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.
Related Publications & Articles
-
Health Canada launches new Clinical Trial Search Portal and publishes updated guidance
As part of its efforts to modernize clinical trials and enhance transparency (see our previous article), Health Canada has launched a new Clinical Trial Search Portal, replacing the Clinical Trials Da...Read More -
New regulatory amendments formalize updates to the drug and medical device shortages framework
On June 17, 2026, Health Canada published the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices).Read More -
Medical device updates: MDEL modernization, Class III & IV licence applications, and MDD performance reports
As we previously reported, Health Canada announced that the Phase II amendments to the Medical Devices Regulations (MDR) regarding medical device establishment licences (MDELs) will come into force De...Read More
