Description

The objective of this document is to ensure that sponsors of SRTDs have the necessary information to satisfy the regulatory requirements under the Food and Drug Regulations with respect to safety, efficacy and quality which provides the basis of Health Canada's drug review and approval process.

Resources

Name	Format	Description	Link
Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience)	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/drug-submissions-relying-third-party-data-literature-market-experience.html
Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience)	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/presentations-drogue-fondees-donnees-tierces-parties-source-documentaire-experience-commercialisation.html

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