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New approach methodologies: EU regulatory horizons
New approach methodologies (NAMs) have the potential to progressively transform medicines development by reducing reliance on animal testing while increasing the relevance of nonclinical data to patients. However, achieving regulatory acceptance of NAMs demands enhanced collaboration, clear guidance and continuous, science-based adaptation of the regulatory environment to accommodate emerging innovation.
European Medicines Agency (EMA), Amsterdam, Netherlands; Department of Dermatology, University Medical Center of the Johannes Gutenberg-University Mainz, Germany.
Although medicine research and development (R&D) continues to rely heavily on data from animal models to evaluate safety, efficacy and quality of medicines1, ethical concerns and the urgent need for human-relevant models demand a shift toward more innovative approaches. This is especially the case for some newer therapeutic modalities such as cell and gene therapies, for which standard preclinical evaluations in animals may have limited or no relevance given the human-specific nature of the biological activity of the therapies.
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Nature Reviews Drug Discovery24, 571-572 (2025)
doi: https://doi.org/10.1038/d41573-025-00053-7
Disclaimer
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 European Medicines Agency or one of its committees or working parties.
Meigs, L., Smirnova, L., Rovida, C., Leist, M. & Hartung, T. Animal testing and its alternatives – the most important omics is economics. ALTEX35, 275–305 (2018).
Edwards, M., Blanquie, O. & Ehmann, F. Insights into new approach methodology innovation: an EMA perspective. Nat. Rev. Drug Discov.https://doi.org/10.1038/d41573-025-00052-8 (2025).
