Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/CVMP/3Rs/94436/2014
Published9/11/2017
Effective from9/11/2017
Keywords3Rs, collaborative trials, quality control tests, method transfer, validation
DescriptionThe guideline applies to regulatory testing used for quality control of medicinal products where animals have been traditionally used. It aims to facilitate transfer of quality control methods validated in collaborative trials with a view to implementing the 3Rs – replace, reduce and refine – principles to testing in a product-specific context.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 9/11/2017–present


Published: 24/01/2018


Published: 29/07/2016


Published: 18/07/2014


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