UK FSA COT Paving the way for a UK Roadmap-Development, Validation and Acceptance of New Approach Methodologies Workshop summary (2021)

A New Hope

Last updated: 14 February 2024

253.             The models and the science are sufficient, there just needs to be a move towards acceptance and integration. With new initiatives it should be possible to see how economics play out to really map out the benefits, gains, and the loss if there is no uptake. If the use of NAMs means that an answer is sooner and there is less uncertainty about an answer, what are the trade-offs?

254.             Development and translation of NAMs into the public domain will aid with the acceptance and confidence building in these and emerging technologies.

255.             This will not only require the historic 3Rs approach (i.e., replacement, reduction, and refinement of animal experiments) but also the expansion to the 6R principle: (to also include) reproducibility, relevance, and regulatory acceptance.

255.             This UK roadmap will pave the way for integration and regulatory acceptance by using the 7 steps: Listening and Learning; Identify and Review; Training; Research and Development; Collaboration and Dissemination; Review and Recommend; and Regulatory acceptance and Integration.

256.             It is a case of Not if, but when…