ATLA::Alternatives to Laboratory Animals

Volume 29, Number 5

The role of ECVAM in promoting the regulatory acceptance of alternative methods in the European Union.

ATLA 29, 525-535, September/October 2001

Andrew P. Worth and Michael Balls

ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, 21020 Ispra (VA), Italy

SUMMARY

The roles played by the European Centre for the Validation of Alternative Methods (ECVAM) and its advisory committee, the ECVAM Scientific Advisory Committee (ESAC), in the evolution of alternative methods are described. Particular emphasis is given to the process by which ECVAM and the ESAC assess the scientific validities of alternative methods, and, in appropriate cases, initiate the progression of scientifically validated methods toward regulatory acceptance.

Keywords: validation, alternative method, ECVAM, ESAC, regulatory acceptance