ALTEX :: Alternatives to Animal Experiments

1999, VOLUME 3

Validation and Regulatory Acceptance of Alternative Test Methods and International Co-operation

Neil L. Wilcox

D.V.M., M.P.H., Senior Science Policy Officer, Food and Drug Administration, Rockville, Maryland, USA

SUMMARY

The U.S. Food and Drug Administration (FDA) is committed to facilitating the development, validation, and regulatory acceptance of new toxicological testing methods. FDAs mission emphasizes protecting public health by using the best science through the most efficient means available. New technologies currently under development have the potential to better predict human and animal endpoints in safety assessment, and to reduce, refine, and replace animal use in product testing. Tremendous progress in the alternatives arena has been made and includes:

  1. International harmonization on validation criteria for new test methods;
  2. Development of a process for the review and validation of new test methods by the European Centre for the Validation of Alternative Methods (ECVAM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM); and
  3. Successful regulatory acceptance and implementation of new validated methods in toxicity testing

There are many participants to be commended for their accomplishments on these complex issues. However, there is much to be done, and continued cooperation between stakeholders internationally is essential. Moreover, mutual agreement must be reached regarding the validation status of those methods subjected to rigorous, expert peer review by organizations such as ECVAM and ICCVAM. International harmonization, based upon sound scientific principles, will prevent duplication of scarce resources, minimize unnecessary use of animals, facilitate safety assessment and regulatory acceptance, and ultimately reduce research-to-market time for regulated products.

Keywords: 3R, international harmonization, validation, regulatory acceptance