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<p>The Medicines and Healthcare products Regulatory Agency (MHRA) is committed to
the principles of the three Rs: replacement, refinement and reduction, developed by
the National Centre for the Replacement, Refinement and Reduction of Animals (NC3Rs).
This commitment extends to both the research undertaken at their laboratories at South
Mimms, and through their interactions with stakeholders. Where Marketing Authorisation
Holders propose to use animals in tests required for ensuring the safety of medicines,
the MHRA requests that non-animal alternatives are investigated and adopted where
appropriate for patient safety.</p><p>The MHRA is also contributor to a revision of
the World Health Organization (WHO) guidelines for Biologicals and Vaccines under
the leadership of the NC3Rs. These revisions propose that the WHO guidelines adopt
the principles of the three Rs and include a general chapter on how regulators and
Marketing Authorisation Holders can end the use of animal testing for biological medicines
including pharmaceutical products for bacterial contamination and vaccines. These
revised guidelines will be presented to the Autumn 2023 summit of the WHO for the
consideration by committee and WHO members.</p>
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