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March 5, 2020

Regulating Medicines in a Globalized World With Increased Recognition and Reliance Among Regulators: A National Academies Report

Author Affiliations
  • 1O’Neill Institute for National and Global Health Law, Georgetown University, Washington, DC
  • 2Vanderbilt University, Nashville, Tennessee
  • 3National Academies of Sciences, Engineering, and Medicine, Washington, DC
JAMA. Published online March 5, 2020. doi:10.1001/jama.2019.21793

Research and development of pharmaceuticals are now complex global endeavors, with drug companies operating worldwide using global supply chains.1 Pharmaceutical companies source their products from many countries, conduct trials in multiple sites, and market essential drugs and vaccines globally. Yet oversight of drug safety and effectiveness is primarily the responsibility of national regulators of variable capacities. National agencies often undertake product reviews without recognizing that similar reviews are occurring elsewhere, sometimes simultaneously.2 The result is duplication and redundancy, which benefits neither national nor global public health. Supported by the US Food and Drug Administration (FDA), the National Academies of Sciences, Engineering, and Medicine convened an expert committee to explore the benefits of mutual recognition and other reliance activities among regulators.3

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