Summary
The European Medicines Agency has endorsed an ICMRA statement calling for scientifically valid alternatives to animal testing throughout the human-medicine lifecycle. Regulators also call for tighter justification of animal-based batch-release tests.
The European Medicines Agency (EMA) has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) urging medicine developers, manufacturers and regulators to advance alternatives to animal testing across the lifecycle of human medicines. The statement sets a long-term goal of replacing animal tests, while calling for a cautious, stepwise transition based on methods that are scientifically valid and acceptable to regulators.
The call covers the full path from screening medicine candidates and early development through pre-clinical and non-clinical testing, licensing and activities after authorisation. EMA says progress depends on international alignment: medicines are developed and regulated across borders, so alternatives need both robust supporting evidence and regulatory acceptance in different regions.
A lifecycle-wide goal, with a focus on batch release
ICMRA calls on medicine developers to use methods that do not involve animals when those methods are acceptable in a regulatory context and maintain scientific quality. It also asks regulators to support and facilitate those efforts where possible.
The statement gives particular attention to batch-release testing, which checks whether a manufactured batch meets the requirements for release. ICMRA identifies wider adoption of non-animal methods for these tests as an area with substantial potential to reduce regulatory animal use. It asks regulators to encourage suitable alternatives, challenge proposed animal testing and approve in-vivo batch-release tests only when there is scientific justification that no equivalent or superior non-animal method is available. Existing requirements should also be reviewed and amended where appropriate.
This emphasis connects the long-term goal to a specific regulatory practice. It is not a blanket instruction to end animal testing immediately: the statement calls for a progressive shift, with decisions grounded in the suitability of alternatives for the relevant test and regulatory purpose.
International coordination and the pace of change
EMA says the joint statement was developed with the UK Medicines and Healthcare products Regulatory Agency, Ireland’s Health Products Regulatory Authority and Swissmedic, and adopted by the ICMRA plenary. ICMRA acknowledges that countries and regions will accept a transition at different speeds, while encouraging regulators, developers and manufacturers to work together towards more harmonised implementation.
The EMA also reports progress in the European Union: from 2015 to 2023, the number of animal uses per year for regulatory purposes for pharmaceuticals approximately halved. That figure describes a reduction in use over that period; the statement presents broader replacement across the medicine lifecycle as a longer-term objective.
The change sought is therefore both scientific and regulatory. Developing an alternative method is not enough on its own: regulators must be able to accept it as a sound way to assess medicines or control manufacturing. The statement’s approach is to advance alternatives where they are scientifically suitable, build the evidence for their use and coordinate acceptance across jurisdictions.