For immediate release
OTTAWA - 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.
Comfortis (spinosad), the product that received the approval, is used to kill fleas and prevent flea infestations in cats. The product is marketed by Elanco.
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.
Prime Minister Stephen Harper and U.S. President Barack Obama announced the creation of the RCC on February 4, 2011, and released the RCC's Joint Action Plan on December 7, 2011. The intent of the RCC is to speed timely access to products, while maintaining safety standards, and to eliminate duplications and differences in the regulatory arena that may limit timely access to products, slow trade and investment opportunities, and add costs to manufacturers and consumers.