BEBAC   Ing. Helmut Schütz

Canada – HPFB

Draft Guidance Document

On 21 Aug 2012 Health Canada published a drafted guidance for a 60 days public consultation period:
Biopharmaceutics Classification System Based Biowaiver (121KB PDF).

The purpose of this document is to provide guidance to sponsors of new drugs with the information necessary to apply for a biowaiver from submitting comparative bioavailability studies as part of the safety and effectiveness requirements under Division 8 of the Food and Drug Regulations. The information required applies to only Biopharmaceutics Classification System (BCS) Class I and III drugs.

This consultation is open for comment starting August 21, 2012 until November 19, 2012. Please submit your comments via email, fax or by mail to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1A 0K9
Telephone: 613-948-4623
Facsimile: 613-941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca

BEBAC