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 and joint reviews
Through international regulatory cooperation, we conduct reviews of veterinary drug submissions with trusted partners. Collaborative (i.e. simultaneous and joint) reviews bring veterinary drugs to market in Canada at the same time as in other countries, which would otherwise not be possible. As a result, companion animal owners, veterinarians and producers have faster access to safe, effective and quality veterinary drugs, and Canadian food producers remain competitive globally.
Simultaneous reviews with the United States
We work with the U.S. Food and Drug Administration's Center for Veterinary Medicine to conduct simultaneous reviews of veterinary drug submissions. Companies that wish to market a veterinary drug in Canada and the U.S. can file submissions 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.
Simultaneous reviews with the United KingdomWe work with the UK Veterinary Medicines Directorate to conduct simultaneous reviews of veterinary drug submissions. Guidance on Veterinary Drug Simultaneous Reviews has been developed to outline the overall process.
Joint reviews with Australia and New Zealand
We conduct joint reviews with the Australian Pesticides and Veterinary Medicines Authority and the New Zealand Ministry of Primary Industries.
Guidance on Veterinary Drug Joint Reviews has been developed to outline the overall process.
Refer here for more information about products approved through joint reviews.
How to apply
If you are a company that is interested in submitting a veterinary drug for simultaneous or joint review, contact us at: email@example.com.
We are 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.
We also work 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 harmonization 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).
To support international collaboration and achievements as laid out above, as well as the routine sharing of review and scientific information with other regulators, we rely 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 Health Products and Food Branch partnerships can be found on the International Agreements webpage. These partnerships help to advance the effective regulation of veterinary medicines and promote timely access to new veterinary drugs.
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