Regulatory cooperation - Canadian Guidance on Veterinary Drug Simultaneous Reviews with the United States: Review process

On this page

• Submission completeness check (screening)
• Clarification requests
• Information reviewed letters
• Meeting requests
• Sovereign decision
• Timelines for review

Submission completeness check (screening)

Health Canada's Veterinary Drugs Directorate (VDD) first looks at the drug submission to ensure it is in an acceptable format and contains sufficient information to enable a proper review.

If there are questions about the content of the submission during this initial screening process, VDD sends a communication to the sponsor, with a copy to the U.S. Center for Veterinary Medicine (CVM). The sponsor should copy CVM on its responses to VDD. VDD should also be copied on any responses to CVM.

Sponsors must ensure that at the end of the screening process, submissions to VDD and to CVM are identical and that no data is missing.

At the end of the screening process, VDD sends a letter to the sponsor indicating that the submission has been accepted for review.

Clarification requests

Once a submission is in review, VDD will discuss the submission, including any questions for the sponsor, with CVM. These discussions continue throughout the submission process. Any questions about the submission are sent to sponsors in the form of a clarification request or a notice of deficiency. This is outlined in the following guidance:

• Veterinary drugs - Management of regulatory submissions

Sponsors are given a certain amount of time in which to submit their responses. Extension requests are considered alongside CVM response timelines.

Sponsors are expected to share their responses to VDD's questions with CVM, and vice versa.

Information reviewed letters

Technical sections of a submission that go through the Regulatory Cooperation Council (RCC) pathway are reviewed on a rolling basis. When applicable, VDD will send an “information reviewed letter” to the sponsor when we have reviewed a technical section and there are no further comments at that time. This letter does not include a decision on the compliance of a technical section.

Meeting requests

Sponsors who wish to meet with VDD at any point during the submission review process must also inform and invite CVM to participate. VDD must also be invited to any discussions with CVM.

Sovereign decision

VDD makes its own sovereign decision in accordance with relevant Canadian legislation.

VDD will undertake the necessary Canadian administrative and legal steps relating to the issuance of a market authorization or negative decision. As much as possible, we will synchronize the timing of communications related to the issuance of decisions with CVM.

Once a product has received market authorization in Canada, the sponsor is responsible for meeting applicable Canadian post-market regulatory requirements. VDD will continue to collaborate and exchange information with CVM to support post-market monitoring, risk assessment and risk management activities, as appropriate.

If there is a negative decision by 1 or both regulators, the sponsor is encouraged to discuss options on how to address deficiencies with VDD, based on the Canadian framework.

VDD will consider opportunities to harmonize maximum residue limits and product labelling when appropriate.

Timelines for review

VDD aims to issue decisions made throughout the RCC process at roughly the same time as CVM. Sponsors should confirm timelines with both regulators before filing a submission.