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PLoS Med. 2012;9(10):e1001327. doi: 10.1371/journal.pmed.1001327. Epub 2012 Oct 23.

Strengthening medical product regulation in low- and middle-income countries.

Author information

1
Office of International Programs, US Food and Drug Administration, Silver Spring, Maryland, United States of America. charles.preston@fda.hhs.gov

Abstract

In summary, the case studies exploring global product supply chains and diethylene glycol poisoning in Panama, clinical trials regulation through AVAREF, premarket assurance through PEPFAR tentative approval, post-market surveillance in sub-Saharan Africa through research on drug and vaccine safety systems, and regulatory science through the creation of a low-cost meningitis vaccine for low- and middle-income countries, demonstrate the essential value of regulatory systems to low- and middle-income countries. When they work, people live; when they fail, people die. 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 global health and development agenda.

PMID:
23109912
PMCID:
PMC3479087
DOI:
10.1371/journal.pmed.1001327
[Indexed for MEDLINE]
Free PMC Article
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