NAMs resources

Our report in collaboration with the ABPI and MHRA, explores how NAMs can transform the way new medicines are developed – harnessing cutting edge human relevant technologies and reducing reliance on animal testing.

The joint report describes insights from a cross-sector workshop convened by the NC3Rs, ABPI and MHRA, bringing together experts from regulatory agencies, industry and academia. Discussions focused on where NAMs are currently being used in medicines development, the scientific and regulatory challenges to broader adoption, and practical steps to accelerate progress.

From a starting point of scientific excellence, we are developing the next generation of preclinical models and supporting the qualification, optimisation and uptake of in vitro alternatives. This briefing paper outlines our work in this area, which focuses on replacing studies that involve large numbers of animals, high levels of animal suffering, or are poorly predictive in terms of their translatability or reproducibility. 

A number of case studies demonstrate how in vitro models can be applied to replace animals in safety and toxicity testing, including:

• An in vitro assay to replace the mouse lethality bioassay for batch release and quality control potency testing of Botulinum neurotoxin and antitoxin products.
• Retinal organoids generated from human-induced pluripotent stem cells to replace the use of rodents and rabbits in ocular disease research and toxicity testing.

There are clear opportunities to harness the strength of the UK science and technology sectors to place it as a world leader with innovative chemicals regulation grounded in the latest technologies. Working with the British Toxicology Society we have identified actions to optimise opportunities presented from exiting the EU to develop a world-leading regulatory framework that firmly embeds the 3Rs in chemical safety testing.

This work follows on from a workshop we held with Unilever which brought together over 50 scientists from government departments responsible for implementing UK chemical safety policy, alongside representatives from industry and UK-based academic scientists. The workshop was the first step in building a consensus vision across the UK science base on the future direction of domestic chemicals regulation.

• Our toxicology bibliography contains all our publications from the NC3Rs Toxicology and Regulatory Science programme.
• Microphysiological systems guidance.
• Animal-free in vitro technologies hub.
• Our webinars provide information on NAMs topics and technologies.