Regulatory cooperation - Canadian guidance on veterinary drug simultaneous reviews with the United States: Pre-submission
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- Expression of interest
- Pre-submission discussions
- Intent to conduct a simultaneous review
- Expectations for sponsors
- Study protocols and experimental studies
Expression of interest
Early interactions by industry with the regulators are important for assessing the feasibility and admissibility of a submission. We encourage sponsors to learn about the simultaneous review process and to begin a dialogue with both regulators as soon as possible. This should be at the protocol or investigational/experimental study stage.
Sponsors should send an expression of interest by emailing the Veterinary Drugs Directorate (VDD) at vdd.international-international.dmv@hc-sc.gc.ca. VDD will work with the sponsor to answer any questions and set up a pre-submission meeting if one has not yet taken place.
Pre-submission discussions
Pre-submission discussions help to inform the Minister's decision on whether to conduct a review of the submission with the U.S. Center for Veterinary Medicine (CVM) under paragraphs C.08.002(8)(a) or C.08.003(8)(a) of the Food and Drug Regulations (regulations). This is an exploratory meeting between the sponsor, including its representatives in both countries, and both regulators.
The sponsor introduces their new drug product or new claim to the regulators and discusses whether the product is a good candidate for this process.
Where possible, VDD encourages sponsors to request joint pre-submission discussions. Pre-submission discussions may also be held just with VDD if the sponsor:
- has already held a pre-submission meeting with CVM or
- wishes to clarify Canadian requirements
The sponsor should:
- present a plan for submitting missing information intended to satisfy subparagraphs C.08.002(8)(b)(i) or C.08.003(8)(b)(i) of the regulations and
- indicate if the submission is a comparative submission
For more information on pre-submission meetings with VDD, please consult:
Intent to conduct a simultaneous review
Sponsors wishing to pursue a simultaneous review must send a formal letter to VDD outlining their request. An authorization permitting the discussion and exchange of product information between VDD and CVM should accompany the letter.
VDD and CVM will then consult on whether the veterinary drug submission is an appropriate candidate for the Regulatory Cooperation Council (RCC) pathway.
On behalf of the Minister, VDD will issue a formal letter to the sponsor. The letter will indicate our intent to conduct a simultaneous review of the submission with CVM. This formal letter is outlined in paragraphs C.08.002(8)(a) or C.08.003(8)(a) of the regulations.
The letter asks the sponsor to:
- confirm their participation in the simultaneous review process and
- authorize VDD to discuss all information included and related to the submission with CVM
This letter also outlines VDD's expectations for the simultaneous review process.
At this stage, VDD informs CVM about the sponsor's intent to conduct a simultaneous review.
Expectations for sponsors
The technical information about the drug and packages that the sponsor submits to both regulators should be identical in every way (for example, drug formulation, proposed dosage, proposed indication). Both regulators should receive the submissions at relatively the same time.
Sponsors should submit any amendments requested during the review process to both regulators. Please note that VDD and CVM will be invited to participate in or observe all sponsor-regulator meetings or teleconferences related to the review of any technical sections.
The success of a simultaneous review depends on open and constant communication between the regulators and sponsors, and between sponsors and the Canadian and U.S. affiliates. Good communications:
- supports a streamlined and timely review process
- ensures informed decision-making
- contributes to greater harmonization between the regulators
For this reason, VDD asks that sponsors commit to:
- sharing identical information with both regulators at the same time
- establishing strong communication channels with both regulators and drug sponsor counterparts by, for example:
- submitting all additional information related to the submission to both regulators, such as information submitted in response to:
- VDD's request for information or
- CVM's “technical section incomplete” letter or other requests for information (such as through email)
- inviting both regulators to all sponsor-regulator meetings or teleconferences related to the review of the submission
- having regular meetings between the Canadian and U.S. sponsors (if different) to coordinate a streamlined filing process
- submitting all additional information related to the submission to both regulators, such as information submitted in response to:
Study protocols and experimental studies
Study protocols and experimental studies are designed and conducted to support a future regulatory submission for market authorization of a drug product.
If a study is conducted in Canada, sponsors may be required to acquire an Experimental Studies Certificate (ESC). For more information on ESC requirements, please consult the ESC application.
If the study does not require an ESC (for example, it takes place outside of Canada), the sponsor may still wish to seek VDD's review of study protocols. We strongly recommend this for:
- pivotal studies that are conducted outside Canada
- new or novel studies that lack established guidelines
If a sponsor does not wish to seek VDD's advice on a study protocol, they should still submit the protocol to VDD when submitting to CVM. This applies to other types of study protocols as well.
Submitting these types of study protocols to VDD gives us a chance to reference the protocols through the simultaneous review process and communicate with CVM about these studies, as needed.
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