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

Health Canada published the Guidance Document titled Use of a Foreign-sourced Reference Product as a Canadian Reference Product. This document replaces the 1995 policy entitled Canadian Reference Product. This new guidance informs sponsors of Abbreviated New Drug Submissions and Abbreviated Extraordinary Use New Drug Submissions of Health Canada’s current approach with respect to the use of a foreign-sourced reference product under paragraph (c) of the definition of Canadian reference product (CRP) in C.08.001.1 of the Food and Drug Regulations.

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Published 22. January 2018 in News Canada