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.

Publisher

Health Canada

Resources

2

Catalogue metadata updated

2023-09-01