The Medicines and Healthcare products Regulatory Agency (MHRA) will offer early review of non-animal data in a decision supporting the government’s strategy to reduce animal testing in drug development.  

The move is intended to help drug developers make greater use of New Approach Methodologies (NAMs), hopefully giving developers more confidence when making marketing applications based on evidence generated without animal testing. 

Though each application will still be assessed on a case-by-case basis, the new guidance does include general regulatory principles, including:   

• 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. 

To support the use of NAMs, the MHRA will review preliminary data from drug trials that use 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. 

In this scheme, companies will submit Module 4, the Investigator Brochure and the final report of at least one clinical trial. The MHRA will give a non-binding written opinion that accepts the adequacy of the data or explains deficiencies.  This will be included in the Marketing Authorisation application, alongside the Module 4 previously submitted and any updated version. 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. Companies submitting Module 4 in advance will be charged a fee to recover administrative costs and discourage unsuitable applications.  

Julian Beach, Interim Executive Director Healthcare Quality and Access said: “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.  

“Our offer to review study data ahead of a full marketing application is designed to help researchers who are adopting these approaches build the robust evidence needed to demonstrate safety and efficacy.” 

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