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

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


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.

MeSH terms

  • Developing Countries
  • Humans
  • Legislation, Drug*
  • Pharmaceutical Preparations*
  • Vaccines


  • Pharmaceutical Preparations
  • Vaccines

Grants and funding

No specific funding was received for writing this article. The authors are employees of the United States Food and Drug Administration.