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Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies- A Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Validation Workgroup (VWG) March 2024
Citation:
Harrill, A., K. Carstens, N. Sipes, A. Lowit, S. Lynn, M. Perron, Pamela Noyes, J. Gordon, S. Fitzpatrick, AND N. Kleinstreuer. Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies- A Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Validation Workgroup (VWG) March 2024. NIH, 2024.
Impact/Purpose:
This document, prepared by the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) Validation Workgroup with input from stakeholders, describes an approach to NAMs validation that reflects modern toxicity testing, placing less emphasis on replacement of in vivo tests 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, it presents a 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.
Description:
ICCVAM described recommended criteria and processes for validation and regulatory acceptance of toxicological test methods in a 1997 document titled 'Validation and Regulatory Acceptance of Toxicological Test Methods'. Advancements in technologies and tools available for toxicity testing are driving a need for new approaches to test method validation. ICCVAM established its Validation Workgroup in 2021 to update the 1997 document. A new document describing criteria and processes for validation and regulatory acceptance of toxicological test methods is currently being drafted. Other charges to the group include establishing flexible robust practices to promote confidence in new methods; examine best practices for quality and quality systems development; and promote harmonization of development and validation for both U.S. and international acceptance. This document is a draft report (updated to Version 2 in 2024) of the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) Validation Workgroup (VWG). The VWG is made up of representatives of the 17 U.S. federal agency members within ICCVAM with expertise in validation, qualification, and/or regulatory acceptance of toxicological test methods. This document is intended to assist method developers, regulated industry stakeholders, and federal agencies in the development, validation, qualification, and acceptance of scientifically relevant new approach methodologies (NAMs). Here, we have described key concepts that should be considered to allow for efficient and timely development of NAMs that are fit-for-purpose, reliable, and provide information relevant to the species of interest.