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Global regulators call for accelerated alternatives to animal testing

International medicines regulators, including the UK's MHRA, have issued a joint statement advocating for the advancement and implementation of alternatives to animal testing for human medicines.

  • The International Coalition of Medicines Regulatory Authorities (ICMRA) statement calls for replacing animal testing at every stage of a medicine's lifecycle.
  • The MHRA, EMA, Irish Health Products Regulatory Authority, and Swissmedic co-developed the statement.
  • Regulators are encouraged to support the development and use of non-animal tests for batch release.

The UK's medicines regulator, the MHRA, has joined international counterparts in a joint statement today, 1 October 2026, calling for the advancement and implementation of alternatives to animal testing for human medicines. The statement, from the International Coalition of Medicines Regulatory Authorities (ICMRA), seeks to replace animal testing throughout the lifecycle of human medicines wherever and as soon as possible.

Co-developed by the European Medicines Agency (EMA), the MHRA, the Irish Health Products Regulatory Authority, and Swissmedic, the statement has been adopted by the ICMRA plenary. It outlines a long-term goal of replacing animal testing from initial screening and early development through to licensing and post-authorisation activities.

For new medicines, ICMRA urges global medicines developers to use non-animal methods that are acceptable in a regulatory context, while maintaining scientific quality. It also calls on international regulators to support these efforts. Regarding batch release testing, ICMRA encourages regulators to promote the development and use of non-animal tests, only approving animal testing when scientifically justified and no equivalent non-animal method is available.

The MHRA has previously issued guidance on assessing applications that rely on New Approach Methodologies (NAMs) and is conducting research into alternatives such as organ-on-a-chip technology, AI-driven predictive models, and 3D bioprinted tissues. The MHRA's priority remains ensuring access to safe and effective medicines, and alternative methods will only be considered once established as reliable.

Why this matters: The joint statement from international regulators signals a coordinated global effort to reduce and ultimately replace animal testing in the development and regulation of human medicines.

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