14 November 2011

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Seville, Spain from 5 - 10 November 2011.

Safety Update

Following an extended consultation period, the SC approved a revised ICH S2(R1) Guideline for genotoxicity testing and data interpretation for medicines intended for human use. This revised Guideline reflects state of the art options for genotoxicity testing and is expected to improve risk assessment of human medicines. It is also expected to reduce the number of animals used for genotoxicity testing alone in the implementing regions and thus to enhance the efficiency and use of resources in the development of medicines.

...

See the complete press release