A call to action: Advancing new approach methodologies (NAMs) in regulatory toxicology through a unified framework for validation and acceptance
Gladys Ouédraogo, Nathalie Alépée, B. Tan, Clive Roper
Abstract
The transition from traditional animal testing to human-relevant New Approach Methods (NAMs) in regulatory toxicology faces a significant challenge: a lack of standardized validation and acceptance criteria. This review analyses the limitations of animal test reproducibility and highlights the growing body of evidence supporting the improved reliability and relevance of NAMs for predicting human toxicity. Successful case studies of NAMs implementation across diverse industries are examined and existing regulatory perspectives and initiatives are critically evaluated. This analysis reveals a pressing need for a unified, cross-industry approach to NAMs validation, grounded in measurable quality standards and standardisation. A framework is proposed based on clearly defined standards, standardized protocols, and transparent data sharing to accelerate the integration of NAMs into regulatory decision-making, ultimately benefiting human health, animal welfare, and scientific progress. All stakeholders are urged to actively participate in this initiative by contributing their expertise, sharing data and insights, and collaborating on the development and implementation of this crucial use of NAMs in regulatory toxicology.