The MHRA has taken decisive action to phase out animal testing by helping developers make better use of New Approach Methodologies (NAMs).
UK slashes animal testing in drug trials with AI and human cell models
By offering early reviews of non-animal data and clarifying how it will be assessed, the initiative gives developers greater confidence in developing marketing applications based on evidence generated without animal testing.
The move supports the UK Government's long-term strategy to reduce the use of animals in drug development, where complete elimination isn't yet feasible, and to ensure medicines continue to meet rigorous safety standards.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, explained: "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.
Advances such as AI-driven analysis and human-derived cell models mean some medicines no longer require animal studies to demonstrate safety and efficacy."
Phasing out animal testing in the medicine industry
Phasing out the use of animals in science and product development must be supported by reliable and effective alternative methods.
The use of animal testing was previously considered essential for providing insights into biology and disease and for protecting humans and the wider environment.
However, there has recently been an increase in the development of new technological methods that can serve as alternatives to using animals.
Now, new advances in technology - particularly AI and genomics, but also organoid and 3D cell systems - finally allow us to see a path to changing our reliance on animals in science.
The UK Government is continuing to implement its long-term strategy; however, it acknowledges that some animal research will remain necessary due to the lack of alternative methods in certain areas.
Clearer principles for a new era of medicine development
While each application will be assessed on a case-by-case basis, considering the totality of the evidence presented and the proposed clinical use, the guidance sets out general regulatory principles:
- Generic/biosimilar products or drugs that are not pharmacologically active in animals should not be tested on animals.
- Toxicity testing of biological products on animals should only be done in species shown to be pharmacologically relevant.
- Products with a well-recognised pharmacological profile may enter UK clinical trials without having first been tested on animals.
- Products with a novel pharmacological action should be tested on animals, in line with international guidelines.
- Products that cannot be tested for efficacy in clinical trials, such as vaccines for some emerging pandemic infectious diseases, should be tested on animals.
"Our offer to review study data prior to a full marketing application is designed to help researchers adopting these approaches build the robust evidence needed to demonstrate safety and efficacy," Beach commented.
Reviewing data to find the safest drug development methods
To support the use of NAMs and reduce the perceived risks of approaches that do not involve animal testing, the MHRA has committed to reviewing preliminary data from drug trials using non-animal models.
By the end of 2026, companies with a product developed without animal testing can have Module 4 of their Marketing Authorisation application reviewed by the MHRA in advance.
The MHRA will undertake a further review, in consultation with the Commission on Human Medicines, and either endorse or reject the application, with reasons for any rejection.
Read also:
- Peptide YY (PYY): Exploring its Role in Appetite Suppression, Intestinal Health, and Cognitive Links
- Toddler Health: Rotavirus Signs, Origins, and Potential Complications
- Digestive issues and heart discomfort: Root causes and associated health conditions
- House Infernos: Deadly Hazards Surpassing the Flames
