Stronger Food and Drug Regulatory Systems Abroad

Consensus

Download PDF

Paperback - $58.50
Ebook - $49.49

Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone.

The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress.

The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.

Additional materials

Publication information

240 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-67043-8
ISBN Ebook: 0-309-67044-6
DOI: https://doi.org/10.17226/25651

Suggested citation

National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press.

Import this citation to:

Consensus

Read Online

Download PDF

A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness.

The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.

Additional materials

Press Release

Publication information

366 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-22408-X
ISBN Ebook: 0-309-22409-8
DOI: https://doi.org/10.17226/13296

Suggested citation

Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press.

Import this citation to:

Log In

Sign in to access your saved publications, downloads, and email preferences.

Former MyNAP users: You'll need to reset your password on your first login to MyAcademies. Click "Forgot password" below to receive a reset link via email. Having trouble? Visit our FAQ page to contact support.

Members of the National Academy of Sciences, National Academy of Engineering, or National Academy of Medicine should log in through their respective Academy portals.

Email (required)
Password (required)

Don't have an account?

Register

Email (required)
New password (required)
Retype password (required) Password must be at least 8 characters
I accept the terms of use
terms of use

Thank You

Thank you for creating a MyAcademies account!

Enjoy free access to thousands of National Academies' publications, a 10% discount off every purchase, and build your personal library.

Forgot Password

Enter the email address for your MyAcademies (formerly MyNAP) account to receive password reset instructions.

Reset Requested

We sent password reset instructions to your email . Follow the link in that email to create a new password. Didn't receive it? Check your spam folder or contact us for assistance.

Reset Password

New password (required)
Retype password (required) Password must be at least 8 characters

Reset Password

Your password has been reset.

Log In

Verify email

Verify Your Email Address

We sent a verification link to your email. Please check your inbox (and spam folder) and follow the link to verify your email address. If you did not receive the email, you can request a new verification link below

Subscribe

First Name
Last Name
Email (required)
I agree to receive emails from the National Academies (required)

We respect your privacy and will never share your information.

Stronger Food and Drug Regulatory Systems Abroad

Featured publication

Publications

Additional materials

Publication information

Suggested citation

Additional materials

Publication information

Suggested citation

My Academies

Stronger Food and Drug Regulatory Systems Abroad

Dropdown items

Featured publication

Stronger Food and Drug Regulatory Systems Abroad

Publications