AI means animal testing not always needed to trial new medicines, says regulator

Animal testing for new drugs is being phased out because of advances made in artificial intelligence (AI), the UK’s medicines regulator has said.

In an announcement on Tuesday, the Medicines and Healthcare products Regulatory Agency (MHRA) said the development of AI will allow some drug trials to begin with humans, rather than being tested on animals first.

Rules are being introduced to clamp down on animal testing in favour of “modern” non-animal methods, following last year’s Government white paper which set out plans to ban using animals for science in all but exceptional circumstances.

Julia Beach, the MHRA’s interim executive director of healthcare quality and access, said: “Advances such as AI‑driven analysis and human‑derived cell models mean some medicines no longer require animal studies to demonstrate safety and efficacy.”

The new guidance also bans testing drugs that are not “pharmacologically active” in the animals they are used on, which means they must produce a biological response which benefits the animal.

It will also only allow toxicity testing of products on animals that would benefit from the drug.

Ms Beach added: “A clearer regulatory route for medicines developed without animal testing will help accelerate the transition to modern, predictive science and support the Government’s strategy to reduce and ultimately replace animals in research.”

The MHRA, which is responsible for regulating all medicines in the UK, said it will work with drug developers to make better use of “New Approach Methodolgies” (NAMs).

NAMs use technological tools such as AI to test the safety of drugs and do not rely on traditional animal studies.

The regulator also offered to review preliminary data from developers’ drug trials that use non-animal models.