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
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Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches (PDF/177.25 KB)
Adopted
First published: 24/02/2017
Last updated: 24/02/2017
EMA/CHMP/CVMP/JEG-3Rs/450091/2012 -
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Overview of comments received on ' Guideline on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches' (EMA/CHMP/CVMP/JEG-3Rs/450091/2012) (PDF/352.23 KB)
First published: 24/02/2017
Last updated: 24/02/2017
EMA/CHMP/CVMP/JEG-3Rs/25975/2015 -
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Draft guideline on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches (PDF/256.58 KB)
Draft: consultation closed
First published: 03/10/2014
Last updated: 03/10/2014
Consultation dates: 03/10/2014 to 31/12/2014
EMA/CHMP/CVMP/JEG-3Rs/450091/2012 -
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Concept paper on the need for revision of the position on the replacement of animal studies by in vitro models (PDF/97.26 KB)
Draft: consultation closed
First published: 11/04/2011
Last updated: 11/04/2011
Consultation dates: 17/03/2011 to 30/06/2011
EMA/CHMP/SWP/169839/2011