This content applies to human and veterinary medicines

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.
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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

     

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    EMA published a Biennial report of the joint CVMP/CHMP working group on the application of the 3Rs in regulatory testing of medical products (2016/2017) 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

    EMA together with the support of its 3Rs Working Party (3RsWP) 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 regularly reviews and updates these guidelines to reflect developments in the field.

    EMA 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:

    Other EMA positions and recommendations on 3Rs

    Recommendations on 3Rs in European Pharmacopeia

    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.

    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:

    Related EU legislation

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