'US Provisional Approval' Diagnostic Kit, Procurement Process Soon... Foreign Ministry "In Close Consultation with US White House"

Ministry of Foreign Affairs Reconfirms US Export Possibility... Individual Companies to Be Notified
"Provisional Approval Granted Through Prior Emergency Use Authorization Number"

[Image source=Yonhap News]

[Asia Economy Reporter Lim Cheol-young] The Ministry of Foreign Affairs reiterated that three domestic companies whose diagnostic kits have received interim approval from the U.S. Food and Drug Administration (FDA) can export their kits to the United States.

An official from the Ministry of Foreign Affairs met with reporters on the morning of the 30th to clarify confusion between the government and industry regarding the nature of the FDA's interim approval, stating that the recent U.S. decision allows the export of diagnostic kits to the U.S. He emphasized, "The U.S. notified us that the interim approval was granted by assigning a pre-Emergency Use Authorization (pre-EUA) number to Korea."

He also added that procurement procedures for Korean-made diagnostic kits are expected to begin soon. The official explained, "This morning, through communication with the White House, we confirmed that procurement procedures will commence shortly," adding, "This means that once contracts are signed and supplies are ready, shipments will be dispatched immediately."

The 'COVID-19 Response Quarantine Supplies Overseas Expansion Support Interagency Task Force (TF),' led by the Ministry of Foreign Affairs, has been closely coordinating with the COVID-19 response TF established within the U.S. White House. Unlike the FDA's formal approval process, which takes a long time, it is understood that the White House allowed exports based solely on interim approval to respond swiftly to the COVID-19 situation.

The Ministry of Foreign Affairs official said, "Following the phone call between the South Korean and U.S. presidents, we have been closely consulting through various channels as a follow-up measure," adding, "Our government prioritized consultations with the U.S. federal government regarding the procurement of diagnostic kits." He also explained that this procedure is completely different from previous cases where kits were supplied to U.S. laboratories at the clinical level.

It is reported that before making the interim approval decision, the U.S. side requested information from Korea regarding FDA application status, available procurement quantities, and prior European approvals.

The official stated, "There are five companies in Korea with emergency use authorization, and seven companies with export approval, among which three have received the first round of interim approval," adding, "We have heard that there may be companies that will receive additional approvals in the future."

The companies that received interim approval this time are expected to be notified of this fact as early as this afternoon. The Ministry of Foreign Affairs previously announced the interim approval news without specifying the three companies, which caused unnecessary confusion.

The official said, "The U.S. government also agreed that companies with interim approval need to prepare in advance to supply diagnostic kits to the U.S., so the Korean government plans to notify them for preparation purposes."

Meanwhile, during the South Korea-U.S. presidential phone call on the 24th, President Moon Jae-in expressed willingness to support Korean-made diagnostic kits at President Trump's request, mentioning the need for FDA approval procedures. President Donald Trump responded that he would take an interest to ensure immediate approval.

The Ministry of Foreign Affairs official explained, "To expedite the export of Korean-made diagnostic kits to the U.S., we will actively support effective consultations between U.S. purchasing agencies and our companies going forward."