Global Regulators Call for Advancing Alternatives to Animal Testing Across the Medicine Lifecycle

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The European Medicines Agency (EMA) has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling for the continued advancement and implementation of alternative methods to animal testing throughout the lifecycle of human medicines. The statement, developed under the leadership of EMA, the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Irish Health Products Regulatory Authority (HPRA), and Swissmedic, sets out the long-term goal of replacing animal testing across all stages of a medicine’s lifecycle, from candidate screening and early development through licensing and post-authorisation activities.

Key Highlights

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• The joint statement was adopted by the ICMRA plenary and calls on medicine developers globally to employ methods that do not involve the use of animals, while safeguarding scientific quality, and on international regulators to support and facilitate these efforts.
• The statement identifies batch release testing as the area of greatest potential impact for reducing animal use, calling on regulators to encourage non-animal tests for batch release, challenge instances where animal use is proposed, approve in vivo batch release testing only when scientifically justified that no equivalent or superior non-animal methodology exists, and review existing in vivo testing requirements.
• The ICMRA acknowledges that different regions and countries will move at different paces, and encourages manufacturers, developers, and regulators to work together toward harmonised implementation.
• From 2015 to 2023, the number of animals used per year for regulatory purposes for pharmaceuticals in the EU approximately halved.
• In June 2026, the European Commission presented a roadmap toward phasing out animal testing for chemical safety assessments, setting tangible steps for the transition.
• The statement frames a cautious and stepwise transition toward non-animal methods supported by robust evidence and open global interaction between regulators, developers, and innovators.

Statements

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International medicines regulators call on medicine developers, manufacturers, regulators and national control laboratories to continue to advance and implement alternative methods or approaches to animal testing throughout the lifecycle of human medicines, wherever, and as soon as possible.

• International Coalition of Medicines Regulatory Authorities (ICMRA) joint statement, endorsed by EMA

About the Organizations

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European Medicines Agency is the agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU.
International Coalition of Medicines Regulatory Authorities is a voluntary, executive-level coalition of heads of medicines regulatory authorities from around the world, addressing strategic regulatory matters.

Learn More

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EMA News: Global Regulators Call for Advancing Alternatives to Animal Testing Across the Medicine Lifecycle
ICMRA Statement on Animal Testing for Human Medicines