In toxicological studies, the overall risk assessment for chemicals has been based on the assumption that effects observed in laboratory animals are predictive of effects in human. However, ethical and animal welfare concerns during the last 20 years,...
In toxicological studies, the overall risk assessment for chemicals has been based on the assumption that effects observed in laboratory animals are predictive of effects in human. However, ethical and animal welfare concerns during the last 20 years, as well as the recently changing EU regulatory environment in the context of the 7th Amendment to the Cosmetics Directive and the EC`s development of REACH (Registration, Evaluation and Authorisation of chemical), FTAs make it obvious that a new approach is needed. The replacement of animal tests for evaluating the safety of chemicals and products is thus a clear necessity. An alternative method is any method that can be used to reduce, refine or replace the use of animal experiments in biomedical research and testing for regulatory or educational purposes. KFDA make an effort to facilitate development, validation and regulatory acceptance of new and revised regulatory test methods that reduce, refine, and replace the use of animals in testing while maintaining and promoting scientific quality and the protection of human health, animal health, and the environment 10 years ago. We are trying to establish an infrastructure for alternative and improve the level of research. Today, I will introduce the present status of research in progress and roadmap for alternative to animal experiments.