Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products (English, HTML)

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Publisher-reported update

2023-12-02

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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