The European Medicines Agency (EMA) has endorsed a joint statement of the International Coalition of Medicines Regulatory Authorities (ICMRA). The statement calls on medicine developers, manufacturers, regulators, and national control laboratories to advance and implement alternatives to animal testing throughout the lifecycle of human medicines. It was developed under the lead of EMA, the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Irish Health Products Regulatory Authority (HPRA), and Swissmedic.

The statement sets the long-term goal of replacing animal testing at all stages, from early development to licensing and post-authorisation activities. The transition is to proceed stepwise and rely on scientifically valid methods acceptable to regulators. As the greatest reduction potential lies in batch release testing, regulators are called on to promote non-animal tests in this area. They should approve in vivo batch release testing only where no equivalent or superior non-animal method is available, and review existing requirements accordingly. ICMRA acknowledged that countries will progress at different paces and encouraged harmonised implementation. In the EU, the number of animal uses per year for regulatory purposes for pharmaceuticals approximately halved between 2015 and 2023.

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