Guidance for Industry - Priority Review of Drug Submissions

Description

This guidance aims to articulate Health Canada's expectations and generate a level of consistency regarding the interpretation of the Priority Review of Drug Submissions policy and the filing of a Priority Review request. Additional clarification of the process by which the Priority Review request is assessed is provided.

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Name Format Description Link
Guidance for Industry - Priority Review of Drug Submissions HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/priority-review/drug-submissions.html#a1
Guidance for Industry - Priority Review of Drug Submissions HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/evaluation-prioritaire/intention-industrie-presentations-drogues.html#a1

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