Description
Health Canada has implemented the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting via our Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products, which took effect on March 3, 2011.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products | HTML | Open resource | |
| Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products | HTML | Open resource |