MFDS Approves Special Import of COVID-19 Treatment Drug 'Remdesivir'

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety announced on the 3rd that it has decided to grant special import approval for 'Remdesivir,' an Ebola treatment drug developed by the U.S. pharmaceutical company Gilead Sciences as a treatment for the novel coronavirus infection (COVID-19).

Special import approval for pharmaceuticals is a system that allows the importation of drugs not approved domestically from abroad to respond to public health crises such as infectious disease pandemics. The Korea Disease Control and Prevention Agency plans to consult with related ministries, the Ministry of Food and Drug Safety, and Gilead Sciences Korea for the prompt importation of the drug into the country.

Earlier, the Korea Disease Control and Prevention Agency requested special import approval from the Ministry of Food and Drug Safety after the Central Clinical Committee on Emerging Infectious Diseases proposed the introduction of Remdesivir domestically. The Ministry of Food and Drug Safety decided on the special import approval of Remdesivir after deliberation by the National Essential Medicines Stable Supply Council (Disease Control Subcommittee).

The Ministry of Food and Drug Safety explained the background of the special import approval decision, stating, "It was judged that the reduction in treatment duration for severe patients using Remdesivir is clinically significant and that additional options for treatment are necessary." It added, "Consideration was also given to the fact that Remdesivir is currently authorized for use in the COVID-19 pandemic situation in the United States, Japan, and the United Kingdom."

The government plans to cooperate with Gilead Sciences Korea, the domestic importer of Remdesivir, to provide maximum support so that the drug can be introduced into the country as soon as possible.