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Draft Guidance Documents - Conduct and Analysis of Comparative Bioavailability Studies; and Comparative Bioavailability Standards: Formulations used for Systemic Effects
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.
The purpose of these documents is to update and consolidate eleven existing Health Canada documents related to the conduct and analysis of comparative bioavailability studies and the standards to be met in those studies in order to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug Regulations. Please note, however, until such time as these guidances are finalized and published, current bioequivalence requirements remain unchanged and proposals in the draft guidances are not to be implemented.
The document is being released for a 60-day comment period. Health Canada will review the comments received during this comment period and revise the Guidance as necessary. A final version of this document will then be posted.
How to Get Involved
This consultation is open for comment starting January 25, 2010 until March 26, 2010. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:
Policy_Bureau_Enquiries@hc-sc.gc.ca
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
Interested parties are encouraged to provide comments and suggestions by March 26, 2010.
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 Policy_Bureau_Enquiries@hc-sc.gc.ca
