South Korean companies’ COVID-19 diagnostic kits have won pre-approval from the Food and Drug Administration (FDA).
The Ministry of Foreign Affairs and Trade said on March 28 that the products of three local companies that produce the COVID-19 diagnostic kits have obtained prior approval in the FDA's emergency use approval process.
The ministry explained that the FDA's pre-approval has made it possible to sell the Korean products in the U.S. market. Exports of Korean diagnostic kits to the U.S. are expected to expand in the future.
The ministry said the FDA's approval of the Korean diagnostic kits was made at an unusually early date. It explained the background that President Moon Jae-in expressed his willingness to support Korean-made diagnostic kits to the U.S. at the request of U.S. President Donald Trump and it needs the FDA approval procedure on March 24, and Trump said he would have interest in the immediate FDA approval.
On March 25, President Moon visited Seegene, a producer of the COVID-19 diagnostic kits, in Songpa-gu, Seoul, and said, "There are many official requests for government-level (COVID-19) diagnostic reagents, along with private-level export consultations. In the phone call, U.S. President Trump also requested urgent support for the diagnostic kits and other quarantine supplies."
At that time, President Moon said, "We visited Seegene to show the public how big and proud our diagnostic drug producers are and to give hope to the international community. We also invited representatives of Kogenebiotech, Solgent, SD Bio-sensor and Biosewoom, who received emergency license together, and the government will actively support your companies' exports.”
Meanwhile, the Ministry of Foreign Affairs said related ministries, including the Foreign Ministry, the Food and Drug Ministry, have been closely consulting with the U.S. side based on cooperation with the companies concerned.
The South Korean government will support consultations between the U.S. purchasing agency and our companies to support the rapid U.S. exports and overseas shipments of COVID-19 diagnostic kits to proceed effectively.