British drug regulator plans framework to reduce animal testing reliance

March 25 (Reuters) – Britain’s medicines regulator said on Wednesday it will introduce a framework by the end of 2026, which would allow drugmakers to ask a review of the data for drugs being developed without animal testing before applying for approval.

The draft guidance from the UK’s Medicines and Healthcare products Regulatory Agency aims to reduce reliance on animal studies and aligns with a broader global push to limit such testing in drug development.

Here are key details of the MHRA’s draft:

* The MHRA will support efforts to move away from animaltesting where scientifically appropriate, while continuing toaccept applications that include animal testing based data inline with international standards, citing patients’ bestinterests. * Developers may submit data from non-animal testing methodsalongside any traditional studies, it said, adding thatdecisions will be taken on a case-by-case basis. * A new review mechanism will allow companies developinganimal-free products to submit preclinical safety data for earlyassessment, the regulator said, adding that companies mustreport at least one human clinical trial to qualify forreceiving a view on whether the data is sufficient for a fullapplication. * The MHRA said it does not support animal testing forgeneric and biosimilar medicines, for drug substances that donot work in animals, and for products whose medicinal profile iswell-known. * However, the regulator said it expects to see relevantanimal studies for new types of drugs being studied anddeveloped, adding that animal data for vaccines will also beaccepted. * It added safety studies must still meet the GoodLaboratory Practice, a set of globally agreed quality controlstandards developed by the Organisation for EconomicCoordination and Development even when using non-animal methods,and may reject applications if key data do not comply. * The U.S. FDA last week issued draft guidance encouragingcompanies to reduce animal testing and adopt alternatives suchas computer simulations and organ-mimicking devices.

(Reporting by Rishab Shaju and Pushkala Aripaka in Bengaluru; Editing by Krishna Chandra Eluri)