Draft Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Market Entry Inhaled Corticosteroid Products for Use in the Treatment of Asthma

The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period.

This guidance is intended to assist sponsors in the collection and analysis of data for Inhaled Corticosteroid (ICS) products for use in the treatment of asthma in order to meet the safety and effectiveness requirements under Part C, Division 8 of the Food and Drug Regulations. The data and standards outlined in this guidance are intended to be applied to a new inhaled corticosteroid product being compared to a product for which clinical safety and effectiveness data exist. For clarity, these types of products will be called "Subsequent Market Entry Products".

How to Get Involved

This consultation is open for comment starting September 19, 2011 until November 18, 2011. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:

bcans_enquiries@hc-sc.gc.ca

Bureau of Cardiology, Allergy and Neurological Sciences
Therapeutic Products Directorate, Health Canada
Finance Building 2,
Address Locator 0202A1
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9

Telephone: 613-941-1499
Facsimile: 613-941-1668

Consultation Document

Interested parties are encouraged to provide comments and suggestions by November 18, 2011.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact us at Bureau of Cardiology, Allergy and Neurological Sciences.