Health Canada may request additional information for backlog generic submissions in review 2: Notice
September 1, 2026
Our file number: 26-105134 - 755
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Background
Health Canada has a backlog of generic submissions. Incomplete submission filings, more complex reviews and a higher volume of submissions received are contributing to this backlog.
A backlog submission is one that’s still in review beyond its performance target. Review 2 is the stage of review after a sponsor has responded to a notice of non-compliance (NON).
Some submissions have been in backlog for an extended period of time. During that time, requirements may have changed. In other cases, we may need more information or material to support a final regulatory decision under section C.08.004 of the Food and Drug Regulations.
What we’re doing
To address the backlog, we’re making changes to how we handle requests for additional information for certain generic backlog submissions in Review 2. These include:
- abbreviated new drug submissions (ANDS) and
- supplements to abbreviated new drug submissions
We may also consider applications for drug identification numbers (DINAs) on a case-by-case basis.
The changes to the review process will also give sponsors an opportunity to sufficiently address the requirements.
These changes do not replace existing policies or procedures, or impact scientific standards that must be met. The changes should also not be viewed as establishing a practice that will apply to future submissions.
This new approach will:
- make the regulatory process more efficient
- provide targeted flexibility and other opportunities to sponsors where appropriate
- help avoid unnecessary withdrawals of drug submissions and
- support timely decision-making in line with established performance standards
This change takes effect as of the date of this notice and only applies to certain generic backlog submissions already in Review 2.
How the new approach works
We’ll first review the sponsor’s response to the NON. We’ll then ask for additional safety, efficacy or quality information or material if we deem it necessary.
At this stage, sponsors can’t make major changes to their submission, such as add a new indication or new route of administration. These types of changes would be considered a major change and would require the filing of a new submission or supplement.
We’ll only accept information or material that’s directly related to the additional information request. We may issue a notice of non-compliance-withdrawal (NON-W) if the information provided isn’t sufficient. Sponsors may refile the submission or supplement with the information or material needed to address the deficiencies we identified.
Submission requirements under the regulations and pause-the-clock provisions will continue to apply.
For more information on submissions, performance standards and refiling requirements, consult:
Learn more:
Contact us
If you have questions, email the Bureau of Pharmaceutical Sciences in the Health Products and Food Branch: BPS_enquiries@hc-sc.gc.ca.