MHRA moves to reduce animal testing with new guidance

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance on how marketing applicants can use non-animal data in their applications. The move comes on the heels of a similar initiative by the US Food and Drug Administration (FDA) to reduce the need for animal testing in drug development.

On 25 March, MHRA published a guidance on how it plans to review clinical trial authorization applications of marketing authorization applications that use non-animal data. The agency said it will work to phase out animal testing as much as possible by helping product developers use New Approach Methodologies (NAM). It also said that applicants using NAMs will be able to get more clarification from its reviewers on how such data can be used, ultimately giving them more confidence in their marketing applications.

"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," said Julian Beach, MHRA interim executive director for healthcare quality and access, in an agency statement published 24 March. "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."

She also noted that new methodologies, such as the use of artificial intelligence (AI) and human‑derived cell models, have negated the need for animal studies to prove the safety and efficacy of some products.

MHRA said that, traditionally, international drug development guidelines have recommended animal testing. However, the guidance noted that advances in global drug development guidelines have enabled trials to proceed without animal data, a position supported by the agency.

“Where it can be shown that deviating from expectations for in vivo studies in current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines seems to pose no risk to human health of the specific clinical use proposed, the MHRA is open to considering proposals that omit animal studies, if alternative methods address safety,” said MHRA. “At this time, the MHRA will continue to accept applications that include animal studies in line with international guidelines in place at the time the studies in animals were done: our position is that refusing such applications because they include animal studies is not in the best interests of UK patients.

“A period can be envisaged in which one developer might apply animal studies and another developer might apply only non-animal based methods, yet each approach could be acceptable,” the agency added.

The guidance echoes a policy paper that MHRA published in November proposing a new regulatory strategy to reduce the need for animal studies. The agency said that each marketing application will be assessed on a case-by-case basis based on the totality of the evidence, but that following a set of principles may reduce the need to conduct animal studies.

Broadly, the principles stated in the guidance include not conducting animal testing with generic drugs and biologics that are not pharmacologically active in animals; conducting toxicity testing of biological products on animals only when they are pharmacologically relevant; and products with a well-recognized pharmacological profile may qualify for human trials without the need for animal testing first.

On the other hand, MHRA said that animal testing should be conducted in accordance with international guidelines when it involves a product with a novel pharmacological action, and for products, such as vaccines for emerging pandemic infections, when they cannot be tested for efficacy in human trials.

“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,” said MHRA. “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.”

MHRA elaborated in the guidance that certain requirements must be met to for it to accept Module 4 of the application when not using animal data, including the applicant must have completed at least one clinical trial and reported it, and they should expect to submit their intended final Module 4, the latest edition of the Investigator Brochure and the final report of at least one clinical trial for review. The agency also provided details on what recourse applicants have if the agency initially denied their Module 4, which includes pre-clinical data.

“This review of Module 4, containing no animal studies, aims to de-risk development strategies that exclude animals,” said MHRA. “There will be a fee set at a level to recover administrative costs and discourage unsuitable applications.

“This relates only to Marketing Authorisation applications and has no impact on Clinical Trial Authorisation applications,” the agency added.

The guidance also detailed MHRA's expectations for good laboratory practices (GLP) and said that it expects safety studies to comply with requirements developed by the Organisation for Economic Co-operation and Development (OECD) that allow data to be accepted between adherent countries.

"A move away from use of animals does not reduce this expectation - where safety studies can be conducted in compliance with OECD GLP, this is expected," said MHRA. "Nevertheless, the MHRA does accept that in some instances, compliance with GLP may not be claimed for a particular study within a dossier; where this is so, a discussion should be presented in the dossier to support this."

"If non-OECD GLP studies are presented as pivotal safety studies, the MHRA position remains that it could reject an application due to lack of OECD GLP compliance," the agency added.

MHRA's announcement comes a week after FDA published a similar guidance intended to encourage drugmakers to rely less on animal studies and instead adopt NAMs. The agency's efforts are part of the mandate issued by Congress under the 2022 FDA Modernization Act 2.0, which explicitly states that NAMs can be used to support an Investigational New Drug (IND) application or a biosimilar biologics license application (BLA). (RELATED: FDA drafts guidance on animal testing alternatives, Regulatory Focus, 18 March 2026)

MHRA statement
MHRA position paper
MHRA guidance

MHRA moves to reduce animal testing with new guidance

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