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CVM’s Involvement in the Regulatory Cooperation Council (RCC) Veterinary Drug Initiative “Beyond the Border – A Shared Vision”

On December 7, 2011, President Obama and Prime Minister Harper announced the launch of the United States-Canada Regulatory Cooperation Council (RCC) Action Plan. Approaches were aimed at reducing unnecessary regulatory differences. The goal is to enhance our joint economic competitiveness while continuing to protect the health, safety, and welfare of the American people. CVM’s role in the RCC is to facilitate simultaneous review of new animal drug submissions in both countries of the same fundamental data set with a view to promote the simultaneous availability of drugs to end users, as well as to further align Maximum Residue Limits (MRLs)/tolerances whenever possible. As part of this initiative, simultaneous reviews will be conducted to explore similarities and differences in approach between the two countries, with a view to develop a mechanism that, subject to some acceptability criteria, would allow for simultaneous submissions and collaborative reviews. Through this simultaneous review pilot project, CVM and VDD will continue to build on scientific collaboration in the establishment of comparable human food safety standards, including the further alignment of MRLs/tolerances whenever possible.

In 2011, the CVM and VDD worked collaboratively from the same fundamental data set to approve Comfortis (spinosad), which is used to kill fleas and prevent flea infestations in cats. Building on the already strong relationship between CVM and VDD, both regulators were able to proceed quickly through the simultaneous review. The result was a more efficient process and greater consistency in the labeling of the product in the two countries. The simultaneous approval of Comfortis was announced as an FDA Blog as well as a White House Press Release dated December 7, 2011. The following is an excerpt from this announcement:

“U.S. and Canada Working Together To Provide Access to Needed Veterinary Drugs

by Bernadette Dunham, D.V.M, Ph.D. and Murray M. Lumpkin, M.D., M.Sc.

The first simultaneous review and approval of a veterinary drug by the United States and Canada marks a successful start to a collaboration aimed at providing consumers quicker access to needed veterinary medicines. The collaboration is also intended to remove trade barriers and reduce costs for consumers, regulators and manufacturers.

This successful collaboration has started with the approval of one medicine for cats, but it portends great things for the future as we improve both safety and efficiency.”

To date, the RCC Veterinary Drug Initiative has evolved to include both food and non-food animal drugs, the sharing of information regarding MRLs, and the promotion of having CMC experts meet to discuss current GMP and other scientific topics. Reports are generated annually by each RCC group and can be found on the internet at http://www.trade.gov/RCC/.