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
Revised: February 27, 2024
Our file number: 24-100744 – 309

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:

• Phase IV trial or late-stage trial involving a drug used outside the conditions of use for which the drug has received market authorization or, in rare cases, a phase III trial of a drug that has not yet received market authorization.
• Examples of appropriate use of ICH E19 include:
  • Clinical trials to support a new indication of an authorized drug where the two populations are similar (e.g., with respect to demographic characteristics, comorbidities, concomitant therapies), or when the patient population in the new indication was well represented in the trials that supported the approved indication.
  • Clinical trials intended to expand the label information of an authorized drug with additional endpoints in the same patient population.
  • Safety trials designed to further investigate potential safety concerns focussing on specific parameters.
  • Clinical trials designed to provide additional evidence of efficacy.
• The trial does not involve a gene therapy or a rare disease.
• The safety profile of the drug is well-understood and documented.

Information to be provided by sponsors

The protocol should clearly describe:

• Which data will not be collected, or be collected at a reduced frequency.
• How the selective safety data collection will be implemented (i.e., for all participants, for a subset of participants, after an initial period of the trial, etc.).

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.

Interim enforcement discretion approach

ICH E19 has already been implemented in other jurisdictions across the world. In the interest of continuing to attract clinical trials that offer access to new therapies to Canadians, Health Canada will not prioritize enforcement of the requirement for sponsors to retain records of all adverse events when the authorized protocol describes a selective safety data collection approach that meet the eligibility criteria. For eligible clinical trials, medical care records may be verified if an inspection takes place to ensure the Selective Safety Data Collection protocol is being followed. This will be in effect until amendments are made to the Food and Drug Regulations and the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations. Health Canada reserves the right to enforce the Food and Drugs Act and its Regulations should actual or potential risks to health and safety be identified.

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.