ICH pre-clinical toxicity study duration guideline is one of 10 guidelines finalized in July.
Executive Summary
ICH PRE-CLINICAL TOXICITY GUIDELINE FINALIZED WITH DIFFERENCES IN DURATION requirements among the ICH regions. The ICH M3 guideline reached Step 4, the final step in harmonization prior to ICH members adopting the guidelines, at the International Conference on Harmonization steering committee meeting July 16 in Brussels. A draft of the guideline, which incorporated regional differences in testing requirements, was issued at a November 1996 steering committee meeting ("The Pink Sheet" Dec. 23, 1996, p. 15).