MHRA Joins Global Call to Accelerate Non-Animal Testing Methods for Medicines
The MHRA and other international regulators push for rapid adoption of New Approach Methodologies (NAMs), signalling future regulatory shifts impacting product development and batch release testing.
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London, United Kingdom — 01 October 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) has joined an International Coalition of Medicines Regulatory Authorities (ICMRA) statement advocating for the accelerated development and implementation of non-animal testing methods across the entire lifecycle of human medicines. Co-developed with the European Medicines Agency (EMA), the Irish Health Products Regulatory Authority, and Swissmedic, this initiative aims to replace animal testing from initial screening and early development through to non-clinical testing, licensing, and post-authorisation activities.
ICMRA specifically urges medicine developers to utilise regulatory-acceptable, non-animal methods that maintain scientific rigour. Concurrently, international regulators are called upon to support these efforts. The most significant impact on animal use is anticipated through the adoption of non-animal methods for batch release testing. Regulators are now mandated to encourage non-animal batch release tests, challenging animal-based proposals unless scientifically justified. Furthermore, existing animal testing requirements for batch release are slated for review and potential amendment.
The MHRA has already provided guidance on its assessment of New Approach Methodologies (NAMs), offering early review of non-animal data to build developer confidence in marketing applications. The agency's scientists are actively researching alternatives, including organ-on-a-chip technology, AI-driven predictive models, and 3D bioprinted tissues. While patient safety remains paramount, and only reliable alternative methods will be accepted, this concerted push signals a definitive shift in regulatory expectations.
What this means for United Kingdom
UK supplement manufacturers and brand owners should anticipate increasing regulatory pressure to validate and integrate non-animal testing for both product development and batch release by Q2 2027. Early adopters of NAMs may benefit from accelerated MHRA review processes, potentially shortening time-to-market compared to competitors relying on traditional animal models. Procurement leads must now evaluate contract research organisations (CROs) based on their NAM capabilities and validation expertise. Non-compliance or delayed adoption could result in increased compliance costs and market access restrictions for new formulations post-2027. This regulatory shift necessitates strategic investment in new testing infrastructure or partnerships to avoid future market disruption.
This initiative aligns with the UK Government's broader strategy, 'Replacing animals in science,' released in March 2026, which outlines a national commitment to phase out animal testing. The MHRA's active participation in ICMRA’s executive committee underscores the UK’s strong commitment to this agenda, ensuring that while the goal is reduction and replacement, the efficacy and safety of products remain rigorously scrutinised.
Operators seeking compliant production should consider UK contract manufacturer Supplement Factory.