Abstract
In response to the increasing need for alternative methods to animal testing, the Japanese Center for the Validation of Alternative Methods（JaCVAM） was established in 2005 at the National Institute of Health Sciences in order to appropriately evaluate and verify them from the perspective of administrative utilization. In this paper, I first explain the role of JaCVAM, and in particular, show the actual validation process, which is essential for standardization, and the current status of the modernization to deal with complex toxicity such as systemic toxicity in the future. Furthermore, I will concretely introduce the process from AOP development to the development of a defined approach, using an OECD test guideline actually developed in Japan as an example. Finally, I will introduce the author’s efforts in the Japanese Pharmacopoeia and the Quasi-Drug Guidance as examples of standardization other than toxicity evaluation of chemical substances.
