ICCVAM document on validation, qualification, and regulatory acceptance of NAMs now available

An ICCVAM document, “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies,” is now available at https://ntp.niehs.nih.gov/go/ICCVAM-submit. This document updates a model for validation and regulatory acceptance of new and alternative test methods originally described in the 1997 ICCVAM report, “Validation and Regulatory Acceptance of Toxicological Test Methods.” The updated document describes an approach to NAMs validation that reflects modern toxicity testing, placing less emphasis on replacement of an in vivo test with a single alternative method and more emphasis on integrating results from multiple in vitro and in chemico assays, and in silico approaches. Guided by the principles articulated in the 2018 ICCVAM Strategic Roadmap (available at https://ntp.niehs.nih.gov/go/natl-strategy), the new document presents a more flexible approach to how confidence is established, to help ensure the adoption of new methods by federal agencies and regulated industries once validated for a specific application or context of use.

The new document was prepared by the ICCVAM Validation Workgroup, which was established in 2021 to update the 1997 document. It reflects input from a number of federal research and regulatory agencies, as well as public comments received following the release of a draft version before the 2023 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods. Materials from that meeting are available at https://ntp.niehs.nih.gov/events/past?type=SACATM.