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
  2. Guidance for implementation
  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

For assistance

Contact us:

Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

E-mail: hc.bcansenquiries.sc@canada.ca
Fax: 613–941-1668

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