Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Keywords Best practise, 3Rs, guidelines, regulatory testing
Description
In February 2014, CHMP and CVMP published a joint concept paper announcing a review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products (EMA/CHMP/CVMP/JEG-3Rs/704685/2012).
As background, it should be noted that the purpose of this review was not to reconsider established testing requirements but, rather, to ensure that EMA guidelines do not make reference to animal tests that are no longer considered appropriate.
The purpose of the current document is to provide an update on the work undertaken and the guidelines that have been or will be updated as a result of this review.

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