Regulatory integration of new approach methodologies for human-relevant developmental and reproductive toxicity (DART) assessment: A systematic cross-sector review

. Particular emphasis is placed on mechanistic frameworks such as Adverse Outcome Pathways (AOPs) and Integrated Approaches to Testing and Assessment (IATA), which facilitate the integration of diverse data streams within weight-of-evidence-based regulatory decision-making. Overall, NAMs offer significant potential to enhance the efficiency, mechanistic understanding, and human relevance of DART assessment. Nevertheless, challenges related to method validation, regulatory harmonization, and integration into existing safety assessment frameworks remain, highlighting the need for continued scientific innovation and international regulatory collaboration.