On February 23, 2024, Health Canada announced that it will expand the information available on the Generic Submissions Under Review (GSUR) list to include the following:
- Year and month in which the submission was accepted for review for each abbreviated new drug submission (ANDS)
- Company (sponsor) name (for ANDSs accepted into review on or after April 1, 2024 only)
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
To allow for the expansion, the column that currently displays the number of submissions under review will be removed, and ANDSs under review will be separated into individual rows.
The purpose of the expansion is two-fold: (i) to reduce the need for requests under the Access to Information Act for the same information; and (ii) to improve the consistency with which transparency measures are applied among brand name, biosimilar, and generic prescription drugs.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.