This news release is brought to you by Health Canada concerning a joint regulatory review of a product.
Health Canada and the U.S. Food and Drug Administration’s Center for Veterinary Medicine today announced the first simultaneous review and approval of a veterinary drug application under an initiative to better align the approval process for these products.
Under an initiative of the Canada-United States Regulatory Cooperation Council (RCC), Health Canada and the FDA worked collaboratively from the same fundamental effectiveness data set to approve Comfortis.
Building on an established and strong relationship, Health Canada and the FDA were able to perform a collaborative review with more consistent labeling of the product as it is marketed in both the Canada and the U.S.
Health Canada and the FDA plan to build a process to allow simultaneous submissions and collaborative reviews where possible, while maintaining each country’s right to decide whether or not products will be approved for its market.
For more information on the RCC, and the full news release please refer to the link above.