Notice – Implementation of ICH E19: A selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials

December 21, 2023
Our file number: 23-111286-769

Health Canada, as an official member to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is committed to the adoption and implementation of ICH guidelines. Health Canada is pleased to announce the implementation of the ICH E19 guideline: "A Selective Approach to Safety Data Collection in Specific Late Stage Pre-approval or Post-approval Clinical Trials".

This guidance was developed by an ICH Expert Working Group and has been subject to consultation. It should be read in conjunction with this accompanying notice. This guidance is available on the ICH Website. 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 document, please contact ich@hc-sc.gc.ca.

Selective Safety Data Collection refers to the recording of certain data by investigators in case report forms. It does not affect the monitoring and clinical care of individual trial participants or documentation of their adverse events in medical records. It also does not affect regulatory reporting requirements. Therefore, all safety reporting requirements outlined in the regulations must still be met.

Eligible clinical trials

Trials to be considered for selective safety data collection must meet all of the following criteria:

Information to be provided by sponsors

The protocol should clearly describe:

The clinical trial application should provide sufficient evidence to support the conclusion that the safety profile of the drug has been sufficiently characterised to justify selective safety data collection.

Contact information

For any comments or inquiries related to this notice, please contact:
Health Canada – ICH Coordinator
E-mail: ich@hc-sc.gc.ca
Please include "Implementation of ICH E19" in the subject line.

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