Draft concept paper on review and update of European Medicines Agency guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products

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Download document Draft concept paper on review and update of European Medicines Agency guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products
Reference number EMA/CHMP/CVMP/JEG-3Rs/704685/2012
Status draft: consultation open
First published 07/02/2014
Last updated 07/02/2014
Consultation start date 07/02/2014
Consultation end date 31/05/2014
Email address for submissions jeg-3rs@ema.europa.eu

Summary

The Joint CHMP/CVMP ad-hoc expert group on the application of the 3Rs in the regulatory testing of medicinal products (JEG 3Rs), in coordination with relevant CHMP and CVMP working parties, has been reviewing existing European Medicines Agency guidance documents with a view to ensuring that these reflect current best practice with regard to implementation of 3Rs approaches.