Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies: A Report of the ICCVAM Validation Workgroup
NAMs incorporate advanced technologies to aid in the investigation of biological mechanisms of toxicity, evaluation of product safety, and determination of hazard levels and dose–response relationships needed for health and environmental risk assessments.
“Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies: A Report of the ICCVAM Validation Workgroup,” developed by ICCVAM with input from 17 federal agencies, offers recommendations on how to establish confidence in NAMs. Confidence is key for methodology acceptance and use in regulatory and nonregulatory settings. The report emphasizes using "fit-for-purpose” validation approaches that align with each NAM's specific application rather than relying on outdated “one-size-fits-all” strategies. Concepts such as context of use, biological relevance, and technical characterization are highlighted as essential components for the effective validation of NAMs.
The report also reviews regulatory acceptance processes by U.S. federal agencies and explores the potential for international harmonization of NAMs. Best practices for ensuring quality and technical reliability are outlined, and the importance of collaboration and communication between developers, users, and regulatory agencies to streamline adoption is stressed.
ICCVAM plays a critical role by coordinating validation efforts, fostering research collaboration, and advising stakeholders on NAM implementation. This report serves as a key resource for advancing NAMs and supporting their integration into health and environmental decision-making processes, helping reduce reliance on animal testing while improving safety assessments.