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BUAV welcomes international drug regulators move on rat carcinogenicity test

12/12/2012

The BUAV has welcomed an announcement by international drug regulators that they are moving away from the need to conduct the rat cancer bioassay for medical drugs. 

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has recently published its intention to consult on a revision to the current guideline for carcinogenicity that will significantly reduce the need to conduct the 2-year rodent study. In these studies, approximately 600 rats or mice are fed a test product for two years to see if they will develop cancer. Not only are these experiments time-consuming and expensive, but they are reported to only correctly predict human cancer 42% of the time. Already drug developers are able to predict the cancer risk of new drugs without this animal test because they recognise its severe limitations.

Experts at the ICH have drafted a new document that asks drug companies to submit their predictions about cancer risk for new drugs. For a period drug regulators will continue to request the rat test to see if the prediction holds true. If the trial period is successful the ICH say that the number of rodent tests can be reduced by approximately 40% or more without significant risk to public health. Although this is encouraging news, we are disappointed, however, that a further period of evaluation is considered necessary. Significant information has already been gathered by regional drug regulators that this test is no longer useful. According to the ICH, final international agreement on the guideline will not be finalised until November 2017.

This proposed revision will be published by the regulatory authorities in Europe, Japan and the USA for a 90-day public commenting period. We shall submit comments, along with our colleagues at the International Council on Animal Protection in Pharmaceutical Programs (ICAPPP), to welcome the improved testing strategy but, at the same time, we shall also criticize the drawn out process of implementing the revision, causing the unnecessary death of thousands of animals.

Source.