Order to extend review period for clinical trial applications and amendments: Notice

Date published: August 14, 2020

On August 13, 2020, the Minister of Health approved an order to temporarily extend the default period to review clinical trial applications and amendments. This Ministerial Order (MO) will give Health Canada an additional 15 days to review all clinical trial applications and amendments submitted under Division 5 of the Food and Drug Regulations.

This MO will not affect clinical trial applications to prevent, mitigate or treat COVID-19. These applications will continue to be expedited.

On this page

• Why the Ministerial Order was introduced
• Extending the default period to review clinical trial applications and amendments
• Duration of the Ministerial Order

Why the Ministerial Order was introduced

The sale and importation of drugs for clinical trials are regulated under division 5 of the Food and Drug Regulations. The regulations include a 30-day default review period for applications to sell or import a drug for use in clinical trials in Canada.

Health Canada can object to a clinical trial if safety requirements or trial objectives will not be met. If Health Canada does not object within 30 days of receiving the clinical trial application, authorization is presumed and the trial may go ahead.

The 30-day default period also applies to the review of amendment submissions for clinical trials that have already been authorized.

The influx of COVID-19-related clinical trial applications is making it difficult for Health Canada to review all applications and amendments in the 30-day period. Authorizing these by default could expose clinical trial participants to undue risk, as Health Canada would have been unable to complete the health and safety assessment.

The goal of the MO is to ensure that we are able to review all applications for new clinical trials or amendments without triggering a default authorization.

Extending the default period to review clinical trial applications and amendments

Extending the default period from 30 days to 45 days makes it possible for us to continue to expedite clinical trial applications for the prevention, mitigation or treatment of COVID-19.

Duration of the Ministerial Order

The revised default period takes effect on the date the MO is approved and expires on November 16, 2020. Applications or amendments for clinical trials that have not received a 'no objection letter' or an authorization at that time will fall into the 45-day default review period. Applications filed after the MO expires will revert to the 30-day period.

If you wish to submit an application or amendment for a clinical trial and have questions about how the MO affects that application, please contact us:

• trials using pharmaceutical drugs: hc.oct.enquiries-requetes.bec.sc@canada.ca
• trials using biologic drugs (including blood and blood components): hc.brdd.ora.sc@canada.ca
• trials using medical devices: meddevices-instrumentsmed@hc-sc.gc.ca

Related links and guidance

• Explanatory note for the order to extend review period for clinical trial applications and amendments
• Guidance document for clinical trial sponsors: Clinical trial applications
• Applications for medical device investigational testing authorizations - guidance document
• Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
• Health Canada's clinical trials database