The Generic Submissions Under Review List (for further details please see "List of generic submissions under review now available") is a list of abbreviated new drug submissions that were accepted into review on or after 1 October 2018 and is intended to be updated on a monthly basis. The list includes the medicinal ingredients, therapeutic area and number of submissions under review. On 7 January 2019 Health Canada published a notice soliciting feedback on its possible impact on and use to stakeholders if the list were updated to include sponsor names (ie, the company that filed the generic submission). Sponsors are included in the Submissions Under Review List for new drug submissions (which includes biosimilars) accepted into review on or after 1 October 2018. Stakeholder feedback should have been submitted by email to Health Canada by 8 February 2019.
For further information on this topic please contact Tierney GB Deluzio 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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