Global 

Engagement

U.S. Food and Drug Administration
Today we recognize that to 

successfully protect U.S. public 

health, we must think, act, and 

engage globally. Our interests 

must be broader than simply 

those within our own borders.

Margaret Hamburg, FDA Commissioner

“

”
Global

Engagement

U.S. Food and Drug Administration

FDA’S MISSION

FDA is responsible for protecting the public health by assuring the safety, efficacy, 

and security of human and veterinary drugs, biological products, medical devices, 

our nation’s food supply, cosmetics, and products that emit radiation, and by 

regulating the manufacture, marketing, and distribution of tobacco products.

FDA is also responsible for advancing the public health by helping to speed 

innovations that make medicines and foods more effective, safer, and more 

affordable; and helping the public get the accurate, science-based information 

they need to use medicines, and to reduce tobacco use to improve health. 
INTRODUCTION

S

weeping economic and technological changes 

have revolutionized international trade over 

the last several decades, creating a truly global 

marketplace for goods and services. Accounting for 

20 to 25 percent of all U.S. consumer spending, 

products regulated by the U.S. Food and Drug 

Administration (FDA) are a substantial component 

of this global economy.1

 Food and medical products, 

and their ingredients and components—products 

that directly and profoundly affect the health and 

welfare of the U.S. public—are increasingly sourced 

from abroad. As U.S. consumers continue to demand 

global products, FDA’s ability to ensure the safety and 

quality of these imported products will depend on its 

execution of a myriad of global engagement strategies. 

Americans benefit greatly from global sourcing of 

products. For example, U.S. consumers can choose 

from a wide variety of fruits and vegetables year 

round, regardless of the domestic growing season. 

Health professionals can also draw on drugs and 

medical devices developed anywhere in the world 

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . 2

Global Challenges: 

Global Strategies . . . . . . . . . . . . . . . . . 4

International Offices and 

Posts . . . . . . . . . . . . . . . . . . . . . . . . . 10

Strengthening Regulatory 

Capacity . . . . . . . . . . . . . . . . . . . . . . . 17

Harmonizing Standards . . . . . . . . . . . 21

Leveraging Resources . . . . . . . . . . . . 24

Risk-Based Monitoring and 

Inspection . . . . . . . . . . . . . . . . . . . . . 26

Global Surveillance, 

Preparedness, and 

Emergency Response . . . . . . . . . . . . 28

Advancing Regulatory Science . . . . . 31

Looking Ahead . . . . . . . . . . . . . . . . . 34

Acronyms . . . . . . . . . . . . . . . . . . . . . . 36

Contact Information for FDA 

International Offices and Posts . . . . . 37

Endnotes . . . . . . . . . . . . . . . . . . . . . . 38

Imports of FDA-Regulated Products 

Have Grown Dramatically in Recent Years

FY = U.S. Government fiscal year

NOTE: An import line represents the portion of a shipment listed as a separate 

item on an import entry document. Items must be listed separately if their tariff 

description differs from other items in the shipment.

Source: Veneziano, D. 2011. Import Stats FY 2002-2010. U.S. FDA, Division of 

Import Operations and Policy, Office of Regulatory Affairs, Washington, DC.
Introduction 

3

if they have been approved for use in the United 

States. But reaping the benefits of the global marketplace requires increased vigilance to protect the 

U.S. public health.

FDA is responsible for ensuring that imported food, 

medical products, and other goods it regulates meet 

the same rigorous standards for safety and quality as 

those products manufactured domestically. This is 

a formidable task, requiring FDA to assess millions 

of products grown, harvested, processed, manufactured, packaged, labeled, and shipped from outside 

U.S. borders. In 2009 alone, $2 trillion worth of 

FDA-regulated products manufactured in more 

than 300,000 foreign facilities entered the United 

States from more than 150 countries.2

The rapid globalization of commerce presents FDA 

with many challenges. For example, many products 

entering the United States are made or grown in 

countries that lack the necessary regulatory oversight to ensure their quality and safety. Greater 

numbers of suppliers, more complex products, and 

intricate multinational supply chains introduce risks 

to product safety and quality, including more opportunities for economic adulteration and the spread of 

contaminated products. In the face of these realities, 

inspection at the U.S. borders or ports-of-entry is no 

longer sufficient to ensure the safety of the everincreasing tide of imports to the United States.

FDA’s success in protecting the U.S. public depends increasingly on its ability to reach beyond 

U.S. borders and engage with its government 

regulatory counterparts in other nations, as well as 

industry and regional and international organizations, to help ensure the quality and safety of products before they reach the United States. Through 

effective global engagement, FDA is working with 

its many international partners to weave a global 

safety net that benefits public health in the United 

States and around the world. 

80 percent of active 

pharmaceutical

ingredients

80 percent of seafood

40 percent of finished

dosage drugs

Approximately 50 percent 

of fresh fruit

The United 

States imports:

Approximately 20 percent 

of fresh vegetables

Sources: Hamburg, M. 2011. Food and Drugs: Can Safety Be 

Ensured In a Time of Increased Globalization? Presented at the 

Council of Foreign Relations New York Symposium, January 31.

Huang, S. and Huang, K. 2007. Increased U.S. Imports of Fresh 

Fruit and Vegetables. U.S. Department of Agriculture, Economic 

Research Service, FTS-328-01. Retrieved March 27, 2012, from 

http://www.unitedfresh.org/assets/files/Increased%20U.S.%20

FFV%20Imports.pdf.

The United States imports:

Over the next decade, FDA 

will continue to transform from 

a predominantly domestically 

focused Agency, operating in a 

globalized economy, to an Agency 

fully prepared for a regulatory 

environment in which FDA-regulated 

products know no borders.

Deborah Autor, FDA Deputy Commissioner for 

Global Regulatory Operations and Policy
XXXX

4Global Challenges: Global Strategies

Formed as a consumer protection agency over 

a century ago, FDA regulates a wide variety of 

products essential to the U.S. public—food, 

medical, and radiation-emitting products, as well as 

pet food, animal feed, tobacco products, and cosmetics. Of these, food and medical products are the most 

numerous and ubiquitous, influencing the health and 

welfare of everyone in the United States.

The surge in the volume and complexity of FDAregulated imports results in increased potential risks 

to the U.S. public. In recent years, FDA-regulated 

imports as diverse as cantaloupes, peppers, toothpaste, 

cough syrup, flu medicine, glucose monitor test strips, 

glycerin, and a blood-thinning agent known as heparin have all adversely impacted the health of consumers in the United States and around the globe.

To better protect the U.S. public, FDA is utilizing a 

variety of engagement strategies, in partnership with 

other agencies and organizations around the world, 

to strengthen global regulatory capacity; develop and 

harmonize science-based regulatory standards; increase awareness about the importance of regulatory 

systems within the broader economic development 

context; and share and analyze information and data 

globally to enhance regulatory decision-making and 

facilitate rapid identification of and response to public 

health emergencies associated from FDA-regulated 

products. These and other efforts enable FDA to more 

strategically leverage and optimize its resources for 

public health protection. 

The U.S. Public Is Consuming Ever Greater 

Quantities of Imported Foods

FDA regulates most food products consumed in the 

United States, from fresh produce to infant formula, 

as well as food ingredients, supplements, and additives 

(e.g., food colorings). As of 2011, roughly one in six 

FDA-regulated food products consumed in the United 

States is sourced from abroad, and this percentage 

is much higher for some foods, such as seafood (80 

percent) and fresh fruit (approximately 50 percent).3, 4

Many imported foods are dietary essentials (such as 

fresh fruits and vegetables) or pantry staples (including coffee, tea, and cocoa)—products likely to be consumed daily in almost every U.S. household. 

From fiscal years5

 2002 to 2010, overall U.S. food 

imports, as measured by the number of “lines” of 

imported food, almost doubled from 4.4 million to 8.6 

million import lines.6

 Imports of fresh fruits, vegetables, coffee, tea, and cocoa have more than doubled 

since 2000.7

 Based on recent trends, the U.S. public is 

likely to consume even greater quantities of imported 

foods in coming years.8

G L O B A L C H A L L E N G E S : 

GLOBAL STRATEGIES

Food

Globalization creates real opportunities 

to collaborate and leverage our 

collective expertise and resources. 

Investments globally are critical to 

FDA’s success domestically.

Mary Lou Valdez, FDA’s Associate 

Commissioner for International Programs
Global Challenges: Global Strategies

Imported Foods Can Pose Risks 5

to U.S. Consumers

As the volume of imported food 

increases, so too does the risk that 

some products will fail to meet FDA 

standards. The realities of the global 

marketplace add substantial challenges to FDA’s ability to protect U.S. 

consumers. Less stringent regulations 

in many source countries, complex 

supply chains, and longer transit 

times for imported food all introduce 

a greater opportunity for contamination, spoilage, adulteration, and 

counterfeiting. 

Many FDA Offices and Centers Play Key Roles in Global Engagement*

Office of Global Regulatory Operations and Policy (GO) provides leadership and policy direction to FDA’s 

domestic and international product quality and safety efforts, including global collaboration; global data-sharing; 

field operations; and compliance and enforcement activities. GO includes:

◆ The Office of International Programs (OIP), which leads, manages, and coordinates FDA’s global engagement 

work, and serves as the Agency’s primary liaison with foreign governments. 

◆ The Office of Regulatory Affairs (ORA), which provides FDA leadership on imports, inspections, and enforcement 

policies to maximize compliance and minimize risk associated with FDA-regulated products.

Office of Medical Products and Tobacco (OMPT) provides high-level coordination and leadership across FDA’s 

Centers for drugs, biologics, medical devices, and tobacco products, and oversees the Agency’s special medical 

programs. OMPT includes: 

◆ The Center for Biologics Evaluation and Research (CBER), which ensures that vaccines, blood, and biologics are 

safe, effective, and available.

◆ The Center for Drug Evaluation and Research (CDER), which regulates the manufacture, labeling, and use of 

over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

◆ The Center for Devices and Radiological Health (CDRH), which assures the safety, effectiveness, and quality of 

medical devices and radiation-emitting products, and fosters innovation in these products.

◆ The Center for Tobacco Products (CTP), which oversees implementation of the Family Smoking Prevention and 

Tobacco Control Act by setting standards, reviewing pre-market applications, requiring warning labels, and 

establishing and enforcing advertising and promotion restrictions.

Office of Foods (OF) provides all elements of FDA’s Foods Program leadership, guidance, and support to achieve 

the Agency’s public health goals. OF includes:

◆ The Center for Food Safety and Applied Nutrition (CFSAN), which ensures that the nation’s food supply is safe, 

sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.

◆ The Center for Veterinary Medicine (CVM), which regulates the manufacture and distribution of feed additives, 

drugs, and biologics intended for companion animals and animals used for food production, and evaluates the 

safety and efficacy of animal-based products, such as genetically modified animals.

Office of the Chief Scientist (OCS) provides strategic leadership, coordination, and expertise to support scientific 

excellence, innovation, and capacity to achieve FDA’s public health mission. OCS includes:

◆ The National Center for Toxicological Research (NCTR), which provides scientific expertise to FDA; develops innovative methods and technologies to support FDA’s mission; and helps disseminate regulatory science practices to countries seeking to develop science-based regulatory systems. 

* This list comprises FDA Offices and Centers with substantial involvement in global engagement. For a complete list of FDA 

Offices and Centers, see http://www.fda.gov/AboutFDA/CentersOffices/default.htm.

Imports of FDA-Regulated Food 

Have Almost Doubled Since 2002

Source: Veneziano, D. 2011. Import Stats FY 2002-2010. U.S. FDA, 

Division of Import Operations and Policy, Office of Regulatory Affairs, 

Washington, DC.
Global Challenges: Global Strategies

6 FDA Has New Authorities to Ensure Food Safety

FDA can only realistically inspect a small percentage (less than 3 percent) of the enormous volume of 

food products arriving at U.S. ports of entry, making 

it crucial that the Agency focus on ensuring that food 

products meet U.S. standards before they reach the 

United States.9

 The Food Safety Modernization Act 

(FSMA), signed into law in January 2011, provides 

FDA with critical authorities to implement a significant new approach for protecting the safety and 

security of the U.S. food supply—one that promotes a 

new level of accountability for all entities in the supply chain from farm to fork—regardless of where they 

are in the world.

Medical Products

U.S. Demand for Medical Products Has Grown 

Substantially Over the Past Decade

FDA regulates a wide variety of medical products:

◆ Pharmaceutical products and components, including brand-name and generic prescription drugs 

and over-the-counter remedies for both humans 

and animals, as well as other health-related products, such as sunscreens and fluoride toothpastes.

◆ Biologics (products typically made from living 

organisms), including human vaccines, blood and 

blood components, gene therapy, and tissues.

◆ Medical devices, from simple tongue depressors, 

surgical gloves, and dental amalgams to complex 

medical equipment—including in-vitro diagnostic 

products; cutting-edge diagnostic imaging equipment; artificial pancreases; robotically controlled 

surgical systems; and complex programmable 

cardiac pacemakers and implantable defibrillators.

U.S. demand for medical products grew substantially 

between the late 1990s and 2010, spurred in large part 

by the emergence of new medical technologies and 

services that were widely adopted by the U.S. health 

care system.10 In recent years, this large U.S. demand 

has increasingly been met by imported products.11

Since 2002, for example, imports of pharmaceutical 

products and biologics have more than doubled, and 

medical device imports have quadrupled.12 Foreignsourced pharmaceuticals now account for some 40 

percent of the drugs consumed in the United States, 

and an astonishing 80 percent of the active ingredients in U.S.-consumed drugs are sourced from 

abroad.13 With respect to medical devices, imports 

now represent more than 35 percent of the U.S. 

medical equipment market.14

Globalization of the medical product industry presents regulatory challenges at every stage—from 

product development to final purchase and use by 

health care providers or consumers, as illustrated by 

the following three examples.

Clinical Trials of New Medical Products Are 

Increasingly Conducted Abroad

All new medical products (drugs, biologics, and 

devices) must receive FDA review and clearance or 

approval before they can be marketed in the United 

States. As part of the premarket approval process, 

manufacturers must conduct clinical trials (scientific 

studies conducted with human subjects) to determine 

if the proposed product is safe and effective. FDA 

inspects clinical trial sites to ensure that participants 

Consumers around the world, not just in 

the United States, expect and demand 

safe food, no matter its source.

Michael Taylor, FDA Deputy Commissioner for Foods
Global Challenges: Global Strategies

are protected and the trial is designed 7

and executed to yield accurate, relevant 

data on the product.

Clinical trials are increasingly conducted 

abroad, often in nations with limited 

regulatory capacity. From October 2007 

to September 2008, for example, clinical 

trials for medical products were conducted at nearly 6,500 foreign research sites 

and involved more than 230,000 subjects.15 The increasing number of clinical trials conducted abroad adds to the 

complexities of FDA reviews of product 

applications.

Imported Medical Products May 

Pose Risks

Due to the high profit potential, imported medical products are vulnerable 

to economically motivated actions that 

can pose a significant risk to consumers. 

For pharmaceuticals, these risks apply 

equally to branded and generic drugs, 

and include economic adulteration and 

substandard/counterfeit/falsified products. With the proliferation of global 

commerce, many U.S. consumers can 

purchase pharmaceuticals electronically 

and more directly from foreign sources, 

increasing their potential exposure to 

these health risks. 

Lack of Unique Identifiers for Medical 

Devices Poses Challenges

Many medical devices are sold in identical or nearly identical forms around the 

world, but are known by different trade 

names depending on the market. Most 

of these devices lack an internationally 

consistent “identifier” (e.g., a unique 

name or number assigned only to that 

product). When a regulatory authority 

discovers a problem with a medical device in one country, counterpart authorities in other countries find it difficult 

or impossible to know whether medical devices used in their countries are 

comparable or identical to the defective 

product. The inability to make a match 

significantly impairs the ability of FDA 

and other authorities to warn medical 

professionals and consumers about potential dangers.

Pharmaceutical Imports Have 

More Than Doubled Since 2002

Biologics Imports Have 

More Than Doubled Since 2002

Import Lines 

Imports of Medical Devices Have 

More Than Quadrupled Since 2002

0

2 million

4 million

6 million

8 million

10 million

Medical Device Imports Have 

Increased Over 450 Percent Since 2002

Source: Veneziano, D. 2011. Import Stats FY 2002-2010. U.S. FDA, 

Division of Import Operations and Policy, Office of Regulatory Affairs, 

Washington, DC.
Global Challenges: Global Strategies

8

With the growing global economy, the risks of imported products are increasingly shared by countries 

around the world. Now more than ever, effective public health protection requires a range of stakeholders, 

including government agencies, industries, academia, 

non-governmental organizations, and scientific communities, to work together in partnership toward a 

single goal: protecting public health worldwide.

In response to these challenges, FDA has embraced a 

wide variety of strategies that increase its engagement 

in the global public health community, integrating 

the Agency’s knowledge of how products are developed, manufactured, and delivered worldwide, and its 

ability to ensure that the imported products available 

to U.S. consumers are safe and effective. These strategies include:

◆ International Offices and Posts. FDA’s international offices and posts build strong, sustained 

partnerships with their counterparts abroad; serve 

as a portal for other countries to the Agency; collect and leverage local and regional knowledge; 

and provide a platform for inspection of foreign 

facilities.

◆ Strengthening Regulatory Capacity. The capacity of governments to manage, assess, and regulate 

products within increasingly complex supply chains 

is a fundamental factor affecting product safety and 

efficacy. FDA is working strategically with a range 

of countries to provide information, tools, training, 

and exchange programs that contribute to building 

or strengthening regulatory capacity.

Strategies for Global Engagement

Tobacco Products

Unlike food and medical products, tobacco products, including 

cigarettes and smokeless tobacco, are inherently unsafe. Their 

use takes a deep toll on U.S. public health and economy, 

resulting in around 443,000 deaths and $193 billion in 

medical costs and lost productivity each year. More than 

8.5 million Americans have chronic illnesses related to 

smoking, and adults who smoke cigarettes die 14 years earlier on average than non-smokers. Virtually all new users of tobacco products are under 18, and one in four U.S. high school students report using tobacco.16, 17

FDA received authority to regulate tobacco products in June 2009, with passage of the historic 

Family Smoking Prevention and Tobacco Control Act. The Agency promptly established the 

Center for Tobacco Products to protect public health and reduce tobacco use by minors by regulating the manufacture, marketing, and distribution of tobacco products. CTP’s work includes 

setting performance standards, reviewing premarket applications for tobacco products, requiring 

new warning labels, and restricting the advertising and promotion of tobacco products. 

In its initial years, CTP has focused on establishing the scientific foundation and regulatory 

framework for regulating tobacco products in the United States. In addition to many domestic 

initiatives, this work involves reaching out to and building relationships with tobacco regulators 

around the world who face similar challenges in protecting the public from the risks and consequences of using tobacco products. CTP officials meet frequently with counterparts individually and at international forums, and are working, in partnership with the World Health Organization (WHO) and others, to lay a foundation for a global coalition of tobacco regulators who 

can share information on best practices, ideas, and resources for effective tobacco regulation. 
Global Challenges: Global Strategies

◆ Harmonizing Science-Based Standards. FDA and its counter-

9

parts around the world have been working for years to harmo-

nize regulatory standards. As a result, participating countries 

increasingly share a common foundation of science-based goals 

for product safety, quality, and efficacy. 

◆ Leveraging Knowledge and Resources. With the challenges of 

today’s global marketplace, regulatory authorities must utilize 

their finite resources strategically and efficiently. Arrangements 

to share knowledge and information, and collaborative partner-

ships for regulatory decision-making, offer powerful and mutu-

ally beneficial leveraging tools for FDA and other countries and 

organizations.

◆ Risk-Based Monitoring and Inspection. To make the most of 

its resources for monitoring and inspecting imported products, 

FDA is developing innovative strategies and tools that take 

advantage of the latest developments in science, engineering, 

and information technology. One example is FDA’s Predictive 

Risk-Based Evaluation for Dynamic Import Compliance 

Targeting (PREDICT) system, which helps screen the millions 

of imported food and medical products that enter the United 

States each year to rapidly identify those that pose the greatest 

risk to public health. 

◆ Global Surveillance, Preparedness, and Emergency Response.

Working with partners in the United States and around the 

globe, FDA helps monitor, prepare for, and respond to global 

public health challenges, such as international pandemics or 

widespread distribution of tainted FDA-regulated products.

◆ Advancing Regulatory Science. The rapid advances in science 

and technology that have contributed to the pace of globaliza-

tion offer tremendous promise for promoting and protecting the 

safety, quality, and security of FDA-regulated products. FDA 

is actively engaging with global partners to harness scientific 

developments and pool products, resources, and brainpower to 

support science-based regulatory decision-making and pursue 

the best possible public health solutions. 

In addition, as described in FDA’s 2011 special report, Pathway to 

Global Product Safety and Quality,

18 the Agency is working to trans

-

form itself over the next ten years from a domestic agency operat-

ing in a globalized economy to a truly global agency fully prepared 

for the regulatory pressures of globalization. Toward that end, the 

Agency will be collaborating closely with its foreign counterparts 

to assemble global coalitions of regulators dedicated to building and 

strengthening a worldwide product safety net, including a global 

data information system they can use to proactively share realtime information and resources across markets. To achieve a true 

and lasting paradigm shift, FDA will be engaging stakeholders in a 

process that will unfold over the next several years.
10

When several imported food and 

medical products caused a series of 

U.S. public health crises in 2007 

and 2008, it became clear that FDA’s lack of 

an overseas presence impaired the Agency’s 

ability to respond quickly and efficiently. FDA, 

with support from the U.S. Congress, reacted 

swiftly by establishing international offices and 

posting staff in strategic locations around the 

world. As of 2011, these include:

◆ China Office, which consists of posts in 

Beijing, Shanghai, and Guangzhou.

◆ India Office, which consists of posts in 

New Delhi and Mumbai.

◆ Latin America Office, which consists of posts 

in San Jose, Costa Rica; Santiago, Chile; and 

Mexico City, Mexico.

◆ Europe Office, which consists of posts in 

Brussels, Belgium; London, United Kingdom; and 

Parma, Italy.

◆ Asia-Pacific Office, located at FDA headquarters.

◆ Sub-Saharan Africa Post, located in Pretoria, 

South Africa.

◆ Middle East and North Africa Post, located in 

Amman, Jordan.

Operating under FDA’s OIP, these offices and posts 

allow FDA to have a presence around the world. FDA 

staff work closely with their foreign regulatory counterparts, the industry and scientific/academic communities 

in-country, as well as with other U.S. Government 

agencies stationed abroad, to perform functions essential to FDA’s ability to protect U.S. consumers. These 

include:

◆ Building linkages and trust with foreign 

counterparts.

◆ Developing a knowledge base of the regulatory, 

public health, cultural, economic, security, and 

geopolitical landscape.

◆ Monitoring local economic developments and 

natural events that may affect the quality and 

availability of food and medical products bound 

for the United States.

◆ Identifying and championing system-based 

approaches and initiatives of priority and mutual 

benefit to the United States and the host 

country/region.

◆ Serving as the face and voice of FDA in-country, 

connecting FDA experts with relevant stakeholders to increase their understanding and knowledge of the Agency’s policies, regulations, and 

guidance for imported products.

International Offices and Posts

I N T E R N A T I O N A L 

OFFICES AND POSTS

Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services 

(HHS), leads a delegation of FDA and other HHS agency representatives to meet with 

Indian Government officials, industry, and other Indian stakeholders in January 2012.
International Offices and Posts

11

FDA opened its first international office—in China—

in November 2008. China was of particular interest to 

FDA because it is a major and rapidly growing source 

of FDA-regulated imports. In 2008, for example, the 

United States imported over $5 billion of food products 

from China (approximately 6 percent, in dollar value, 

of total U.S. food imports that year);19, 20 almost $700 

million of pharmaceutical products;21 and more than 

$3 billion of medical devices.22 Comprising three posts 

(in Beijing, Shanghai, and Guangzhou), the Office 

includes experts in food, drugs, and medical devices. 

Strengthening Regulatory Capacity

FDA’s China Office collaborates with its counterparts to build regulatory capacity and share best 

practices—for example, by facilitating FDA training 

in important regulatory areas, including low-acid 

canned foods,23 aquaculture, good clinical practices, 

and quality systems.

The China Office has also collaborated with FDA 

Centers and Peking University to establish a worldclass graduate degree program in pharmaceutical 

engineering management. This model program 

trains future leaders in China’s pharmaceutical 

industry, while accelerating modernization of the 

industry itself.

FDA’s International Offices and Posts Cover Every Region of the World

China Office

New York City’s Chinatown district is one of many places across the United 

States where consumers can purchase food imported from China.

The opening of FDA’s China Office was a 

critical milestone in the new era in U.S.–

China cooperation on the safety of food, 

animal feed, and medical products.

Chris Hickey, Director, FDA China Office
International Offices and Posts

12

India Office

Commencement of the Peking University 2011 Master’s Degree Program in International Pharmaceutical Engineering Management.

FDA opened its India Office in November 2008. 

With a rapidly growing economy, India has been 

emerging as a key U.S. trading partner. For example, 

in 2009, India was the fourth largest drug exporter 

(by volume) and the eighth largest food exporter (by 

volume) to the United States.26, 27 Also, with a diverse 

population, a highly skilled work force, and favorable 

economic conditions, India has become an increasingly attractive location for clinical trials. As a result, 

the value of India’s clinical trial market more than 

tripled between 2002 and 2008.28, 29

FDA’s India Office consists of two posts, in New Delhi 

and Mumbai, staffed by experts in drugs, devices, and 

food, and by inspectors. The India Office has been 

working to build and sustain productive relationships 

with its counterparts to address regulatory issues of 

mutual interest and rapidly coordinate responses to 

emergent or other urgent public health situations.

Strengthening Regulatory Capacity

Working with its Indian counterparts and with FDA 

Centers and ORA, the India Office identifies priorities for building capacity and technical collaboration, and partners with the Indian Government and 

industry stakeholders, where possible, to address these 

In-Country Inspectors

The China Office includes several inspectors posted 

in Shanghai and Guangzhou. In addition to scheduled 

inspections, they can respond rapidly when needed 

to inspect high-risk facilities and in times of crisis—

for example, when a safety issue is discovered with 

a Chinese-manufactured product. Since regulation 

of much of the food, drug, and device safety work in 

China is done at the local level, the FDA inspectors take time to build strong relationships with local 

Chinese regulators. They also help train Chinese regulators in good inspection practices, conduct outreach 

to Chinese industry, and participate in public forums. 

A New Era in U.S.–China Cooperation

FDA and its Chinese counterparts formalized a new era of cooperation in December 2007, when 

the United States and China signed two precedent-setting memoranda of agreement to enhance 

the safety of food, drugs, medical devices, and animal feed traded between the two countries.24

Under these legally binding agreements, the United States and China have agreed to notify one another as soon as they discover a circumstance, such as a product recall, that could endanger public health. 

In addition, Chinese regulators will require registration of products exported to the United States and 

work toward a system to certify that these products meet FDA standards before they are exported.25

These agreements—currently the only binding agreements FDA has with another regulator—have 

provided an important framework for FDA’s China Office to enhance technical cooperation and 

information flow with its Chinese counterparts.
International Offices and Posts

13

Latin America Office

FDA’s Latin America Office (with posts in San 

Jose, Costa Rica; Santiago, Chile; and Mexico City, 

Mexico) opened in April 2009. The Office covers 44 

countries and territories in Mexico, Central America, 

South America, and the Caribbean—a large and 

geographically varied region, with a diverse range of 

regulatory systems and product issues. FDA staff in 

Latin America have traveled extensively to meet with 

relevant stakeholders—including government representatives from the regulatory, health, agriculture, 

commerce, and trade sectors; industry and trade associations; development organizations; multilateral organizations; and academia—many of whom have expressed 

a strong appreciation for FDA’s presence. Key activities 

include increasing knowledge and information about 

FDA regulations, guidelines, and requirements; building FDA’s knowledge base about regional systems and 

practices; and identifying the most strategic areas for 

collaboration, capacity building, and harmonization of 

standards and practices. Though FDA inspectors are 

not part of the Latin America Office per se, FDA posts 

create a foundation for FDA food safety and surveillance inspections by providing advance liaison with 

industry and regulatory authorities.

Strengthening Regulatory Capacity

Given the diversity of FDA-regulated products imported from Latin America, the strategic use of limited 

resources is critical. To that end, the Latin America 

Office has focused on programs designed to foster 

broad dissemination of key information. For example, 

for many of its “train-the-trainer” programs, FDA’s 

Latin America Office invites officials to participate 

who have the capacity and authority to widely disseminate training in their home countries. A number 

of FDA documents have been translated into Spanish 

to expand FDA’s reach. Training and guidance on food 

labeling has been a priority topic to help ensure that 

exports comply with FDA requirements for entry into 

the United States.

Local governments and health organizations in the region have expressed a significant interest in strengthening their capacity to perform food and clinical 

research inspections comparable to FDA inspections. 

Future work to build inspection capacity will help 

increase FDA’s confidence in using data from inspections conducted by local authorities.

priorities. For example, in response to Indian regulators’ request for a multi-year “train-the-trainers” 

program on good clinical practices/clinical research 

inspections, FDA’s India Office and experts worked 

to adapt a program for delivery in India.30 As a 

direct result, the Indian drug regulatory authority 

now certifies inspectors for clinical trial inspections, 

as well as trainers to expand future capacity.

In-Country Inspectors

FDA’s India Office includes five inspectors posted 

in Mumbai who receive regular inspection assignments from FDA headquarters covering the 

full spectrum of FDA-regulated products. The 

in-country inspectors can also respond rapidly 

when needed to meet a short timeframe (such as a 

regulatory deadline) or to inspect high-risk facilities 

when a safety issue is discovered with an Indianmanufactured product. For example, the India Office 

was able to send investigators to inspect an Indian facility within one working day after a pharmaceutical 

product manufactured in the facility was voluntarily 

recalled from U.S. commerce by the U.S. distributor due to contamination concerns. The investigators identified several Good Manufacturing Practices 

(GMP) violations, and the inspection results enabled 

FDA to place the manufacturer on import alert until 

the violations were corrected.

Since most of the food, drug, and device safety work 

in India is regulated at the local level, FDA in-country 

inspectors set aside time to interact with their local 

counterparts and build strong relationships with statebased regulators. They also participate in public forums 

hosted by Indian manufacturing associations to educate manufacturers about FDA requirements and help 

them improve their ability to meet U.S. requirements.

India provides about a quarter of the spices, oils, and food colorings used in 

the United States.31
International Offices and Posts

14

FDA’s Europe Office enhances a longstanding tradition of cooperation with European regulatory authorities on public health issues of mutual importance. 

The Office, which covers the European Union (EU) 

and individual countries that are not EU members, 

such as Switzerland and Norway, facilitates progress 

on many joint European–U.S. projects spanning the 

full spectrum of FDA-regulated products. Shared 

interests, well-honed relationships, and comparable 

regulatory standards provide a rich foundation for 

productive partnerships and leveraging of resources to 

benefit public health on both sides of the Atlantic.

FDA opened its Europe Office in Brussels, Belgium, in 

May 2009. Under reciprocal arrangements, FDA staff 

members are also based at the European Medicines 

Agency (EMA) in London, United Kingdom, and 

the European Food Safety Agency (EFSA) in Parma, 

Italy, while EMA and EFSA staff are posted at FDA 

headquarters in the United States.

FDA’s Europe Office maintains an active bilateral 

relationship with national regulatory authorities 

(NRAs) throughout Europe, and has confidentiality 

commitments with a number of European authorities 

and countries, including the European Commission, 

France, Germany, Ireland, Italy, and the Netherlands.

Leveraging Inspection Resources

With comparable rigor in FDA and EMA inspections, 

significant opportunities exist for the two agencies to 

leverage their inspection resources. FDA and EMA 

have been exploring this potential through a series 

of activities. They have observed each other’s inspections and jointly inspected manufacturing sites in the 

United States and the EU. Through this work, FDA 

and EMA are building a foundation for understanding, trust, and data-driven decisions.

Parallel Scientific Advice

FDA and EMA have been collaborating in providing 

parallel scientific advice to drug sponsors who want to 

submit a new drug application for review in both U.S. 

and European markets. The voluntary process is initiated at the request of the sponsor early in the product 

development phase. The agencies agree to look at the 

sponsor’s application in parallel and provide advice 

to the sponsor at the same time. The sponsor submits 

the same briefing package to both agencies, who share 

their responses with one another. FDA and EMA 

meet jointly with the sponsor on what may be needed 

for approval, while also learning from each other’s 

concerns. Though FDA and EMA issue separate responses, sponsors benefit from increased efficiency and 

opportunities for alignment, while the agencies benefit 

from communication and interaction and gain increased understanding in case of divergent outcomes.

Product Evaluation and Surveillance

FDA and EMA scientists leverage their knowledge by 

participating in regular discussions and information 

exchanges about ongoing industry marketing applications for products in areas of common interest, such as 

oncology, vaccines, advanced therapies, pharmacovigilance, blood products, gene therapy, biomarkers, pediatric medicines, veterinary products, and orphan drugs 

for rare diseases. Discussions include data interpretation, product approval requirements, and post-marketing studies. In many of the topic areas, FDA and EMA 

scientists are among only a small number worldwide 

working on these issues, making these discussions 

particularly critical to inform the agencies’ decisions 

about the marketing applications received. FDA and 

EMA also hold extensive ad hoc exchanges on other 

product-specific review and safety issues, and provide 

advance notice of important regulatory decisions.

Food Safety Comparability 

FDA’s Europe Office has made invaluable inroads on 

several food issues where the United States and the 

EU have differing perspectives. For example, the FDA 

and the EU have been assessing the comparability of 

their two food safety systems to lay the groundwork 

for future comparability work under FSMA.

FDA’s Asia-Pacific Office, based at FDA’s headquarters, is responsible for a broad area comprising 

Canada and the 29 countries of the Asia-Pacific 

region, excluding China and India. These countries 

are diverse, ranging from tiny island nations to major 

world economies. They include countries with highly 

developed regulatory systems and longstanding FDA 

Europe Office

Asia-Pacific Office

EMA–FDA interactions contribute to 

the availability of safe and effective new 

medicines, as early as possible, with 

data relevant to all regions.

Hilde Boone, European Medicines 

Agency Liaison to FDA
International Offices and Posts

15

relationships (such as Canada, Japan, Australia, and 

New Zealand), as well as emerging economic powers 

(such as South Korea and Singapore). 

FDA has worked multilaterally with the Asia-Pacific 

Economic Cooperation (APEC), an intergovernmental forum comprising 21 member economies in 

the Asia-Pacific region, to provide advanced Good 

Clinical Practices (GCP) inspection training; work 

towards strengthening food safety systems; and combat falsified or counterfeit medicines. In 2011, FDA 

Commissioner Margaret Hamburg led the U.S. delegation to the third meeting of APEC’s Food Safety 

Cooperation Forum, which was hosted by the United 

States. FDA is also a partner with the Food Safety 

Cooperation Forum’s Partnership Training Institute 

Network, which strengthens capacity building in food 

safety by engaging the food industry and academic 

food safety experts with the regulators.

FDA’s Middle East and North Africa (MENA) post, 

located in Amman, Jordan, covers 20 countries in the 

region with varying levels of regulatory maturity. The 

post, which opened in June 2011, is becoming increasingly important as the number of FDA-regulated 

product lines exported to the United States from the 

region continues to rise. 

Through its Senior Regional Advisor for the Middle 

East and North Africa, FDA is working to build 

collaborative relationships with its counterparts and 

support implementation of preventive, risk-based 

approaches to ensuring product safety and quality. 

For example, FDA’s OIP recently helped Jordanian 

counterparts better understand the Agency’s food 

packaging regulations as a possible model for developing Jordanian food packaging regulations; and FDA 

sent experts to Saudi Arabia to explain FDA medical 

device regulations and to discuss potential pathways 

for the Saudi Food and Drug Authority to establish its 

own in vitro diagnostic laboratory. The MENA post is 

also engaging with industries to help them understand 

and comply with FDA’s import requirements.

As a trading crossroads, the MENA region often 

serves as an interim destination (e.g., for labeling and 

packaging) for products bound for the United States. 

FDA’s Senior Regional Advisor for the Middle East 

and North Africa is working with counterparts to 

support development of mechanisms that will better 

enable FDA to identify at U.S. borders adulterated 

and misbranded products shipped from the region. 

FDA is also providing training and information 

exchange to strengthen regulatory capacity. For example, OIP hosted a conference in Cairo, Egypt, in 2010 

to create an opportunity for food regulators to share 

their experiences with the elements and challenges of 

strong food safety systems. In 2012, FDA will provide 

GCP training for regulators of clinical trials. In addition, FDA is translating key documents into Arabic 

(the major language of the region) and making them 

available to regulatory counterparts and industry to 

help ensure the safety of FDA-regulated foods and 

medical imports from the region. 

Pilot Project to Compare the New Zealand and 

U.S. Food Safety Systems 

FDA has a longstanding, collaborative working relationship with its counterpart 

agency in New Zealand, the New Zealand Food Safety Authority (NZFSA), which 

merged with New Zealand’s Ministry of Agriculture and Fisheries in 2010. Recently, 

NZFSA participated in a comparability pilot project conducted by FDA. The 

project involved extensive review by FDA of New Zealand’s food safety system 

to determine whether it provides a comparable level of public health protection to 

the U.S. food safety system. The project results are being assessed. If the outcome shows positive comparability, this 

may enable FDA and New Zealand to leverage their food safety resources in the future. The comparability review will 

also form the basis for renewing Memoranda of Understanding between the two countries regarding New Zealand 

exports of seafood, shellfish, and non-Grade A dairy products to the United States. 

Middle East/

North Africa Post 

The globalization trajectory among 

nations is clearly toward greater 

collegiality, collaboration, transparency, 

and data-sharing, leading to a greater 

reliance on each other.

Paul Seligman, Director, FDA Asia-Pacific Office
International Offices and Posts

16

FDA’s Sub-Saharan Africa (SSA) post, which opened 

in Pretoria, South Africa, in June 2011, covers the 

48 countries of Sub-Saharan Africa. While many of 

Africa’s developing economies continue to struggle, 

some are poised to take advantage of import/export 

initiatives. 

In prior years, staff operating out of FDA headquarters 

had built a framework of relationships and sharing 

with several African countries through information exchange and training. With its SSA Post, the 

Agency can now reach out to more Sub-Saharan 

African countries, particularly those with limited 

government public health staff. 

The SSA post will leverage its resources in several 

ways. For example, African countries have bound 

together in multiple regional blocks, known as 

Regional Economic Communities (RECs), to pool 

their resources and expertise and work towards mutual development and economic goals. The SSA post 

plans to mirror this approach by working under the 

umbrella of the REC Secretariats; targeting country 

blocks; and focusing on collaborative efforts designed 

for maximum benefit and impact. 

The SSA post will partner with other U.S. agencies 

at the U.S. Embassy in Pretoria to build on the relationships these agencies have already established with 

government counterparts in the region. During the 

initial months of the SSA post, the Senior Regional 

Advisor for Sub-Saharan Africa has met with U.S. 

Government colleagues and regional intergovernmental organizations to develop relationships; understand their priorities; and consider potential areas for 

mutual support, collaboration, and synergy. 

With many clinical trials now taking place in the 

Sub-Saharan Africa region, strengthening regulatory 

oversight of these trials is an important FDA priority. 

FDA conducted GCP inspection training for the region in 2010 and 2011, with 11 nations participating, 

and advanced GCP training in 2011, with 13 nations 

participating. South Africa, which has had wellconducted trials for decades, has been participating to 

assist neighboring countries with little experience. Reviewing case materials at GCP training in Botswana in October 2010.

The President’s Emergency Plan 

for AIDS Relief (PEPFAR) 

FDA supports the U.S. Government’s 

PEPFAR program, the largest commitment 

by any single nation to combat a disease 

internationally.32 One of the program’s key 

areas of focus is to make antiretroviral treatment—currently the most effective treatment for AIDS—available to persons living 

with AIDS. Antiretroviral treatment, which 

typically involves administering at least 

three drugs, dramatically reduces the number and severity of HIV-associated illnesses, 

improving both the duration and quality of 

life for AIDS patients.

Under PEPFAR, FDA’s CDER has been 

responsible for coordinating a process 

whereby generic antiretroviral medicines, 

including formulations for children, have 

received approvals certifying that they 

meet the safety and quality standards of 

products in the United States. Purchasers of 

products under the PEPFAR program use 

these “tentative” approvals to guide their 

purchases. FDA is now working collaboratively with industry and other health organizations to promote faster approval of these 

medicines by the regulatory authorities in 

PEPFAR countries so they can reach AIDS 

patients without delay. 

By streamlining the decision process, these 

approvals save many millions of dollars per 

year and enable millions of people in PEPFAR countries, including those in Africa and 

Asia, to receive life-preserving therapies for 

HIV/AIDS. As of September 30, 2010, more 

than 3.2 million men, women, and children 

worldwide had received anti-retroviral treatment supported by PEPFAR.33

Sub-Saharan 

Africa Post
17

Regulatory capacity is the ability of government 

authorities to ensure the availability of safe, 

high quality food, medical, and other FDAregulated products by effectively performing critical 

regulatory functions—including product review, 

registration, licensing, inspection, laboratory testing, 

and post-market surveillance.

With substantial U.S. consumption of imported food 

and medical products, the ability of other countries 

to ensure the safety and quality of products they 

export has direct relevance to U.S. public health. A 

vital element of FDA’s global engagement portfolio, 

strengthening regulatory capacity promotes the safety 

of imported products and improves the control of 

diseases before they reach U.S. borders.34, 35 In addition, stronger regulatory capacity abroad significantly 

improves the health and quality of life for individuals 

and communities in the developing world, and helps 

reinforce and secure public and private investments in 

the development of new drugs and vaccines, as well as 

agriculture and food production.36 Capacity building 

activities can take place at multiple levels: a country’s 

regulatory environment, its organizations and institutions, and/or with individuals in the relevant scientific and regulatory communities.37

OIP works with all of FDA’s Centers and Offices 

in the area of capacity building. These efforts 

involve transferring essential information, knowledge, tools, and strategies to other nations so that 

they can apply and adapt them to develop and 

strengthen their own regulatory infrastructures. 

The work generally takes the form of education/

training, dissemination of materials, and the 

translation of training modules and documents in 

scientific, technical, regulatory, and inspection 

areas. The following examples highlight a range 

of strategies that FDA employs to help strengthen 

regulatory capacity. 

FDA Forums for International Regulatory 

Authorities

FDA Centers host frequent forums where regulatory 

counterparts from around the world can exchange 

information, build collaborative relationships, and 

deepen their understanding of FDA operations and 

regulatory requirements for medical products: 

◆ Drugs. Since 2005, CDER has organized the 

“CDER Forum for International Drug Regulatory 

Authorities” twice a year, in April and October. The 

forums provide an opportunity for foreign regulators to learn about FDA and its drug review process, and to exchange drug regulatory information. 

Collectively, almost 500 international colleagues 

from more than 70 countries have attended the 13 

forums CDER has held through October 2011. 

S T R E N G H T H E N I N G 

REGULATORY CAPACITY

Strengthening Regulatory Capacity

Transferring 

Regulatory Knowledge 

and Information

By helping countries build their 

regulatory capacities, we strengthen their 

power to improve the safety and value of 

goods their own people consume, while 

also building confidence in the imports 

they send to the United States.

Margaret Hamburg, FDA Commissioner
Strengthening Regulatory Capacity

18

◆ Medical Devices. Since 2009, CDRH has hosted 

two forums a year to provide an opportunity for 

medical device regulators to build collaborative 

relationships; exchange regulatory information 

and perspectives; and receive basic and advanced 

training on FDA-regulated medical devices and 

radiation-emitting products. 

◆ Biologics. Starting in 2008, CBER has conducted 

a recurring seminar for foreign regulators on FDA 

regulation of biologics. 

Online Educational Tools

◆ CDER World. Interest among foreign regulators in learning about the science, technology, 

regulations, and processes CDER uses to protect 

public health has grown exponentially in recent years. To meet this demand, and the needs 

of foreign colleagues who are unable to attend 

CDER’s Forums for International Drug Regulatory 

Authorities, CDER with OIP support recently 

developed a Web-based information compendium called “CDER World.”38 This compendium 

comprises information about how CDER carries 

out its mission, adapts to new legislative initiatives, and initiates directions in regulatory science 

to improve public health. CDER World will grow 

and evolve as more modules are added over time. 

◆ CDRH Learn. After developing online training 

modules for internal FDA use, CDRH learned 

that foreign regulators and device manufacturers 

also found them valuable. Accessible on FDA’s 

website as “CDRH Learn,”39 this comprehensive, 

interactive educational tool comprises a series of 

self-paced training modules covering a wide variety of topics on medical device and radiological 

health regulation—from FDA’s authority to 

CDRH’s premarket review, postmarket surveillance, and enforcement programs. To expand the 

global reach, OIP and CDRH collaborated to 

translate the modules into Mandarin and Spanish 

in 2010 and 2011.

◆ CBER Web-Based Biologics Seminar. CBER 

maintains an online educational tool on FDA’s 

website40 to provide regulators around the world 

with ready access to information on U.S. regulatory oversight of biological products. This information mirrors that presented during CBER’s 

recurring seminars for foreign regulators, amplifying the global reach of this information. Users 

can email CBER with questions once they complete the online seminar. 

International Scientist Exchange Program

In 2009, FDA’s NCTR established the International 

Scientist Exchange Program (ISEP). ISEP builds 

global regulatory science capacity by training students, regulators, and academicians from developing 

countries. Through intensive hands-on research and 

mentorship onsite at NCTR in Jefferson, Arkansas, 

participants learn concepts, skills, and techniques essential to five core competencies in regulatory science: 

laboratory safety, study design, research ethics, bioinformatics, and data integrity. The goal is to provide 

participants, selected in part for their leadership 

potential, with sufficient training to successfully utilize 

these competencies when they return to their respective countries. Participants have included:

◆ Three scientists from China’s State Food and 

Drug Administration, who spent more than 

four months at NCTR applying bioinformatics 

Participants at the October 2011 CDER Forum for International Drug Regulatory Authorities.
Strengthening Regulatory Capacity

technologies to regulatory data so they could re- 19

turn to facilitate development of a bioinformatics 

infrastructure in China.

◆ A scientist from the University of São Paulo, 

Brazil, who spent a year collaborating in a community-based biomedical participatory research 

project so she could apply this research approach 

in Brazil to support the protection of ethnically 

diverse populations.

◆ A mathematical statistician from Korea 

University, South Korea, who trained in 

toxicogenomics, a new discipline to assess 

the health risks of drugs. This research has 

relevance to regulatory decision-making in a 

number of countries, including the United States 

and South Korea.

Joint Institute for Food Safety and Applied 

Nutrition (JIFSAN)

FDA’s CFSAN, as an integral component of FDA’s 

foods program, leverages part of its international 

capacity building efforts with the University of 

Maryland’s JIFSAN to:

◆ Conduct in-country food safety training programs 

to build global capacity (e.g., Good Agricultural 

Practices).

◆ Participate in APEC’s Partnership Training 

Institute Network to strengthen food safety 

capacity.

◆ Provide food safety risk analysis training to enhance the global use of risk analysis principles.

◆ Provide laboratory hands-on training through the 

International Food Safety Training Laboratory at 

JIPSAN.

FDA Participation in Regional Capacity Building 

in Africa

CBER serves as a mentor within the African Vaccine 

Regulators Forum (AVAREF). Established by WHO 

in 2006, AVAREF acts as an ad hoc scientific advisory 

body to help NRAs in African countries develop and 

enhance their capacity to:41

◆ Review clinical trial authorizations and monitor 

vaccine clinical trials that foreign companies are 

proposing to conduct in their countries.

◆ Assess vaccine clinical data and product quality 

to determine whether to license vaccines for use 

in their country.

AVAREF provides a safe, secure environment for 

NRAs to discuss concerns and ask questions of 

experts and colleague regulators. For instance, when 

a manufacturer proposes conducting clinical trials in 

several African countries, NRAs can jointly discuss 

the protocol within AVAREF. CBER experts may 

help mentor NRA review of the protocol, including 

suggesting questions to raise about the protocol to 

help ensure that the trials will protect participants 

and meet appropriate standards for quality. 

FDA’s systems-strengthening activities include support for development of information networks that 

can help strengthen capacity in different countries 

and organizations. These tools facilitate timely 

exchange of regulatory data, approaches, and tools, 

and strengthen the ability of organizations to better prevent, detect, assess, and respond to potential 

public health issues associated with food and medical 

products. For example:

◆ Medical Products “Information Hub” for the 

Americas. FDA is supporting the Pan American 

Health Organization (PAHO) in developing an 

“information hub.”42 This tool will help build capacity for effective regulation of medical products 

by making information about regulatory authorities, products, and the associated regulatory 

landscape in the Americas readily available.

◆ WHO Drug Information Platform. FDA, the 

WHO Secretariat, and WHO member states are 

working together to construct a global surveillance and monitoring system to combat substandard/counterfeit/falsified medicines. FDA and 

other WHO member states are working together 

to construct a sound evidence base that will underpin planning and implementation of policies 

and programs to tackle this global threat, ultimately benefiting patients and consumers in the 

United States and abroad. 

◆ Antimicrobial Resistance Information Exchange. 

FDA and WHO are collaborating to support a 

worldwide exchange of information and expertise 

in matters concerning resistance of foodborne 

pathogens and disease to anti-microbial treatments (known as anti-microbial resistance, or 

AMR). By providing rapid access to AMR data 

worldwide, such a network will strengthen AMR 

Catalyzing Regional 

and Global Networks
Strengthening Regulatory Capacity

20 decision-making and help build capacity for 

laboratory-based AMR surveillance in developing 

regions.43

◆ Global Collaboration on Veterinary Drugs.

FDA collaborates with the World Organization 

for Animal Health (OIE) to raise awareness 

among foreign regulators about the importance 

of science-based safety standards for veterinary 

drugs, and strengthen their capacity to adopt and 

implement such standards at the country level to 

improve animal health and welfare and increase 

the safety of food of animal origin. FDA’s CVM 

was recently designated as an OIE Collaborating 

Centre in recognition of its expertise in veterinary drug regulatory programs.

In November 2011, FDA’s CTP and OIP held an 

international conference for tobacco regulators. 

Co-sponsored with WHO’s Tobacco Free Initiative, 

the International Tobacco Regulators’ Conference 

was attended by regulators from 22 countries that are 

actively regulating tobacco products or considering 

doing so.

The conference provided a unique opportunity for 

participants to learn from one another and engage in 

robust dialogue about successes and failures in global 

tobacco regulation; specific tobacco control initiatives; and opportunities for international collaboration. Conference participants agreed to establish an 

informal network of tobacco regulators from around 

the globe to share information and collaborate on 

tobacco control efforts. 

FDA’s assistance in strengthening foreign regulatory 

capacity is often sought by other governments and 

public health organizations. The need for capacity building is compelling, given the large number 

of countries that have limited or under-resourced 

regulatory systems for ensuring the safety and quality 

of FDA-regulated products they export to the United 

States. Consequently, OIP has been working collaboratively with FDA Centers and Offices to ensure that 

the Agency’s capacity building resources are deployed 

strategically. To support strategic resource use, FDA 

has invested in several baseline studies to learn where 

FDA investments can have maximum impact in 

strengthening regulatory decision-making:

◆ International Regulatory Capacity Study. At 

FDA’s request, the National Academy of Sciences’ 

Institute of Medicine (IOM) is working to characterize the regulatory landscape and the essential elements of regulatory systems in developing countries 

within the broader development assistance and 

economic development context. This work includes 

assessing where the greatest potential exists for FDA 

to facilitate strengthening regulatory systems in developing countries and how the Agency can partner 

with other relevant organizations (e.g., bilateral 

donors, development banks, foundations, academia, 

industry and non-governmental organizations) to 

leave a sustainable “footprint” that benefits the 

countries involved and the United States.44, 45

◆ Global Training Landscape Study. FDA has begun a 

global assessment of regulatory training institutions, 

capacities, and approaches. This study will help 

the Agency identify gaps in training; particular 

niches that FDA can uniquely fill; and areas where 

collaboration and synergies with other regulatory 

authorities and institutions could be explored.

◆ Pharmaceuticals Systems Review.

Pharmacovigilance is the science relating to the 

detection, assessment, understanding, and prevention of adverse effects of medicines. In partnership with the U.S. Agency for International 

Development’s Strengthening Pharmaceuticals 

Systems Program, FDA is analyzing pharmacovigilance capacities in Africa to better understand 

existing efforts and identify needs and opportunities for building capacity.

International Tobacco 

Regulators’ Conference

Strategic Investment 

of Capacity Building 

Resources
XXXX

21Harmonizing Standards

Harmonization involves the alignment among 

different nations of science-based regulatory 

standards for the quality, safety, and efficacy 

of imported and exported products. Food and medical 

products imported to the United States from countries that have adopted and successfully implemented 

internationally harmonized standards may be less 

likely to require FDA intervention or endanger U.S. 

public health. U.S. products, in turn, may be more 

readily accepted by other countries that use those 

same standards, as regulators abroad are assured that 

the products meet standards comparable to their own. 

Harmonization helps governments realize efficiencies 

in developing, implementing, and enforcing standards. 

Industries also benefit from harmonization because 

they can focus on maintaining strict compliance with a 

single set of strong standards. By unifying the efforts of 

regulators and providing clear guidance to industry, harmonization benefits consumers through the availability 

of safer, more effective products.

FDA has been engaged over decades in a variety of 

formal harmonization efforts for many foods, drugs, 

medical devices, and other FDA-regulated products. In addition, FDA has led in the establishment 

of—and participates in—numerous international 

conferences and forums. These meetings provide 

opportunities for Agency staff to work informally 

with their international counterparts at all levels to 

identify, discuss, and address harmonization issues and 

associated regulatory and scientific challenges.

As of 2011, FDA has worked with regulators from 

more than 180 countries to develop food standards 

and guidelines, and with many countries to develop 

harmonized standards for pharmaceuticals, medical 

devices, and veterinary medicines. FDA also continues to work towards harmonization on a myriad of 

other related priorities, including product labeling 

and medical device identifiers. As science, technology, and society continue to evolve, new regulatory 

areas ripe for harmonization will emerge. The developing field of nanotechnology, for example, will 

require new, uniform standards to be developed and 

adopted around the world.

FDA has participated in the work of the international, science-based Codex Alimentarius Commission 

(Codex) for more than 40 years. Codex develops science-based international food standards, guidelines, 

and codes of practice that protect the public health 

while ensuring fair practices in food trade. A joint 

program of the United Nations Food and Agriculture 

Organization (FAO) and WHO, Codex incorporates 

and builds on prior food standards work by national, 

regional, and international organizations. Codex 

comprises more than 180 countries, accounting for 

97 percent of the world’s population.

HARMONIZING STANDARDS

Food Standards 

The process of working with scientists from 150 nations toward consensus on 

food standards development is dynamic and continually exciting. It’s one of 

the most important things we do in CFSAN.

Camille Brewer, Director, International Affairs Staff, FDA Center for Food Safety and Applied Nutrition 
Harmonizing Standards

22 Codex’s work covers foods and food-related products, 

and issues such as labeling, food additives, nutritional 

supplements, and pesticides and veterinary medicines that may affect food safety and quality. FDA has 

participated actively in Codex throughout its history. 

Over the course of its involvement, FDA has provided 

leadership in every one of Codex’s 20-plus technical 

committees. As of October 2011, FDA’s CFSAN and 

CVM provide the U.S. delegate or alternate delegate 

to 16 Codex committees.

International Conference on Harmonization

FDA is a founding member of the International 

Conference on Harmonization of Technical 

Requirements for Registration of Pharmaceuticals 

for Human Use (ICH), which seeks to harmonize 

regulatory standards, processes, and procedures for 

the pharmaceutical industry. Established in 1990, 

ICH brings together drug regulatory authorities and 

pharmaceutical industry experts of the United States, 

European Union, and Japan. Additional participants, 

as observers, include WHO, Canada, and Australia.

Through its Global Cooperation Group, ICH has 

involved countries and regions with a history of 

implementing ICH guidelines and/or where major 

drug production and clinical research is conducted. In 

2008, ICH further expanded the involvement of nonICH countries by establishing the Global Regulators 

Forum, a yearly regulators-only meeting to promote an 

understanding of ICH guidelines, share expertise and 

best practices for implementing guidelines in non-ICH 

countries, and identify training and capacity needs. 

ICH has developed a set of harmonized guidelines to 

help ensure drug safety and quality, while streamlining the development process for new drugs and the 

regulatory assessment of new drug applications. As of 

July 2010, ICH had finalized more than 80 guidelines 

for quality, safety, efficacy, and other areas for adoption by ICH members and other interested countries.

CBER, CDER, and OIP participate in and contribute expertise to ICH guideline development efforts 

and other activities to advance global harmonization. FDA’s CVM participates in a related Veterinary 

Conference on International Harmonization (VICH), 

which harmonizes standards for veterinary products.

Standards for Pharmaceutical Inspections

In January 2011,46 FDA was granted membership 

to the Pharmaceutical Inspection Cooperation 

Scheme (PIC/S). Using a cooperative approach, 

Codex has:

◆ Developed over 200 food standards for 

commodities and more than 40 codes 

of hygienic or technological practice.

◆ Evaluated over 180 pesticides and 

established more than 3,200 limits for 

pesticide residues.

◆ Developed more than 25 guidelines for 

contaminants.

◆ Evaluated over 1,000 food additives and 

more than 50 veterinary drugs.

Pharmaceutical 

Standards

ICH Global Cooperation Group 

Members

◆ European Union, United States, Japan, 

Australia, Brazil, China, Chinese Taipei, 

India, Republic of Korea, Russia, and 

Singapore.

◆ Regional Harmonization Initiatives:

➣ Asia-Pacific Economic Cooperation 

(APEC)

➣ Association of Southeast Asian 

Nations (ASEAN)

➣ East African Community (EAC)

➣ Gulf Cooperation Council (GCC)

➣ Pan American Network on Drug 

Regulatory Harmonization (PANDRH)

➣ South African Development 

Community (SADC)

Standards for Animal Health 

and Welfare

FDA’s CVM supports the World Organization for Animal Health in its work to harmonize international standards and guidelines for animal welfare. CVM was recently 

designated as an official OIE Collaborating 

Centre, providing an important mechanism 

for CVM to offer its expertise to improve 

global capacity for animal disease prevention, detection, and control.
Harmonizing Standards

the 39-member PIC/S, comprised of regulators from 23

around the world, pursues the international improvement and alignment of pharmaceutical inspections 

through information exchange, training, and harmonization of GMP standards and procedures among 

regulatory agencies. 

PAHO/WHO Collaborating Center for Biological 

Standardization

FDA’s CBER is a PAHO/WHO Collaborating Center for 

Biological Standardization. In that capacity, CBER experts have contributed for many years to a range of global 

public health priorities that include providing expertise 

for developing WHO written standards and guidelines; 

undertaking collaborative studies for establishing WHO/

international biological reference preparations; and conducting research and testing to improve the standardization and control of biologicals used in humans.

Medical devices run the technological gamut from 

the ancient to the ultramodern, from simple tongue 

depressors to complex programmable pacemakers and 

cutting-edge diagnostic imaging machines. With increased globalization, nations of vastly different levels 

of technological and regulatory advancement now 

produce and export these devices. 

Since 1992, device regulators and industry from the 

European Union, United States, Canada, Australia, 

and Japan have worked collaboratively under the 

Global Harmonization Task Force (GHTF) to achieve 

greater uniformity in national medical device regulatory 

systems. For example, to promote global harmonization 

of approaches to regulating unique device identification 

(UDI) systems for medical devices, GHTF developed a 

framework (published in September 2011) that GHTF 

members are encouraged to follow when regulating 

these systems in their countries. Global harmonization 

of UDI systems helps regulatory authorities respond 

swiftly and effectively to protect public health when a 

problem is discovered with a particular device. 

Through liaison with other countries and involvement of observer organizations, GHTF also works to 

foster awareness and adoption by developing economies of GHTF documents and harmonized regulatory 

practices measures. 

GHTF is aiming, by the end of 2012, to complete 

its regulatory documents and finalize a regulatory 

model that can be used by developing economies. 

During 2012 to 2013, GHTF will transition to a new 

format, the International Medical Device Regulators 

Forum (IMDRF), with a focus on maintaining the 

harmonized documents. IMDRF will comprise an 

expanded membership of regulatory bodies, observer 

organizations, and related communities that share 

a common goal of achieving greater international 

uniformity and convergence in regulatory practices 

for medical devices. 

ICH’s major progress toward 

standardizing the information filed 

about the side effects of drugs makes 

it possible for FDA and our foreign 

counterparts to detect unexpected side 

effects much earlier than before.

Janet Woodcock, Director, FDA Center 

for Drug Evaluation and Research

Breaking Down Barriers to 

Timely Treatments

“Harmonization by Doing” is a U.S.–Japanese bilateral effort to develop harmonized 

standards for global clinical trials and address 

regulatory barriers that may delay timely 

medical device approvals. The process is 

a cooperative effort to move both Japan 

and the United States toward international 

regulatory harmonization. The two countries 

currently diverge in regulatory practices, but 

are willing to consider new ways of working to improve clinical trials. The effort aims 

to decrease the lag time between U.S. and 

Japanese product approval and ensure the 

early market availability of new treatment and 

devices for patients in both countries.

Harmonizing 

Regulatory Practices 

for Medical Devices
XXXX

24

Organizations and agencies such as FDA leverage resources when they work in partnership 

to address issues of mutual interest and concern. By sharing knowledge, information, expertise, 

and work, partners create synergies and efficiencies 

that enhance their ability to achieve mutual public 

health goals—goals that would be difficult, often impossible, for a single organization to achieve alone.

FDA engages with a wide variety of organizations—

including other government agencies, international 

organizations, regional consortiums, and non-government organizations—to leverage resources. Through 

effective engagement with selected partners, FDA 

expands its reach to protect public health with finite 

resources.47 Similarly, FDA is placing increased reliance on audits by public and private third parties 

to help assure the quality and efficacy of products 

exported to the United States.

Leveraging may take many forms, including informal 

arrangements or formal agreements. Some partnerships 

are bilateral, while others involve multiple organizations and/or nations. For each partnership, FDA may 

select from a variety of reciprocal arrangements, which 

can be expanded or refined over time as appropriate. 

One type of arrangement is a confidentiality commitment, which allows FDA and a foreign counterpart to 

exchange non-public information with the assurance 

that the receiving agency will maintain the confidentiality of the information. Such agreements are an 

important public health tool, since a critical portion of 

the information needed for regulatory decision-making 

and the protection of public health is pre-decisional, 

deliberative, and/or of a confidential nature. For example, FDA’s collaboration with WHO, the European 

Union, and Canada, among others, to coordinate a 

response to the 2009 H1N1 outbreak, including sharing vaccine review and adverse event information, 

was possible because the partners held confidentiality 

commitments.48 As of 2011, FDA had 50 confidentiality commitments with foreign counterparts.

To help protect U.S. public health, investigators with 

FDA’s ORA regularly travel around the globe to inspect foreign facilities involved in producing food and 

medical products intended for import to the United 

States. Inspections may be conducted for many reasons, including general surveillance and pre-approval 

inspections (to ensure that the facility is meeting GMP 

requirements), or in response to a specific concern with 

an import from a foreign facility. FDA’s Centers work 

with ORA to identify risk and prioritize foreign firms 

Leveraging Resources

LEVERAGING RESOURCES

Resources are fully leveraged when 

countries have developed sufficient systems, 

relationships, and trust to rely on information 

and findings from their counterparts as 

completely as they rely on their own work.

Murray Lumpkin, FDA Senior Advisor 

and Representative for Global Issues

Frameworks for 

Partnerships Foreign Facility 

Inspections
Leveraging Resources

to inspect. When an inspection identifies significant 25

violations, FDA may establish immediate controls to 

restrict the import of products from that facility until 

the violations are corrected. If a foreign facility refuses 

FDA’s attempts to conduct an inspection, the Agency 

will restrict imports from that facility until an FDA 

inspection is conducted. 

Because of the vast and growing 

number of foreign facilities, FDA 

does not have—nor will it—the 

resources to directly inspect all 

the higher-priority facilities at 

desired frequencies. For example, 

though ORA inspected more 

foreign facilities in FY 201149

than ever before in a single year, 

these inspections still account 

for only a small fraction of the 

more than 300,000 foreign facilities manufacturing or processing 

FDA-regulated products for the 

U.S. market. Leveraging resources 

with trusted partners offers a 

powerful way to address this gap 

and extend oversight to a higher 

number of facilities. 

To leverage resources, the Agency establishes guidance 

and performs outreach with foreign industries to help 

them understand FDA requirements, and with foreign 

regulatory counterparts to help them build capacity 

in their country. Where confidentiality commitments 

allow, ORA collaborates with foreign regulatory 

counterparts to share laboratory and inspection information. Under the 2011 Food Safety Modernization 

Act, FDA is studying how regulatory controls and 

inspectional oversight in other countries compare to 

FDA’s system, to help determine when it may be able 

to rely on foreign inspection and testing data as a 

cost-effective alternative to direct FDA inspections. In 

addition, the Agency has been exploring:

◆ Joint inspections with inspection authorities from 

other countries and regions.

◆ Using accredited third parties to conduct audits/

inspections.

Trilateral Joint Inspections 

In 2009, FDA joined with EMA and Australia’s 

Therapeutic Goods Administration to conduct a pilot 

program—the Active Pharmaceutical Ingredient 

Inspection Pilot—to demonstrate the potential for 

leveraging their inspection resources. Before the pilot, 

these agencies had been conducting separate GMP 

inspections at the same overseas 

manufacturing sites, often within just 

months of one another50—a needless 

duplication of precious resources.

Under the pilot, the three agencies planned and conducted joint 

inspections at participating foreign 

facilities, and shared information 

from independent inspections they 

had conducted over the past two to 

three years. These exchanges have 

allowed FDA to redeploy inspection resources, and alerted the 

Agency to sites requiring heightened scrutiny. Since then, FDA has 

engaged in similar projects with 

additional counterparts.51

Third-Party Inspection/Audits

To enable closer regulatory cooperation, FDA and 

Health Canada (HC) initiated the pilot Multipurpose 

Audit Program in 2006. The pilot explored the potential benefits to medical device manufacturers and the 

agencies of using a single third party for inspections/

audits to simultaneously meet FDA and HC regulatory 

requirements for systems quality. It was anticipated 

that a multipurpose audit could reduce the overall 

time spent on site by an official Agency audit/inspection team, reducing the regulatory burden for industry.

FDA and HC conducted 11 joint audit/inspections 

under the pilot, of which 10 were assessed for program benefit. Results showed that the joint approach 

reduced the time-in-facility spent at participating 

manufacturers by about one-third, on average, compared to the estimated time required for separate FDA 

and HC audit/inspections. In addition, FDA and HC 

gained a better understanding of their respective auditing/inspection approaches, providing a foundation 

for leveraging inspection resources in the future.52, 53, 54

The process of interaction with our regulatory counterparts around the 

world is proving invaluable as the United States continues to be part of the 

international marketplace for food, feed, and medical products.

Bernadette Dunham, Director, FDA Center for Veterinary Medicine
XXXX

26Risk-Based Monitoring and Inspection 

With 20 million FDA-regulated import lines 

entering the United States each year,55

monitoring and inspection are critical to 

identify and prevent entry of imports that may pose 

risks to U.S. public health. To make optimal use of its 

monitoring and inspection resources, FDA is developing innovative strategies that take advantage of 

the latest developments in science, engineering, and 

information technology. 

The lack of rigorous, widely accepted, and globally 

enforced standards and approaches has at times led to 

dangerous public health consequences from substandard/counterfeit/falsified, adulterated, or fraudulent 

products. To address this risk, FDA is deploying new 

technologies to help the Agency detect products of 

concern and prevent them from ever reaching U.S. 

consumers. Premier among these is a sophisticated 

information technology system called PREDICT. 

PREDICT helps FDA screen the millions of imported food and medical products that enter the United 

States each year to rapidly identify those that pose 

the greatest risk to public health. With instant access 

to numerous FDA and public databases, PREDICT 

uses data mining and pattern discovery techniques to 

evaluate and rank FDA-regulated imports based on 

their potential health risk. The system provides entry 

reviewers with a list of imports receiving higher risk 

scores, as well as those that appear to be in violation of 

U.S. regulations. FDA import entry reviewers use 

PREDICT to determine which imports should be 

examined or sampled for laboratory analysis; which 

should be referred to compliance officers for detention; 

and which should be cleared to enter U.S. commerce. 

By identifying high-risk shipments, PREDICT allows 

the Agency to strategically focus its resources to better 

protect public health.

R I S K - B A S E D M O N I T O R I N G 

A N D I N S P E C T I O N 

Counterfeit drugs often look like the legitimate product, making it difficult 

or impossible for consumers to distinguish them.

FDA’s PREDICT model is a significant 

advance, institutionalizing a smart, 

risk-based approach to import border 

controls by identifying the commodities 

that are most vulnerable.

Margaret Hamburg, FDA Commissioner

Risk-Based Strategies 

to Identify Products 

That Pose Health Risks 
Risk-Based Monitoring and Inspection 

27

FDA’s CDER and ORA have been collaborating to 

determine the feasibility of using portable analytical 

instruments to screen FDA-regulated products in the 

field. To be effective, such tools must be portable and 

easy to use, and provide rapid results with sufficient 

accuracy for screening purposes. FDA researchers have 

developed methods, now being deployed in China and 

India on a pilot basis, to screen for several potential 

contaminants in FDA-regulated products, including:

◆ Toxic metals.

◆ Diethylene glycol (a toxic but less expensive 

chemical substitute for glycerin) in drug syrups.

◆ Sibutramine, a synthetic drug used in prescription 

weight loss products.

◆ Melamine (an adulterant) in milk powder.

One such method, using an ion mobility spectrometer 

(IMS), has detected sibutramine—which has been 

linked to heart problems in some consumers—in more 

than 25 percent of screened dietary supplements. All 

IMS results indicating the presence of sibutramine 

have been confirmed through laboratory analysis.

The explosion of Internet commerce has led to a 

dramatic increase in the number of FDA-regulated 

products being shipped into the United States via 

international mail and private courier services. Many 

of these products are prescription drugs purchased 

by U.S. residents from online pharmacies abroad, a 

practice that, with few exceptions, is illegal. 

Pharmaceuticals purchased online and shipped by 

mail or private courier—estimated to number more 

than 10 million packages per year—might not have 

been subjected to the safety and quality checks 

FDA places on products imported through proper 

channels, and may pose health risks to consumers. 

Working side by side with other federal agencies, including Customs and Border Protection and the Drug 

Enforcement Agency, FDA is deploying risk-based 

strategies at mail and private courier facilities nationwide to effectively and efficiently identify, examine, 

and intercept these shipments.

Rapid Product 

Screening for 

Contaminants 

of Concern

Use of the portable ion mobility spectrometer to screen for active 

pharmaceutical ingredients in dietary supplements.

Addressing the 

Challenges of 

Internet Commerce

With large, complex supply chains, problems are rarely limited to one country, and 

the line between domestic and international has become almost indistinguishable.

John Taylor, Counselor to the FDA Commissioner
XXXX

28Global Surveillance, Preparedness, and Emergency Response 

Working with partners in the United States 

and around the globe, FDA plays a key role 

in helping the United States monitor, prepare for, and when necessary respond to global public 

health challenges, such as international pandemics, 

widespread distribution of tainted products, outbreaks 

of food-borne illness, and infectious diseases. 

With world commerce growing larger, more complex, 

and even more intricately interconnected, surveillance is increasingly essential to protect the U.S. 

public health. FDA participates in global networks of 

regulators and non-governmental public health organizations, and continually monitors information from 

several international alert systems, including:

◆ International Food Safety Authorities Network 

(INFOSAN). A joint program of WHO and FAO, 

INFOSAN monitors international food safety 

events such as illnesses and outbreaks, and facilitates quick exchange of information and requests 

for assistance among its 177 member states.

◆ European Rapid Alert System for Food and Feed 

(RASFF). This system facilitates quick sharing of 

information when a food- or feed-related public 

health risk is identified by one of its European 

member states or organizations.

◆ WHO’s International Health Regulations (IHRs). 

These regulations legally bind 194 States Parties 

to help prevent and respond to acute public health 

risks that can potentially cross borders and threaten people around the globe. Public health risks of 

international concern include pandemics and other 

diseases that can spread via international travel 

and trade, and risks from chemical spills or leaks.

FDA also receives information on emergent public 

health issues through many other channels, including 

other U.S. and foreign counterpart agencies, industry, 

and the public via its call center.

G L O B A L S U R V E I L L A N C E , P R E PA R E D N E S S , 

A N D E M E R G E N C Y R E S P O N S E 

Global Surveillance

Mobile Laboratories for 

Emergency Response

Immediate response is imperative when it 

comes to food-associated outbreaks and other emergencies. FDA’s mobile laboratories 

can be quickly deployed to areas of interest, 

including the U.S. borders, for rapid sample 

analysis. For example, FDA’s microbiology 

mobile lab has often been used at the U.S.–

Mexico border to check for pathogens on 

leafy greens and other fresh produce, and the 

Agency’s chemistry mobile lab was deployed 

to the U.S.–Canadian border to examine 

food samples for pesticides and toxins.
Global Surveillance, Preparedness, and Emergency Response 

29

As the Agency’s focal point for coordinating emergency preparedness and crisis response activities, 

FDA’s Emergency Operations Center (EOC), operated by FDA’s Office of Crisis Management (OCM), 

is in a constant state of readiness. In coordination 

with FDA Centers and Offices, OCM reviews and 

analyzes information about threats and hazards for 

early alerts to domestic and international emergencies, including disease outbreaks, natural disasters, 

and terrorism or other criminal acts that may require 

FDA action to protect U.S. public health.

FDA uses traceback investigations to locate the 

source (such as a specific farm or factory) and distribution of a product implicated in a public health 

incident, and then takes action to prevent additional 

illnesses by issuing product recalls and identifying 

hazardous practices or violations. Tracebacks also 

enable the Agency to distinguish between several implicated products, and determine how the product was 

compromised, in order to prevent future incidents.

Due to the increasing complexity of global supply chains, 

tracebacks are more challenging than ever because the 

ingredients and finished products may come from a variety of nations and travel through several countries before 

reaching U.S. borders. FDA works collaboratively with 

international regulators to rapidly identify the sources of 

risk and contamination.

For example, the EOC was activated in response to 

the 2007 melamine crisis, when thousands of cats and 

dogs in the United States were sickened by contaminated pet food.56 EOC worked with CVM and other 

FDA Offices to trace the problem back to a contaminated adulterant, melamine, that was substituted for 

protein in pet food ingredients shipped to the United 

States from China. After weeks of complex, in-depth 

investigative work, EOC was able to determine that 

the adulterated product had contaminated not only 

pet food, but also farm animal feed and fish feed. As 

soon as the full scope of the problem had been diagnosed, all contaminated products were recalled from 

the market and destroyed.

FDA launched the Coordinated Outbreak 

Response and Evaluation (CORE) Network in 

August 2011 to manage surveillance, response, 

and post-response activities related to incidents of 

illness linked to FDA-regulated human and animal 

food. The CORE Network is comprised of a team 

of epidemiologists, veterinarians, microbiologists, 

environmental health specialists, emergency coordinators, and risk communication specialists who 

are charged with: 

◆ Building on the best of how FDA currently responds to incidents of foodborne illness.

◆ Streamlining and strengthening the Agency’s 

efforts to prevent, detect, investigate, respond to, 

and learn from incidents and outbreaks.

The team coordinates closely with FDA Offices and 

other U.S. agencies involved in responding to illness 

outbreaks. During its first few months of operation, the CORE Network directed response and 

post-response activities for several foodborne illness 

outbreaks, including a norovirus outbreak linked to 

frozen oyster products from Korea, and an outbreak 

of salmonellosis sourced back to Turkish pine nuts 

sold in bulk, which caused illnesses, including hospitalizations, in multiple states.

Response to 

Foodborne 

Illness Outbreaks

FDA’s Emergency 

Operations Center 

FDA’s Emergency Operations Center provides a central location where 

experts from across the Agency can convene to coordinate response to 

emergencies. In 2010, two separate Incident Management Groups worked 

simultaneously in the EOC to respond an outbreak of Salmonella enteritidis

in eggs (foreground) and the Deepwater Horizon oil spill (background). Traceback 

Investigations
Global Surveillance, Preparedness, and Emergency Response 

30

The emergence of a new influenza virus for which 

people have little or no immunity, and for which there 

is no vaccine, poses the threat of a pandemic—a global 

disease outbreak. CBER helps prepare the nation and 

the world to respond to influenza pandemics by facilitating the development, production, and regulatory review 

of biological products, such as vaccines. CBER also 

conducts post-market surveillance of these products.

On April 26, 2009, the Secretary 

of the U.S. Department of Health 

and Human Services declared a 

national public health emergency in 

response to a large number of confirmed cases of H1N1 influenza in the 

United States. WHO followed on 

June 11, 2009, with its declaration 

of an influenza pandemic, and FDA 

moved quickly to establish a command system to coordinate a response 

to the new pandemic and facilitate 

collaboration with and outreach to 

the Agency’s U.S. and international 

partners. FDA established cross-cutting teams to address vaccines, antivirals, diagnostics, 

personal protection, and consumer protection.

CBER, which had been strengthening the U.S. 

influenza vaccine infrastructure and enhancing global 

pandemic preparedness for several years, stepped in 

rapidly and decisively on the research and regulatory 

fronts. CBER also took a leadership role in the international arena, supporting WHO’s global efforts and 

partnering with foreign regulatory agencies to mount 

a coordinated emergency response. In addition, during the pandemic, WHO recognized CBER as the 

“Reference National Regulatory Authority” for five 

influenza vaccines under WHO’s vaccine prequalification program, including three H1N1 monovalent 

influenza vaccines.

Working with the vaccine manufacturers, the Agency 

approved four safe and effective vaccines against the 

2009 H1N1 influenza virus only three months after 

the WHO declaration. Two months later, FDA approved two additional vaccines, one for adults and 

another for children as young as six months. These 

approvals were achieved rapidly, while following the 

scientific and regulatory procedures essential to ensure 

the vaccine’s safety and effectiveness.57

Natural disasters such as earthquakes, hurricanes, and 

floods have the potential to affect the global supply 

chain for FDA-regulated products, and FDA vigilance 

is essential to ensure that any products imported to 

the United States from disaster-stricken areas are safe.

The March 11, 2011, tsunami and subsequent nuclear 

accident in Fukushima, Japan, is a case in point. On 

March 22, 2011, to complement the 

measures taken by the Government 

of Japan and strengthen the global 

food safety net, FDA issued an import 

alert banning the import of all milk, 

milk products, fresh vegetables, and 

fruits produced or manufactured 

from Japanese prefectures near the 

Fukushima Daiichi nuclear reactor.

For food products from areas near 

the reactor but not covered by the 

import alert, FDA began monitoring for elevated radiation levels. 

FDA screened the incoming food 

items from Japan for the three types 

of radionuclides—Iodine-131, Cesium-134, and 

Cesium-137—that are of greatest concern to food 

supplies following a nuclear power plant accident, and 

for others as needed. As of June 1, 2011, FDA import 

investigators had performed over 18,000 field examinations for radionuclide contamination, and had 

tested almost 800 samples. Only one sample was found 

to contain detectable levels of Cesium, but was below 

levels that pose a public health concern.58

To ensure the safety of drugs from Japan, FDA established special procedures to evaluate drugs originating 

from the ten prefectures closest to the Fukushima 

Daiichi plant. FDA physically examined radiation 

levels of all drugs originating from these ten prefectures, and began examining and testing all injectable 

and inhalable drugs regardless of origin within Japan, 

since these drugs directly enter the bloodstream.

In response to a request from the Japanese 

Government for assistance designing effective risk 

communication, an FDA radiation expert advised 

Japanese counterparts about food and water safety, 

including the potential for radioactive contamination of current and future food supplies and the risk to 

consumers from ingesting contaminated food.

Response to 

International 

Disasters

Response to the 

H1N1 Influenza 

Pandemic
XXXX

31

I

n today’s globalized economy, FDA’s engagement with global partners to advance regulatory science is essential to fulfilling its mission. 

Regulatory science applies basic science to develop 

the tools, standards, and approaches that FDA and 

its global counterparts use to assess the safety, effectiveness, quality, and performance of regulated 

products. Advancements in regulatory science can 

lead to more cost-effective and timely product 

development and evaluation; increased capacity for 

post-market detection of product-associated adverse 

events and safety assessment; and rapid resolution 

of incidents involving product contamination or 

other concerns.59

The need for strong regulatory science is urgent. 

Scientific advances—from sequencing the human 

genome to applications of nanotechnology to innovations in information technology—have the potential 

to transform the ability of FDA, and its international 

counterparts, to ensure product safety, yet development 

of the next generation of assessment tools has not kept 

pace with these advances. Harnessing advances in life 

sciences and engineering in the service of public health 

is a global endeavor, since no single country has the 

financial, human, or scientific resources—or answers—

needed to fully ensure the safety of food, drugs, and 

devices. International scientific collaboration is helping FDA benefit from, and contribute to, the global 

regulatory community to better protect public health. 

Advancing Regulatory Science

ADVANCING REGULATORY SCIENCE

International Leadership in DNA Microarray Research

DNA microarray technology enables regulatory and 

clinical scientists to simultaneously evaluate the relative 

expression of thousands of genes. It offers a powerful 

tool for understanding how genes influence individual 

response to pharmaceuticals or toxic substances, and 

for rapidly identifying early biomarkers (distinctive 

biological indicators) of toxicity and disease. However, 

standards and quality measures were needed before the 

technology could be applied reliably and successfully to 

clinical practice and regulatory decision-making. 

To meet this critical need, NCTR led an international 

consortium in the first MicroArray Quality Control 

(MAQC-I) project, an unprecedented effort to develop 

quality control guidelines and data analysis evaluation 

methods for DNA microarray data. More than a hundred 

researchers at 51 U.S. and foreign academic, government, and commercial institutions participated. The An NCTR scientist analyzes a readout of microarray data.
Advancing Regulatory Science

32 results, which were published in the journal Nature 

Biotechnology in 2006,60 were a landmark in DNA 

microarray research and have been cited more than 

1,000 times since then. Nature Biotechnology highlighted the MAQC-1 project in its 15th anniversary 

edition, published in March 2011, as it revisited ten 

of the most important advances and most highly cited 

research articles of the past five years.61

MAQC-1 provided an important foundation for deriving essential guidelines for use of microarrays in the 

discovery, development, and review of products regulated by FDA and its counterparts around the world. 

Since then, under NCTR’s stewardship, the MAQC 

project has continued its international leadership by 

expanding to evaluate microarray-based predictive 

models (MAQC-II) and next-generation sequencing 

platforms (MAQC-III).62

The potential for infectious diseases to spread rapidly 

from one country to another grows ever greater as 

more people travel internationally and as increasing 

quantities of goods are shipped around the world. In 

response, CBER works with international partners 

on many fronts to reduce the risk and prevalence of 

infectious disease. A key example of this work is a 

breakthrough vaccine technology that was developed 

by CBER scientists and then leveraged, through 

an international partnership, to protect millions in 

Africa against meningitis. 

Deadly and debilitating, meningitis affects many 

thousands of people throughout Sub-Saharan Africa, 

killing one in ten people who contract the disease and 

leaving one in four survivors with permanent disabilities.63 In the mid-1990s, after the deadliest meningitis 

outbreak in African history killed more than 20,000 

people,64 health ministers of several African countries 

turned to WHO for help. The vaccine they had been 

using had substantial disadvantages: it was expensive, 

only protected people for two to three years, and did 

not protect very young children or prevent infected 

individuals from transmitting the disease to others.

WHO convened global health leaders, including 

CBER, to discuss possible solutions. They agreed the 

most promising strategy would be to develop a potent, 

affordable vaccine against the group A meningitis 

strain, which causes 80 percent of meningitis cases in 

Africa. A year later, the Meningitis Vaccine Project 

(MVP) was established, with funding from the Bill 

and Melinda Gates Foundation, to develop and introduce such a vaccine.

Key to development was access to “conjugation technology,” a method that would boost the vaccine’s potency, ensure it would provide long-lasting protection, 

and prevent infected individuals from transmitting 

the disease to others. Typically, the cost for private 

development of such technology would render the 

resulting vaccines unaffordable to African countries.

CBER approached MVP to offer a solution. Through 

prior work over many years, CBER scientists had 

developed a high-efficiency, general purpose conjugation method. CBER donated this technology to the 

project and transferred it to MVP’s vaccine production 

About 430 million people, in a region called the “meningitis 

belt,” are at risk of meningitis in Africa.65

Scientists from FDA’s CBER were instrumental in developing an affordable vaccine 

against meningitis—the first vaccine ever developed specifically for Africa.

Photo source: M. Berlier/PATH. Used with permission.

International 

Collaboration to 

Prevent Meningitis
Advancing Regulatory Science

33

partner, the Serum Institute of India (SII), at almost 

no cost. CBER scientists trained SII scientists at 

CBER facilities, and then worked with Indian scientists at SII’s research facility to help them produce the 

vaccine based on CBER’s conjugation technology. The 

method was simple and easily scalable to produce vaccines costing less than US $0.50 per dose.

As of May 2011, nearly 20 million people had received the new vaccine. Six months after the vaccine’s 

introduction, the countries of Burkina Faso, Niger, 

and Mali reported the lowest number of meningitis A 

cases ever recorded. MVP hopes to vaccinate 300 million people throughout the “meningitis belt” by 2015, 

potentially preventing 1 million cases of the disease 

and saving 150,000 lives by 2020.66 This effort would 

end meningitis epidemics in the 25 African countries 

of the “meningitis belt” forever.67

First produced in the 1980s, genetically engineered (GE) 

animals offer a powerful approach to developing novel 

pharmaceutical products and many other applications 

that hold great promise for improving human health and 

welfare. Research is currently under way in the private 

and academic sectors on GE animals for use as food; to 

produce cells, tissues, and organs for transplantation; to 

produce high-value products such as fibers for personal 

protection garments; and to resist diseases such as bovine spongiform encephalopathy, to name a few. 

The “rDNA construct”—the new DNA in a GE 

animal that confers the desired trait or characteristic—is regulated under the Federal Food, Drug 

and Cosmetic Act. CVM developed guidance in 

2009 clarifying how the Agency regulates rDNA 

constructs in GE animals and what risk questions 

industry needs to address when seeking FDA approval.68 These guidelines provided the framework 

for the Agency’s first approval of a GE animal—a 

goat that produces the human anticoagulant drug 

antithrombin in its milk—in 2009. They also provide a basis for ongoing dialogue with international 

counterparts about the safety and effectiveness of 

GE animals. 

To develop the 2009 guidance, CVM scientists 

analyzed the potential risks posed by GE animals. 

This analysis provided the basis for development of 

a rigorous, risk-based approach to regulatory review 

that looks at potential effects of the rDNA construct 

on the animals themselves, on any food derived from 

the animals, and on the environment. CVM scientists 

also led the development of a critical tool for FDA’s 

first approval of a GE animal: a method the Agency 

can use to detect rDNA constructs in the approved 

GE animals and their edible products. 

As the current world leader in the science-based 

regulation of GE animals, FDA is working with U.S. 

Government agencies to answer scientific questions 

to help minimize or prevent possible trade disruptions. In addition, CVM is working with its foreign 

counterparts to strengthen international capacity for 

regulatory review of GE animals. 

Mother and son with a “carte de vaccination” during the December 2010 

mass vaccination campaign in Burkina Faso, Mali, and Niger against epidemic 

meningitis A.

Photo source: G. Bienczycki/PATH. Used with permission.

Ensuring the Safe 

Application of 

Genetic Engineering 

Technology

A tool developed by FDA scientists was critical to the Agency’s approval 

of goats that had been genetically engineered to produce a human 

anticoagulant drug in their milk. The tool enables FDA to confirm the identity 

of these goats and their edible products.
XXXX

34Looking Ahead

The need for effective global engagement will only 

become more pronounced as the forces propelling globalization continue—or even accelerate. 

Over the next decade, emerging markets will continue 

to grow, fueling increased worldwide competition for 

scarce natural resources and raw materials. Facing 

intense market pressures to lower costs, U.S. companies manufacturing FDA-regulated products will likely 

move more of their operations abroad. The distinction 

between foreign and domestic products will continue 

to blur, with goods flowing through complex, multistep supply chains that make the source of a product 

difficult to identify. Countries with developing economies will export greater quantities of products to the 

United States, leading to an anticipated dramatic rise 

in imports of FDA-regulated products compared to today’s already high levels. Growing access to the global 

marketplace and increased Internet commerce will 

expose Americans to increasingly sophisticated threats 

of fraud, product adulteration, and even terrorism—

threats that likely will grow as resource scarcity renders 

fraud and adulteration more profitable.

To meet the growing global challenges, FDA has committed to a fundamental shift in its approach to product safety and quality. As described in its 2011 special 

report, Pathway to Global Product Safety and Quality,

69

the Agency will transform itself over the next ten 

years from a domestic agency operating in a globalized 

economy to a truly global agency fully prepared for the 

regulatory pressures of globalization. To achieve this 

transformation, FDA is developing an international 

operating model with four core building blocks:

◆ Global coalitions of regulators dedicated to building and strengthening the product safety net 

around the world.

◆ A global data information system and network in 

which regulators worldwide can regularly and proactively share real-time information and resources 

across markets.

◆ Expanded FDA capabilities in intelligence gathering and use, with an increased emphasis on risk 

analytics and thoroughly modernized information 

technology capabilities.

◆ Allocation of Agency resources based on risk, 

leveraging the combined efforts of government, industry, and public- and private-sector third parties.

To achieve a true and lasting shift in strategy, FDA 

will be engaging stakeholders—including global 

regulators, industry, academia, and other stakeholders. 

The Agency will also look to the U.S. Congress to 

help in modernizing its authorities to enable FDA to 

keep pace with globalization.

Fostering Global Coalitions

Recognizing that shared concerns create shared opportunities, FDA has been working with regulatory 

counterparts abroad for many years to strengthen 

LOOKING AHEAD

Blazing a New 

Pathway

Leaders around the world have a shared interest in and responsibility for ensuring the 

safety and quality of food and medical products. By working together to monitor and 

improve safety and quality globally, we will benefit all of the world’s citizens.

Margaret Hamburg, FDA Commissioner
Looking Ahead

regulatory capacity, harmonize standards, and lever- 35

age resources. However, with the increased intensity 

and complexity of the regulatory environment, much 

deeper engagement among global partners will be essential to protect public health. 

FDA will work to foster and strengthen global coalitions of regulators in different product areas to build, 

support, and maintain a global public health safety 

net for consumers. FDA likely will begin by working 

with a core set of partners on two primary goals: 

◆ Developing procedures to share information 

across borders in a more comprehensive and systematic way than is currently possible.

◆ Coordinating deployment of resources toward 

shared goals. 

This work will be founded on the premise of “comparability”—that all partners will strive for comparable 

safety outcomes, though they may use different approaches to achieve them.

Global Data Information Sharing

To effectively identify signals of potential future 

threats to public health, regulatory authorities will 

need rapid access to multiple sources of information 

around the world. FDA will work with its global 

partners to identify critical data for risk models and to 

standardize how this information is reported. This will 

provide the foundation for building global data and 

information systems and networks to facilitate regular, 

systematic information exchange among FDA and its 

partners. Such systems will enable the Agency to better identify and analyze risks globally, and apply the 

necessary action to prevent or minimize harm.

Passage of the Food Safety Modernization Act in 

January 2011 provided FDA with crucial new authorities and tools to ensure the safety of imported food. 

These authorities create exciting opportunities for FDA 

to implement its Pathway to Global Product Safety and 

Quality in the area of food safety. For example, FSMA 

explicitly recognizes that food safety agencies around 

the world need to work together in an integrated way 

to achieve shared public health goals. FSMA encourages arrangements with foreign governments to leverage resources. And, FSMA directs FDA to develop 

a comprehensive plan to strengthen the regulatory 

capacity of foreign governments and their industries—

for example, by training foreign regulatory agencies and 

food producers on U.S. food safety requirements.

Under FSMA, FDA will build a new oversight system 

to hold importers accountable for the safety of the 

food they bring into the United States. The Agency 

also has the power to enlist qualified third parties in 

certifying that foreign food facilities comply with U.S. 

food safety standards and to require this certification 

as a condition of entry for certain high-risk foods.

Implementing a 

New Paradigm for 

Food Safety

Working together can help us advance 

solutions through the development and 

application of new tools and approaches. 

Mary Lou Valdez, FDA Associate 

Commissioner for International Programs

WEAVING A GLOBAL SAFETY NET

Meaningful progress will depend on sustaining vigorous momentum in the United 

States and the global community to make these changes real and enduring. Weaving 

a vibrant global safety net across all borders will be challenging and require the support of many nations and organizations in light of the tough global challenges ahead. FDA is 

committed to productive and pragmatic dialogue and collaboration—with regulators, consumers, academics, industry leaders, and others at home and abroad—to discover and achieve new 

ways to promote public health in the United States and around the globe.
36Acronyms

AMR anti-microbial resistance

APEC Asia-Pacific Economic 

Cooperation

ASEAN Association of Southeast 

Asian Nations

AVAREF African Vaccine Regulators 

Forum

CBER FDA Center for Biologics 

Evaluation and Research

CDER FDA Center for Drug 

Evaluation and Research

CDRH FDA Center for Devices 

and Radiological Health

CFSAN FDA Center for Food 

Safety and Applied 

Nutrition

Codex Codex Alimentarius 

Commission

CORE Coordinated Outbreak 

Response and Evaluation

CTP FDA Center for Tobacco 

Products

CVM FDA Center for Veterinary 

Medicine

EAC East African Community

EFSA European Food Safety 

Agency

EMA European Medicines 

Agency

EOC FDA Emergency 

Operations Center

EU European Union

FAO United Nations Food and 

Agriculture Organization

FDA U.S. Food and Drug 

Administration

FSMA Food Safety Modernization 

Act

FY U.S. Government 

fiscal year

GCC Gulf Cooperation Council

GCP Good Clinical Practice(s)

GE genetically engineered/

genetic engineering

GHTF Global Harmonization Task 

Force

GMP Good Manufacturing 

Practice(s)

GO FDA Office of Global 

Regulatory Operations 

and Policy

HC Health Canada

HHS U.S. Department of Health 

and Human Services

ICH International Conference 

on Harmonization of 

Technical Requirements 

for Registration of 

Pharmaceuticals for 

Human Use

IHR International Health 

Regulation

IMDRF International Medical 

Device Regulators Forum 

IMS ion mobility spectrometer

INFOSAN International Food Safety 

Authorities Network

IOM Institute of Medicine

ISEP International Scientist 

Exchange Program

JIFSAN Joint Institute for Food 

Safety and Applied 

Nutrition

MAQC MicroArray Quality Control

MENA Middle East/North Africa

MVP Meningitis Vaccine Project

NCTR FDA National Center for 

Toxicological Research

NRA national regulatory 

authority

NZFSA New Zealand Food Safety 

Authority

OCM FDA Office of Crisis 

Management

OCS FDA Office of the Chief 

Scientist

OF FDA Office of Foods

OIE World Organization for 

Animal Health

OIP FDA Office of International 

Programs

OMPT FDA Office of Medical 

Products and Tobacco

ORA FDA Office of Regulatory 

Affairs

PAHO Pan American Health 

Organization

PANDRH Pan American Network 

on Drug Regulatory 

Harmonization

PEPFAR President’s Emergency 

Plan for AIDS Relief

PIC/S Pharmaceutical Inspection 

Cooperation Scheme

PREDICT Predictive Risk-Based 

Evaluation for Dynamic 

Import Compliance 

Targeting

RASFF Rapid Alert System for 

Food and Feed

REC Regional Economic 

Community

SADC South African 

Development Community

SII Serum Institute of India

SSA Sub-Saharan Africa

UDI unique device 

identification

VICH Veterinary Conference 

on International 

Harmonization

WHO World Health Organization

ACRONYMS
37OIP Contact Information

U.S. Food and Drug

 Administration

Office of International Programs

10903 New Hampshire Avenue

Building 31/32

Silver Spring, MD 20993-0002

USA

Tel: +1.301.796.4600

Fax: +1.301.595.7937

Executive Operations Office

U.S. Food and Drug

 Administration

Office of International Programs

10903 New Hampshire Avenue

Building 31/32

Silver Spring, MD 20993-0002

USA

Tel: +1.301.796.4600

Fax: +1.301.595.7937

E-mail: US-FDAOIPEXECOPS

 @fda.hhs.gov

Office of Global Engagement

U.S. Food and Drug

 Administration

Office of International Programs

10903 New Hampshire Avenue

Building 31/32

Silver Spring, MD 20993-0002

USA

Tel: +1.301.796.4600

Fax: +1.301.595.7937

E-mail: US-FDA-OGE

 @fda.hhs.gov 

Harmonization and Multilateral

 Relations Office

U.S. Food and Drug

 Administration

Office of International Programs

10903 New Hampshire Avenue

Building 31/32

Silver Spring, MD 20993-0002

USA

Tel: +1.301.796.4600

Fax: +1.301.595.7937

E-mail: US-FDA-HMRO

 @fda.hhs.gov 

Asia-Pacific Office

U.S. Food and Drug

 Administration

Office of International Programs

10903 New Hampshire Avenue

Building 31/32

Silver Spring, MD 20993-0002

USA

Tel: +1.301.796.4600

Fax: +1.301.595.7937

E-mail: US-FDA-AP@fda.hhs.gov 

China Office

U.S. Food and Drug

 Administration

Office of International Programs

U.S. Embassy-HHS/FDA

#55 An Jia Lou Road

Chaoyang District, Beijing

100600, China

Tel: +86.10.8531.3000 or 

+86.10.8531.3924

Fax: +86.10.6532.2032

E-mail: ChinaFDA@state.gov 

Europe Office

U.S. Food and Drug

 Administration

Office of International Programs

10903 New Hampshire Avenue

Building 31/32

Silver Spring, MD 20993-0002

USA

Tel: +1.301.796.4600

Fax: +1.301.595.7937

Email: OC-OIP-Europe

 @fda.hhs.gov 

India Office

U.S. Food and Drug

 Administration

Office of International Programs

United States Embassy

Shantipath, Chanakyapuri

New Delhi, India - 110021

Tel: +91.11.2419.8269

Fax: +91.11.2419.8770

E-mail: NDBoxFDAIndiaOffice

 @state.gov 

Latin America Office

U.S. Food and Drug

 Administration

Office of International Programs

United States Embassy

Ave 0 Calle 120 

Frente al Centro Comercial del

 Oeste 

Rohrmoser, San José, Costa Rica

Tel: +506.2519.2224

E-mail: US-FDA-LAO@fda.hhs.gov 

Middle East and 

 North Africa Post

U.S. Food and Drug

 Administration

Office of International Programs

United States Embassy

P.O. Box 354, Amman

11118 Jordan

Telephone: +962.6.590.6000

Fax: +962.6.592.0163

E-mail: US-FDA-MENA

 @fda.hhs.gov 

Sub-Saharan Africa Post

U.S. Food and Drug

 Administration

Office of International Programs

United States Embassy

877 Pretorius Street

Pretoria, South Africa 0001

Tel: +27.12.431.4632 or 

+27.12.431.4654

Fax: +27.12.342.6167

E-mail: US-FDA-SSA

 @fda.hhs.gov

C O N TA C T I N F O R M AT I O N F O R F D A 

INTERNATIONAL OFFICES AND POSTS
38Endnotes

1 U.S. FDA. 2011. Pathway to Global Product Safety and Quality. Retrieved July 19, 2011, from http://www.fda.gov/

AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm.

2 Hamburg, M. 2010. FDA and the American Public: The Safety of Foods and Medical Products in the Global Age. 

Presented at Center for Strategic and International Studies, February 4.

3 Hamburg, M. 2011. Food and Drugs: Can Safety Be Ensured In a Time of Increased Globalization? Presented at the 

Council of Foreign Relations New York Symposium, January 31.

4 Huang, S. and Huang, K. 2007. Increased U.S. Imports of Fresh Fruit and Vegetables. U.S. Department of Agriculture, 

Economic Research Service, FTS-328-01. Retrieved March 27, 2012, from http://www.unitedfresh.org/assets/files/

Increased%20U.S.%20FFV%20Imports.pdf.

5 “Fiscal year” (FY) refers to the U.S. federal government annual accounting period, which begins on October 1 and ends 

on September 30. The fiscal year is designated by the calendar year in which it ends. For example, FY 2010 runs from 

October 1, 2009, to September 30, 2010.

6 Veneziano, D. 2011. Import Stats FY 2002-2010. U.S. FDA, Division of Import Operations and Policy, Office of Regulatory 

Affairs, Washington, DC.

7 U.S. Department of Commerce and U.S. International Trade Commission. 2011. Data presented by U.S. Department of 

Agriculture, Foreign Agricultural Service, Global Agricultural Trade System. Retrieved May 25, 2011, from http://www.fas.

usda.gov/gats/default.aspx.

8 U.S. FDA. 2011. Pathway to Global Product Safety and Quality. Retrieved July 19, 2011, from http://www.fda.gov/

AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm.

9 Veneziano, D. 2011. Import Stats FY 2002-2010. U.S. FDA, Division of Import Operations and Policy, Office of Regulatory 

Affairs, Washington, DC.

10 U.S. Congressional Budget Office. 2008. Technological Change and the Growth of Health Care Spending. Retrieved July 

21, 2011, from http://www.cbo.gov/ftpdocs/89xx/doc8947/MainText.3.1.shtml.

11 U.S. Congressional Budget Office. 2008. Technological Change and the Growth of Health Care Spending. Retrieved July 

21, 2011, from http://www.cbo.gov/ftpdocs/89xx/doc8947/MainText.3.1.shtml.

12 Veneziano, D. 2011. Import Stats FY 2002-2010. U.S. FDA, Division of Import Operations and Policy, Office of Regulatory 

Affairs, Washington, DC.

13 Hamburg, M. 2010. FDA and the American Public: The Safety of Foods and Medical Products in the Global Age.

Presented at Center for Strategic and International Studies, February 4.

14 U.S. FDA. 2011. Pathway to Global Product Safety and Quality. USA Medical Device Market Intelligence Report, Quarter 

III, 2010, Espicom Business Intelligence. Retrieved July 19, 2011, from http://www.fda.gov/AboutFDA/CentersOffices/

OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm.

15 U.S. Department of Health and Human Services. 2010. Challenges to FDA’s Ability to Monitor and Inspect Foreign 

Clinical Trials. Retrieved June 16, 2011, from http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf.

16 U.S. FDA. 2011. Overview of the Center for Tobacco Products: Consumer Fact Sheet. Retrieved September 16, 2011, 

from http://www.fda.gov/TobaccoProducts/NewsEvents/ucm265521.htm.

17 U.S. FDA. 2011. Overview of the Family Smoking Prevention and Tobacco Control Act. Retrieved September 16, 2011, 

from http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm.

18 U.S. FDA. 2011. Pathway to Global Product Safety and Quality. Retrieved July 19, 2011, from http://www.fda.gov/

AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm. 

19 Becker, G.S. 2008. Report to Congress: Food and Agricultural Imports from China. Congressional Research Service 

Report RL34080.

20 Brooks, N., Regmi, A., and Jerardo, A. 2009. U.S. Food Import Patterns, 1998-2007. U.S. Department of Agriculture, 

Economic Research Service, FAU-125. Retrieved June 8, 2011, from http://www.ers.usda.gov/publications/

fau/2009/08aug/fau125/fau125.pdf.

21 Shute, N. 2007. Are Your Drugs Safe? Shoddy and fraudulent pharmacy products pose a growing threat. U.S. News 

& World Report. Retrieved June 10, 2011, from http://health.usnews.com/health-news/managing-your-healthcare/

healthcare/articles/2007/10/05/are-your-drugs-safe.

ENDNOTES
39 22 Chantianzhi, M. 2009. China’s Medical Device Import and Export Trade Continued to Maintain a High Growth Rate in 

2008. Retrieved June 8, 2011, from http://www.gotocmp.com/insight/00453094.html.

23 Foods with low acidity, such as meats, seafood, poultry, dairy products, and vegetables, are at higher risk of becoming 

contaminated with botulism, a rare but serious form of food poisoning.

24 U.S. Trade Representative. 2007. The United States–China Government Signing Ceremony Fact Sheet. Retrieved October 

9, 2011, from http://www.ustr.gov/sites/default/files/uploads/factsheets/2007/asset_upload_file675_13697.pdf.

25 U.S. FDA. 2008. Consumer Health Information: FDA Beyond Our Borders. Retrieved October 9, 2011, from http://www.

fda.gov/downloads/ForConsumers/ConsumerUpdates/ucm103044.pdf.

26 Ross, B. 2009. A Call to Action: Opening FDA Offices in India. Retrieved June 8, 2011, from http://www.usp.org/pdf/EN/

meetings/indiaPresentations/rossBruce.pdf.

27 Xinhua. 2009. FDA Opens Offices in India. People’s Daily Online. Retrieved June 8, 2011, from http://english.people.com.

cn/90001/90778/90858/90864/6575518.html.

28 Basu, I. 2004. India’s clinical trials and tribulations. Asia Times. Retrieved August 3, 2011, from http://www.atimes.com/

atimes/South_Asia/FG23Df03.html.

29 Cygnus Cygnus Business Consulting & Research. 2010. Clinical Trials in India. Retrieved June 8, 2011, from http://www.

cygnusindia.com/pdfs/TOC_Clinical%20trials_Feb-2010.pdf.

30 D’Sa, A. 2010. Overview of FDA India Office Activities and Recent Initiatives of FDA. Retrieved June 8, 2011, from http://

www.ipapharma.org/events/IPA%20%20EDQM%20pdf/Albinus_overview_FDA.pdf.

31 Brooks, N., Regmi, A., and Jerardo, A. 2009. U.S. Food Import Patterns, 1998-2007. U.S. Department of Agriculture, 

Economic Research Service, FAU-125. Retrieved June 8, 2011, from http://www.ers.usda.gov/publications/

fau/2009/08aug/fau125/fau125.pdf.

32 Office of the Global AIDS Coordinator. 2011. About PEPFAR. Retrieved June 8, 2011, from http://www.pepfar.gov/about/

index.htm.

33 Office of the Global AIDS Coordinator. 2011. Latest PEPFAR Program Results. Retrieved June 8, 2011, from http://www.

pepfar.gov/results/index.htm. 

34 U.S. FDA. 2011. Technical Cooperation and Capacity Building. Retrieved February 25, 2011, from http://www.fda.gov/

InternationalPrograms/CapacityBuilding/default.htm.

35 Midthun, K. 2011. Regulatory Capacity Building and Developing Countries: CBER Perspective. Presented at Institute of 

Medicine Meeting, March 2. 

36 Autor, D. 2011. Globalization, Challenges, and Global Solutions. Presented at Institute of Medicine Meeting, March 2.

37 Bond, K. 2010. Strengthening Regulatory Capacity in a Globalized World. Presented at FDA Office of International 

Programs International Forum, November 4.

38 CDER World is available at: http://www.fda.gov/Training/ForHealthProfessionals/ucm274163.htm 

39 CDRH Learn is available at: http://www.fda.gov/Training/CDRHLearn/default.htm 

40 CBER’s Web-Based Biologics Seminar is available at: http://www.fda.gov/BiologicsBloodVaccines/InternationalActivities/

ucm272086.htm

41 World Health Organization. 2010. African Vaccine Regulatory Forum (AVAREF). Retrieved July 20, 2011, from http://www.

who.int/immunization_standards/vaccine_regulation/africa_network/en/index.html.

42 U.S. FDA. 2011. Technical Cooperation and Capacity Building. Retrieved February 25, 2011, from http://www.fda.gov/

InternationalPrograms/CapacityBuilding/default.htm.

43 U.S. FDA. n.d. FDA-WHO AGISAR/GFN Cooperative Agreement. Information provided by U.S. FDA.

44 Institute of Medicine. 2011. Strengthening Core Elements of Regulatory Systems in Developing Countries. Retrieved May 

31, 2011, from http://www.iom.edu/Activities/Global/RegulatoryCoreElements.aspx. 

45 U.S. FDA. 2010. Draft Reference Document. Strengthening Core Elements of Regulatory Systems in Developing 

Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration. Information 

provided by U.S. FDA.

46 Hamburg, M. and Lumpkin, M. 2011. Interview with Eastern Research Group, Inc. February 10, 2011.

47 Lumpkin, M. 2009. U.S. FDA and Globalization.

Endnotes
40Endnotes

48 Eckel, M. 2010. Other International Arrangements: Agreements, Memoranda of Understanding, and Confidentiality 

Arrangements.

49 Elder, D. 2011. Email communication to Eastern Research Group, Inc. November 8, 2011.

50 International Pharmaceutical Quality. 2011. International Joint API Inspection Pilot Program Sees Positive Results.

Retrieved June 3, 2011, from http://www.ipqpubs.com/joint_inspection/.

51 U.S. FDA. 2010. Globalization of Pharmaceuticals. Information provided by U.S. FDA.

52 U.S. FDA. 2010. Globalization of Medical Products. Information provided by U.S. FDA.

53 U.S. FDA. 2010. Final Joint Report of the Pilot Multipurpose Audit Program (pMAP). Retrieved June 3, 2011, from 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ThirdPartyInspection/

ucm232806.htm.

54 U.S. FDA. 2010. Announcement: Completion of the pilot Multipurpose Audit Program (pMAP). Retrieved June 

3, 2011, from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/

ThirdPartyInspection/ucm232802.htm.

55 Hamburg, M. 2011. Import Safety: Status of FDA’s Screening Efforts at the Border. Statement to the House, 

Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, April 13. 

56 U.S. FDA. 2010. Melamine Pet Food Recall of 2007. Retrieved June 8, 2011, from http://www.fda.gov/animalveterinary/

safetyhealth/recallswithdrawals/ucm129575.htm.

57 Blair, J. 2011. Email communication to Eastern Research Group, Inc. December 16, 2010. 

58 U.S. FDA. 2011. Radiation Safety. Retrieved June 8, 2011, from http://www.fda.gov/newsevents/publichealthfocus/

ucm247403.htm#usfromjapan.

59 Hamburg, M. 2011. Increasing the Prestige of Regulatory Sciences. Presented at Society of Toxicology Annual Meeting, 

March 28.

60 Microarray Quality Control. 2006. Nature Biotechnology. 24:9. Retrieved December 13, 2011, from http://www.nature.

com/nbt/focus/maqc/index.html.

61 Baker, M. and DeFrancesco, L. 2011. Five more years of Nature Biotechnology research. Nature Biotechnology. 29:3,221-

227. Retrieved December 13, 2011, from http://www.nature.com/nbt/journal/v29/n3/full/nbt.1798.html. 

62 U.S. FDA. 2011. MicroArray Quality Control (MAQC). Retrieved December 13, 2011, from http://www.fda.gov/

ScienceResearch/BioinformaticsTools/MicroarrayQualityControlProject/default.htm.

63 PATH. 2011. Meningitis Vaccine Project: A century of destruction. Retrieved May 23, 2011, from http://www.path.org/

menafrivac/about-meningitis.php.

64 LaForce, F.M., Konde, K., Viviani, S., Préziosi, M. 2007. The Meningitis Vaccine Project. Vaccine 25S, A97-A100. Retrieved 

May 23, 2001, from http://www.hkmacme.org/course/2008BW12-05-00/ID1208.pdf.

65 Meningitis Vaccine Project. 2011. Epidemics in Africa. Retrieved September 30, 2011, from http://www.meningvax.org/

epidemics-africa.php.

66 Meningitis Vaccine Project. 2011. Meningitis Vaccine Project. Retrieved May 23, 2011, from http://www.meningvax.org/.

67 PATH. 2011. Hope for an End to Epidemic Meningitis. Retrieved May 23, 2011, from http://www.path.org/media/

slideshow-end-meningitis/index.php.

68 U.S. FDA. 2009. Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable 

Recombinant DNA Constructs. Retrieved May 23, 2011, from http://www.fda.gov/downloads/animalveterinary/

guidancecomplianceenforcement/guidanceforindustry/ucm113903.pdf.

69 U.S. FDA. 2011. Pathway to Global Product Safety and Quality. Retrieved July 19, 2011, from http://www.fda.gov/

AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm.
As our world transforms 

and becomes increasingly 

globalized, we must come 

together in new, unprecedented, 

even unexpected, ways to build 

a public health safety net for 

consumers around the world. 

Margaret Hamburg, FDA Commissioner

“

”
U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

http://www.fda.gov/