https://ntp.niehs.nih.gov/go/n464316

Updated criteria and processes for validation, qualification, and regulatory acceptance of toxicological test methods

In 1997, ICCVAM published “Validation and Regulatory Acceptance of Toxicological Test Methods,” which recommended criteria and processes for validation and regulatory acceptance of toxicological testing methods that would be useful to federal agencies and the scientific community. Approaches to validating new methods have evolved considerably since the publication of this document. New concepts have emerged related to the development of new approach methodologies (NAMs) and the evaluation of their utility for regulatory uses, such as the qualification of a NAM for a particular context of use. However, guidance is needed on specific processes to put these concepts into practice.

In 2021, ICCVAM established a Validation Workgroup to consider this issue. The workgroup, which has members from ten ICCVAM agencies, applied the advances of the last two decades to a new document describing criteria and processes for validation and regulatory acceptance of toxicological testing methods. The new document provides more specific insight on establishing confidence in NAMs building upon the principles outlined in the ICCVAM 2018 Roadmap. In addition to supporting development of flexible validation practices that consider context of use (as described, for example, in van der Zalm et al. 2022), the new document addresses the need to align validation approaches in a manner that encourages international harmonization and incorporates best practices for quality and quality systems development (Petersen et al. 2023). The document draws upon recent well established validation publications to ensure alignment of approaches.

A draft of the new document was made public in August 2023. Comments were requested from the public via the Federal Register (88 FR 54342), and the document was discussed at the September 2023 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods. The new document is being finalized to address comments received and will be published in early 2024.