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

Name: Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience)
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

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.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2023-09-01

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

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

Related open data

Health Canada