NAMs In France And Europe: The Current Landscape

By Lilas Courtot, Ph.D., scientific manager, and Emeline Gougeon, strategy development head, Pro Anima Scientific Committee

New approach methodologies (NAMs) encompass a wide range of in vitro and in silico methods, mainly non-animal, developed to better explore human physiopathology. They generate data on the biological and toxic effects of substances and are no longer a distant scientific aspiration. With the potential to reduce the cost and time of R&D activities, they are becoming more and more important in the process of designing, testing, and approving chemicals and (next-generation) therapeutics. In addition, an increasing number of studies suggest that NAMs can be as good as, or even better than, animal tests.

Led by the U.S., an international movement is accelerating the development and acceptance of NAMs. Since the adoption of the FDA Modernization Act 2.0 in 2022, the United States has implemented structured measures (FDA Roadmap, FDAMA 3.0, NIH new offices, and the Standardized Organoid Modeling [SOM] center) and targeted funding and programs (Innovative Science and Technology Approaches for New Drugs, Complement Animal Research In Experimentation, and the Validation and Qualification Network) encouraging NAMs. All these actions send a strong message to the global scientific and regulatory community worldwide, as well as to economic decision makers.

In Asia, momentum is building. Japan is incorporating NAMs into the guidelines of the Pharmaceuticals and Medical Devices Agency (PMDA) and recently announced its support for the world’s first positive approval recommendations for two allogenic (from human donors) cell therapies derived from induced pluripotent stem cells (iPSCs). South Korea is strengthening its national capabilities and engaging in international collaborations, while China is showing growing interest, particularly in the cosmetics sector.

With a bold decision taken in 2013 to ban animal testing for cosmetics, Europe is not too far behind in adopting NAMs for more substances. Since 2013, tangible progress has been made within the European Union (EU) with the dual objective of strengthening competitiveness, sovereignty, and innovation in the life sciences. These strategies have and will continue to have a direct impact on EU member states (MS) and their own policies, agencies, and strategies. Finally, last November, the United Kingdom published an ambitious and detailed strategic plan to phase out animal testing and gradually introduce NAMs.

This article outlines how Europe and France are establishing a credible and scalable NAM ecosystem and what challenges remain to be overcome before life sciences professionals and patients can reap the benefits.

Where Are France And Europe In The Transition Movement?

Legislative And Policy Framework

In the EU, MS and their national agencies operate within the broader regulatory framework of the European Commission (EC), in line with the European Directive 2010/63/EU, and where agencies such as the European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA), and the European Medicines Agency (EMA) increasingly encourage the development and adoption of human-relevant NAMs.

For instance, in September 2024, EFSA published proposals for a NAM qualification system in the food and feed sector,¹ specifically aimed at facilitating the regulatory use of NAM data (e.g., for the risk assessment of nanomaterials) and encouraging the adoption of practical criteria for evaluating scientific validity and context of use. The EMA is currently revising its main guidelines on the regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches, including potential acceptance criteria for complex in vitro models and updating the voluntary data submission mechanism (safe harbor) with a pilot project planned to collect NAM evidence separate from formal marketing applications. The European agency also offers information meetings through its Innovation Task Force, which allow developers to discuss NAM data proposals before submitting marketing authorization applications (MAAs). In early 2026, as part of an international collaboration, the EMA and FDA jointly published 10 guiding principles for the responsible use of artificial intelligence (AI) throughout the drug life cycle.

Among the most eagerly awaited strategic documents is the EC Roadmap for phasing out animal testing for controlled chemicals, which is expected to be published by the end of the first quarter (Q1 2026) and will provide clearer and much-needed guidance to all stakeholders (MS, agencies, industry, public research). While this roadmap is a major step forward for the EU and will require significant efforts for effective implementation, projects such as NAMWISE, Partnership for the Assessment of Risks from Chemicals (PARC), and structures such as the Joint Research Centre (JRC) are already playing a key role in this shift toward the acceptance of NAMs. At the end of 2025, the JRC launched BimmoH, the largest data set containing references to scientific articles using human biology-based models.

Structuring And Developing The Organoid And Organ-On-Chip Ecosystem

The most advanced in vitro NAMs include organoids — 3D cultures derived from iPSCs — and microphysiological systems (MPS), also known as organs-on-chips (OoCs). These microfluidic devices, first developed in 2010, allow human cells to grow in controlled, physiologically relevant environments that can be monitored in real time. Their potential was highlighted in 2022 when Emulate reported that its liver-chip predicted drug-induced liver injury with 87% accuracy and identified toxic compounds that had escaped animal testing.² These advances have contributed to formal recognition of NAMs by major regulatory agencies as credible alternatives in defined contexts.

In Europe, significant efforts have been made to structure and advance this field. The European Organ-on-Chip Society (EUROoCS) encourages collaboration between academic laboratories, industry, clinicians, and policymakers. In 2024, the CEN and CENELEC OoC Focus Group published a roadmap developed by 120 experts, identifying priorities such as harmonization of terminology, standardization of experimental protocols, and FAIR data practices. These measures aim to improve reproducibility, enable regulatory qualification, and support industrial and clinical deployment. However, the European MPS/OoC landscape remains fragmented. The Industry Alliance for Microphysiological Systems (IAMPS), launched in 2026, seeks to unify stakeholders, harmonize technologies, and strengthen regulatory engagement.

France is also investing heavily. The PEPR MED-OOC program, with a budget of 48.5 million euros and funded by France 2030, aims to reduce animal testing, accelerate personalized medicine, and strengthen national sovereignty in preclinical research through the development of organoids and OoC. Complementary initiatives, including the F3OCI organoid and OoC industry network, aim to connect stakeholders.

Despite this momentum, closer coordination between public and private actors and sustained dialogue with regulators remain essential to ensure the validation and widespread adoption of OoC technologies.

AI, Human Data, And Digital Twins

AI, machine learning (ML), human health data, and digital twins are becoming central pillars of Europe’s strategy for drug development, precision medicine, and regulation.^3,4 Digital twins — virtual representations of organs or entire individuals built from clinical, biological, and physiological data — enable predictive simulations to support diagnosis, treatment selection, and drug development. Their reliability critically depends on access to high-quality, well-annotated patient data, as incomplete, biased, or poorly standardized data sets can lead to inaccurate predictions. Ensuring secure and ethical access to patient-derived data, while preserving privacy and consent, is therefore essential to train robust and clinically trustworthy AI models.

At the European level, the European Health Data Space (EHDS) establishes a common regulatory and technical framework to facilitate secure access, sharing, and reuse of health data for research and innovation purposes while preserving patient confidentiality and data sovereignty. Complementing this effort, the Ecosystem for Digital Twins in Healthcare (EDITH) project aims to build a coordinated ecosystem and roadmap toward the virtual human twin by integrating data sets, computational models, and simulation platforms across Europe. These initiatives promote interoperability, standardized data governance, and federated infrastructures necessary for scalable and reproducible AI applications. France is embracing AI/ML and health data through national infrastructures such as the Health Data Hub and the AI and health data strategy, which provides secure access to large-scale national health data sets and rigorous evaluation of AI systems for biomedical and clinical research. Owkin, a French biotechnology company that develops AI systems trained on multimodal patient data, recently announced the creation of the first pan-European infrastructure dedicated to biology, combining agentic AI systems and biomedical data structuring to establish a new reasoning model capable of automating and improving every stage of biological research, drug development, and clinical applications. The use of digital twins raises significant legal and ethical challenges that require clearer and harmonized regulatory frameworks. Key issues include ensuring informed patient consent for secondary data use, defining data ownership and governance, guaranteeing transparency and explainability of AI-driven predictions, and clarifying responsibility in clinical decision-making.

Strengthening these frameworks will be essential to building public trust, ensuring the ethical use of patient data, and enabling the safe and widespread adoption of AI-based technologies and digital twins in the European healthcare system and its member states.

Integration Of NAMs For Human Relevance And Regulatory Purposes

The integration of complementary human-based experimental and computational approaches is essential to improve the predictive power and human relevance of biomedical research and toxicological testing. Their combined use enables the generation, integration, and interpretation of human-specific data within iterative workflows, where experimental results train computational models with outcomes guiding the refinement of future experiments.^5,6 This synergy enhances the reliability of predictions, reduces uncertainty, and promotes more efficient and translationally relevant research and development processes.⁷

Integrated Approaches to Testing and Assessment (IATA) has been promoted by the OECD to assess the safety of chemicals in a regulatory context. This methodology provides structured frameworks that combine multiple sources of evidence within a defined context of use. From a biomedical research perspective, major international initiatives are accelerating the convergence and integration of human-relevant methods. The Roche Institute of Human Biology is developing interdisciplinary platforms that combine advanced human-derived experimental systems with data integration and analysis to better predict clinical outcomes and improve translation to patients. Similarly, the new Centre for Animal-Free Biomedical Translation (Ombion) is creating new business opportunities around animal-free technologies and biomedical translation. These initiatives illustrate the growing need for coordinated infrastructures, common standards, and regulatory commitment to fully leverage integrated approaches and enable more reliable, human-relevant biomedical innovation.

Conclusion: From Momentum To Mainstream

The landscape of NAMs in Europe is evolving, as it is in the rest of the world, reflecting a broader scientific and societal shift toward research models that are more predictive, more human relevant, and more ethically responsible. In Europe, the Netherlands and the United Kingdom are leading the way with dedicated funding and ambitious policy strategies and decisions.

As this article shows, significant challenges remain in order to fully unlock the transformative potential of NAMs. Although regulatory adoption of NAMs is progressing relatively rapidly in toxicology — where standardized assessment criteria and validation pathways facilitate their integration — their wider adoption in biomedical research, both for regulatory purposes and in routine laboratory practice, will likely require more time and effort.

For life sciences companies, NAMs are transitioning from experimental supplements to expected components of preclinical strategy. Predictive toxicology, microphysiological systems, and AI-driven drug discovery are the pillars of innovation.

In the future, the success of NAMs in France and Europe will depend mainly on their regulatory acceptance, strategic investments, and the coordination of policy measures. This could be achieved through methodological harmonization, improved accessibility and quality of human data, and sustained pedagogical efforts aimed at building confidence in the translational relevance and scientific robustness of NAMs.

Actionable Considerations

Aligning regulatory frameworks with scientific innovation in order to reduce regulatory friction, overcome socio-technical barriers, and increase targeted investments requires sustained, constructive, and robust dialogue between researchers, industry stakeholders, regulators, and policymakers.

These dialogues are essential in light of the growing incidence and complexity of chronic multifactorial diseases, as well as the considerable volume and continuous influx of chemicals requiring safety assessment.

NAMs offer a scientifically sound and economically strategic pathway to generate more human-relevant data, improve translational predictability, accelerate decision-making, enhance patient safety, and ultimately foster a more efficient, ethical, and sustainable ecosystem for biomedical innovation and risk assessment. As the paradigm shifts, NAMs are poised to redefine the science of safety — provided that this ambition is accompanied by practical implementation and long-term vision.

References

1. A. Haase et al., ‘Proposal for a qualification system for New Approach Methodologies (NAMs) in the food and feed sector: example of implementation for nanomaterial risk assessment’, EFSA Support. Publ., vol. 21, no. 9, p. 9008E, 2024, doi: 10.2903/sp.efsa.2024.EN-9008.
2. L. Ewart et al., ‘Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology’, Commun. Med., vol. 2, no. 1, pp. 1–16, Dec. 2022, doi: 10.1038/s43856-022-00209-1.
3. W. R. Pitt et al., ‘Real-World Applications and Experiences of AI/ML Deployment for Drug Discovery’, J. Med. Chem., vol. 68, no. 2, pp. 851–859, Jan. 2025, doi: 10.1021/acs.jmedchem.4c03044.
4. ‘Artificial intelligence workplan to guide use of AI in medicines regulation | European Medicines Agency’. Accessed: Apr. 29, 2024. [Online]. Available: https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation
5. N. Milani, N. Parrott, A. Galetin, S. Fowler, and M. Gertz, ‘In silico modeling and simulation of organ‐on-a‐chip systems to support data analysis and a priori experimental design’, CPT Pharmacomet. Syst. Pharmacol., p. psp4.13110, Feb. 2024, doi: 10.1002/psp4.13110.
6. K. Cheng et al., ‘Machine learning-enabled detection of electrophysiological signatures in iPSC-derived models of schizophrenia and bipolar disorder’, APL Bioeng., vol. 9, no. 3, p. 036118, Sep. 2025, doi: 10.1063/5.0250559.
7. M. S. Mirlohi, T. Yousefi, A. R. Aref, and A. Seyfoori, ‘Integrating New Approach Methodologies (NAMs) into Preclinical Regulatory Evaluation of Oncology Drugs’, Biomimetics, vol. 10, no. 12, Nov. 2025, doi: 10.3390/biomimetics10120796.

About The Authors

Lilas Courtot, Ph.D., holds an engineering degree in biochemistry from INSA Toulouse and a doctorate in oncology from the CRCT/Paul Sabatier University Toulouse III. After completing a post doctorate at the University College of London, she decided to take a step back from university research to reflect on a more relevant science to humans. Within the Pro Anima Scientific Committee, Courtot brings her experience and scientific knowledge to the acceptance and implementation of NAMs. She promotes open and constructive dialogue between different stakeholders and provides education and training on NAMs.

With a multidisciplinary academic background, Emeline Gougeon graduated from the universities of Versailles St-Quentin, Panthéon-Assas, and Panthéon-Sorbonne. Combining psychology, law, and project management, she has been in charge of the coordination and strategy of the Pro Anima Scientific Committee since late 2020. She also represents the committee before various bodies at the national and European level, such as the European project PARC.