On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent.  Specifically, for generic drug submissions accepted into review on or after April 1, 2024, Health Canada will start disclosing: (i) the year and month that the submission was accepted for review; and (ii) the company sponsoring the generic drug.

Background on the GSUR List

Since 2018, Heath Canada has disclosed abbreviated new drug submissions (ANDSs) that it is currently reviewing on the Generic Submissions Under Review List (GSUR List).  In Canada, the ANDS pathway is used to review and approve generic prescription drugs (but not biosimilars).  The GSUR List is updated monthly and provides the following information for each generic drug under review:

  • the medicinal ingredient(s);
  • the therapeutic area; and
  • the number of ANDSs currently under review having the medicinal ingredient(s).

More disclosure coming to the GSUR List

According to the Notice, for ANDSs accepted into review on or after April 1, 2024, the GSUR List will start providing:

  • the year and month in which the ANDS was accepted for review; and
  • the company (sponsor) name.

The Notice provides several reasons for making this change, including:

  • Reducing ATI requests: According to the Notice, “requests under the Access to Information (ATI) Act for information associated with ANDSs on the GSUR List have increased considerably, and few third-party objections to the disclosure of this information have been received.”
  • Making transparency consistent across drug classes:  For innovative and biosimilar drugs, Health Canada’s Submissions Under Review (SUR) List already provides the year and month that the new drug submission was accepted into review, as well as the company (sponsor) name.