US to Notify 3 Diagnostic Kit Companies with 'Provisional Approval'... Foreign Ministry "Real-time Consultation with White House TF"

US Likely to Initiate Procurement Procedures After Official Notification
US Emergency Use Procedure for COVID-19 Response... Ministry of Foreign Affairs Reconfirms 'Export Possible' Status of the Product

[Image source=Yonhap News]

[Asia Economy Reporter Lim Cheol-young] Confusion has arisen between the government and the industry regarding the interim FDA approval process for three domestic companies' COVID-19 diagnostic kits. The Ministry of Foreign Affairs claims that it has received notification that there are no issues with exporting to the U.S. following the interim approval, while frontline industry sources counter that they have not received official notification from the FDA and find the process unfamiliar.

In response to the controversy surrounding the export of Korean diagnostic kits to the U.S., a Foreign Ministry official told reporters on the 30th, "The Korean government has prioritized consultations with the federal government and has been conducting discussions accordingly," adding, "The counterpart is the COVID-19 task force (TF) established within the White House, with whom real-time consultations are ongoing."

The official further stated, "The governments of Korea and the U.S. have been closely coordinating to facilitate the entry of domestically produced diagnostic kit products into the U.S. market," and added, "Three domestic companies that applied for the FDA Emergency Use Authorization (EUA) through diplomatic channels have received notification that their diagnostic kit products have been granted interim approval, meaning there are no issues with exporting to the U.S."

The Ministry of Foreign Affairs, which leads the 'Task Force for Supporting Overseas Expansion of COVID-19 Prevention Supplies,' did not disclose the names of the three domestic companies. However, it is known that the U.S. side plans to notify the companies and will soon initiate procurement procedures for these products in the U.S.

The government's announcement sparked unnecessary varied interpretations, intensifying the controversy. The diagnostic kit industry found it difficult to identify the companies in question and began inquiries, while also questioning the meaning of the 'pre-approval' procedure mentioned by the Foreign Ministry. The FDA's official website still does not list any Korean companies' diagnostic kits on the EUA approval list.

The Foreign Ministry emphasized that the recent interim FDA approval notification is a federal-level approval. This is a completely different procedure from the existing method where some companies supplied to U.S. laboratories. The U.S. has implemented a regulatory relaxation policy allowing use within certain laboratories only for products approved at the state level or those with EUA applications, as part of its emergency COVID-19 response.

A Foreign Ministry official said, "This interim approval is a federal-level procedure different from the method some companies used to supply U.S. laboratories," and emphasized, "We will actively support effective consultations between U.S. purchasing agencies and our companies to expedite the export of domestic diagnostic kits to the U.S."

Within the industry, there is speculation that the FDA notified the interim approval results for three Korean diagnostic kits at the request of U.S. President Donald Trump. During the Korea-U.S. summit call on the 24th, President Moon Jae-in conveyed support for Korean diagnostic kits at President Trump's request and mentioned the need for FDA approval procedures. President Trump responded that he would take an interest to ensure immediate approval. It is explained that a temporary procedure may have been introduced following the summit discussions to enable the supply of Korean diagnostic kits nationwide in the U.S.

Although confusion arose over the possibility of exporting Korean diagnostic kits to the U.S., the government plans to actively supply prevention supplies domestically considering demand from the U.S., the United Arab Emirates (UAE), Indonesia, and other countries. On the evening of the 28th, Indonesian Foreign Minister Retno Marsudi personally requested support for prevention supplies during a phone call with Foreign Minister Kang Kyung-wha.

According to the Ministry of Foreign Affairs, requests for exports of Korean prevention supplies have come from 31 countries, and humanitarian aid requests have come from 30 countries. Including 36 countries engaged in private-sector cooperation, a total of 117 countries have requested exports or humanitarian support.

[Image source=Yonhap News]

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