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

October 31, 2018
Our file number: 18-111871-354

Health Canada is pleased to announce the release of the Guidance Document Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma. This guidance was developed following stakeholder consultation in 2011 and in consultation with the Scientific Advisory Committee on Respiratory and Allergy Therapies.

This guidance document provides sponsors of subsequent entry inhaled corticosteroid (ICS) products for the treatment of asthma with information on the comparative clinical data requirements in order to establish the safety and effectiveness of their products under Section C.08 of the Food and Drug Regulations.

This guidance should be read in conjunction with other applicable Health Canada guidances.

This guidance document is effective as of November 1, 2018.

Questions or comments regarding this guidance document should be directed to:

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
Ottawa, Ontario
K1A 0K9

Email: hc.bcansenquiries.sc@canada.ca
Fax: 613-941-1668