Guidance Document: Pre-market Evaluation of Hepatotoxicity in Health Products

Hepatotoxicity caused by exposure to a drug or non-infectious agent is injury or damage to the liver that may be associated with impaired liver function. This document is intended to provide basic considerations for the detection, assessment, mitigation and reporting requirements of hepatotoxicity caused by human health products, both alone and in the presence of other health products, foods or xenobiotics, prior to market authorization by Health Canada.