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		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/efficacy/notice-guidance-reporting-adverse-reactions-marketed-health-products.html
Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/efficacite/avis-ligne-directrice-declaration-effets-indesirables-produits-sante-commercialises.html

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