About FDA

Strategic Plan

Enhancement of Global Outreach through
Leadership, Coordination, and Management

Center for Veterinary Medicine
International Programs Team

Strategic Plan (FY 2011-FY 2015)

Mission

The mission of the Center for Veterinary Medicine (CVM) is to protect U.S. human and animal health by assuring the safety and efficacy of animal drugs, including drugs intended for food producing animals, and the safety of animal feeds and pet foods.

The role of the International Programs Team (IPT) is to lead, coordinate, and manage CVM’s international activities in collaboration with relevant FDA Centers and Offices, including the Office of International Programs and Office of Regulatory Affairs, as well as FDA’s international regulatory counterparts, to advance the overall mission of CVM and FDA.

As part of its work, IPT will seek the establishment of programs that promote and protect animals, and humans who are exposed to them, through use of One Health strategies that decrease the spread of zoonotic diseases and enhance the societal importance of the human-animal bond globally.

Strategic Partners

The IPT will accomplish its mission by working with various strategic partners within and outside of FDA. The following are the primary partners the IPT will engage with:

  • FDA’s Office of International Programs
  • Other FDA Centers and Offices
  • USDA
  • USAID
  • CDC
  • EPA
  • WHO and PAHO
  • OIE
  • CODEX
  • VICH
  • Other regulatory agency counterparts
  • FAO 

Summary of Goals

  • Goal A – Regulatory and Technical Capacity Building
  • Goal B – Innovative and Emerging Technology Initiatives
  • Goal C – Global Pharmacovigilance and Post-Market Surveillance
  • Goal D – Leverage Resources Across Internal and External Stakeholders 

Goals and Objectives

Goal A – Regulatory and Technical Capacity Building - Provide scientific and regulatory knowledge to CVM’s regulatory counterparts, international standard-setting organizations, and industry

  • Exchange scientific/regulatory information between CVM and its regulatory counterparts, international standard-setting organizations, and industry
    • Periodically distribute the “Informational Needs Assessment Questionnaires” internationally for CVM to gain insight into the scientific and regulatory needs of its international counterparts and industry
    • Develop and maintain working relationships with regulators, scientists, and industry personnel in foreign countries
    • Use multilateral discussion groups/scientific forums for sharing current information
    • Develop alternative approaches to resolving non-scientific issues for any products including products involving new technologies
    • Reduce barriers that hinder collaboration among a global network of international counterparts and industry (for example, by using Confidentiality Agreements)
    • Develop and maintain an FDA CVM IPT Internet web page devoted to CVM’s international activities
    • Maintain list of frequently asked questions (FAQs) on the CVM IPT website for public information that relates to import safety and other topics of interest to an international audience
    • Participate in the work of international organizations including those provided in Section D of this plan
      • Use CVM’s membership on leadership/steering committees to help guide the direction of international organizations
      • Use CVM’s support role as members of various international working groups to provide technical/regulatory assistance within these working groups  
  • Sponsor and maintain educational programs for international training on both regulatory and technical topics
    • Use the CVM IPT internet web page as a training platform to include:
      • Training portal for U.S. and International animal health workers
      • Web-based training videos
    • Sponsor and participate in international scientific and regulatory training workshops to improve regulatory science and increase the awareness worldwide of FDA requirements in a proactive effort to reduce the incidence of inspectional issues at the border
    • Improve regulatory science by sponsoring, maintaining, and participating in educational programs for international training both on regulatory and technical topics
    • Support translation of FDA educational and training documents into various languages

Goal B – Innovative and Emerging Technology Initiatives - Lead coordination within CVM of international issues involving innovation

  • Be a source of information about innovative developments internationally and guide CVM’s work to avoid duplication of effort
    • Maintain awareness of developments in other countries
  • Ensure CVM’s presence at the table whenever innovative technologies in animal health are topics of international discussions
    • Identify the appropriate countries and international organizations to approach about working jointly on specific innovations
    • Establish communications between CVM experts and appropriate international partners
      • Maintain liaisons with international partners concerning innovative technologies
  • Reach out to identify new innovative technologies in other countries
    • Match CVM experts with foreign counterparts to analyze important public and animal health questions about emerging, innovative technologies
  • Work to eliminate international barriers that would prevent innovations from reaching the marketplace
    • Identify potential international bottlenecks of high costs, high levels of corporate protectiveness; and provide guidance for avoiding problems
    • Provide guidance on potential non-scientific hurdles in other countries

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

  • CVM can serve as an international collaborating center with additional funding, professional staff expansion, and IT support. Implementation of such a program would include:
    • Utilizing questionnaires/surveys and other tools (PVS Gap Analysis) to assess country needs
    • Developing memoranda of understanding
    • Establishing legal/regulatory framework/guidance (VICH implementation)
    • Using adverse event reports that are submitted electronically
    • Using pharmacoepidemiology and data analysis reports
  • The IPT will use the pharmacovigilance program to assist CVM to:
    • Identify potential drug residue or contamination issues in food animals
    • Serve as an early warning surveillance system to identify drug safety signals and effectiveness issues, and help identify emerging global issues
    • Enhance the societal importance of the human-animal bond by protecting and promoting companion animal health
    • Promote international collaboration, education, and training (outreach)

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, including:

  • FDA Office of International Programs
  • USDA (APHIS, FSIS, FAS)
  • USAID
  • CDC
  • EPA
  • Increase number, scope, and effectiveness of joint regulatory programs with foreign regulatory counterparts using various tools including:
    • Inspections (PIC-S)
    • Exchange of inspectional reports
    • Parallel scientific advice for the review of veterinary drug applications
  • Develop and sustain appropriate systems, processes, and procedures to assure alignment with the CVM International Programs’ Strategic Plan
    • Maintain alignment with the CVM’s strategic priorities (to be developed)
    • Adopt Results Oriented Management (ROM) strategies to assess performance
    • Utilize activity time reporting tied in with specific milestones (project management tool)
    • Develop situational awareness and environmental competency of issues both domestic and global
    • Commit to and value continual learning
  • Coordinate the participation of CVM and ORA’s regulatory investigators in joint/collaborative exercises with international counterparts (e.g., cGMP collaboration – EMA)

Next Steps

This Strategic Plan will guide CVM’s international activities as the IPT seeks to achieve its mission of the protection of human and animal health by approving safe and effective animal products given to food-producing and companion animals and monitoring the safe use of those products. The Plan outlines CVM’s strategic priorities for developing programs that assure the safety of imported veterinary drugs and feeds, the safety of human food, and the prevention and mitigation of animal disease worldwide.

The IPT will leverage its efforts to develop appropriate controls on animal drugs and feed by collaborating with international standard-setting and capacity building organizations and appropriate USG and foreign agencies to, for example, set standards for product reviews and develop conformity assessment procedures. The IPT will use tools such as Results Oriented Management techniques, training and educational activities developed by Decernis, and the results of the Best Practices Survey to help us accomplish its goals.

The IPT will work closely with its foreign regulatory counterparts, especially in countries that export products to the United States, and explain CVM’s requirements for assuring that only safe and effective animal drugs and feed are imported into the United States.

Finally, the IPT recognizes that the use of appropriate performance metrics and benchmarks will be an important component of this plan. The IPT will develop and use these tools to make timely assessments of the progress of the strategic plan's goals and objectives. The IPT will prepare annual progress reports to review with CVM’s CEB and with OIP in conjunction with CVM and OIP Strategic and Operational plans. Course changes will be made as new information or new opportunities develop.

Page Last Updated: 08/25/2014
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