How long does it take a drug product to be approved in Canada?

 

WHAT ARE HEALTH CANADA’S TIMELINES TO PROVIDE AUTHORIZATION FOR A DRUG TO BE SOLD ON THE CANADIAN MARKET?

The Canadian review timeline for a New Drug Submission (NDS) is competitive.

  • A standard review consists of a maximum of 10 days eCTD validation,
  • followed by 45 days administrative screening where it is verified that the content is acceptable and that no key information is missing,
  • following the screening period, a 300-day scientific review of the quality, non-clinical and clinical data packages, applies

Therefore, a total of 355 review days applies, before a sponsor obtains a final review decision.

Should the NDS qualify for an accelerated review either under a Priority Review or a Notice of Compliance with condition, the review timelines are shorter.

Please read our Canadian Drug Review & Approval  Guide for further information on the drug approval process in Canada. 


 

For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.