South Korea Was Prepared to Combat COVID-19

The U.S. FDA's Center for Devices and Radiological Health has issued a new report on May 25, 2021, that describes the approaches used by the South Korean government to address COVID-19, particularly regarding the development, authorization.

South Korea’s approach was based on lessons they learned from a deadly Middle Eastern Respiratory Syndrome outbreak in 2015 and the steps they took before the COVID-19 pandemic hit.

First, the government invested in the commercial development of diagnostic testing technology. Since 2017, the Ministry of Science and Information and Communications Technology has invested almost 25 million U.S. dollars in infectious disease diagnosis technology.

As a result of these investments, a subset of South Korean commercial manufacturers was well-positioned to develop and manufacture tests quickly.

Second, the government designed an emergency use authorization pathway modeled on the system used in the U.S.

Third, the South Korean legislature amended the Infectious Disease Prevention and Control Act of Korea in 2015 to allow relevant authorities to collect personal data on confirmed and suspected cases of infection during an infectious disease emergency.

In early April 2020, numerous sources worldwide declared South Korea’s response strategy had successfully "flattened the curve" of COVID-19.

As South Korea's experience may be informative for future considerations, the FDA reviewed the information, including reports in the press and information made publicly available by the South Korean government about their COVID-19 response strategy.

The FDA recognizes different approaches may work for different countries. This report does not recommend what approaches could or should be adopted in the USA for emerging infectious diseases.