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.
With a quarter of a century of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada.
Avec un quart de siècle de résultats et de succès constants , SPharm est devenue une entreprise de services de référence au Canada en stratégie de développement de médicaments et affaires réglementaires. Des compagnies pharmaceutiques à travers le monde comptent sur SPharm pour faciliter le processus d’homologation de leurs médicaments (et autres produits de santé) au Canada.