[Press Release, May 22, 2020] K-Quarantine Testing Reagents in the Post-Corona Era
- Registration Date 2020-06-17
- Hit 1717
[ unofficial translation ]
K-Quarantine Testing Reagents in the Post-Corona Era
- Global Status Raised Thanks to “Speed,” Will Cement Its Place Thanks to “Quality” -
□ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung), while judging that there has been an increase in the global position of COVID-19 testing reagents, a core element of the K-Quarantine system, through emergency use authorization and quick response,
○ has announced an intention to solidify the reputation of K-Quarantine in the post-Corona era as well while thoroughly preparing the propulsion of the international standardization of diagnosis techniques, etc., the construction of a systematic authorization support system for in vitro testing products such as testing reagents, etc., and a switch to official authorizations for emergency use authorizations and export authorizations.
< The global status of K-testing reagents has increased thanks to “speed.” >
[1] Swift testing was possible thanks to emergency use authorization.
○ After the outbreak of COVID-19, document review, clinical performance evaluation, expert conference, among others, were carried out swiftly and presently a total of 6 products have received emergency use authorization.
* Total of 64 products applied → 6 received emergency authorization / currently clinical performance evaluation on 10 products in progress
[COVID-19 Testing Reagent Products with Emergency Use Authorization]
Number Manufacturer Product Name Authorization Date
1 KOGENEBIOTECH PowerCheckTM 2019-nCoV RT PCR kit 2.4
2 Seegene Inc. AllplexTM 2019-nCoV Assay 2.12
3 SolGent Co., Ltd. DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit 2.27
4 SD Biosensor, INC. STANDARDTM M nCoV Real-time Detection Kit 2.27
5 BioSewoom Inc. Real-Q 2019-nCoV Detection Kit 3.13
6 BIOCORE CO., LTD. BioCore 2019-nCoV Real Time PCR Kit 5.8
○ The 6 products authorized for emergency use in Korea have a daily maximum production quantity of around enough products for 150,000 people, as of May 20th their accumulated production amount is enough products for 1.5 mil people.
- as of May 20th, products for 1.31 mil people have been supplied and up to now a total of 760,000* tests have been carried out, while currently around enough products for 190,000 people are secured as inventory, and thereby stable supply is being realized.
* Korea Centers for Disease Control and Prevention COVID-19-related accumulated test statistics
○ For reference, the Ministry of Food and Drug Safety has collaborated with the Korea Centers for Disease Control and Prevention to establish emergency use authorization procedures and standards for “emergency nucleic acid detection reagents” which can analyze a specimen within 1 hour, from pretreatment of the sample to the deduction of a result.
- Compared to existing products with emergency use authorization which take 6 hours to reach a diagnosis, emergency testing reagents reduce the testing time to within 1 hour and are planned to be used only for testing patients requiring urgent action, such as emergency surgery
- When application is received, clinical performance evaluation, expert review, etc. is performed, and products which satisfy at least a certain level of performance standards* are to be approved quickly.
* Sensitivity of 95% or higher, specificity of 97% or higher according to results of clinical performance evaluation
[2] As one of K-Quarantine’s model outcomes, international demand for testing reagent has increased.
○ As of May 20th, 73 products have received export authorization (gene: 50, immunity: 23) and a quantity of products for about 56,460,000 people (as of 5/19) is being exported to around 110 countries including the USA, Italy, Brazil, Saudi Arabia, Egypt, and Indonesia.
- It is foreseen that advancement into the USA, etc. will expand further for 7 Korean testing reagent products which have received emergency use authorization from the USA’s FDA.
We will solidify the global position of K-testing reagents through “quality” and prepare for the post-Corona era.
[1] We intend to improve the reliability of product quality by transferring to formal authorizations.
○ By transferring to formal authorizations for products with emergency use authorization and products authorized for export, we plan to improve global trust in the quality of K-testing reagents, and to this end we will strengthen our in-depth support at each stage.
- (Application preparation stage) Time needed to prepare application documents for authorization reduced (30 days → 7 days) by utilizing authorization guide, providing tailored consulting
- (Clinical trial stage) Time needed for the development and implementation of clinical trial reduced (90 days → 22 days or less) by providing guide and approving plan quickly
- (Screening/authorization stage) Time needed is reduced (80 days → 30 days or less) by providing authorization screening guidelines and selecting products to receive priority
[2] We will lead the world’s epidemic prevention market through the international standardization of the K-Quarantine model.
○ We are currently propelling tasks for the establishment of international standards for the K-Quarantine model, such as 2 standards related to infectious disease testing techniques and 1 standard related to testing kit emergency use authorization procedures, by cooperating with related governmental departments and private-sector experts.
. Gene amplification-based testing technique (RT-PCR): Methods and procedures for the entirety of nucleic acid amplification testing which can be used for testing for infectious diseases such as COVID-19
. Testing technique-related reagents, testing methods: Testing reagents/equipment types needed for testing for infectious diseases such as COVID-19 and usage methods for each stage, etc.
. Emergency use authorization procedures and follow-up evaluation for in intro diagnostic devices (testing kits, etc.) during an infectious disease disaster: Testing reagent emergency use authorization procedures/evaluation methods, etc. during an infectious disease pandemic such as COVID-19
- Amongst these, the international standard for a “Gene amplification-based testing technique” was approved as a draft international standard (DIS) by an International Organization for Standardization medical device technical committee (ISO/TC 212) this past February, and it is expected that it will receive final approval by each member nation and complete its establishment as an international standard within the year.
○ The international standardization of the K-Quarantine model will become a good opportunity to both increase faith in our diagnostic testing system, which the whole world is paying attention to, and share Korea’s COVID-19 testing policy and technologies with countries that wish to learn them.
[3] We will establish and propel policy for the safety management of testing reagent across its entire life-cycle.
○ Following the coming into force of the “ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES” on May 1st of this year, we plan to introduce a whole life-cycle safety management system matching the specific characteristics of in vitro diagnostic devices and thereby
- propel policy* for the ▲ construction of a tailored safety management system, ▲ strengthening of professionalism, ▲ and securing the competitiveness of the industry and the safety/effectiveness of in vitro diagnostic medical devices through technical support.
* Management by class (1 to 4) based on influence on public health, tailored management employing follow-up reporting for minor changes, expansion of foundation for clinical performance trials (designation of medical institutions, blood centers, sample consignment/analysis institutions, etc.), etc.
○ Furthermore, we intend to construct a system that can quickly supply excellent-quality, safe testing reagents by propelling the establishment of an organization to assume full charge of safety management across the whole life cycle of the process, from development of an in vitro diagnostic medical device to the clinical performance evaluation, quality management system, authorization, and finally commercialization.
[4] We will support the R&D for diagnostic products in the post-Corona era.
○ We will enhance the professionalism of clinical evaluations and improve the quality of domestic testing reagents.
- We will produce, manage, and distribute reference standards, which is necessary for quality control, and provide domestic and foreign technical information and the latest clinical information, etc. in a timely manner, and thereby promote the industry's own product improvements, and also
- require that clinical performance examiners receive professional training and, for the sake of fostering core talent in the in vitro diagnostics field, connect with the regulator science professional training of the National Institute of Medical Device Safety Information and thereby work to cultivate professional workforce.
○ We will actively support the localization of major in vitro diagnostic products such as gene amplification equipment, nucleic acid extraction reagent, etc. through an all-department whole-life-cycle medical device research project.
○ We will respond to the unexpected outbreak of novel infectious diseases such as COVID-19, and thereby actively support R&Ds for testing reagents and try to expand the international status of the K-Quarantine brand.
□ Going forward as well, the Ministry of Food and Drug Safety will, for the sake of transparent and open disease prevention response regarding COVID-19, closely monitor production/supply conditions of testing reagents and work towards foreign exports/support while maintaining stable domestic supply.
○ In addition, we will continuously work to ensure that domestic in vitro diagnostic medical devices such as COVID-19 testing reagents can grow on a basis of a high level of trust in the health environment of the post-Corona era as well.
1. COVID-19 testing reagent emergency use authorization procedures - please find the attached file
K-Quarantine Testing Reagents in the Post-Corona Era
- Global Status Raised Thanks to “Speed,” Will Cement Its Place Thanks to “Quality” -
□ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung), while judging that there has been an increase in the global position of COVID-19 testing reagents, a core element of the K-Quarantine system, through emergency use authorization and quick response,
○ has announced an intention to solidify the reputation of K-Quarantine in the post-Corona era as well while thoroughly preparing the propulsion of the international standardization of diagnosis techniques, etc., the construction of a systematic authorization support system for in vitro testing products such as testing reagents, etc., and a switch to official authorizations for emergency use authorizations and export authorizations.
< The global status of K-testing reagents has increased thanks to “speed.” >
[1] Swift testing was possible thanks to emergency use authorization.
○ After the outbreak of COVID-19, document review, clinical performance evaluation, expert conference, among others, were carried out swiftly and presently a total of 6 products have received emergency use authorization.
* Total of 64 products applied → 6 received emergency authorization / currently clinical performance evaluation on 10 products in progress
[COVID-19 Testing Reagent Products with Emergency Use Authorization]
Number Manufacturer Product Name Authorization Date
1 KOGENEBIOTECH PowerCheckTM 2019-nCoV RT PCR kit 2.4
2 Seegene Inc. AllplexTM 2019-nCoV Assay 2.12
3 SolGent Co., Ltd. DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit 2.27
4 SD Biosensor, INC. STANDARDTM M nCoV Real-time Detection Kit 2.27
5 BioSewoom Inc. Real-Q 2019-nCoV Detection Kit 3.13
6 BIOCORE CO., LTD. BioCore 2019-nCoV Real Time PCR Kit 5.8
○ The 6 products authorized for emergency use in Korea have a daily maximum production quantity of around enough products for 150,000 people, as of May 20th their accumulated production amount is enough products for 1.5 mil people.
- as of May 20th, products for 1.31 mil people have been supplied and up to now a total of 760,000* tests have been carried out, while currently around enough products for 190,000 people are secured as inventory, and thereby stable supply is being realized.
* Korea Centers for Disease Control and Prevention COVID-19-related accumulated test statistics
○ For reference, the Ministry of Food and Drug Safety has collaborated with the Korea Centers for Disease Control and Prevention to establish emergency use authorization procedures and standards for “emergency nucleic acid detection reagents” which can analyze a specimen within 1 hour, from pretreatment of the sample to the deduction of a result.
- Compared to existing products with emergency use authorization which take 6 hours to reach a diagnosis, emergency testing reagents reduce the testing time to within 1 hour and are planned to be used only for testing patients requiring urgent action, such as emergency surgery
- When application is received, clinical performance evaluation, expert review, etc. is performed, and products which satisfy at least a certain level of performance standards* are to be approved quickly.
* Sensitivity of 95% or higher, specificity of 97% or higher according to results of clinical performance evaluation
[2] As one of K-Quarantine’s model outcomes, international demand for testing reagent has increased.
○ As of May 20th, 73 products have received export authorization (gene: 50, immunity: 23) and a quantity of products for about 56,460,000 people (as of 5/19) is being exported to around 110 countries including the USA, Italy, Brazil, Saudi Arabia, Egypt, and Indonesia.
- It is foreseen that advancement into the USA, etc. will expand further for 7 Korean testing reagent products which have received emergency use authorization from the USA’s FDA.
We will solidify the global position of K-testing reagents through “quality” and prepare for the post-Corona era.
[1] We intend to improve the reliability of product quality by transferring to formal authorizations.
○ By transferring to formal authorizations for products with emergency use authorization and products authorized for export, we plan to improve global trust in the quality of K-testing reagents, and to this end we will strengthen our in-depth support at each stage.
- (Application preparation stage) Time needed to prepare application documents for authorization reduced (30 days → 7 days) by utilizing authorization guide, providing tailored consulting
- (Clinical trial stage) Time needed for the development and implementation of clinical trial reduced (90 days → 22 days or less) by providing guide and approving plan quickly
- (Screening/authorization stage) Time needed is reduced (80 days → 30 days or less) by providing authorization screening guidelines and selecting products to receive priority
[2] We will lead the world’s epidemic prevention market through the international standardization of the K-Quarantine model.
○ We are currently propelling tasks for the establishment of international standards for the K-Quarantine model, such as 2 standards related to infectious disease testing techniques and 1 standard related to testing kit emergency use authorization procedures, by cooperating with related governmental departments and private-sector experts.
. Gene amplification-based testing technique (RT-PCR): Methods and procedures for the entirety of nucleic acid amplification testing which can be used for testing for infectious diseases such as COVID-19
. Testing technique-related reagents, testing methods: Testing reagents/equipment types needed for testing for infectious diseases such as COVID-19 and usage methods for each stage, etc.
. Emergency use authorization procedures and follow-up evaluation for in intro diagnostic devices (testing kits, etc.) during an infectious disease disaster: Testing reagent emergency use authorization procedures/evaluation methods, etc. during an infectious disease pandemic such as COVID-19
- Amongst these, the international standard for a “Gene amplification-based testing technique” was approved as a draft international standard (DIS) by an International Organization for Standardization medical device technical committee (ISO/TC 212) this past February, and it is expected that it will receive final approval by each member nation and complete its establishment as an international standard within the year.
○ The international standardization of the K-Quarantine model will become a good opportunity to both increase faith in our diagnostic testing system, which the whole world is paying attention to, and share Korea’s COVID-19 testing policy and technologies with countries that wish to learn them.
[3] We will establish and propel policy for the safety management of testing reagent across its entire life-cycle.
○ Following the coming into force of the “ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES” on May 1st of this year, we plan to introduce a whole life-cycle safety management system matching the specific characteristics of in vitro diagnostic devices and thereby
- propel policy* for the ▲ construction of a tailored safety management system, ▲ strengthening of professionalism, ▲ and securing the competitiveness of the industry and the safety/effectiveness of in vitro diagnostic medical devices through technical support.
* Management by class (1 to 4) based on influence on public health, tailored management employing follow-up reporting for minor changes, expansion of foundation for clinical performance trials (designation of medical institutions, blood centers, sample consignment/analysis institutions, etc.), etc.
○ Furthermore, we intend to construct a system that can quickly supply excellent-quality, safe testing reagents by propelling the establishment of an organization to assume full charge of safety management across the whole life cycle of the process, from development of an in vitro diagnostic medical device to the clinical performance evaluation, quality management system, authorization, and finally commercialization.
[4] We will support the R&D for diagnostic products in the post-Corona era.
○ We will enhance the professionalism of clinical evaluations and improve the quality of domestic testing reagents.
- We will produce, manage, and distribute reference standards, which is necessary for quality control, and provide domestic and foreign technical information and the latest clinical information, etc. in a timely manner, and thereby promote the industry's own product improvements, and also
- require that clinical performance examiners receive professional training and, for the sake of fostering core talent in the in vitro diagnostics field, connect with the regulator science professional training of the National Institute of Medical Device Safety Information and thereby work to cultivate professional workforce.
○ We will actively support the localization of major in vitro diagnostic products such as gene amplification equipment, nucleic acid extraction reagent, etc. through an all-department whole-life-cycle medical device research project.
○ We will respond to the unexpected outbreak of novel infectious diseases such as COVID-19, and thereby actively support R&Ds for testing reagents and try to expand the international status of the K-Quarantine brand.
□ Going forward as well, the Ministry of Food and Drug Safety will, for the sake of transparent and open disease prevention response regarding COVID-19, closely monitor production/supply conditions of testing reagents and work towards foreign exports/support while maintaining stable domestic supply.
○ In addition, we will continuously work to ensure that domestic in vitro diagnostic medical devices such as COVID-19 testing reagents can grow on a basis of a high level of trust in the health environment of the post-Corona era as well.
Division 국제협력담당관
Written by 배성명
Telephone 043-719-1559