MHRA Offers Early Review of Non-Animal Data for Marketing Authorisations
Summary
The MHRA announced a new early-review pathway for pharmaceutical developers using New Approach Methodologies (NAMs), offering to assess Module 4 of Marketing Authorisation applications that rely on non-animal data before a formal submission. By the end of 2026, companies can submit Module 4, the Investigator Brochure, and at least one clinical trial final report for a non-binding written opinion on data adequacy, with a fee charged to recover administrative costs. Pharmaceutical companies developing drugs without animal testing now have a clearer regulatory route to obtain early feedback, reducing uncertainty and supporting the transition to NAM-based development.
“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.”
Pharmaceutical companies with NAM-based development programmes should assess whether their evidence package aligns with MHRA's stated case-by-case principles, particularly the distinction between products with well-recognised versus novel pharmacological profiles. Preparing Module 4, the Investigator Brochure, and at least one clinical trial final report in advance will enable companies to take full advantage of the early-review offer by end of 2026.
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
The MHRA has established a voluntary early-review programme for pharmaceutical developers using New Approach Methodologies (NAMs), allowing companies to submit Module 4 of their Marketing Authorisation application—along with the Investigator Brochure and at least one clinical trial final report—for MHRA assessment before a formal filing. The agency will provide a non-binding written opinion accepting the adequacy of the data or identifying deficiencies, with the opinion includable in the eventual Marketing Authorisation submission. Companies using animal-free development pathways should consider taking advantage of this advance review to reduce uncertainty, identify gaps early, and build robust evidence packages aligned with the MHRA's stated principles on when animal testing is or is not required.
Pharmaceutical companies developing products without animal testing gain a concrete new engagement mechanism with the regulator, addressing the primary barrier of uncertainty about whether non-animal evidence will satisfy approval requirements. Developers should review the MHRA's published principles—including when animal testing is required for novel pharmacological actions or products where clinical efficacy cannot be demonstrated—to determine whether their NAM-based approach aligns with regulatory expectations before seeking early review.
Archived snapshot
Mar 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Press release
MHRA action boosts drive to phase out animal testing
Medicines and Healthcare products Regulatory Agency (MHRA) takes decisive action to phase out animal testing by helping developers to make greater use of New Approach Methodologies (NAMs).
From: Medicines and Healthcare products Regulatory Agency, Department for Science, Innovation and Technology and Lord Vallance Published 24 March 2026
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 making marketing applications based on evidence generated without 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.
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.
Clearer principles for a new era of medicines 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 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. 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.
Notes to editors
- In November 2025, the Government published Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods.
- 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.
- Review of Module 4 relates only to Marketing Authorisation applications and has no impact on Clinical Trial Authorisation applications.
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
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Published 24 March 2026
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