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

October 18, 2018
Our reference number: 18-114739-190

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.

The ICH E2D guidance was developed by the appropriate ICH Expert Working Group and was subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.

Please note that the ICH website is only available in English. If you would like to request a copy of the French version of the ICH E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting Guidance document, please contact the HPFB ICH inbox.

Should you have any questions or comments regarding the content of the guidance, please contact:

Health Canada - ICH Coordinator
E-mail: HPFB_ICH_DGPSA@hc-sc.gc.ca

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