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
Holland Cross, Tower B, 2nd Floor
Address Locator: 3102C3
1600 Scott Street
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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