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

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. 2023-09-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetydrug submissionsthird-party dataliterature and market-experienceregulatory requirementsdrug review-and-approval process 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

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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