Consultation on Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products

This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (i.e., new drug and abbreviated new drug submissions), of proposed modifications to Health Canada’s comparative bioavailability requirements when multiphasic plasma concentration profiles have been demonstrated to be integral to the product’s therapeutic effect.

How to Get Involved

This consultation is open for comment starting July 27, 2017 until September 25, 2017. 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
Holland Cross, Tower B, 2^nd Floor
Address Locator: 3102C3
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Fax: 613-941-1812
Policy_Bureau_Enquiries@hc-sc.gc.ca

Consultation Document

Interested parties are encouraged to provide comments and suggestions by September 25, 2017.

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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