Notice: Consultation on the Use of a Foreign-sourced Reference Product as a Canadian Reference Product

December 18, 2017
Our file number: 17-114303-908

Health Canada recently posted the Guidance Document entitled: 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.

Health Canada is seeking stakeholder input on potential changes to the Use of a Foreign-sourced Reference Product as a Canadian Reference Product guidance document. Some examples of potential changes are the inclusion of guidance for other dosage forms, and different limitations on the attributes of the medicinal ingredient. We invite stakeholders to provide comments and recommendations with supporting rationales and data where applicable. This information will be taken into consideration in future updates to this guidance. As part of these considerations, this information may be used as the basis for consultation with external experts such as the Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology.

Comments should be provided to Health Canada, preferably in electronic format, within 90 days of the publication of this Notice to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812
E-mail: policy_bureau_enquiries@hc-sc.gc.ca