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. In sub-Saharan Africa alone, poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 deaths from malaria every year. Ensuring the safety and quality of food and medicines in a country is an important role of government and essential for public health.
The capacity of regulatory systems abroad is of special interest to the U.S. Food and Drug Administration (FDA) Office of Global Policy and Strategy, the office that commissioned this study and a similar one released in 2012. This report discusses changes in the field since the 2012 study and outlines a strategy to strengthen food and medical products regulatory systems in low- and middle-income countries, recommending actions at the global, national and agency levels (see condensed recommendations table).