On the afternoon of the 10th, researchers are conducting research and analysis on a Corona 19 diagnostic kit at Protan Bio, a diagnostic reagent developer located in the Biotechnology Research Building of the College of Veterinary Medicine, Seoul National University, Gwanak-gu, Seoul. Newsis
The emergency use of 7 products of genetic diagnostic reagents for confirmation that were approved for emergency use in February of last year for the confirmation test for the novel coronavirus infection (Corona 19) has ended.
The Ministry of Food and Drug Safety and the Korea Centers for Disease Control and Prevention announced on the 4th that they decided that they could replace emergency products in the future, taking into account the license status, production, supply, and inventory of 12 officially approved products.
‘Emergency use’ requires an urgently needed diagnostic reagent due to the fear of a pandemic of infectious diseases pursuant to Article 46-2 of the Medical Devices Act, but if there is no licensed product in Korea, the product requested by the head of the central administrative agency may be temporarily manufactured (imported) and used for sale. It is a special system that allows them to be allowed. In February of last year, during the early days of the outbreak of Corona 19, the Ministry of Food and Drug Safety and the Korea Disease Administration promoted the emergency use of diagnostic reagents and approved 7 products.
The companies that made the seven products are Kogen Biotech, Seegene, Solgent, SD Biosensor, Bioseum, Biocore, and Wells Bio. Since April of last year, the Ministry of Food and Drug Safety has prepared and supported the’Corona 19 Diagnosis Reagent Rapid Authorization Support Plan’ in order to convert the official license for emergency use products. Currently, 12 genetic diagnostic reagents have been officially licensed, and 7 diagnostic reagents can be replaced, and emergency use was terminated on the 3rd.
A novel corona diagnostic reagent kit approved for emergency use in February. Newsis
Companies that make officially licensed products are SD Biosensor, Bioseum, Gaze Biomaterials, Cancer Rob, Kogen Biotech, Seegene, and SML Genitry.
Four of the companies that used to make products for emergency use have already completed applications for official approval and are producing officially licensed products. An official from the Ministry of Food and Drug Safety explained, “The three companies Solgent, Biocore, and WellsBio did not receive the approval due to the late application for formal approval.” “There is no problem with the product function.”
According to the Ministry of Food and Drug Safety, the maximum daily production of 12 officially approved products is about 640,000 people, which is 3.9 times more than the maximum production volume of about 165,000 people a day of 7 products approved for emergency use. Since the average number of tests per day for the last two weeks is 175,000, it is possible to produce about 3.7 times more, so there is no problem of supplying diagnostic reagents to the medical field.
Reporter Lee Tae-yoon [email protected]