ARCHIVED Guidance on applications for drug clinical trials under the interim order: Post-authorization requirements
Notice to Reader:
We have replaced the Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19. See the regulations notice about the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.
On this page
- Suspending a clinical trial
- Reinstating a clinical trial
- Additional information
- Discontinuing a clinical trial
- Revoking a clinical trial
- Serious unexpected adverse drug reactions
- Records
Suspending a clinical trial
Under section 29 of IO No. 2, Health Canada may suspend authorization of a COVID-19 drug clinical trial, in whole or in part, if:
- we believe that any of the requirements of the authorization have not been met
- the requested information was not submitted in the time, form and manner requested or
- the authorization holder has contravened IO No. 2 or the Food and Drugs Act
For example, Health Canada will be able to suspend 1 arm, or treatment group, of a multi-arm trial, if needed. This makes it possible for the rest of the trial to proceed so that other patients can continue to receive a promising therapy.
Note: All suspensions, in whole or part, for clinical trials issued under IO No. 1 will remain in effect under IO No. 2.
Reinstating a clinical trial
Health Canada must reinstate a suspended trial if the holder of the suspended authorization:
- provides the required information or material in the time, form and manner specified
- demonstrates that the situation giving rise to the suspension did not exist or has been corrected
Additional information
Health Canada may request additional information, materials or samples when deciding whether to issue, amend or suspend a clinical trial authorization. This information must be provided within the time, form and manner specified by Health Canada.
Note: A request that was made by Health Canada under IO No. 1 continues to be in effect under IO No. 2.
Discontinuing a clinical trial
As per section 31 of IO No. 2, if an authorization holder discontinues a previously authorized COVID-19 drug clinical trial, in whole or in part, the holder must notify Health Canada as soon as possible in writing. (See Who to contact.)
All qualified investigators must also be informed in writing.
As well, the holder must stop the importation or sale of the drug at each clinical trial site at which the trial has been discontinued.
For information on the requirements and what should be included in the notification, please refer to section 2.8.1 of the Guidance document for clinical trial sponsors: Clinical trial applications.
If the authorization holder discontinues and subsequently wants to resume their trial, they will have to refile a new clinical trial application.
Note: A notice of discontinuance that was provided to Health Canada in IO No. 1 continues to be in effect under IO No. 2.
Revoking a clinical trial
Mandatory revocation
When we receive a notice of discontinuance of the COVID-19 drug clinical trial by an authorization holder, Health Canada must revoke, in whole or in part, the authorization.
Discretionary revocation
Health Canada may, at any time, revoke, in whole or in part, the authorization if the holder fails to provide satisfactory information following a suspension. This includes:
- not providing the requested information under subsection 29(2) in the specified time frame or
- providing information that Health Canada determines does not demonstrate that the situation resulting in the suspension did not exist or has not been corrected
Notice/transparency
Following a mandatory or discretionary revocation, Health Canada will issue a cancellation letter to the authorization holder. We will either confirm we have received the notice of discontinuation (mandatory revocation) or give reasons for the revocation (discretionary revocation).
We will update information on the status of the COVID-19 drug clinical trial following a revocation on our vaccines and treatments for COVID-19 webpage and clinical trial database.
Note: A COVID-19 drug authorization that was revoked in part by Health Canada under IO No. 1, and has not been revoked in whole since, will continue to be considered revoked in part under IO No. 2.
Serious unexpected adverse drug reactions
Subsection C.05.014(1) of Division 5 of the Regulations, which covers serious unexpected adverse drug reactions, was carried over into section 34 of IO No. 2. In line with existing guidance, the authorization holder must inform us of all serious unexpected adverse drug reactions from a drug used during a COVID-19 drug clinical trial:
- within 15 calendar days of becoming aware of the event
- within 7 calendar days after becoming aware if the event is fatal or life-threatening
Records
Existing requirements under C.05.012 of Division 5 of the Regulations on the maintenance of complete and accurate records have been carried over into Section 35 of IO No. 2.
For information on the records that must be maintained, please refer to section 2.8.6 of the Guidance document for clinical trial sponsors: Clinical trial applications.
The authorization holder must maintain all records for the period that IO No. 2 is in force (that is, 1 year). However, these should be kept beyond this time frame in line with existing clinical trial guidance and Division 5 requirements.
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