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)
Download PDF (264 KB, 14 pages)
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
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