14/15 December 2021
The beginning of the 3 Rs activities in the EU legislation can maybe dated to 1986, when the first EU legislation for the protection of animals used for experimental and other scientific purposes was adopted. But in the last years, especially with the Directive 2010/63/EU on the protection of animals used for scientific purposes, for the first time in the EU legislation specifically defines the principle of the “Three Rs” and makes it a firm legal requirement. In December 2016, the European Medicines Agency has released for public consultation a reflection paper on providing an overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs. They summarized in their information for stakeholders:
"In October 2014 the CHMP and CVMP published a draft guideline on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches (EMA/CHMP/CVMP/JEG-3Rs/450091/2012). The current reflection paper has been developed as a follow up to that draft guideline and provides an overview of the main animal tests required for the regulatory testing of medicinal products for human use (a parallel document has been developed in relation to veterinary medicinal products - EMA/CHMP/CVMP/JEG-3Rs/740772/2015). It includes information on opportunities for limiting animal testing that can already be implemented, where appropriate, as well as information on opportunities that may become available in the future. In so doing, it is hoped that the document may stimulate future submissions for CHMP advice on the regulatory acceptance of new 3Rs approaches.
The current reflection paper provides a snapshot of the testing requirements at the time of publication. It is to be expected that, over time, new testing approaches will become accepted and the tables will become out of date."
So the reflection paper on testing requirements and opportunities for implementation is open for consulting until 31 May 2017. Comments should be provided using this template.