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.

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Champ	Valeur
Dernière modification	avril 17, 2026, 21:24 (TU)
Créé le	avril 17, 2026, 21:24 (TU)
criticality_level	[]
geographic_scope	[]
open_canada_collection	publication
open_canada_date_published	2018-07-27 00:00:00
open_canada_keywords	{"fr": ["Présentation de drogue nouvelle", "présentation abrégée de drogue nouvelle", "présentation abrégée de drogue nouvelle pour usage exceptionnel", "équivalence pharmaceutique", "bioéquivalence", "médicament de référence", "produit de référence canadien", "PRC", "produit de référence de source étrangère"], "en": ["New-Drug-Submission", "Abbreviated New-Drug Submission", "Abbreviated Extraordinary-Use New-Drug-Submission", "pharmaceutical equivalence", "bioequivalence", "reference drug", "Canadian reference product", "CRP", "foreign-sourced reference product"]}
open_canada_subject	["health_and_safety"]
sensitivity_level	unrestricted
title_fr	Ligne directrice : Utilisation d'un produit de référence étranger comme produit de référence canadien
update_frequency	as_needed