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U.S. Department of Health and Human Services

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CVM’s Participation in Bi- and Trilateral Meetings

The Center for Veterinary Medicine actively participates in regularly scheduled meetings with our foreign counterparts such as the European Medicine Agency (EMA) and Heath Canada (HC). CVM Quarterly Bilateral Meetings include discussions related to current and proposed animal drug approvals, collaborative efforts in sharing of scientific advice and information, post-approval monitoring, MRLs, participation and planning for CODEX and other Food Safety related interagency activities (CONUS and International), as well as current issues in the animal drug realm. These issues have included, but not limited to, discussions regarding the labeling requirements and prudent use of cephalosporins in food animal drugs, concept of cGMP collaborative efforts, and brief discussions regarding the sharing of resources to further scientific research efforts. Each quarterly meeting, as well as other impromptu meetings are always well organized, and address several high-level issues that fully utilize each agencies time and effort. In addition to the quarterly meetings, additional, "break-out" sessions are instigated with the discussion of current agenda topics. Several break-out groups have resulted from previous bilateral meetings with the out come of these sessions becoming an agenda topic for the next quarterly meeting. In addition to regular quarterly meetings, meetings on specific topics or products have been held with EMA and HC with CVM experts to compare approaches and seek advice on technical issues. These interactions have provided opportunities for International delegations to visit CVM and for several CVM experts the opportunity to visit our international counterparts. Examples of such visits include activities involving both the EMA and HC. The EMA hosted a visit of several experts from CVM in January of 2010 and Dr. David MacKay and others from EMA visited FDA in June 2010. The Director General of Health Canada, Mr. Daniel Chaput, also visited CVM in June of 2010 establishing a forum for scientific discussion of current animal health topics, as well as, discussion of potential future development of enhanced scientific information sharing for both new and approved animal drugs. Trilateral conferences, in 2010 allowed CVM, HC, and EMA to meet and discuss the concept of science based information, collaborative efforts, as well as, ways to harmonize Food Safety initiatives. A concerted effort by all three agencies to share information helps promote a global understanding of each agency’s animal drug regulatory processes and provides a global network for monitoring animal drug safety and efficacy. All international arrangements are set with the notion of maintaining human and animal safety under the One Health Initiative.