New approach methodologies (NAMs*) are replacement technologies used to assess drug and chemical safety. They are rapidly emerging as key enabling technologies for improved, biologically relevant hazard and risk assessment and reducing the reliance on animal toxicity tests.
As part of our work to increase confidence in the use and application of NAMs for regulatory decision making and accelerate their adoption, we conducted a survey to identify areas of unmet need and prioritise future NC3Rs activities that support the scientific community in using NAMs for safety assessment. The results will be used by the NC3Rs Regulatory Sciences Forum, an expert-cross sector advisory group, to devise potential projects and workstreams and contribute to our future work in this area.
Survey
The survey gathered information from across the community, including method developers, conducting laboratories, industry data submitters, data assessors at regulatory agencies, consultants and other relevant stakeholders. We are currently analysing the results and will share the next steps soon.
* We use the term new approach methodologies specifically to refer to full and partial replacement approaches for assessing chemical or drug toxicity. Learn more on our page on NAMs terminology.