Product regulatory systems in low-and middle-income countries must be strengthened

October 23, 2012 in Health

When regulatory systems for medical products in low-and middle-income countries work, people live but when such systems fail, people die, according to experts from the US Food and Drug Administration (FDA) writing in this week's PLOS Medicine.

Charles Preston, Mary Lou Valdez, and Katherine Bond from the Office of International Programs at the FDA, argue that few global initiatives focus on strengthening the medical product regulatory systems in low-and middle-income countries but that globalization and the scaling up of medicines and vaccines to these countries are highlighting the urgent need for systems to assure product efficacy, safety, and quality.

Using recent examples, such as the successful MenAfriVac (a vaccine against meningitis designed for ), the authors argue that 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, whether in high, middle, or low-income countries should have, such as firm rules and a mechanism to take regulatory action when necessary. They say: "To this end, it will be important to begin a global dialogue on the subject of strengthening in low- and middle-income countries."

The authors conclude: "As the challenges of globalization mount, and efforts to provide medical products to low- and middle-income countries scale up, there is no better time to put regulatory system strengthening squarely on the and development agenda."

More information: PLoS Med 9(10): e1001327. doi:10.1371/journal.pmed.1001327

Journal reference: PLoS Medicine search and more info website

Provided by Public Library of Science search and more info website

not rated yet  

Rank not rated yet
Relevant PhysicsForums posts

More news stories

Aggressive behavior linked specifically to secondhand smoke exposure in childhood

Children who are exposed to secondhand smoke in early childhood are more likely to grow up to physically aggressive and antisocial, regardless of whether they were exposed during pregnancy or their parents have a history ...

Health created 1 hour ago | popularity 1 / 5 (1) | comments 0

Most elite athletes believe doping substances are effective in improving performance

Most elite athletes consider doping substances "are effective" in improving performance, while recognising that they constitute cheating, can endanger health and entail the obvious risk of sanction. At the same time, the ...

Health created 2 hours ago | popularity not rated yet | comments 0

New rice contamination reported in China

Authorities are investigating rice mills in southern China following tests that found almost half of the staple grain in one of the country's largest cities was contaminated with a toxic metal.

Health created 5 hours ago | popularity 5 / 5 (1) | comments 0

Warning images for cigarette packs do not make a strong enough emotional impact

The warning images Brussels proposes to include on tobacco packages in order to reduce consumption do not make the desired impact on smokers because they only find some of them really unpleasant. So, if the ...

Health created 6 hours ago | popularity not rated yet | comments 0

Cancer and birth defects in Iraq: The nuclear legacy

Ten years after the Iraq war of 2003 a team of scientists based in Mosul, northern Iraq, have detected high levels of uranium contamination in soil samples at three sites in the province of Nineveh which, coupled with dramatically ...

Health created 6 hours ago | popularity not rated yet | comments 0


B vitamins could delay dementia

(Medical Xpress)—Despite spending billions of dollars on research and development, drug companies have been unable to come up with effective treatments for dementia and Alzheimer's Disease (AD). Now, A. ...

Drugs found to both prevent and treat Alzheimer's disease in mice

Researchers at USC have found that a class of pharmaceuticals can both prevent and treat Alzheimer's Disease in mice.

Enrichment therapy effective among children with autism, study finds

Children with autism showed significant improvement after six months of simple sensory exercises at home using everyday items such as scents, spoons and sponges, according to UC Irvine neurobiologists.

Poliovirus vaccine trial shows early promise for recurrent glioblastoma

An attack on glioblastoma brain tumor cells that uses a modified poliovirus is showing encouraging results in an early study to establish the proper dose level, researchers at Duke Cancer Institute report.

'Doctor shopping' by obese patients negatively affects health

Overweight and obese patients are significantly more likely than their normal-weight counterparts to repeatedly switch primary care doctors, a practice that disrupts continuity of care and leads to more emergency room visits, ...

Decisions to forgo life support may depend heavily on the ICU where patients are treated

The decision to limit life support in patients in the intensive care unit (ICU) appears to be significantly influenced by physician practices and/or the culture of the hospital, suggests new findings from researchers at the ...