Strengthening Medical Product Regulation in Low- and Middle-Income Countries

Autor: Mary Lou Valdez, Katherine Bond, Charles Preston
Rok vydání: 2012
Předmět:
Zdroj: PLoS Medicine, Vol 9, Iss 10, p e1001327 (2012)
PLoS Medicine
ISSN: 1549-1676
Popis: 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.
Databáze: OpenAIRE