The European Medicines
Agency has produced a position paper titled “Reflection paper providing an
overview of the current 4 regulatory testing requirements for medicinal
products for 5 human use and opportunities for implementation of the 6 3Rs.”
The reference is: EMA/CHMP/CVMP/JEG-3Rs/742466/2015
This relates to regulatory
acceptance of 3R 29 (replacement, reduction, refinement) testing approaches
(EMA/CHMP/CVMP/JEG-3Rs/450091/2012). 30 The current reflection paper has been
developed as a follow up to that draft guideline and provides an 31 overview of
the main animal tests required for the regulatory testing of medicinal products
for human 32 use (a parallel document has been developed in relation to
veterinary medicinal products – 33 EMA/CHMP/CVMP/JEG-3Rs/740772/2015). It
includes information on opportunities for limiting animal 34 testing that can
already be implemented, where appropriate, as well as information on
opportunities 35 that may become available in the future. In so doing, it is
hoped that the document may stimulate 36 future submissions for CHMP advice on
the regulatory acceptance of new 3Rs approaches.
Posted by Dr. Tim Sandle