Animal Experiments
The question
To ask the Secretary of State for Health and Social Care, with reference to the policy paper entitled Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods, published on 11 November 2025, what progress he has made on phasing out preclinical animal testing of biologicals where no pharmacologically relevant animal models exist.
Answered by Dr Zubir Ahmed
Where there is no pharmacologically relevant animal species for testing a biological product, the position of the Medicines and Healthcare products Regulatory Agency (MHRA) is that there should be no studies done on animals, and in March 2026, the MHRA published a statement on its website that included this text: “For certain drug substances that are not pharmacologically active in animals, the MHRA does not support testing in animals (including with surrogate molecules). For this group of drugs, non-animal-based methods suffice to support expectations for efficacy and safety in clinical development”. This position is represented to companies that seek scientific advice from the MHRA on drug development in this context. Further information is available at the following two links:
https://www.gov.uk/guidance/mhra-approach-to-medicines-using-non-animal-methods
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