Testing the safety of a medicine in animals, before it is tested in humans in a clinical trial, significantly reduces the risk of a potential new medicine causing serious side effects or adverse reactions in patients.

When developing a new medicine, pharmaceutical companies must follow rigorous international and UK regulatory requirements designed to protect patients. Global medicines regulators, including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), require animal testing to provide essential data about the safety of a potential new medicine before it is used in human clinical trials.

Animal models are also used in medical research to understand the cause of a disease. Once the mechanism of disease is understood, further research can develop novel medicines to specifically target the disease pathway.

The pharmaceutical industry is committed to the principles of reduction, replacement, and refinement (3Rs) in the use of animals in research.

Key projects delivered through the NC3Rs include:

• Removing the requirement for single dose acute toxicity tests from the international pharmaceutical guidelines
• Re-evaluating the need for monoclonal antibody (mAb) chronic toxicity studies

Priorities for this partnership in 2024/25 include:

• Reviewing the use of two species in regulatory toxicology studies.
• Funding for the development of a “virtual dog” using advanced computational and mathematical modelling approaches
• Accelerating the development and uptake of new approach methodologies (NAMs).