Ministry of Foreign Affairs: Three Korean Companies' Diagnostic Kits Obtain US FDA Pre-Approval

[Image source=Yonhap News]

[Asia Economy Reporter Hwang Yoon-joo] The Ministry of Foreign Affairs announced on the 28th that three domestic manufacturers of COVID-19 diagnostic kits have obtained pre-approval in the U.S. Food and Drug Administration (FDA) emergency use authorization process. Accordingly, the supply of Korean-made diagnostic kits to the United States is expected to accelerate.

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

The Ministry also stated that the FDA pre-approval for these three Korean diagnostic kit products was completed unusually quickly.

Earlier, during a phone call between the South Korea-U.S. leaders on the 24th, U.S. President Donald Trump requested COVID-19 diagnostic kit support from President Moon Jae-in. President Moon expressed willingness to provide Korean-made diagnostic kits and mentioned the necessity of FDA approval procedures, which is regarded as a follow-up action to that request.

This content was produced with the assistance of AI translation services.