title: Strengthening medical product regulation in low- and middle-income countries.
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.
authors.affiliation: Office of International Programs, US Food and Drug Administration, Silver Spring, Maryland, United States of America. charles.preston@fda.hhs.gov
authors.forename: Charles
authors.initials: C
authors.lastname: Preston
authors.forename: Mary Lou
authors.initials: ML
authors.lastname: Valdez
authors.forename: Katherine
authors.initials: K
authors.lastname: Bond
mesh_terms: D003906:Developing Countries; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations; D014612:Vaccines
chemical_list: D004364:Pharmaceutical Preparations; D014612:Vaccines