Overview

The U.S. Food and Drug Administration’s (FDA) Office of International Programs (OIP) is the focal point for the agency’s international efforts. Working with representatives of the various program components, the mission of the agency is accomplished in collaboration with international health and regulatory partners through ongoing communications, both emergency and ad hoc, cooperation on health and regulatory issues, exchanges of public and non-public information and documents, technical cooperation and training, personnel exchanges, and certification of certain products exported to and from the United States.

The Federal Food, Drug and Cosmetic Act mandates, as part of FDA’s statutory mission, collaboration with foreign regulatory authorities to reduce regulatory burdens, harmonize regulatory requirements, and establish appropriate reciprocal arrangements. FDA’s international work has grown exponentially over the past decade, as we respond and adapt to a global society.

FDA’s international work can be categorized as follows:

• Bilateral – with and without formal arrangements. Under the auspice of memoranda of understanding and confidentiality arrangements, FDA has formal annual bilateral meetings with our counterpart agencies in Europe, Switzerland, Canada, Mexico, Japan, Singapore, Australia, and New Zealand. 
• Formal Arrangements – FDA has 106 formal arrangements with regulatory counterparts in 29 countries, including 8 with the European Union, and 2 with the World Health Organization. These arrangements facilitate leveraging of human, scientific, and investigational resources, and enable us to share science, expertise, and ultimately promote responsible international standards and regulatory harmonization. 
• Regional – examples include Trilateral Cooperation (U.S./Canada/Mexico); Food Safety Quadrilaterals (U.S./Canada/Australia/New Zealand); European Union 
• Multilateral - with organizations such as the World Health Organization (WHO) and its associated bodies such as the Pan American Health Organization (PAHO), the Asian Pacific Economic Cooperation (APEC), and the Organization for Economic Cooperation and Development (OECD); 
• Harmonization and Multilateral Relations- including, Codex Alimentarius, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the International Cooperation of Harmonization of Technical Requirements for Registration of Veterinary Products (VICH), the Global Harmonization Task Force for Medical Devices (GHTF), and the International Cooperation on Cosmetics Regulation (ICCR) for cosmetics and over-the-counter (OTC) drugs. Harmonization by Doing (HBD) is a cooperative effort between FDA’s Center for Devices and Radiological Health (CDRH), its key regulatory counterparts in Japan, institutions in the U.S. academic community, and Japanese and U.S. medical device manufacturers and trade associations. The goal is to foster joint clinical trials and address regulatory barriers that may be impediments to timely device development and approvals.

As a global public health agency, FDA can only meet its domestic mission in the 21st century through its essential engagement with counterpart agencies around the world – an engagement that is critical to ensuring the protection of the U.S. public health.

Specific examples of FDA’s international activities follows:

• Transatlantic Economic Council (TEC): This includes, the administrative simplification initiative with the European Union/European Medicines Agency (EU/EMEA) and member state authorities, and an initiative with the EU, Canada, and Japan to cooperate on the validation of alternatives to animal testing. 
• Strategic Economic Dialogue: Under this U.S. Government-China forum, FDA participates with counterpart Chinese ministries (and ministers) on product safety, including the Agreements signed in December 2007 with the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and the State Food and Drug Administration (SFDA). 
• Trade Issues: FDA acts as a resource to the U.S. Trade Representative (USTR), the Department of Commerce, and other trade mission agencies of the United States Government to assure that our ability to protect public health is not compromised under trade agreements and implementation of the World Trade Organization and other international trade obligations. 
• PEPFAR (President’s Emergency Plan for AIDS Relief): Since December 2004, FDA has approved or tentatively approved 82 antiretroviral therapies under the PEPFAR expedited review program; including tentative approval of two fixed-dose combination products to treat children under the age of 12; and FDA has provided significant technical assistance and training to counterpart regulatory agencies in the PEPFAR focus countries. 
• Pan American Network for Drug Regulatory Authorities (PANDRA): Since 1997, FDA has actively participated in PAHO's PANDRA to establish better harmonized technical standards for drug and biologic development and authorization in the Americas. FDA has been active in Good Manufacturing Practices (GMP), BE (Bioequivalance) and Good Clinical Practices (GCP) working groups. 
• Pandemic Preparedness: FDA, along with our counterparts at Health Canada and WHO, participate actively (including hosting one meeting) in the international effort toward regulatory convergence/preparedness for vaccine production. FDA hosted representatives from 15 countries that are engaged with domestic vaccine production on a workshop on Good Manufacturing Practices (GMPs). FDA continues to provide GCP technical assistance in Vietnam and Latin America; GCP workshops were conducted in 2008 in India and Vietnam; and FDA has a partnership with WHO on pandemic preparedness – drafting guidelines, regulatory collaborations, and scientific exchanges; 
• Security and Prosperity Partnership (SPP): FDA has consistently contributed to SPP since its inception in 2005, offering deliverables to advance public health in North America. FDA’s existing bilateral work with Canada and Mexico was used as the framework to resurrect a dormant North American Free Trade Agreement (NAFTA) Technical Working Group, and to provide an appropriate forum for advancing goals related to food safety; 
• Capacity Building: FDA’s technical cooperation and training activities include a range of education, outreach, and other activities that are designed to improve the regulatory infrastructure, preventive controls, and production practices in selected foreign countries to help ensure that products exported to the U.S. meet FDA requirements.

Globalization has caused a significant increase in the international trade of FDA-regulated products. To ensure the safety and integrity of these products, FDA has maintained a robust international program as described above. While the Agency has partnered with its foreign regulatory counterparts for many years, the FDA Beyond Our Borders Initiative is intended to advance and enhance those partnerships and the agency’s multifaceted efforts to protect and promote the public health. A key component of this initiative is FDA’s Global Presence. The goal of this program is to engage more proactively and consistently abroad in strategic countries/regions to assure the safety, efficacy and quality of products on the U.S. market.

To work more closely with our foreign counterpart regulatory agencies, FDA has established a permanent presence in China, India, Europe, and Latin America and efforts are ongoing to establish a presence in the Middle East. FDA’s foreign presence will help improve product safety by:

• Gathering better knowledge about the production and transport of products; 
• Leveraging the knowledge and resources of trusted counterpart agencies; 
• Building regulatory capacity in countries where such assistance is needed; 
• Working closely with regulated industry so they understand FDA requirements; and 
• Expanding our ability to perform inspections and in a more timely manner.