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

This guideline applies to human and veterinary medicines.

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/CVMP/JEG-3Rs/450091/2012
Published22/12/2016
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

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline


PDF iconConcept paper

In operation from: 01/07/2017

Published: 24/02/2017

Published: 03/10/2014


Published: 11/04/2011

Superseded document PDF iconPosition paper Published: 19/02/1997


Related content


How useful was this page?

Add your rating