Participation on ICH
The FDA Center for Drug Evaluation and Research pursues international harmonization of nonclinical recommendations for pharmaceutical development through its engagement with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. These activities prevent repetition of studies and reduce and refine animal use in overall drug development. New guidance recently approved will continue to contribute to the 3Rs as will future guidance currently being developed or revised.
FDA published guidance aligned with ICH documents on carcinogenicity testing of pharmaceuticals as discussed elsewhere in this report.