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.

Data and Resources

Additional Info

Field Value
Source
Version None
Author None
Author Email None
Maintainer None
Maintainer Email None
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward
Title (French)
Update Frequency
Geographic Scope
Criticality Level
Sensitivity Level
Language
Contact Person
Contact Email
Data Dictionary
Open Canada Date Published
Open Canada Date Modified
Open Canada Subject
Open Canada Keywords
Open Canada Collection
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Reference Data
Official Source