Guidance Document: Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma - Summary

From Health Canada

Overview

This guidance is intended to assist sponsors in the collection and analysis of comparative clinical data for Inhaled Corticosteroid (ICS) products used for the treatment of asthma. This guidance applies to products that contain the same medicinal ingredient and have the same conditions of use as the Canadian Reference Product (CRP).

Who this guide is for

• Drug manufacturers

In this guide

1. Introduction
   • 1.1 Policy Objectives
   • 1.2 Policy Statement
   • 1.3 Scope and Application
   • 1.4 Background
2. Guidance for implementation
   • 2.1 General filing requirements for subsequent entry inhaled corticosteroid products
   • 2.2 Therapeutic equivalence study requirements for subsequent entry inhaled corticosteroid products
     • 2.2.1 General considerations
     • 2.2.2 Clinical endpoint study with FEV1 as the primary endpoint
     • 2.2.3 Clinical endpoint study with sputum eosinophils as the primary endpoint
   • 2.3 Clinical study requirements for systemic exposure to subsequent entry inhaled corticosteroid products
3. Enquiries
4. Glossary of abbreviations
5. References

View complete guide

Download PDF (264 KB, 14 pages)

Details and history

Published: 2018/10/24
Part of topic(s): Guidance on legislation

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