Notice: Expansion of the Generic Submissions Under Review List

• February 23, 2024
• Our file number: 23-109491-316

The Generic Submissions Under Review (GSUR) List helps make Health Canada's review processes more transparent. The list provides Canadians with information about generic versions of prescription brand name drugs currently under review in Canada. The GSUR List includes abbreviated new drug submissions (ANDSs) accepted into review on or after October 1, 2018.

The GSUR List currently includes the following information:

• Medicinal ingredient(s)
• Therapeutic area
• Number of submissions for the same medicinal ingredient under review with Health Canada that month

Health Canada will expand the information available on the GSUR List to include:

• Year and month in which the submission was accepted for review for each ANDS
• Company (sponsor) name (for ANDSs accepted into review on or after April 1, 2024 only)

To allow for this expansion, the column displaying the number of submissions under review will be removed, and ANDSs under review will be separated into individual rows in the expanded GSUR List.

Background

Feedback received from various consultations since 2016 have highlighted the need to increase transparency related to generic drug submissions, and to apply transparency measures equally between innovative and generic drug submissions. Launched in 2018, the GSUR List is among the transparency measures implemented in response to feedback from stakeholders. The GSUR List was announced as part of Phase III of the Submissions Under Review (SUR) List initiative, which publishes information about prescription new drug submissions and their supplements under review.

A consultation was held in 2019 to assess the use and impacts on stakeholders of adding the company (sponsor) name to the GSUR List. Results were mixed in terms of the need for this information to be released, and whether its release would cause potential injury to drug sponsors.

However, since that time, 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. The expansion of the GSUR List will facilitate access to the information and reduce the need for ATI requests. Furthermore, it will improve the consistency with which transparency measures are applied among brand name, biosimilar, and generic prescription drugs.

Where to find more information

• Information on the GSUR List initiative
• Information on the SUR List initiative
• Access to Generic Drugs in Canada

Any comments regarding the above notice should be directed to:

Office of Planning, Performance and Review Services (OPPRS)
Pharmaceutical Drugs Directorate
Health Products and Food Branch

E-mail: opprs.enquiries-enquetes.bprse@hc-sc.gc.ca