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.

On this page

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 iconreport 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

EMA develops scientific guidelines to help medicine developers comply with Directive 2010/63/EU in integrating the 3Rs and welfare standards for the treatment of animals in the testing of medicines:

EMA's Joint CVMP/CHMP 3Rs Working Group also conducted a review of all EMA guidelines to ensure that they do not make reference to animal tests that are no longer considered appropriate. For more information and the guidelines that EMA has or will update as a result, see:

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

In the table below, EMA provides recommendations on 3Rs methods in the European Pharmacopoeia to help marketing authorisation holders comply with new or revised measures.

Document Applies to
PDF iconRecommendation highlighting the need to ensure compliance with 3R methods described in the European Pharmacopoeia All medicinal products
PDF iconRecommendation highlighting recent measures in the human field to promote 3Rs measures described in the European Pharmacopoeia Human vaccines
PDF iconRecommendation highlighting recent updates for the 3Rs methods described in the European Pharmacopoeia applicable to human vaccines against hepatitis A Human vaccines against hepatitis A
PDF iconRecommendation highlighting recent measures in the veterinary field to promote 3Rs measures described in the European Pharmacopoeia Veterinary vaccines
PDF iconRecommendation for veterinary vaccines, highlighting the need to update marketing authorisations to remove the target animal batch safety test (TABST) following removal of the requirement from the European Pharmacopoeia monographs Veterinary vaccines

How useful was this page?

Add your rating