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

November 27, 2017
Our file number: 17-113510-833

This Notice serves to inform sponsors of Abbreviated New Drug Submissions and Abbreviated Extraordinary Use New Drug Submissions of Health Canada's position, which is currently in effect, 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.

The release of the document entitled Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product replaces the 1995 policy entitled Canadian Reference Product.

Health Canada is publishing this new guidance to ensure that all stakeholders are aware of our current practice and how it has evolved since 1995. It has been more than 20 years since the publication of the original 1995 policy and significant experience has since been gained in the evaluation of drug submissions seeking to use a foreign-sourced reference product as a Canadian reference product.

We will be consulting with stakeholders on potential future revisions to this guidance. An additional Notice to be posted in the near future will invite stakeholders to provide comments and recommendations for future updates to this guidance.

Questions concerning the publication of this guidance should be directed 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