Accelerating Access to in vitro Diagnostics: Urgent Need for Increasing the Speed and Efficiency of Regulatory Review and Policy Development for in vitro Diagnostics for Antimicrobial Resistance and Epidemic Preparedness and Response

In 2015, the US National Academy of Medicine convened a workshop entitled, Global Health Risk Framework for Research and Development of Medical Products. According to Hans-Georg Eichler, European Medicines Agency, “Even though regulators have the same overall goals, there are many different actors and often a divergence of outcomes. There are costs and risk associated with nonconvergence among regulators and other decision makers. In 2016, member states of the United Nations committed to a set of Sustainable Development Goals with which countries pledged to make health care available for all and to leave no one behind. The diagnosis of HIV born to HIV-infected mothers requires molecular testing to detect virus in the blood of infants as maternal HIV antibodies tend to stay in the blood of infants up to 18 months of age.