines Agency, Amsterdam, The Netherlands.

  4. Daniel Prieto-Alhambra

    1. University of Oxford, Oxford, UK.

  5. Patrice Verpillat

    1. European Medicines Agency, Amsterdam, The Netherlands.

  6. Emmanuel Cormier

    1. European Medicines Agency, Amsterdam, The Netherlands.

  7. Irene Norstedt

    1. European Commission, Brussels, Belgium.

  8. Aimad Torqui

    1. Dutch Medicines Evaluation Board, Utrecht, The Netherlands.

  9. María Jesús Lamas Díaz

    1. Spanish Agency of Medicines and Medical Devices, Madrid, Spain.

  10. Carmen Laplaza Santos

    1. European Commission, Brussels, Belgium.

  11. Munir Pirmohamed

    1. University of Liverpool, Liverpool, UK.

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doi: https://doi.org/10.1038/d41573-025-00178-9

Acknowledgements

The authors would like to thank V. Cordo, C. Urseiu, J. Mwinyi, N. Blomberg, M. Maliepaard, M. Gordillo-Marañon, A. Llerena Ruiz, J. Bourgeois, C. Scholl, M. Ingelman-Sundberg, S. Reisberg, J. Xie, S. Simou, F. Houÿez, V. Deneer, G. Patrinos, J. Swen, J. Riese Jorda and M. Garmhausen.

References

  1. Apellaniz-Ruiz, M. et al. Status of the implementation of pharmacogenetics in clinical practice in Spain: from regional to national initiatives. Drug Metab. Pers. Ther. 39, 183–199 (2024).

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  2. Bourgeois, J. et al. Unravelling the implementation of pharmacogenetic testing in Belgium. Eur. J. Clin. Pharmacol. 81, 711–718 (2025).

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  3. Swen, J. J. et al. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study. Lancet 401, 347–356 (2023).

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Competing Interests

D.P.-A.’s group has received funding from the EMA and the IMI, and partial support from the Oxford NIHR Biomedical Research Centre, and research grants from Gilead Sciences, Theramex and UCB Biopharma (none related to this article). M.P. receives research funding from the MRC, NIHR, the EU IHI initiative, and the NHS Race and Health Observatory, and partnership funding, paid to the University of Liverpool, for the MRC Medicines Development Fellowship Scheme. None of this funding has been used for this work.

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