EMA’s New NAMs Pilot: Building Regulatory Confidence Through Better Data
On 1 September 2026, the European Medicines Agency (EMA) launched a new voluntary data submission pilot for New Approach Methodologies (NAMs) creating a structured mechanism for companies, contract research organisations, technology and method developers and academic laboratories to submit NAM-generated data and receive feedback outside a marketing authorisation application. NAM developers and regulators now have an opportunity to examine emerging evidence together, identify knowledge gaps and build regulatory experience with these approaches.
Creating a Route for Regulatory Learning
For many years, discussions about NAM adoption have focused primarily on regulatory acceptance. However, EMA’s announcement highlights a more fundamental obstacle: although NAMs are increasingly used in research and early medicines development, the resulting data are rarely shared with regulators. This limits regulators’ opportunities to evaluate the scientific value of different methodologies, understand how their outputs should be interpreted and develop confidence in their potential regulatory applications. Conversely, uncertainty about regulatory acceptance may discourage organisations from generating or submitting NAM data in the first place.
In our review examining barriers to the accelerated adoption of NAMs, Sewell et al. (2024) described this as a persistent “chicken-and-egg” problem. If NAM data are not submitted, regulators have limited opportunities to become familiar with these approaches. Without regulatory familiarity, feedback or precedent, sponsors may remain reluctant to invest in or submit them.
EMA’s pilot is therefore significant because it provides a “safe harbour” in which NAM-generated evidence can be evaluated independently of a regulatory decision on a particular medicinal product. It offers an opportunity to begin breaking this cycle through early dialogue, shared learning and practical regulatory experience.
Regulatory Acceptance Is Only Part of the Challenge
Creating a submission pathway is important, but regulatory acceptance is not the only factor affecting NAM adoption. International panel discussions summarised by Courtot et al. (2025) identified harmonisation, stakeholder engagement, data sharing, standardisation and clearer guidance on implementation as additional priorities. These issues are closely connected. Regulators cannot gain confidence in a method if its experimental conditions are inadequately described, its results cannot be compared across laboratories, or its limitations and uncertainties are not transparently communicated.
The question is therefore not simply whether NAM data are submitted. It is whether the submitted evidence is sufficiently rigorous, transparent and interpretable to support meaningful scientific assessment.
From Data Availability to Data Quality
Data submission alone will not build regulatory confidence. The quality and completeness of the evidence will determine what regulators can learn from it.
The recently published NC3Rs DRIVER Recommendations establish six core principles for improving the design, conduct, analysis and reporting of in vitro research (Roper TCL Blog link). They address issues such as the experimental unit, risk of bias, the experimental model, experimental procedures, data handling and transparent reporting.
Although DRIVER applies specifically to in vitro studies rather than every type of NAM, its underlying principles are highly relevant to regulatory confidence. A study that is poorly designed or incompletely reported may generate data, but those data may not provide a reliable basis for evaluating the method or reproducing its findings.
Assay-specific initiatives provide another important layer of standardisation. The Minimum Information for Reporting on the TEER Assay (MIRTA) recommendations developed by Sharma et al. (2024) provide a practical example. By specifying the information that should be reported for transepithelial or transendothelial electrical resistance measurements, MIRTA supports more consistent interpretation and comparison of results across laboratories.
DRIVER and MIRTA perform complementary roles. DRIVER provides a broad framework for improving the quality and transparency of in vitro research, while MIRTA translates these principles into detailed reporting expectations for a particular assay. Together, they illustrate how general quality standards and method-specific guidance can support reproducibility and confidence. Reporting guidance can also improve the conduct of research itself. A study cannot be documented appropriately unless essential quality considerations such as model characterisation, controls, sources of bias, equipment calibration, acceptance criteria, and data handling have been addressed during its design and execution.
Rethinking Validation and Scientific Confidence
In parallel, recent discussions around NAM validation and acceptance are increasingly moving away from simple comparisons with animal studies and towards concepts such as regulatory context of use, reproducibility, transparency and scientific confidence. We argued that regulatory acceptance should be built around standardisation, repeatability and reproducibility rather than direct comparison with imperfect animal models (Ouedraogo et al., 2025). This is highly consistent with both the DRIVER recommendations and assay-specific reporting initiatives such as MIRTA (Sharma et al., 2024).
The objective is not to lower the evidentiary threshold for NAMs. It is to apply a scientifically appropriate framework for evaluating whether a method provides sufficiently reliable and relevant evidence for a particular purpose.
An Opportunity and a Shared Responsibility
Viewed together, the EMA pilot, DRIVER Recommendations, MIRTA reporting framework and recent publications on NAM acceptance appear to be addressing different aspects of the same challenge. The future success of NAMs will depend on more than scientific innovation alone. It will also depend on whether data are generated, documented, reported and communicated in a manner that supports scientific confidence and regulatory decision-making. The real question may now be whether the NAMs community is ready to provide the high-quality, well-documented evidence needed to make full use of that opportunity.
Further Reading
EMA
EMA News: Voluntary data submission pilot to advance innovative alternatives to animal testing. https://www.ema.europa.eu/en/news/voluntary-data-submission-pilot-advance-innovative-alternatives-animal-testing
EMA Pilot Information Page: New approach methodologies to replace and reduce animal testing: Voluntary data submission pilot. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/ethical-use-animals-medicine-testing/regulatory-acceptance-new-approach-methodologies-nams-reduce-animal-use-testing/new-approach-methodologies-replace-reduce-animal-testing-voluntary-data-submission-pilot
Publications
Sewell F, Alexander-White C, Brescia S, Currie RA, Roberts R, Roper C, Vickers C, Westmoreland C, and Kimber I (2024). New approach methodologies (NAMs): identifying and overcoming hurdles to accelerated adoption. Toxicology Research, 13(2), tfae044. https://doi.org/10.1093/toxres/tfae044
Sharma M, Huber E, Arnesdotter E, Behrsing HP, Bettmann A, Brandwein D, Constant S, Date R, Deshpande A, Fabian E, Gupta A, Gutierrez R, Gutleb AC, Hargrove MM, Hollings M, Hutter V, Jarabek AM, Kaluzhny Y, Landsiedel R, Milchak L, Moyer RA, Murray JR, Page K, Patel M, Pearson SN, Petersen EJ, Reinke E, Roldan N, Roper C, Scaglione JB, Settivari RS, Stucki AO, Verstraelen S, Wallace JL, McCullough S, and Clippinger AJ (2024). Minimum information for reporting on the TEER (trans-epithelial/endothelial electrical resistance) assay (MIRTA). Archives of Toxicology 99(1):57-66. doi: 10.1007/s00204-024-03879-z
Ouedraogo G, Alépée N, Tan B, and Roper CS (2025). A call to action: advancing new approach methodologies (NAMs) in regulatory toxicology through a unified framework for validation and acceptance. Regulatory Toxicology and Pharmacology. doi: 10.1016/j.yrtph.2025.105904.
Courtot L, Fritsche E, Hobi N, Kleinstreuer N, Lee R, Parvatam S, Riskes-Hoitinga M, Roper C, Westmoreland C, and Gougeon E (2025). Panel discussions on the global regulatory acceptance and harmonisation of non-animal NAMs. NAM Journal. doi: https://doi.org/10.1016/j.namjnl.2025.100027
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