First report on EMA’s actions to replace, reduce, refine use of animals in medical research
The European Medicines Agency (EMA) has published today its first report summarising the Agency’s actions carried out by two of its committees in 2016 and 2017 – the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) – to support the implementation of the so-called 3Rs principles for more ethical use of animals in medicine testing across the European Union (EU).
‘3Rs’ is an acronym for replacement (switch from animal studies to non-animal methods), reduction (perform as few animal studies as required and necessary) and refinement (minimise animal stress).
Although the ultimate aim is to replace the use of live animals in medicine testing, they continue to be necessary in some areas of medical research to protect human and animal health and the environment, until further scientific advancements enable the development of adequate alternatives. EU legislation requires marketing authorisationholders to integrate the 3Rs and welfare standards for the treatment of animals in all aspects of the development, manufacture and testing of medicines.
The actions described in this report are driven by a dedicated, long-term working group, the Joint CVMP/CHMP 3Rs Working Group (J3RsWG) that provides advice to the CVMP and the CHMP on all matters concerning the use of animals in regulatory testing of medicines. The working group is made up of members from working parties that develop guidance on aspects such as efficacy and safety in medicines development that still require some animal testing, together with co-opted experts and observers from the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM).
Two new guidelines developed by J3RsWG have been adopted by the CVMP and the CHMP and published by the Agency, to encourage proposals for alternative testing approaches and give guidance to individual laboratories in collaborative trials. The group has also coordinated a number of important public consultations which are detailed in the report.
The group continues to review animal tests included in product release specifications for centrally authorised veterinary and human medicines to ensure best practice in 3Rs is applied to the methodology for conducting any in vivo tests.
Through this working group and its committees, EMA will continue its efforts to further engage with stakeholders on 3R initiatives and provide expert input on regulatory issues for a smooth implementation of the principles.
EMA intends to publish a report on this topic every two years.