On December 18 2017 Health Canada published a notice soliciting comments and recommendations from stakeholders regarding potential changes to its Guidance Document: Use of a Foreign-Sourced Reference Product as a Canadian Reference Product (for further details please see "Health Canada issues guidance on use of foreign-sourced reference products as CRPs").
The guidance, which took effect on November 24 2017, is directed at sponsors of all abbreviated new drug submissions and abbreviated extraordinary use new drug submissions that seek to obtain approval based on a demonstration of pharmaceutical equivalence and bioequivalence to a reference drug product marketed outside Canada (ie, under the definition of a 'Canadian reference product' provided in Paragraph (c) of Section C.08.001.1 of the Food and Drug Regulations).
Stakeholder feedback should be submitted to Health Canada by March 18 2018, preferably in electronic form.
For further information on this topic please contact Andrew Mandlsohn at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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