ICMRA statement on implementing alternative methods to animal testing for human medicines
01/10/2026 Regulatory newsThe International Coalition of Medicines Regulatory Authorities (ICMRA) has published a statement calling on medicines developers, manufacturers, regulators and national control laboratories to continue advancing and implementing alternative methods to the use of animals in the testing of human medicines.
ICMRA notes that scientific developments in recent years suggest that regulatory dependence on animal testing for human medicines can be reduced, provided that quality and patient safety are appropriately ensured. The statement encourages the development, validation, and adoption of non-animal-based testing methods for regulatory purposes where possible.
The call applies to all stages of the medicines life cycle, from initial candidate screening and early development, through pre-clinical and non-clinical testing, and into the licensing and marketing stages.
The development of the joint statement was led by the HPRA, the EMA, the UK Medicines and Healthcare Products Regulatory Authority (MHRA) and Swissmedic, the Swiss Agency for Therapeutic products.
Read the ICMRA statement.