Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches - Scientific guideline

This guideline applies to human and veterinary medicines.

This document describes the process for submission and evaluation of a proposal for regulatory acceptance of 3R testing approaches for use in the development and quality control during production of human and veterinary medicinal products. It also presents the scientific and technical criteria for validation of 3R testing approaches and explains the pathways for regulatory acceptance of 3R testing approaches.

Keywords: 3Rs, regulatory acceptance, testing approaches, non-clinical, quality, human medicinal products, veterinary medicinal products, qualification, validation, replacement, reduction, refinement