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.

Replace animal studies with non-animal methods; Reduce to minimum required and necessary; Refine practices minimise stress of study animals

New approach methodologies

New approach methodologies (NAMs) refer to non-animal methods which may be incorporated in the assessment of the safety and efficacy of new medicines to replace or reduce animal use. Examples include in vitro (cell-based) systems and computer modelling.

These methods represent potential alternatives to animal testing in the non-clinical development phase of new medicines. Their use should be carefully considered.

Where animal testing is still needed, researchers should design and conduct such studies in line with the 3Rs principles.

EMA role

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

Working parties and other groups

EMA has a dedicated 3Rs Working Party (3RsWP), which provides advice to its scientific committees on all matters concerning the use of animals in regulatory testing of medicines.

In addition, EMA's Non-Clinical and New Approach Methodologies European Specialised Expert Community provides a forum for information-sharing between regulatory and academic experts on innovative non-clinical testing methods. These include new approach methodologies.

    Long-standing commitment

    The Joint Expert Group (JEG3Rs) and the 3Rs Working Group (3RsWG) preceded the establishment of the 3Rs Working Party, demonstrating EMA's long-standing commitment to the 3Rs.

    For more information, see:

    EMA reporting on 3Rs

    Biennial report 2016/2017 - Joint CVMP/CHMP Working group on the Application of the 3Rs in Regulatory Testing of Medical ProductsEMA 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 will resume its reporting on 3Rs activities in 2024. It will issue reports every two years.

    This decision follows the establishment of the 3Rs Working Party in November 2022 and the end of business continuity measures in 2023. The latter ditacted the suspension or reduction of the activities of non-product-related working parties / groups.

    Scientific guidelines

    Other EMA positions and recommendations on 3Rs

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