Regulatory cooperation - Canadian guidance on veterinary drug simultaneous reviews with the United States: Overview

This guidance is a draft version for consultation purposes only. It is not to be implemented at this time.

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Organization: Health Canada

Date published: 2022-12-13

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This Health Canada guidance outlines the Canadian process for simultaneously reviewing veterinary drug submissions by:

The review is conducted under the Regulatory Cooperation Council (RCC) initiative.

The purpose of the simultaneous review process is to create a more favourable environment for manufacturers and animal owners without compromising domestic standards and scientific rigour. The process:

Note: Unless indicated, "sponsor" means the Canadian manufacturer that has filed a new drug submission or a supplement to a new drug submission. Unless specified, "submission" means the Canadian veterinary new drug submission or a supplement to the new drug submission as submitted to VDD.

For questions about the U.S. process, send an email to

For information on administrative processes and data requirements for Canadian veterinary drug submissions, please consult:

Defining a simultaneous review

Simultaneous reviews may occur when manufacturers submit a veterinary drug submission to both regulators at the same time. Typically, simultaneous reviews with CVM are reviewed in a rolling fashion. Subsections C.08.002(8) and (9) and C.08.003(8) and (9) of the Food and Drug Regulations (regulations) set out the requirements for a rolling collaborative review with a foreign regulatory authority.

Submissions must also meet all applicable Canadian regulatory requirements. Health Canada conducts our evaluation independently, in parallel with the U.S. evaluation, with the objective of issuing regulatory decisions at the same time.

The simultaneous review process typically follows CVM's phased review process. For this process, a sponsor may file all or part of the data or information needed to address the regulatory requirements of both countries at the most appropriate and productive times in the drug development process. If all the data is filed at the same time, the simultaneous review is not considered a rolling review.

Simultaneous review involves exchanging submission information between the regulators and the sponsors. This exchange between the U.S and Canadian regulators is facilitated by the "Confidentiality Commitment Statements of Legal Authority and Commitments" between our Health Products and Food Branch and the FDA.

Eligible products

When indicating their intent to conduct a review of the submission with a foreign regulatory authority under paragraphs C.08.002(8)(a) or C.08.003(8)(a) of the regulations, the Minister will consider the submission's eligibility for the pathway.

Eligible submissions may be for new veterinary drug products or for new uses of veterinary drug products that already hold marketing authorizations in both countries. In Canada, this includes a new drug submission (NDS) and supplement to a new drug submission (SNDS).

The veterinary drug product submitted for review must:

Submissions for drug products for minor uses/minor species (MUMS) are encouraged. New biologic entities are handled on a case-by-case basis.

The following are not eligible for simultaneous review at present:

As well, products are not eligible for this process if they cannot be reviewed at the same time, for example, if:

Sponsors interested in filing a submission for a generic drug under the RCC pathway should contact VDD to discuss the drug product's eligibility.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of other applicable guidance documents.

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