Health Canada has published its long anticipated notice regarding changes to the Generic Submissions Under Review (GSUR) List.1
The GSUR List currently identifies the medicinal ingredient(s), therapeutic area, and number of generic submissions under review with Health Canada.
Health Canada has confirmed that it will soon also publish:
- The year and month in which each submission was accepted for review; and
- The company (sponsor) name for ANDSs accepted into review on or after April 1, 2024.
Given this timing, the first expanded GSUR List is likely to be published sometime in mid-May.
Once updated, the GSUR List will provide the same type of information that is already available with respect to biosimilar submissions (on the Drug Submissions Under Review database).
For ANDS submissions filed before April 1, 2024 requests under the Access to Information (ATI) Act for information associated with ANDSs on the GSUR List continue to be available. Health Canada advises that few third-party objections to the disclosure of this information have been received.
Furthermore, under Canada's "Open Government" repository, previous ATI requests can be searched and copies of information that was previously provided pursuant to an ATI request can be requested informally with a shorter turnaround time, free of charge.
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