Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether non-animal alternatives must be validated if they are being used to provide data on the safety and efficacy of potential new pharmaceuticals within submissions to the Medicines and Healthcare products Regulatory Agency.

The term ‘validation’ is broad and subject to a variety of definitions. Regarding the use of animal models for submission to the Medicines and Healthcare products Regulatory Agency (MHRA), non-animal alternatives must be demonstrated to be fit for the purpose intended when used to characterise the safety and potential efficacy of new pharmaceuticals. A new guideline issued in March of this year describes the current MHRA approach to medicines using non-animal methods, and is available at the following link:

https://www.gov.uk/guidance/mhra-approach-to-medicines-using-non-animal-methods#:~:text=In%20making%20an%20application%20to,not%20support%20testing%20in%20animals