Emergency Use Authorization for COVID-19 Diagnostic Kits Ends... Only 'Officially Approved' Products Allowed from Today

On the 3rd, medical staff are collecting specimens at a temporary COVID-19 screening clinic set up at Seoul Plaza. Photo by Mun Ho-nam munonam@

[Asia Economy Reporter Lee Chun-hee] The emergency use of diagnostic reagents used to quickly establish diagnostic capabilities at the early stages of the COVID-19 outbreak will end. From the 4th, diagnostic tests using 12 reagents that have been officially approved will be conducted.

The Ministry of Food and Drug Safety (MFDS) and the Korea Disease Control and Prevention Agency (KDCA) announced on the 3rd that the emergency use of seven genetic diagnostic reagents for COVID-19 confirmation, which were granted emergency use authorization since February last year, will end, and from the 4th, only officially approved products must be used for confirmation tests.

This measure is in accordance with the 'Enforcement Decree of the Medical Devices Act' and is based on the assessment that considering the approval status, production volume, supply volume, and inventory of genetic diagnostic reagents for confirmation, the 12 officially approved products (SD Biosensor, Bioseum, Seasun Biomaterials, Cansorop, CoGen Biotech, Seegene, SML Genetree, etc.) can sufficiently replace the emergency use products. Accordingly, the seven products whose emergency use will end are CoGen Biotech, Seegene, Solgent, SD Biosensor, Bioseum, BioCore, and Wells Bio.

Emergency use is a special system under the 'Medical Devices Act' that allows products requested by central administrative agencies such as the KDCA to be temporarily manufactured (imported), sold, and used when there is a concern about a pandemic and no approved products are available domestically. At the early stage of the COVID-19 outbreak, the MFDS and KDCA approved seven products for emergency use to secure large-scale testing capacity.

Along with this, the MFDS has been providing close support step-by-step since April last year by establishing the 'COVID-19 Diagnostic Reagent Rapid Approval Support Plan' to transition emergency use products to official approval. Through this, 12 genetic diagnostic reagents have been officially approved to date.

According to the MFDS, the maximum daily production capacity of the 12 officially approved products is about 640,000 tests, which is approximately four times higher than the maximum daily production capacity of about 165,000 tests of the seven emergency use approved products. This is 3.7 times the average daily number of tests of about 175,000 conducted from the 18th to the 31st of last month, indicating that there is no problem with the stability of supply and demand of diagnostic reagents.

An MFDS official stated, "We will continue to monitor the supply of diagnostic reagents and conduct on-site monitoring to ensure that COVID-19 testing proceeds without issues and will actively strive to maintain smooth COVID-19 diagnostic testing."

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