Proposed Policy on Bioequivalence Standards for Highly Variable Drug Products

This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (that is, new drug and abbreviated new drug submissions) of proposed changes in Health Canada's comparative bioavailability requirements for drug products which exhibit large pharmacokinetic within-subject variation in extent of absorption, as measured by area under the concentration versus time curve (AUC).

How to get involved

This consultation is open for comment starting June 26, 2015 until August 25, 2015. 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
Holland Cross, Tower B, 2^nd Floor
Address Locator: 3102C3
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613- 957-1058
Fax: 613-941-1812

Consultation Document

Interested parties are encouraged to provide comments and suggestions by August 25, 2015.

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.