Draft Guidance Document - Biopharmaceutics Classification System Based Biowaiver

Notice to the reader:

The online consultation is now closed. The final guidance is available now.

Health Canada is pleased to announce the release of the draft guidance document Biopharmaceutics Classification System Based Biowaiverfor stakeholder consultation.

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.

How to Get Involved

This consultation is open for comment starting August 21, 2012 until January 1, 2013. Please select and read through the link below titled "consultation document". Once read 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
Fax: 613-941-1812

Consultation Document: To obtain a copy of the draft guidance document that was consulted upon, please contact Bureau of Policy, Science and International Programs.

Interested parties are encouraged to provide comments and suggestions by January 1, 2013.

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 Policy, Science and International Programs.

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