In November 2011, ICH issued Step 4 of its revised guidance on the genotoxicity testing of pharmaceuticals for human use (recommended for adoption to the regulatory bodies of the European Union, Japan and the USA). Therein a standard test battery for genotoxicity testing of new “small molecule” drug substances is described, and recommendations for in vitro and in vivo testing protocols are made. Advice is also given on the evaluation of test results and on follow-up test strategies.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use. S2(R1). Current Step 4 version dated 9 November 2011.

The above item was taken from the January/February 2012 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).