Regulatory systems for medical products in low- and middle-income countries can save lives but people can die when such systems fail, U.S. researchers say.
Charles Preston, Mary Lou Valdez and Katherine Bond of the Office of International Programs at the U.S. Food and Drug Administration said few global initiatives focus on strengthening the medical product regulatory systems in low- and middle-income countries — frequently referred to as developing nations.
Globalization and the scaling up of medicines and vaccines to such countries are highlighting the urgent need for systems to assure product efficacy, safety and quality, the researchers said.