Global medicines regulators call for replacing animal testing
In a landmark joint statement, medicines regulators from around the world have set out a long-term goal of replacing animal testing throughout the entire lifecycle of human medicines. The European Coalition to End Animal Experiments (ECEAE) welcomes this clear international commitment and calls for it to be translated swiftly into harmonised rules, concrete deadlines and regulatory practice.
The statement was published on 1 October 2026 by the International Coalition of Medicines Regulatory Authorities (ICMRA), a global coalition that brings together leading medicines authorities, including the European Medicines Agency (EMA), the European Commission, the US Food and Drug Administration (FDA), and regulatory agencies from 21 further countries, with the World Health Organization participating as an observer (1,2).
ICMRA calls on medicine developers, manufacturers, regulators and national control laboratories to advance and implement non-animal methods wherever and as soon as possible. This applies across the whole medicine lifecycle – from candidate screening and early development through non-clinical testing to authorisation and post-authorisation activities.
Crucially, ICMRA identifies the complete elimination of animal use in general toxicity, reproductive toxicity, carcinogenicity, pharmacodynamic and pharmacokinetic studies as a long-term goal. It calls on developers to use methods that do not involve animals and on regulators to actively support and facilitate their use.
“The statement sends an exceptionally strong signal: some of the world’s most influential medicines regulators are no longer discussing merely how to reduce animal testing, but are defining its replacement across the medicine lifecycle as the destination,” said Dr Dilyana Filipova, Deputy Chair of the ECEAE. “The next step must be to turn this shared ambition into binding, internationally harmonised requirements and measurable timelines.”
Immediate action on batch testing
ICMRA sees the greatest immediate potential to reduce animal use in routine batch-release testing, which is performed to confirm the quality and consistency of individual production batches. Regulators are urged to encourage the development, validation, and adoption of non-animal tests and to challenge proposals to use animals for batch release testing.
The ICMRA statement also calls on authorities to review existing animal-based batch-testing requirements and amend them where appropriate. This is particularly important for products that may still be subjected to animal tests for routine quality control despite the availability of scientifically valid non-animal methods.
“This commitment could spare very large numbers of animals from repetitive regulatory tests,” said Dr Filipova. “Authorities must now systematically remove outdated animal-test requirements and ensure that animal testing is not accepted.”
Global harmonisation is essential
Because medicines are developed and marketed internationally, a non-animal method accepted in one region must not be undermined by animal-test requirements elsewhere. ICMRA therefore emphasises global harmonisation of assessment standards and acceptance criteria to prevent unnecessary duplication and enable non-animal methods to be used across markets.
ECEAE particularly welcomes the leading role of EMA, which developed the statement together with the UK Medicines and Healthcare products Regulatory Agency (MHRA), Ireland’s Health Products Regulatory Authority (HPRA), and Swissmedic, the Swiss Agency for Therapeutic products. The statement was subsequently adopted by the ICMRA plenary (3).
The statement acknowledges that countries will progress at different speeds and describes the transition as cautious and stepwise. For ECEAE, this must not become a reason for delay. Regulators should establish transparent implementation plans, remove administrative barriers, create incentives for developers using non-animal approaches and report publicly on progress.
The direction is now clear: modern, human-relevant methods must become the international standard for developing, assessing and controlling medicines. ECEAE will continue advocating for this historic commitment to be translated into a swift and complete transition away from animal testing.