Working Group on the Application of the 3Rs in Regulatory Testing of Medicinal Products

The Joint Committee for Medicinal Products for Veterinary Use (CVMP)/Committee for Medicinal Products for Human Use (CHMP) Working Group on the Application of the 3Rs in Regulatory Testing of Medicinal Products (Joint 3Rs Working Group) provides advice to the CVMP and the CHMP on all matters concerning the use of animals in regulatory testing of medicines with particular focus on the application of the so-called 3Rs principles (replace, reduce and refine).

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.

For more information on how the European Medicines Agency (EMA) and its Joint 3Rs Working Group support the implementation of the 3Rs principles in the European Union, see:

• Ethical use of animals in medicine testing.

Mandate, rules of procedure and work programme

For more information on the Joint 3Rs Working Group's responsibilities and composition, see:

• Mandate
• Work plan

Composition

The Joint 3Rs Working Group consists of:

• a core-group of European experts from each of the following CHMP and CVMP working parties that develop guidance on aspects such as pre-clinical studies, safety and efficacy requirements in the development and controls applied to medicines that may still require some animal testing:
  • Safety Working Party (human medicines);
  • Safety Working Party (veterinary medicines);
  • Biologics Working Party;
  • Immunologicals Working Party;
  • Efficacy Working Party

• members from CVMP and CHMP, as necessary;
• co-opted experts and observers from the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM).
• experts from other working parties, as necessary, such as the Vaccines Working Party, Biosimilar Medicinal Products Working Party and the Joint CHMP/CVMP Quality Working Party.

Members

Below (in alphabetical order of surname) are the current members of the Joint 3Rs Working Group. The members' declarations of interests are available in the European expert list.