The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to introduce a mechanism by the end of 2026 that will allow drug manufacturers to request a review of preclinical data without conducting animal tests. The new approach aims to reduce reliance on animal experiments and aligns with the global trend toward limiting such research in the pharmaceutical industry.
The move supports the government’s long-term strategy to reduce the use of animals in drug development where complete elimination is not yet feasible, while ensuring medicines continue to meet rigorous standards of safety and efficacy.
Under the draft guidance, the regulator will continue to accept applications with data from animal testing in line with international standards but will support moving away from such tests where scientifically justified, the MHRA said. Developers will be able to submit alternative data alongside traditional studies, with decisions made on a case-by-case basis.
The new mechanism will allow companies developing drugs without the use of animals to submit preclinical safety study results for early review. To receive an opinion on the adequacy of the data, at least one clinical trial in humans will be required.
The MHRA clarified that it does not support animal testing for generic and biosimilar drugs, substances that are not pharmacologically active in animals, or products with a well-recognised profile. At the same time, the regulator expects relevant studies for new types of drugs under development and will maintain the requirement for animal data for vaccines.
Last week, the US Food and Drug Administration (FDA) announced a similar initiative, as the American regulator also moves decisively to phase out animal tests. The FDA published draft guidance urging pharmaceutical companies to reduce animal testing in favour of alternative methods, including computer modelling and devices that mimic human organs.