Responsibities and Objectives
The U.S. Food and Drug Administration’s (FDA) Office of International Programs (OIP) is the focal point for all international matters concerning the Agency. OIP’s responsibilities are to:
- Serve as the primary agency liaison with other U.S. Government (USG) components, international and foreign governments (including Washington, DC embassies) for policy formulation and execution impacting FDA and FDA regulated products.
- Provide leadership to agency program areas for international activities.
- Serve as the focal point and final clearing authority for the agency and the authority for policies and procedures pertaining to international travel.
- Serve as the focal point and final clearing authority for agency international technical cooperation and assistance activities.
- Serve as the agency focal point and final clearing authority for all international programs and interactions with foreign counterpart regulatory agencies, international organizations, foreign embassies, all foreign officials, and with HHS and all other USG components when international issues are involved. Direct, manage, and lead agency strategic planning, priority-setting, and resource allocation processes for agency international programs.
- Serve as the agency focal point and final clearing authority for trade issues involving e.g., North American Free Trade Agreement (NAFTA), World Trade Organization (WTO), Free Trade Area of the Americas (FTAA), Asia Pacific Economic Cooperation (APEC), and United States Trade Representative (USTR).
- Serve as the agency focal point and final clearing authority for formal arrangements with foreign governments e.g., memoranda of understanding (MOU), mutual recognition agreements (MRAs), exchange of letters, partnerships, equivalence issues, country assessments, and confidentiality commitments.
- Serve as the agency focal point on policies and procedures for sharing public and non-public information and, in conjunction with the Office of Regulatory Affairs, import/export policy issues.
- Manage the agency’s foreign offices, including FDA staff deployed in foreign locations and all related budgeting, strategic planning, priority setting and resource allocation.
- Work regionally, for example, Food Safety Quads (US-Canada-Australia-New Zealand); and
- Work multilaterally through organizations such as the World Health Organization (WHO), World Trade Organization (WTO), Asia Pacific Economic Cooperation (APEC), Organization for Economic Cooperation and Development (OECD), or Pan American Health Organization (PAHO); and harmonization bodies including the Codex Alimentarius Commission, International Conference on Harmonization (ICH), International Conference on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), International Cooperation on Cosmetics Regulations (ICCR), and Global Harmonization Task Force (GHTF), including activities to combat counterfeiting.
OIP is lead by the Deputy Commissioner for International Programs and the Associate Commissioner for International Programs who manage the eight FDA offices covering the following countries/regions/areas of activity: Africa, Asia and the Pacific; Canada, Australia and New Zealand; China; Europe; Harmonization and Multilateral Relations; India; Latin America; Middle East and North Africa. Each foreign office is also managed by a Director, who is located in-country (countries include China, India, Latin America and Europe).
Globalization fundamentally changed the environment for regulating food and medical products and has created unique regulatory challenges for FDA:
- More foreign facilities are supplying products to the U.S.;
- Increasing volume of imported products;
- More outsourcing of manufacturing and clinical trials;
- Greater complexity in supply chains;
- Growing complexity of products and manufacturing methods;
- Imports coming from countries with less well developed regulatory systems; and
- Greater opportunities for economic fraud.
Based on the volume of imported products from specific areas, and the value to be derived from leveraging the activities and resources of trusted foreign counterpart regulatory authorities, FDA identified China, India, the Middle East, Europe, and Latin America as areas in which to establish a permanent in-country presence. The overall goal is to engage more effectively abroad to be more effective at home.
The objectives of the foreign offices are to:
- Gather better information about the production, regulation and transport of FDA-regulated products;
- Engage with trusted counterpart agencies to leverage scientific, inspectional and other resources;
- Provide technical assistance, as necessary and when requested, develop counterpart agencies to build their capacity;
- Engage with private and public-sector trusted third parties to provide information about regulated industry compliance with FDA standards;
- Engage with the regulated industry to ensure that they understand FDA requirements and expectations;
- Coordinate with other U.S. Government agencies with complementary missions; and
- Maintain an in-country inspectional capability, where necessary.
This will enable FDA officials in our product centers, at our borders, in the Office of the Commissioner, and in our Department to make better decisions about the safety, efficacy, and quality of FDA-regulated products that are destined for the USA.