Priority review of veterinary drug submissions: Interim approach
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Overview
Health Canada is updating its priority review policy for veterinary drug submissions. We will be taking an interim approach that will enhance transparency and clarity in our review processes.
This approach outlines our current practices and provides details on eligibility criteria and procedural steps for priority review.
We are taking this approach to:
- provide clarity on the priority review process
- be able to adjust to account for other related work that is under way, such as the:
- Draft guidance on terms and conditions for human and veterinary drugs
- Precision Regulating initiative
- List of Needed Veterinary Drugs
- gain real world experience and gather feedback and lessons learned
Learn more about terms and conditions: Draft guidance on terms and conditions for human and vet drugs: Notice
This interim approach will be reviewed in 2 years to reflect lessons learned, stakeholder feedback and any considerations related to other initiatives that are under way.
Priority review
Health Canada regulates veterinary drugs used for pets and food-producing animals to ensure that these drugs are safe, effective and of high quality. To sell a veterinary drug in Canada, manufacturers (drug companies or sponsors) must provide evidence for our review and approval.
Learn more about our review processes:
In certain exceptional circumstances, there may be a need to review a veterinary drug submission under an accelerated process. We would consider prioritizing these submissions (called a priority review).
Eligibility
We will grant priority status for a veterinary drug submission for a serious or severely debilitating disease or condition or urgent unmet health need in animals. The drug must be:
- effective at treating, preventing or diagnosing a disease or condition for which no veterinary drug is presently marketed in Canada or
- significantly more effective, or pose a significantly lower risk, such that the overall benefit-risk profile is improved over existing veterinary drug therapies, preventatives or diagnostic agents marketed in Canada
There must be substantial evidence to show that the drug meets either of these 2 criteria.
Process
All regulatory requirements (for example, scientific evidence, labelling, post-market reporting of adverse events) apply or must be met for drugs granted priority review status.
Veterinary drug submissions that are granted this priority status are assessed as quickly as possible based on current workload and the order they are received. This includes expediting the pre-submission meeting process.
Pre-submission phase
Early interactions between Health Canada and the applicants are important and help determine if the drug is eligible for a priority review.
To send a pre-submission meeting request, use the pre-submission meeting request template. The template is available on the Applications and submissions for veterinary drugs web page.
Your information package for a pre-submission meeting should be under 40 pages. It should be comprehensive and include the following:
- relevant information outlined in the Veterinary drugs - Management of regulatory submissions guidance
- explanation on how the drug meets the criteria for priority review
- brief summary of the supporting evidence
- proposed submission plan, including target filing date
The pre-submission meeting is an opportunity for applicants to demonstrate how the drug meets the eligibility criteria and to clarify the requirements and processes. We may ask for additional information to help us make a decision about eligibility.
If there are early indications that the submission would qualify for a priority review, the pre-submission meeting request process could be decreased from 60 calendar days to 30 calendar days.
Health Canada's Veterinary Drugs Directorate will confirm priority review status in an acceptance letter within 30 calendar days of receiving the finalized pre-submission meeting minutes.
For any submissions not granted priority review, applicants will receive a rejection letter that explains our reasons for the decision.
Applicants may ask us to reconsider a negative decision by emailing us at vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.
Submission filing phase
When a submission is granted priority review status, the applicant should:
- file a submission within the timelines proposed in the submission plan
- recommended within 60 calendar days
- follow the submission-related processes
Learn about how regulatory information is filed and processed in Regulatory enrolment process.
For information on submission format and content, screening and review steps and the clarification request process, consult:
Comprehensive and high-quality submissions help streamline procedures significantly. The sooner this information is provided, the more efficient the process.
If an authorization is issued, the applicant is expected to market the drug in a timely fashion, ideally within 60 calendar days.
Contact us
If you have any questions about our interim approach for priority review status, you may email us at vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.
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