Profile of the Guidance document for the Regulatory requirements for intravenous immunoglobulin products in Canada

Overview

The purpose of this guidance document is to provide guidance to sponsors of intravenous immunoglobulin (IVIG) products on the regulatory requirements, particularly minimum clinical data requirements for submissions involving approved and non-approved IVIG products in Canada.

In this guide

• 1. Introduction
  • 1.1 Purpose/Overview
  • 1.2 Scope and application
  • 1.3 Policy Statement
  • 1.4 Background
• 2. Submission Information Requirements
  • 2.1 Non-approved IVIG Products Seeking Approval
    • 2.1.1 General
    • 2.1.2 Chemistry and Manufacturing (Quality) Information
    • 2.1.3 Clinical Safety and Efficacy Information.
  • 2.2 Approved IVIG Product Seeking to Add a Non-Approved Indication
    • 2.2.1 General
    • 2.2.2 Chemistry and Manufacturing (Quality) Information
    • 2.2.3 Clinical Safety and Efficacy Information.
• 3. Safety and Efficacy Information Requirements
  • 3.1 Pre-Clinical Information.
    • 3.1.1 Non-approved IVIG Products seeking approval
    • 3.1.2 Non -Approved IVIG Products Seeking Approval for ITP and PID/SID
    • 3.1.3 Approved IVIG Product Seeking to Add an Indication(s) for Use
  • 3.2 Clinical Information
    • 3.2.1 General
    • 3.2.2 Approved and Non-Approved IVIG Products Seeking Approval for Indications Other than PID/SID and ITP
    • 3.2.3 Non -Approved IVIG Products Seeking Approval for ITP and PID/SID
• Contact Information
• Appendices
  • Appendix A – Glossary
  • Appendix B – References

View complete guide
Download PDF (675 KB, 12 pages)

Details and history

• Published: August 4, 2004
• Updated: October 1, 2018
• Part of topic(s): Guidance on legislation