What action(s) is the MHRA taking in order to phase out animal testing?
The MHRA has taken decisive action to phase out animal testing by helping developers to make greater use of New Approach Methodologies (NAMs).
By offering early review of non‑animal data and clarifying how it will be assessed, the UK’s medicines regulator aims to give developers more confidence when submitting marketing authorisation applications (MAAs) based on evidence generated without animal testing.
What are New Approach Methodologies (NAMs)?
New Approach Methodologies (NAMs) are modern, non-animal scientific methods used to assess the safety, efficacy, and biological effects of medicines and chemicals.
Instead of relying on traditional animal studies, NAMs generate data using human-relevant systems and computational tools.
What is driving the MHRA move to phase out animal testing?
The move supports the Government’s long-term strategy to reduce use of animals in drug development, where complete elimination is not yet feasible, and ensure medicines continue to meet rigorous standards of safety and efficacy.
What are the general regulatory principles that will be employed for Marketing Authorisation Applications to achieve the aim of reducing/eliminating animal testing?
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
How will the MHRA support the use of NAMs and reduce perceived risks of approaches that do not involve animal testing?
To support the use of NAMs and reduce perceived risks of approaches that do not involve animal testing, the MHRA has committed to review preliminary data from drug trials that use non-animal models.
- 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.
When is the scheme expected to begin?
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.
Will the prior review of Module 4 have any impact on Clinical Trial Authorisation applications?
No, review of Module 4 relates only to Marketing Authorisation applications and has no impact on Clinical Trial Authorisation applications.
Source: MHRA