Veterinary drugs – International collaboration

Health Canada's Veterinary Drugs Directorate participates in international regulatory cooperation work and shares knowledge with other jurisdictions around the world. This page explains how we collaborate with our regulatory partners for both pre-market and post-market submissions, to promote harmonization of regulatory practices and standards, leverage resources, and facilitate timely access to safe and effective veterinary drugs.

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Simultaneous veterinary drug reviews

The Veterinary Drugs Directorate works with the U.S. Food and Drug Administration’s Center for Veterinary Medicine to conduct simultaneous reviews of veterinary drug applications.  Companies that wish to market a veterinary drug in Canada and the U.S. can submit applications to have their product reviewed by both agencies at the same time. This process allows veterinary drugs to be available at the same time on either side of the border.

Several drugs have been approved under simultaneous review and more product reviews are underway.

If you are a company that is interested in submitting a veterinary drug for simultaneous consideration by the U.S. and Canada or want to learn more about simultaneous reviews, contact the Veterinary Drugs Directorate at:

Simultaneous reviews are a Regulatory Cooperation Council (RCC) initiative. For information on the RCC veterinary drugs workplan, click here.

Joint reviews

The Veterinary Drugs Directorate is also exploring ways to review veterinary drug submissions jointly with our international partners. For example, we have collaborated with the Australian Pesticides and Veterinary Medicines Authority Australia and the New Zealand Ministry of Primary Industries, to jointly review and enable simultaneous access to a new animal drug in three major markets, leading to improved animal health and food safety.

Companies seeking to simultaneously market a veterinary drug in these countries are invited to contact the Veterinary Drugs Directorate at: .

Click here for more information about products approved through joint reviews.

International forums

The Veterinary Drugs Directorate is an active participant in several important international initiatives. Collaboration with international partners contributes to important public health objectives, promotes regulatory harmonization and innovation, and ultimately improves access to safe and effective veterinary drugs around the world.

The Codex Alimentarius is a collection of standards, guidelines and codes of practice that protect consumer health and promote fair practices in food trade. The Veterinary Drugs Directorate supports the Codex Program in Canada by:

  • participating in setting international standards for veterinary drug residues in foods, and
  • contributing to the work of the Ad Hoc Codex Intergovernmental Task Force on Antimicrobial Resistance.

The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), is a trilateral (EU-Japan-USA) program aimed at harmonizing technical requirements for veterinary product registration. Canada participates on the VICH Steering Committees as an observer country, and in the VICH expert working groups.

The Veterinary Drugs Directorate works with the Canadian Food Inspection Agency (for veterinary biologics) to adopt VICH guidelines for implementation in Canada.

The CFIA Canadian Centre for Veterinary Biologics and the Health Canada Veterinary Drugs Directorate participate in international harmonisation through the Committee of the Americas for Veterinary Medicines (CAMEVET).  The group is comprised of representatives of the regulatory agencies for animal health products (drugs and vaccines) from each country in the Americas, and operates under the World Organisation for Animal Health (OIE)

Bilateral partnerships

To support international collaboration and achievements as laid out above, as well as the routine sharing of review and scientific information with other regulators, the Veterinary Drugs Directorate relies on bilateral confidentiality arrangements with several countries: Australia, the European Union, France, New Zealand, Switzerland, the United Kingdom, and the United States of America. A complete list of these partnerships for the Health Products and Food Branch can be found here. These partnerships help to advance the effective regulation of veterinary medicines and promote timely access to new veterinary drugs.

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