The Draft (Step 2) ICH Guidance: E19 Optimization of Safety Data Collection was released by the International Council for Harmonisation (ICH) Assembly and is posted in English only on the ICH website for information and comment.

If you wish, you may provide comments to Health Canada by Friday, September 13, 2019 on this draft guidance. Comments should be directed to Health Canada – ICH Coordinator at The comments will be sent to the ICH with a disclaimer that they are for information and do not necessarily represent the views of Health Canada, except as specified in separate comments.