Accelerating the Transition from Animal Studies to Next Generation Risk Assessment for Pharmaceuticals

Abstract

New approach methodologies (NAMs) are techniques that can be used for the safety assessment of pharmaceuticals and other chemicals. These techniques exclude the use of animals. The regulatory acceptance of the usage of those NAMs in next generation risk assessment (NGRA) proceeds very slow. This writing assignment shows by a literature study, in the form of a literature mapping review, which workflows are currently available for pharmaceuticals (and also for other chemicals and cosmetics), what are the regulations and which stakeholders are involved when performing risk assessment with NAMs in NGRA. Moreover, opportunities are summarized how to accelerate the transition, in this case the regulatory acceptance, from animal studies towards NAMs in NGRA for safety assessment of pharmaceuticals.