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
-
Canada’s Drug Agency releases new resource and data on drug approval and reimbursement pathway
Canada’s Drug Agency (CDA-AMC) published data on Canada’s drug system as part of the Data Systems and Analytics program.Read More -
Health Canada and U.S. FDA agree to establish information sharing program for generic drug submission reviews
Health Canada and the U.S. Food and Drug Administration (FDA) have created a program to support the establishment of a Request for Information Sharing (RIS) program, which will enhance the exchange of...Read More -
Medical Devices updates: Phase II consultation on Medical Devices Regulations amendments, medical device licences guidance and IMDRF table of contents guidance
On November 17, 2025, Health Canada proposed Phase II amendments to the Medical Devices Regulations (MDR). The first phase of amendments came into force on December 14, 2024 and relate to recalls, mod...Read More
