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
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
E-mail: [email protected]
document date 2012-08-21 | last update 2022-10-19