Canada’s Intellectual Property Firm

Health Canada requests feedback if company names were added to the Generic Submissions Under Review List

The Generic Submissions Under Review (GSUR) list is a list of Abbreviated New Drug Submissions (generic submissions) that were accepted into review on or after October 1, 2018 and is intended to be updated on a monthly basis. The list currently includes the medicinal ingredient(s), therapeutic area and number of submissions under review. On January 7, 2019, Health Canada published a Notice soliciting feedback on possible impacts and uses to stakeholders if the GSUR list is updated to include sponsor names (i.e., 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 October 1, 2018. Stakeholder feedback should be submitted by email to Health Canada by February 8, 2019.