ASK JEAN Fall 2020: Clinical Trial Application Default Period Order

15 October 2020

The Chronicle Fall 2020 – by Jean Smart, Regulatory Affairs and Quality Officer, Clinical Trials BC

Question:

Was the Clinical Trial Application (CTA) Default Period changed?

Answer:

There was a recent but temporary change. Health Canada will have an additional 15 days to review Clinical Trial Applications (CTA’s) for drugs that are unrelated to the Corona virus disease COVID-19 pandemic. This change is in effect from 13 August 2020 to 16 November 2020.

Normally Health Canada has 30 days to review clinical trial applications and amendments for drugs submitted under Part C Division 5 of the Food and Drug Regulations. If the agency does not object to an application or amendment within 30 days the application or amendment is authorized ‘’by default’. This is an internationally admired feature of Health Canada’s CTA review process.

With the heavy volume of COVID-19 related clinical trial applications, it has been very difficult for Health Canada to review all applications and amendments within the 30 day. Authorizing these by default was considered to expose clinical trial participants to unreasonable risk, as Health Canada would have been unable to complete the health and safety assessment.

The 45 day review period applied retroactively to any applications and amendments for clinical trials submitted up to 30 days prior to the orders official enforcement date of the 13 of August 2020 and will cover all applications and amendments submitted through to the 16th of November.

It is emphasised that the order does not apply to or impact clinical trial applications related to the prevention mitigation or treatment of COVID-19. These applications will continue to be expedited.

It is possible that there could be an extension to this order. Otherwise do check to see if the 30-day default has resumed.

The Health Canada website provides a good explanation notice regarding this. Below is the link to the order and contact information for those who have questions on applications for pharmaceuticals, biologics and medical device trials.