Health Canada, as an official member to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is committed to the adoption and implementation of ICH guidelines. Health Canada is pleased to announce the implementation of the ICH E19 guideline: « A Selective Approach to Safety Data Collection in Specific Late Stage Pre-approval or Post-approval Clinical Trials ».
This guidance was developed by an ICH Expert Working Group and has been subject to consultation. It should be read in conjunction with this accompanying notice. This guidance is available on the ICH Website. Please note that the ICH website is only available in English. If you would like to request a copy of the French version of the document, please contact ich@hc-sc.gc.ca…
