Guidance on applications for COVID-19 drug clinical trials under the Regulations: Post-authorization requirements   

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 the Regulations, Health Canada may suspend authorization of a COVID-19 drug clinical trial, in whole or in part, if:

• we determine that any of the requirements of the authorization have not been met
• any additional requested information or material was not submitted in the time, form and manner specified in the request or
• the authorization holder has contravened the Regulations or the Food and Drugs Act

For example, we will be able to suspend an 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. 2 will remain in effect under the Regulations.

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 and
• 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 us.

Note: A request that was made by Health Canada under IO No. 2 continues to be in effect under the Regulations.

Discontinuing a clinical trial

As per section 31 of the Regulations, 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. (Refer to 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:

• 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. 2 continues to be in effect under the Regulations.

Revoking a clinical trial

Mandatory revocation

When Health Canada receives a notice of discontinuance of the COVID-19 drug clinical trial by an authorization holder, we 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. The letter will either confirm that the notice of discontinuation has been received (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. 2, and has not been revoked in whole since, will continue to be considered revoked in part under the Regulations.

Serious unexpected adverse drug reactions

Subsection C.05.014(1) of Division 5 of the FDR, which covers serious unexpected adverse drug reactions, was carried over into section 34 of the Regulations. In line with existing guidance, the authorization holder must inform Health Canada 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 FDR on the maintenance of complete and accurate records have been carried over into section 35 of the Regulations.

Under the Regulations, records for all clinical trials of COVID-19 drugs must be kept for 15 years. This obligation continues to apply to former authorization holders who have had their authorizations revoked in whole.

Note: The retention period applies to drug clinical trials previously authorized under IO No. 2.