Emergency Use Authorization Ends for 9 COVID-19 Genetic Diagnostic Reagents... 3-Month Grace Period

The Ministry of Food and Drug Safety announced that as of the 1st, it will terminate the emergency use authorization of nine COVID-19 emergency gene diagnostic reagent products that were granted emergency use approval in 2020 to shorten the COVID-19 testing time for emergency patients during the early stages of the pandemic. Emergency use authorization is a system that allows the Ministry of Food and Drug Safety to temporarily manufacture, import, sell, and use products that have not been approved in response to public health crisis situations such as the COVID-19 pandemic.

The Ministry explained that the termination of emergency use for the nine COVID-19 emergency gene diagnostic reagent products is due to the COVID-19 crisis level being downgraded from "severe" to "alert" as of today.

Nine emergency genetic diagnostic reagent products for COVID-19 that have been urgently discontinued.

The Ministry believes that the termination of emergency use authorization can be sufficiently replaced by 21 emergency-use products that have already received formal approval.

However, the Ministry added that a three-month grace period will be provided to allow medical institutions to use up existing product inventories and prepare for the introduction of other products.

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