Use of a Foreign-sourced Reference Product as a Canadian Reference

From Health Canada

Overview

This guidance document provides the criteria for using a drug marketed in a country other than Canada as a Canadian Reference Product (CRP). This applies to

• Abbreviated New Drug Submissions
• Abbreviated Extraordinary Use New Drug Submissions

Who this guide is for

• generic drug manufacturers

In this guide

1. Introduction

1.1 Policy Objectives

1.2 Policy Statements

1.3 Scope and Application

1.4 Background

2. Guidance for Implementation

3. Appendices

Appendix 1 - Determining Solubility

Appendix 2 - Calculation of Similarity Factor (f₂)

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Details and history

Published: November 24, 2017

Updated: July 12, 2018

Consulted: December 18, 2017

Part of topic(s): Guidance on legislation

Related guides and help

• Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies
• Guidance Document: Comparative Bioavailability Standards: Formulations use for Systemic Effects
• Guidance Document: Patented Medicines (Notice of Compliance) Regulations

Related acts and regulations

• Food and Drug Regulations
• Patented Medicines (Notice of Compliance) Regulations