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Ethical use of animals in medicine testing

This content applies to human and veterinary medicines

The European Medicines Agency (EMA) supports the implementation of the so-called 3Rs principles - replace, reduce and refine - for the ethical use of animals in medicine testing across the European Union (EU). These principles encourage alternatives to the use of animals in the testing of medicines while safeguarding scientific quality and improving animal welfare where the use of animals cannot be avoided.

Directive 2010/63/EU requires marketing authorisation holders to integrate the 3Rs and welfare standards for the treatment of animals in all aspects of the development, manufacture and testing of medicines.

The Directive aims to protect animals in scientific research, with the final aim of replacing all animal research with non-animal methods.

3Rs principles

The 3Rs stand for:

  • replacing the use of animals with non-animal methods where possible;
  • reducing the number of animals used to a minimum while still obtaining scientifically valid results;
  • refining practices to minimise the stress and improve the welfare of study animals used for regulatory purposes.

3Rs principle

EMA role

EMA supports the implementation of Directive 2010/63/EU and the 3Rs principles in the EU, by:

EMA has a dedicated Joint CVMP/CHMP 3Rs Working Group (J3RsWG), which provides advice to its scientific committees on all matters concerning the use of animals in regulatory testing of medicines.

For more information, see:

EMA actions on 3Rs in 2016-17

Biennial report 2016/2017 - Joint CVMP/CHMP Working group on the Application of the 3Rs in Regulatory Testing of Medical ProductsEMA has published a PDF icon report summarising actions carried out by its committees in 2016 and 2017 to support the implementation of the 3Rs principles.

EMA intends to publish a report on this topic every two years.


Scientific guidelines

Veterinary medicine testing outside the EU

Wherever the manufacture or batch testing of veterinary medicines to be marketed in the European Economic Area (EEA) takes place, they must conform to EU ethical and animal welfare standards.

For more information, see:

Recommendations on 3Rs in European Pharmacopoeia


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