Animal Experiments
(asked on 20th April 2026) - View Source
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Department for Science, Innovation and Technology's 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 his Department has made in applying only validated alternative methods for pharmacopoeial adventitious agent testing for human medicinal products licensed in the UK.
In line with the Government’s strategy to replace animals in science, the Medicines and Healthcare products Regulatory Agency (MHRA) supports the use of non-animal approaches where they are fit for purpose and accepts that, where a biological product is not pharmacologically active in animals and no relevant animal model exists, studies in animals, including with surrogate molecules, should not be undertaken and first-in-human applications can be supported using non-animal data, such as in vitro methods and computer modelling, to inform expected human exposure and safety. Further information is available at the following link:
More broadly, alternative methods used to characterise safety must be demonstrated as fit for their intended purpose, and MHRA guidance, published in March 2026, sets out its current approach to medicines using non-animal methods, including how such approaches can support regulatory submissions and the adoption of validated alternatives as they become available. For potency testing and for adventitious agent testing, separate information for manufacturers on controls for batch release is on the MHRA website explaining how adoption of non-animal methods for these purposes is supported. Further information is available at the following two links:
https://www.gov.uk/guidance/mhra-approach-to-medicines-using-non-animal-methods