How long does it take a life science 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.

 


 

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