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

October 23, 2012

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."

Explore further: Canada should play a role in addressing the global cancer epidemic: researchers

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

Related Stories

Canada should play a role in addressing the global cancer epidemic: researchers

April 10, 2012
Cancer is a growing health concern in low- and middle-income countries, and there is an opportunity for Canada to make a significant contribution to help tackle the disease, states an analysis in CMAJ (Canadian Medical Association ...

Obesity linked to economic status in developing countries

July 18, 2012
(HealthDay) -- In low- and middle-income developing countries, socioeconomic status (SES) plays an important role in the development of obesity, particularly in women, according to research published online July 5 in Obesity ...

How health systems factors affect access to psychotropic medicines

January 31, 2012
In a cross-sectional analysis of WHO-AIMS data published in this week's PLoS Medicine, Ryan McBain of Harvard School of Public Health, Boston, USA and colleagues investigated the associations between health system components ...

Low and middle income countries are the recent targets of processed food manufacturers

June 26, 2012
"There is significant penetration by multinational processed food manufacturers such as Nestle, Kraft, PepsiCo, and Danone into food environments in low-and-middle income countries, where consumption of unhealthy commodities ...

Low levels of care-seeking for newborn illness in low- and middle-income countries

March 7, 2012
In this week's PLoS Medicine, Abdullah Baqui from the Johns Hopkins Bloomberg School of Public Health, USA and colleagues systematically review studies describing newborn care-seeking behaviours by caregivers in low- and ...

Time to invest in trauma care

March 19, 2012
Up to two million lives, annually, could be saved globally with improvements in trauma care, particularly in low- and middle-income countries. This estimate by Charles Mock, from the University of Washington in Seattle, and ...

Recommended for you

Americans misinformed about smoking

August 22, 2017
After voluminous research studies, numerous lawsuits and millions of deaths linked to cigarettes, it might seem likely that Americans now properly understand the risks of smoking.

Women who sexually abuse children are just as harmful to their victims as male abusers

August 21, 2017
"That she might seduce a helpless child into sexplay is unthinkable, and even if she did so, what harm can be done without a penis?"

To reduce postoperative pain, consider sleep—and caffeine

August 18, 2017
Sleep is essential for good mental and physical health, and chronic insufficient sleep increases the risk for several chronic health problems.

Despite benefits, half of parents against later school start times

August 18, 2017
Leading pediatrics and sleep associations agree: Teens shouldn't start school so early.

Doctors exploring how to prescribe income security

August 18, 2017
Physicians at St. Michael's Hospital are studying how full-time income support workers hired by health-care clinics can help vulnerable patients or those living in poverty improve their finances and their health.

Schoolchildren who use e-cigarettes are more likely to try tobacco

August 17, 2017
Vaping - or the use of e-cigarettes - is widely accepted as a safer option for people who are already smoking.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.