EMEA: ICH M 3 (R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety studies recommended to support human clinical trials of a given scope and duration as well as marketing authorization for pharmaceuticals. Harmonisation of the guidance for nonclinical safety studies will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.