Korea ends emergency use of nine COVID-19 diagnostic reagents
Follow-up measures for lowering the crisis level… 3-month grace period granted
[Newsmp] The emergency use of nine products approved for emergency use in 2020 by the Ministry of Food and Drug Safety for COVID-19 emergency use was terminated on June 1.
In response, starting June 2, the Ministry of Food and Drug Safety urged medical institutions to use only officially approved products for COVID-19 testing.
Considering the existing inventory of previous products in medical institutions and the time required for the implementation of officially approved products on-site, as well as the importance of maintaining the testing capacity and accuracy of healthcare facilities, a three-month grace period has been provided.
This measure is in accordance with the downward adjustment of the COVID-19 crisis level from serious to alert.
In response, the Ministry of Food and Drug Safety engaged in dialogue with nine product manufacturers, who had received advance approval for emergency use while considering approval status, production volume, supply quantity, and inventory levels comprehensively.
As a result, the Ministry of Food and Drug Safety decided to discontinue the emergency use of the nine approved products, as 21 officially approved emergency diagnostic reagents could replace them.