ICMRA calls for alternatives to animal testing in drug development

The International Coalition of Medicines Regulatory Authorities (ICMRA) has issued a joint statement calling for the accelerated development and implementation of alternatives to animal testing in the development of human medicines. The coalition, which includes the Spanish Agency of Medicines and Medical Devices (AEMPS), aims to eventually replace animal experimentation across all stages of a medicine's life cycle whenever scientifically possible.

To achieve this goal, the declaration emphasizes the need for robust scientific evidence, international collaboration, and the acceptance of validated non-animal methods by regulatory authorities. The statement urges developers and manufacturers to utilize non-animal methods that maintain scientific quality and comply with regulatory contexts.

Furthermore, the ICMRA highlights that significant reductions in animal use could be achieved by adopting non-animal methods for batch release testing. The coalition encourages international regulators to promote these alternatives and to approve in vivo testing for batch release only when it is scientifically justified that no equivalent or superior non-animal methodology exists.