Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products

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.

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Last Updated April 17, 2026, 21:57 (UTC)
Created April 17, 2026, 21:57 (UTC)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2018-11-02 00:00:00
open_canada_keywords {"fr": ["Lignes directrices de l'ICH", "rapports", "effets indésirables des produits de santé", "produits de santé commercialisés", "gestion des données de sécurité après approbation E2D"], "en": ["ICH guidance", "reporting", "adverse reactions to-health-products", "marketed health products", "E2D post-approval safety data-management"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Avis: la ligne directrice d'ICH sur la déclaration des effets indésirables des produits de santé commercialisés
update_frequency as_needed