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27 - 08 - 2018

The European Medicines Agency and the 3Rs

The European Medicines Agency (EMA), which imposes the use of animal testing for certain preclinical studies, works in favor of the 3Rs and for the ethical use of animals.


Among other things, the EMA defines the conditions necessary for placing medicines and vaccines on the market.

Among these conditions are animal studies. In France, for example, in 2016, safety, production and quality control tests for human and veterinary drugs accounted for 25% of the animals used in research. Why is that? In accordance with the requirements of Directive 2010/63, EMA acts in favor of the 3Rs (Replace, Reduce, Refine) in the European Union.





The agency has issued recommendations to institutions on the regulatory acceptance of the 3Rs approaches. It specifies: the criteria and the conditions of demonstration of the scientific validity including the inter laboratory validation and the approval procedure by the EMA.

The EMA has also issued recommendations to the national authorities for the pharmacopoeia * of human and veterinary drugs and vaccines. Regarding human vaccines, for example, the EMA specifies that tests on adult mice and guinea pigs for cell substrates for vaccine production are abandoned.

Lastly, the EMA's Biennial Report 2016-2017 assesses these activities.


* the pharmacopoeia refers to both the organization and the reference document that describes the quality controls for medicines and vaccines