EMA, MHRA Lead Call for Animal-Testing Alternatives

Four medicines regulators published a joint statement on 1 October 2026 calling on drug developers, manufacturers, regulators and national control laboratories to advance and implement alternatives to animal testing across the medicine lifecycle. The statement’s development was led by the European Medicines Agency, the UK’s MHRA, Ireland’s HPRA and Switzerland’s Swissmedic, and it was adopted under the International Coalition of Medicines Regulatory Authorities, the global network through which national regulators coordinate policy. It is a call to action, not a new rule — no approval requirement or testing standard changes because of it — but it signals where four regulators with outsized influence over global drug development want the standard to move.

What the statement asks for

The statement calls on medicine developers, manufacturers, regulators and national control laboratories — the full set of actors who generate or rely on nonclinical safety data — to favor non-animal methods wherever a validated alternative exists, and to actively develop alternatives where none yet does. It points to physicochemical, immunochemical, ex vivo and in vitro methods, including two- and three-dimensional cell-culture models, as the categories of replacement technology it wants to see adopted more widely.

The statement notes that in most regions there is already consensus that animal studies are not scientifically justified in certain circumstances — for generics and biosimilars, for example, where the reference product's safety profile is already established. Its ask goes further than that existing consensus: it wants the same scrutiny applied earlier in development, at candidate screening and non-clinical testing, and later, at post-authorisation batch-release testing, where regulators have historically been the most conservative about accepting non-animal evidence.

Where in the lifecycle it applies

• Early candidate screening — before a molecule enters formal nonclinical development.
• Non-clinical (preclinical) testing ahead of a marketing application, covering general toxicity, reproductive toxicity, carcinogenicity and pharmacodynamic/pharmacokinetic studies.
• Licensing — what regulators will accept as adequate evidence in a marketing-authorisation dossier.
• Post-authorisation activities, including batch-release testing, where the statement encourages regulators to favor non-animal methods and reserve animal testing for cases with no validated alternative.

A call to action, not a new rule

Nothing in the statement is self-executing. It does not amend EMA's, MHRA's, HPRA's or Swissmedic's existing guidance, and it sets out a long-term goal rather than a compliance deadline. What it carries is the weight of four regulators — covering the EU, UK and Switzerland — aligning in public on a direction, under the banner of the broader international coalition most national regulators belong to. For a sponsor planning a nonclinical program today, the statement is a signal to watch rather than a requirement to meet: it indicates where review divisions are likely to be more receptive to non-animal evidence going forward, without yet obligating anyone to use it.

A second MHRA item this year

This is not MHRA's only animal-testing announcement in 2026. In March, the UK regulator separately set out new regulatory principles and a pathway for advance review of non-animal evidence submitted in UK marketing applications — a more concrete, UK-specific mechanism aimed at giving sponsors an early read on whether non-animal data will be accepted. The 1 October statement is broader and multilateral, but non-binding; the March pathway is narrower, UK-only, but operational. Sponsors tracking both should not treat the October statement as an extension of the March pathway into the EU or Switzerland — it is a parallel, separate initiative with a different legal character.

Frequently asked questions

Who published the statement, and when?

Published 1 October 2026. Its development was led by EMA, MHRA, HPRA and Swissmedic, and it was adopted under ICMRA, the umbrella network of national medicines regulators.

Is this a new rule or regulation?

No. It is a non-binding joint statement calling for action; it does not itself change any approval requirement, testing standard or guideline.

What does it ask for specifically?

Advancing and implementing non-animal testing alternatives across the medicine lifecycle — candidate screening, non-clinical testing, licensing and post-authorisation batch-release testing — with a long-term goal of eliminating animal use in general toxicity, reproductive toxicity, carcinogenicity and PD/PK studies.

How does this differ from MHRA's earlier 2026 animal-testing announcement?

MHRA's March 2026 announcement set out a concrete, UK-specific pathway for advance review of non-animal evidence. The 1 October statement is a broader, non-binding, multi-regulator call to action, not a new review pathway.