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.
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:
- Health Canada's Veterinary Drugs Directorate (VDD) and
- U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM)
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:
- offers simultaneous access to 2 major markets for veterinary drug manufacturers
- encourages harmonization where possible while respecting independent, sovereign decision-making by the 2 regulators
- provides faster access and more treatment options for Canadian animal owners and food producers
- creates a stronger global review community that allows both regulators to share knowledge and expertise
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 AskCVM@fda.hhs.gov.
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.
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:
- not have been subject to relevant or significant safety-related regulatory action in either country
- be identical in formulation and manufacturing in each country, including the source of the medicinal ingredient
- may be differences in product labels
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:
- veterinary health products as defined in section C.01.001 of the regulations
- products that are seeking to be indexed in the U.S.
- products seeking approval in the U.S. through expanded conditional approval or conditional approval under the U.S. MUMS Act
As well, products are not eligible for this process if they cannot be reviewed at the same time, for example, if:
- the sponsor has already filed the submission in Canada and VDD has accepted the submission into review
- 1 or more technical sections have been filed and are already under review in the U.S.
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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