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Expanding International Outreach

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2011 Annual Report

CVM’s international activities have continued to grow in response to the increased globalization of the markets for the products that CVM regulates. The passage of the Food Safety Modernization Act, with its strong emphasis on the regulation of imported food products, illustrates this point. The number of international staff members has increased in recent years, in response to CVM’s expanding international involvement. The Center’s International Programs Team leads, coordinates, and manages CVM’s international activities in collaboration with relevant FDA Centers and Offices, including FDA’s Office of International Programs. The goal is to advance the overall mission of CVM and FDA in an international context. To better meet that challenge, the International Programs Team has adopted a strategic plan to enable CVM to better meet that challenge.

Challenges and Accomplishments

CVM’s International Programs Strategic Plan: 2011-2015

The CVM International Programs Strategic Plan is designed for the enhancement of global outreach through leadership, coordination, and management. The plan provides that, as part of its work, the International Programs Team will seek the establishment of programs that promote and protect animals, and humans who are exposed to them, through use of One Health (see the sidebar, “One Health,” on page xx) strategies that decrease the spread of zoonotic diseases and enhance the societal importance of the human-animal bond globally.

The International Programs Team will accomplish its mission by working with various strategic partners within and outside of FDA, including, among others, FDA’s Office of International Programs, other FDA centers and offices, the U.S. Department of Agriculture, the U.S. Agency for International Development, the Centers for Disease Control and Prevention, the U.S. Environmental Protection Agency, the World Health Organization, the Pan American Health Organization, the World Organisation for Animal Health, the Codex Alimentarius Commission, VICH, and the Food and Agriculture Organization of the United Nations.

The strategic plan establishes four goals:

Goal A – Regulatory and Technical Capacity Building

Provide scientific and regulatory knowledge to CVM’s regulatory counterparts, international standard-setting organizations, and industry.

Goal B – Innovative and Emerging Technology Initiatives

Lead coordination within CVM of international issues involving innovation.

Goal C – Global Pharmacovigilance and Post-Market Surveillance

The detection and investigation of adverse events from the use of animal drug products. The goal of this program is to identify safety signals and effectiveness issues of concern in order to protect animal and human health.

Goal D – Leverage Resources Across Internal and External Stakeholders

CVM’s goals and mission should align with other FDA centers and Federal agencies that have public health as a primary mission.
 

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World Organisation for Animal Health (OIE) Collaborating Centre

CVM was selected during the year as an OIE Collaborating Center. CVM is thereby recognized by OIE, the organization dedicated to controlling animal disease, as having competency in the overall area of strengthening animal drug regulatory infrastructure. The designation extends CVM’s ability to enhance animal drug and food safety around the world. It also gives the Center greater international status and provides our training courses with the status of OIE training courses.


CVM’s Participation in Bi- and Trilateral Meetings

During FY 2011, CVM representatives actively participated in regularly scheduled meetings with our foreign counterparts such as the European Medicine Agency and Health Canada. 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, maximum residue levels (MRLs), participation and planning for Codex Alimentarius Commission and other food safety related interagency activities, and current issues in the animal drug realm. Issues discussed during FY 2011 included antimicrobial resistance and associated labeling requirements and prudent use of cephalosporins in food animal drugs. The year also included a joint current good manufacturing practice (cGMP) effort and preparation of a significant cGMP collaboration document between FDA and the European Medicine Agency. There were scientific discussions regarding the sharing of resources and exchange of personnel to further scientific research efforts, and the further enhancement of real-time scientific collaboration and information sharing for the simultaneous approval of animal drugs in the United States and other countries.

These interactions have provided opportunities for international delegations to visit CVM, and for several CVM experts to visit FDA’s international counterparts. As a result, many CVM regulatory and scientific experts have been afforded the opportunity to participate in scientific and technical meetings and in workshops designed both to build relationships and share scientific information with colleagues from many foreign governments, such as China, South Africa, Chile, Costa Rica, Canada, and the European Union.

Consistent with the first goal in the International Programs Strategic Plan, CVM has assisted in capacity-building through several venues including onsite education, webinars, and joint technical assistance with regulatory counterparts. A concerted effort by all regulatory 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. CVM’s international arrangements are set with the notion of maintaining human and animal safety under the One Health Initiative.

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Leadership and Innovation in the International Arena

Working with a number of different organizations in a number of different settings has provided CVM staff with opportunities for leadership and innovation. For example, the Director of CVM’s Office of New Animal Drug Evaluation, had the opportunity to oversee the initiation and progress of seven intercessional CCRVDF electronic working groups drafting policy documents and recommendations related to residue levels, analytical methods, risk analysis and risk management, and similar topics. He also oversaw U.S. representation at two VICH technical expert working groups in Tokyo, Japan. The groups addressed guidelines that enhance international harmonization of safety requirements for veterinary drugs.

During the 2011 Global Animal Health Conference in London (organized jointly with the Drug Information Association and the International Federation of Animal Health and hosted by the European Medicines Agency), a transformational approach to evaluation of new animal drugs was introduced, and CVM staff members successfully engaged regulatory authorities from other countries so that they joined the United States in this novel regulatory approach. This approach will enable simultaneous international evaluation of innovative animal health products, expediting their introduction into the global marketplace.

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CVM Training Presentations and Travel for International Events
 

In September 2011, CVM leadership led a delegation to China that provided training on Codex processes, regulatory requirements for active pharmaceutical ingredients, bioequivalence, and antimicrobial resistance. The focus of the meeting was to prepare and educate China’s veterinary drug regulatory authorities and industry for the manufacture, production, and distribution of veterinary drug products. China supplies the United States with approximately 80 percent of all active pharmaceutical ingredients used in the production of U.S.-made human and veterinary drug products. The team had multiple interactions with regulatory, academic, and industry representatives in achieving its goals.

In June 2011, CVM staff participated in the Regional Training Seminar for OIE National Focus Points on Veterinary Products in Siem Reap, Cambodia, to train national regulatory authorities in the regulation of animal drugs. The Director of the Office of New Animal Drug Evaluation and members of the International Programs Team gave presentations on the newly established OIE Collaborating Center at CVM.

In September 2011, three members of the CVM staff traveled to Argentina to participate in an OIE Focal Points meeting, to attend the 17th Seminar of the Americas Committee of Veterinary Medicines (CAMEVET), and present a 1-day workshop on the regulatory life cycle of animal drugs. The CVM presentations at the workshop covered animal drug life-cycle management and biopharmaceutic veterinary drug products, the National Antimicrobial Resistance Monitoring System, and CVM’s Minor Use and Minor Species program.
 

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CVM Meetings With Foreign Officials
 

Each year, CVM hosts regulatory officials from several countries. The visitors, typically CVM’s regulatory counterparts, come to discuss a number of topics, including the processes used by CVM and by foreign governments to determine safety and efficacy of animal drugs during the pre-market review process. Visiting officials also come to talk about the processes used to ensure the continued safety of drugs after they reach the market. They confer on issues of mutual interest concerning the regulation of animal feeds and pet food. During FY 2011, CVM met with visitors from Australia, Canada, China, Costa Rica, France, Japan, Korea, and Thailand.



 

Sanitary/Phytosanitary Notifications
 

CVM actively participates in the review of animal drug and feed and food related notifications called sanitary/phytosanitary notifications. Those are notifications required for participants in the World Trade Organization. Whenever a member changes its regulations or laws pertaining to an exported commodity – in CVM’s case, animal drugs or feed – that member must notify all other members. The notification gives the other World Trade Organization members a chance to respond if the change would violate international rules.

We received a total of 49 sanitary/phytosanitary notifications during FY 2011. Notifications are received by the International Programs Team, which then triages the documents and forwards the information on to the respective experts within the Center. Typically, the documents are reviewed to determine whether proposed sanitary/phytosanitary standards are consistent with existing international standards, such as Codex Maximum Residue Limits (MRLs), or whether they appear to be appropriate science-based measures to protect human and animal health.
 

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