Guidance for Industry - Priority Review of Drug Submissions

Guidance for Industry - Priority Review of Drug Submissions 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. 2021-07-07 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGuidance for industrypriority review of drug submissionsinterpretation of the priority review of drug submissions policypriority review request Guidance for Industry - Priority Review of Drug SubmissionsHTML 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 SubmissionsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/evaluation-prioritaire/intention-industrie-presentations-drogues.html#a1

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.

Data and Resources

Similar records