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

Name: Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

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.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2023-12-02

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

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

Related open data

Health Canada