Thursday, December 13, 2012
FYI : FDA and Health Canada announce first simultaneous review and approval of a veterinary drug product
FDA and Health Canada announce first simultaneous review and approval of a veterinary drug product
December 12, 2012
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM), in cooperation with Health Canada’s Veterinary Drugs Directorate (VDD), announced today the first simultaneous review and approval of a veterinary drug application under a joint 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 Regulatory Cooperation Council (RCC) CVM and VDD worked collaboratively from the same fundamental effectiveness data set to approve Comfortis.
Building on an established and strong relationship, CVM and VDD were able to perform a collaborative review with more consistent labeling of the product as it is marketed in both the U.S. and Canada.
CVM and VDD 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.
President Barack Obama and Canadian Prime Minister Stephen Harper announced the creation of the RCC on February 4, 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.
U.S. and Canada Working Together To Provide Access to Needed Veterinary Drugs
Freedom of Information Summary for Comfortis (PDF - 270KB)