The Veterinary Medicines Directorate and Health Canada’s Veterinary Drugs Directorate (VDD) have been discussing the opportunity to conduct simultaneous reviews of veterinary medicines submissions.
The VMD is pleased to announce the publication of the United Kingdom-Canada Regulatory Cooperation: Guidance on Veterinary Drug Simultaneous Reviews.
This guidance document will serve as the foundation for simultaneous reviews of veterinary medicines submissions by our two agencies.
The guidance represents an important step forward by expanding opportunities for industry to simultaneously access two major markets. It provides opportunities to reduce burdens and to have a single project team working on the submission pathway working to common assessment timeframes. It also supports our shared aim of expanding access to treatment options for animals and helping food producers stay competitive globally.
The guidance outlines how the review process will work. It is intended to complement each country’s legislative and regulatory framework and associated technical guidelines, which remain in place.
This is an exciting opportunity and we look forward to working with the veterinary pharmaceutical industry on this new initiative.
Please contact Gavin Hall g.hall@vmd.gov.uk, the VMD’s Head of Regulatory Affairs, if you would like further clarification or would like to discuss any potential projects that you may have which would benefit from this opportunity.
To contact the Canadian Authorities directly, email: hc.vdd.international-international.dmv.sc@canada.ca marked for the attention of Meggan Davis.
