Regulations needed for medical products

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WASHINGTON, Oct. 25 (UPI) -- 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.

Using recent examples, such as the successful MenAfriVac -- a vaccine against meningitis designed for African populations -- the authors argued although the global health community is gradually awakening to the role that regulatory systems play in low- and middle-income countries, more needs to be done to make strengthening these systems a global health priority.

The authors propose several elements that all regulatory systems should have -- whether in high-, middle- or low-income countries -- such as firm rules and a mechanism to take regulatory action when necessary.

"To this end, it will be important to begin a global dialogue on the subject of regulatory system strengthening in low- and middle-income countries," the researchers said.

The findings were published in the journal PLOS Medicine.