Carcinogenicity Testing of Pharmaceuticals in the European Union: A Workshop Report

Abstract

Recently, documents have been developed by the International Conference on Harmonisa-tion (ICH) to guide industry on when long-term carcinogenicity bioassays are needed, testing strategy approaches, selection of the high dose, toxicokinetic evaluations, and preclinical testing of biotechnology-derived medicinal products. In the European Union (EU), the CPMP guideline on testing for carcinogenic potential was issued in 1983. Where the ICH guidelines overlap the old guideline, the industry should refer to these guidelines. Aspects of test designs and data analysis of the Committee for Proprietary Medicinal Products (CPMC) guideline need to be updated to reflect the current state of testing. This report summarizes the outcome of discussions at a DIA workshop held in September 1999 in Switzerland. Discussions included threshold concepts of nongenotoxic compounds, practical features of testing, statistical design of the study; terminal investigations, including a list of tissues to be examined histologically; principles of reporting and analysis of data; and the use of short-term carcinogenic studies, that is, aspects of the CPMP guideline which are not covered by the ICH guidelines.