Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product

Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product To provide sponsors of an Abbreviated New Drug Submission or an Abbreviated Extraordinary Use New Drug Submission who are seeking to demonstrate pharmaceutical equivalence and bioequivalence with a reference drug under paragraph (c) of the definition of Canadian reference product (CRP) in C.08.001.1 of the Food and Drug Regulations with guidance on how they may demonstrate that this reference drug is acceptable to the Minister as a CRP. 2023-09-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyNew-Drug-SubmissionAbbreviated New-Drug SubmissionAbbreviated Extraordinary-Use New-Drug-Submissionpharmaceutical equivalencebioequivalencereference drugCanadian reference productCRPforeign-sourced reference product Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference ProductHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/canadian-reference-product-guidance.html Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference ProductHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/produit-reference-canadien-ligne-directrice.html

To provide sponsors of an Abbreviated New Drug Submission or an Abbreviated Extraordinary Use New Drug Submission who are seeking to demonstrate pharmaceutical equivalence and bioequivalence with a reference drug under paragraph (c) of the definition of Canadian reference product (CRP) in C.08.001.1 of the Food and Drug Regulations with guidance on how they may demonstrate that this reference drug is acceptable to the Minister as a CRP.

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