Korean Diagnostic Kits Sold in the US... 3 Companies First to Obtain US FDA Pre-Approval

Obtaining Prior Approval in Emergency Use Authorization Process... Unusually Fast US Prior Approval
Requested by US President Donald Trump in Korea-US Summit Call on the 24th

[Image source=Yonhap News]

[Asia Economy Reporter Lim Cheol-young] Three domestic manufacturers of novel coronavirus (COVID-19) diagnostic kits have obtained 'pre-approval' under the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) process.

According to the Ministry of Foreign Affairs on the 28th, three domestic manufacturers received pre-approval under the U.S. FDA EUA process on the 27th (local time). The diagnostic kits produced by these companies can now be sold in the United States.

The FDA pre-approval for the three Korean diagnostic kit products was achieved in an unusually short period. It came just four days after President Moon Jae-in expressed willingness to support Korean diagnostic kits at the request of U.S. President Donald Trump during a Korea-U.S. presidential phone call on the 24th, mentioning the need for FDA approval procedures.

An official from the Ministry of Foreign Affairs explained, "This is considered a follow-up result of President Trump's commitment to expedite approval," adding, "To implement the follow-up measures of the presidential phone call, the Ministry of Foreign Affairs, including the Ministry of Food and Drug Safety and other related ministries, has been closely consulting with the U.S. side based on cooperation with the relevant companies."

Previously, the Korean government formed the 'COVID-19 Response Quarantine Supplies Overseas Expansion Support Task Force (TF)' centered on the Ministry of Foreign Affairs. The government plans to actively support effective negotiations between U.S. purchasing agencies and Korean companies to expedite exports of domestic diagnostic kits to the U.S.

The TF includes related ministries such as the Ministry of Foreign Affairs, Ministry of Food and Drug Safety, Ministry of Health and Welfare, Korea Disease Control and Prevention Agency, Ministry of Trade, Industry and Energy, Ministry of Land, Infrastructure and Transport, Ministry of SMEs and Startups, and KOTRA.