Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience)

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.

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Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward
Title (French) Ligne directrice : Présentations de drogue fondées sur les données de tierces parties (Source documentaire et expérience de commercialisation)
Update Frequency as_needed
Geographic Scope []
Criticality Level []
Sensitivity Level unrestricted
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Data Dictionary
Open Canada Date Published 0202-03-03 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["présentations de médicaments", "données de tiers", "documentation et expérience du marché", "exigences réglementaires", "processus d'examen et d'approbation des médicaments"], "en": ["drug submissions", "third-party data", "literature and market-experience", "regulatory requirements", "drug review-and-approval process"]}
Open Canada Collection publication
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