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

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This guideline applies to human and veterinary medicines.

Current effective version

Adopted guideline

Reference numberEMA/CHMP/CVMP/JEG-3Rs/450091/2012
Effective from01/07/2017
Keywords3Rs, regulatory acceptance, testing approaches, non-clinical, quality, human medicinal products, veterinary medicinal products, qualification, validation, replacement, reduction, refinement
DescriptionThis 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.

Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

Concept paper

In operation from: 01/07/2017


Published: 24/02/2017


Published: 03/10/2014

Published: 11/04/2011

Superseded documentPosition paperPublished: 19/02/1997

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