Global Regulatory Authorities Advocate for Reducing Animal Testing in Medicines Development

The EMA has long supported the 3Rs principles—replace, reduce, and refine—aimed at minimizing the use of animals in medicine development and regulation. As medicines are developed and regulated globally, significant progress in reducing animal use hinges on the worldwide acceptance of scientifically valid, 3Rs-compliant approaches. Promoting international alignment and harmonization of regulatory methods via ICMRA is central to this effort.

The joint statement was developed by EMA alongside the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Irish Health Products Regulatory Authority (HPRA), and Swissmedic, the Swiss Agency for Therapeutic Products. Adopted during the ICMRA plenary, the statement outlines a long-term goal of replacing animal testing in all stages of a medicine’s lifecycle—from initial candidate screening and early development to pre-clinical and non-clinical testing, licensing, and post-authorization activities. This transition requires a cautious approach towards scientifically valid non-animal methods, supported by robust evidence and global collaboration among regulators, medicine developers, and innovators in alternative testing.

For new medicines, ICMRA calls on:

- Global medicine developers to use methods that avoid animal use and meet regulatory standards while ensuring scientific integrity.

- International regulators to support these initiatives where possible.

ICMRA also emphasizes that the most significant reduction in animal use for regulatory compliance can be achieved through non-animal methods for batch release testing. They request international regulators to:

- Encourage the development and adoption of non-animal tests for batch release, and challenge proposals for animal testing in this context.

- Approve in vivo batch release testing only when no scientifically equivalent or superior non-animal methodology exists.

- Review and potentially amend existing in vivo testing requirements for batch release.

The statement recognizes that regions and countries will transition at different rates towards drug development and licensing without animal testing. ICMRA encourages collaboration among manufacturers, developers, and regulators to facilitate this paradigm shift and support harmonized implementation.

At the EU level, significant strides are being made toward innovative non-animal methods. In June, the European Commission unveiled a roadmap aimed at phasing out animal testing for chemical safety assessments, detailing concrete steps for this transition. Additionally, from 2015 to 2023, the annual number of animals used for regulatory purposes in pharmaceuticals has roughly halved.