- LOGIN
- MemberShip
- 2026-05-05 11:34:57
- Policy
- Security elaboration/ ultra-high-priced new drug coverage
- by Kim, Jung-Ju Aug 05, 2022 06:04am
- In order to strengthen accessibility to new drug patients, the government has steadily increased coverage by opening a benefit gateway. However, due to the development of innovative new drugs, limited funding of health insurance is a problem to catch up with the ultra-high price trend of anticancer drugs and rare disease treatments. The challenge of overcoming the sustainability issue remains a challenge. As Zolgensma, a treatment for Spinal Muscle Atrophy (SMA), called "ultra-high-priced one-shot treatment," was listed on the benefit starting this month, the government considered ways to improve accessibility from the basic definition of expensive new drugs. The procedure for registering new drug benefits in Korea is carried out sequentially by applying for benefits from pharmaceutical companies, deliberating and evaluating the HIRA, negotiating drug prices between the NHIS and companies, and deliberating and voting by the Health Insurance Policy Review Committee. However, it has been pointed out that the accessibility of drugs requiring urgent benefits is disrupted as HIRA deliberation and evaluation usually takes 120 days, 150 days for RSA targets, 60 days for drug price negotiations, and 30 days for review by the Health Insurance Policy Review Committee. The biggest problem is by far the price. The problem of price has been a constant obstacle even in the 2010s, when social needs were not heavily reflected. Since the government and the insurance authorities judged whether or not the salary was paid and the price was the top priority, there were many problems with the appearance of high-priced new drugs. Starting with the introduction of RSA in 2014, the government introduced a permit-evaluation linkage system in the same year and introduced a new economic evaluation data submission system and a drug price negotiation system in 2015 to improve accessibility to high-priced new drugs. With the listing of Zolgensma, the government announced plans to create a definition of expensive drugs that it has been preparing and expand the mechanism for shortening negotiations, while strengthening follow-up management and monitoring. The government will actively adopt a patient-level performance-based model by improving RSA, which used to be a financial base, but strengthen follow-up monitoring to utilize a payment method suitable for treatment effects and improve PVA in operation. In addition, it was decided to prepare a pre-approved standard operating procedure (SOP) before taking ultra-high-priced drugs. In addition, the National Assembly's legislative investigation office says it is desirable to discuss the introduction of a "pre-entry and post-evaluation" method as a new benefit pharmaceutical companies by paying the cost or evaluating the effectiveness of treatment after administration when claiming treatment expenses exceeding the set total benefit. This is the way that related academia and patient organizations have suggested so far, and it can be said that it belongs to the same context in the large framework as RSA's performance-based model. In order to make it common, the authorities and insurers should consider weakening the insurer's bargaining power and devices for effective operation in the process of negotiating drug prices. In addition, the National Assembly also suggested the need to set up a separate fund to solve financial problems that will be affected by strengthening the guarantee of expensive new drugs. This can be referenced in that advanced insurance countries such as the United Kingdom operate various types of drug funding systems as a mechanism for salary exceptions in consideration of uncertainties that arise when there is not enough data to evaluate the value of drugs. The government plans to subdivide the management method and registration process by lowering the speed and evaluation barrier of the benefit entry stage, increasing follow-up monitoring and evaluation, and improving the reference criteria for foreign drug price adjustment in the future. It is important to pay attention to how much more sophisticated the new drug guarantee policy will become in the future, so it is also important to pay attention to the parliamentary audit in the second half.
- Policy
- MOHW reluctant to CVS's request to expand SRADs
- by kang, hae-kyung Aug 05, 2022 06:04am
- The Ministry of Health and Welfare expressed disapproval over the convenience store industry's request that the scope of Safe and Readily Available Drugs (SRADs) should be expanded to antacids and burn ointments for sale at convenience stores. The MOHW explained that the SRAD system is a unique exception made from the healthcare system’s perspective, and that the policy environment is now changing so that drugs may be purchased from pharmacists at public late-night pharmacies or pharmacy vending machines. At the 'Policy Improvement Seminar for the Sustainable Development of Close-to-Life Retail Industry' that was organized by the Korea Franchisee Union and hosted by Seung-Jae Choi's Office of the People Power Party, Tae-Gil Ha, Director of Pharmaceutical Policy at MOHW, reiterated that the SRAD system is a special exception made from the perspective of Korea’s healthcare system. Director Ha said, “Pharmaceuticals are biologically active, and contrary to the claim that ‘no side effects have been reported from the use of SRADs sold at convenience stores, around 200-400 adverse events are being reported annually through the Ministry of Food and Drug Safety and Korea Institute of Drug Safety & Risk Management. Although in principle, pharmacists need to dispense pharmaceuticals, the SRAD system was allowed as an exception for the convenience of the patients for their use at times that pharmacists cannot cover. We are not aware how much SRADs' sales contribute to sales at convenience stores, but we have to put consumer convenience and health first." Director Ha added, “Although there is a claim that the operation of late-night pharmacies is poor, policy changes such as the expansion of public late-night pharmacies and pharmacy vending machines are currently being made. Still, there is much conflict over SRADs in reaching a social consensus.” In other words, in addition to the occupational conflicts that arise among pharmacists, experts have concluded that it is difficult to designate antacid and antidiarrheal drugs as SRADs. Director Ha also noted that contrary to the claims of the convenience store industry, problems such as rule violations on the sellers’ part are also being raised. He said, "Some media outlets have covered how seller compliance violations are made in almost 85% of the cases, and that there is demand for legislation to strengthen seller education and reinforce enforcement of regulations. The lack of a systemic system for dispensing SRADs at convenience stores also acts as a burden.” When a policy signal is issued, pharmacists’ associations deliver the news to local pharmacist societies, but no clear systematic delivery route for such news exists for SRADs in convenience stores. Director Ha said, “Patient convenience is of course most important, but please do understand that national statistics on such a demand are not clear and we have to prioritize patient convenience while ensuring the safety of the healthcare system."
- Policy
- Biogen’s Alzheimer’s disease TX entry unclear in Korea
- by Lee, Hye-Kyung Aug 04, 2022 06:05am
- Introduction of the world’s first Alzheimer’s disease treatment, ‘Aduhelm (aducanumab),’ has virtually become unclear in Korea. The results of the Central Pharmaceutical Affairs Council meeting that was held on July 12th that was recently disclosed by the Ministry of Food and Drug Safety showed that the expert advisory board concluded that the application data filed for an Alzheimer’s disease treatment "was not sufficient to be accepted as a confirmatory clinical trial." Although the deliberated product's name and ingredient were not disclosed in the minutes of the meeting, one committee member mentioned, “Since the FDA approval, the US news had covered how the ‘Biogen's statisticians used magic' to become up with much analysis favorable to Biogen, which it had submitted for accelerated approval.” From the comment, it can be inferred that the item that was deliberated was Aduhelm, for which Biogen submitted an application for approval in July last year. Aduhelm received conditional approval from the U.S. FDA in June last year with a post-approval trial required to verify that the drug provides the expected clinical benefit. The conditional approval made in the US was in itself not easy. In November 2020, the company was unable to satisfy the primary endpoints in the EMERGE and ENGAGE trials, due to which the FDA advisory committee had decided to recommend non-approval due to insufficient evidence proving its effectiveness. However, Biogen further analyzed its clinical data and received conditional approval from the FDA based on efficacy validated in the high-dose group. The clinical trial results that Biogen submitted for marketing authorization in Korea were data that did not satisfy the primary and secondary efficacy endpoints. One committee member said, “It is not reasonable to discuss approval when the data submitted did not achieve the primary efficacy endpoint. The members of the FDA advisory committee opposed to the approval, but clinicians’ position was that the drug should be approved as there is no other treatment available and the biomarkers showed an effect. Many of the advisory board members resigned, opposing the approval.” Another member said, “It is understandable that such discussions arise because there are currently no treatments available in the field of dementia treatment, but from a statistical point of view, there is no controversy that the data submitted was from a failed clinical trial. We will not be accepting additional analysis results on the submitted data after declaring the data non-acceptable.” Most of the members agreed that the clinical data alone cannot be accepted as confirmatory clinical results, and the committee chair also said, “The biomarker part will be discussed afterward. The conclusion that was made this time is that the Phase III clinical trial results cannot be accepted as a confirmatory trial.” Meanwhile, iBiogen’s CEO Michel Vounatsos had resigned at Biogen’s 2022 Q1 earnings release in May, taking responsibility for Aduhelm's poor performance, upon which Biogen announced that it would substantially eliminate its commercial infrastructure for Aduhelm.
- Policy
- Mandatory notification for correctional facilities
- by Kim, Jung-Ju Aug 02, 2022 06:02am
- A bill that stipulates that the MFDS should also notify the MFDS of narcotics prescriptions conducted at correctional facilities and military units will be promoted. Representative Choi Yeon-sook of the People's Power represented the partial revision bill of the Drug Management Act. With the increase in the handling of medical narcotics, the MFDS is reporting related matters from drug handlers through the integrated drug management system to manage the handling of narcotics. It is pointed out that the integrated drug management system cannot confirm the prescription of drugs in the correctional facility, and that it is difficult to confirm the prescription of drugs in the Ministry of National Defense under the current law. The main purpose of this amendment is to prevent misuse of narcotics and to resolve blind spots by stipulating to the MFDS about the prescription of narcotics and prescription of narcotics in the Ministry of National Defense. This bill is based on the premise of the resolution of the "Partial Amendment of the Act on the Execution of Sentences and the Treatment of Detainees" proposed by Choi. Therefore, if this bill is not resolved or revised, it must be adjusted accordingly. This initiative will be joined by Rep. Choi, Kang Min-guk, Kwon Eun-hee, Seo Byung-soo, and Chung Chang-min, Kim Min-seok of the Democratic Party of Korea, Rep. Ryu Ho-jung, and Rep. Lee Eun-joo of the Justice Party , Independent Party Yang Jung-sook and Yang Hyang-ja.
- Policy
- Daewoong sells the original Ebixa
- by Lee, Tak-Sun Aug 01, 2022 09:16pm
- Daewoong Pharmaceutical, which once sought to develop a high-dose dementia treatment Ebixa, sells original drug in Korea instead of giving it up. Ebixa 20mg, a higher dose than the existing product, is expected to greatly improve the convenience of taking it because patients only need to eat one dose a day. According to the industry on the 29th, Daewoong Pharmaceutical, which has signed a joint sales contract with the original company Lundbeck since 2019, will also carry out a copromotion of Ebixa 20mg, which will be listed on August 1. Ebixa 20mg will be listed at 1, 606 won starting August 1. It is twice the price of the existing Ebixa at 803 won. However, it improves the ease of use. Existing Ebixa requires two tablets a day, but Ebixa 20mg, which has increased the dose, requires only one tablet a day. Daewoong Pharmaceutical is conducting domestic sales and marketing of Ebixa in all sectors, including hospitals, hospitals, and clinics, while conducting a copromotion between Lundbeck and Ebixa in 2019. Ebixa is an NMDA receptor antagonist and has a mechanism to alleviate symptoms by inhibiting excessive NMDA receptor stimulation in the brain of Alzheimer's patients. It is the second most commonly used drug after Eisai's Aricept. Based on UBIST last year, Aricept was 86.1 billion won and Ebixa was 16.9 billion won. Lundbeck is counting on this Ebixa 20mg to close the gap with Aricept. It is calculated that as the convenience of taking has improved, the number of Rxs will increase. Daewoong Pharmaceutical also expects Ebixa 20mg to help improve the market share of dementia drugs in Korea. In particular, Daewoong Pharmaceutical attempted to develop 20mg of Memantine directly before Ebixa 20mg was approved in Korea. In April 2020, the MFDS approved a phase 1 clinical trial under the name DWJ1458, which is known as the development of Memantine 20mg.Daewoong Pharmaceutical stopped clinical research after two months of clinical approval. There were various interpretations of this at the time, but the original Ebixa 20mg copromotion solved the curiosity neatly. Aricept had the domestic license right. After that, the license was transferred to Handok, and Daewoong is currently registered as a consignment producer. Daewoong entered the dementia treatment market directly from Ebixa. Ebixa's propaganda is also needed to make up for the reduction in benefit through re-evaluation of its affiliate, Daewoong Bio's brain function improvement drug Gliatamin.
- Policy
- MFDS Minister promises COVID-19 vaccineˑTx support
- by Lee, Hye-Kyung Aug 01, 2022 05:58am
- The Minister of Food and Drug Safety Yoo-Kyung Oh met with COVID-19 vaccine and treatment developers and relevant associations and promised support in the future. On the 29th, the MFDS held an MFDS-Industry roundtable meeting for the COVID-19 vaccine-treatment development support. The meeting was held to discuss the difficulties experienced by developers in conducting clinical trials and MFDS’s measures of support in situations where the development of a homegrown vaccine or treatment becomes imperative due to an epidemic. At the event, the MFDS introduced its measures for support in commercializing such products, listened to the difficulties that the industry experienced in the process of developing COVID-19 vaccines, and discussed measures of MFDS support for the development of vaccines and treatments. Minister Oh said, “Korea is an established leader in the pharma-bio sector that owns both a vaccine and treatment for COVID-19. The MFDS will continue to innovate regulations in the field to support the rapid commercialization of homegrown COVID-19 vaccines and treatments." Also, Oh mentioned that it has been linking development-non-clinical trials, clinical trials-approval & review processes while providing professional support on clinical trial design through the commercialization strategy support task force that had been established in April. Minister Oh said, “We plan to seek more efficient operation of the approval and review process for COVID-19 vaccines and treatments through rapid review, rolling review, etc. while thoroughly reviewing their efficacy and safety through close review and expert advice." Companies and related associations that participated in the meeting expressed their gratitude to the MFDS for enabling easier export of products upon domestic approval, which has advanced its regulations through safety-based regulatory innovation and commercialization support efforts and asked for the ministry’s continued support for rapid vaccine development against variants and clinical trial subject recruitment. The companies said, “It is imperative that the MFDS recruits more review personnel to enable rapid development of the second, third homegrown vaccines and treatments. We ask the MFDS to increase their review personnel and strengthen its expertise.” The MFDS expects the meeting to help identify various difficulties experienced in development and come up with support measures. The ministry added it will do its best to support the rapid development of domestic vaccines and treatments by operating programs specialized for COVID-19 and commercialization strategy support teams - such as ‘Our Vaccine Project’ and the ‘Development-focused support council’ - for the prompt development of homegrown vaccines and treatments.
- Policy
- MFDS announces a series of tasks for innovation
- by Lee, Hye-Kyung Jul 29, 2022 05:51am
- “If the 3 strategies set for the direction of the food and drug administration are the three mountains to conquest for the Ministry of Food and Drug Safety, the 100 National Tasks Roadmap that will be announced soon is like the 100 trees that we will be planting on the 3 mountains." Yu-Kyoung Oh, Minister of Food and Drug Safety, announced so at the ‘Briefing on the Standards for Globally Leading Innovative Food and Drug Administrative Measures ’ that was held at 1:30 p.m. on the 28th. After holding a public debate on regulatory innovation for the pharmaceutical sector on the 21st and the food sector on the 25th, the MFDS finally announced the measures for food and drug administrative innovation at the briefing. The 100 regulatory innovation tasks that will form the detailed tasks under the innovative measures, will be established and announced in line with the 100th day of President Suk-Yeol Yoon’s inauguration. The MFDS’ administrative measures for innovation will be to innovate its regulatory capabilities to a global level, support the global entry of new technologies with guaranteed safety, and enable the public to quickly enjoy the benefits of new technologies. Minister Oh said, “Global entry of drugs in the past had been difficult because the private companies had to seek their own paths of entry after the MFDS completes the approval process. As it is a regulated industry, each country has its own and diverse regulatory barriers." Therefore, the MFDS plans to analyze the global food and drug regulatory policies and operate a strategy task force to allow the industry to enter the global market after penetrating the regulatory barriers set for each country. Yoon-Joo Park, Director-General of the MFDS’s Drug Evaluation Department, said, “New product development has been increasing in the biohealth industry with scientific innovations like AIs as well as environmental changes. We will raise our regulatory capabilities so that passing the regulatory scientific standards set by the MFDS would mean that it could pass those set by global regulatory institutions.” Also, the operation of the three-tier system for regulatory relief that includes outside experts had been further explained at the briefing. (From the left) Yu-Kyoung Oh, Minister of Food and Drug Safety; Sang-Bae Han, Director General for Planning & Coordination; Oh-Sang Kwon, Director-General of the Food Safety Policy Bureau; Yoon-Joo Park, Director General of the Drug Evaluation Department; Sang-Bong Kim, Director General of Biopharmaceuticals and Herbal Medicine Bureau; Nam-Hee Lee, Director-General of the Medical Device Safety Bureau; Suk-Yeon Kang, Director-General of the Pharmaceutical Safety Bureau Sang-Bae Han, Director General for Planning & Coordination, said, “When a company requests regulation relief, the relevant departments first respond and make evaluations at the first tier. If the request is not accepted at in first tier, the company’s request goes on to the second tier and is applied the regulatory verification responsibility system.” The second tier mainly consists of civilian experts who will be determining whether the deregulation request should be accepted. Han said, “If the request is again not accepted at the second tier, we apply the last and final third tier, where the Minister of Food and Drug Safety directly checks the facts and seek for alternatives.” Regarding the ‘WHO Listed Authorities (WLA)’ that is being promoted, Minister Oh said, “The WHO has high regards for Korea’s regulatory capabilities and is reviewing Korea as the first candidate for WLA listing. We will be listed on the WLA at the end of this year at the earliest, and by next year at the latest. Suk-Yeon Kang, Director-General of the Pharmaceutical Safety Bureau, said, “We have started receiving the WLA review from March this year, and 56 countries are currently on the tentative list. Korea is also on the tentative list, but we are being reviewed as the first candidate as the WHO recommended that we receive evaluations as the most qualified country for listing.”
- Policy
- 500 billion won fund by the end of this year
- by Lee, Jeong-Hwan Jul 28, 2022 05:54am
- Public-private partnerships to develop blockbuster vaccines and treatments. The government will focus on supporting vaccines and treatments for infectious diseases under development by domestic bio-health companies. It plans to fully support vaccine candidate materials for diseases such as COVID-19 and core technologies for responding to infectious diseases, and strengthen licensing, location, and foundation support, tax deduction and financial support to revitalize private investment in biohealth. It will also expand public-private investments such as K-bio and vaccine funds, and will create a joint public-private fund worth 500 billion won within this year and pay a total of 2.2 trillion won in R&D expenses for new drug pipelines. The MOHW discussed the "BioHealth Industry Innovation Plan" at the 4th Emergency Economic People's Assembly presided over by President Yoon Seok-yeol on the morning of the 27th. The MOHW diagnosed that Korea's investment in vaccine and treatment development support is limited compared to other developed countries. Compared to AstraZeneca's development of COVID-19 vaccines and treatments with 2 trillion won, 1.9 trillion won for Novavax, and 550 billion won for Janssen, Korea spent only 257.5 billion won for vaccines and 155.2 billion won for treatments. The MOHW decided to continue to support the development of COVID-19 vaccines and treatments from 17 companies under clinical trials in six domestic companies. It helps Korea's No. 1 vaccine to enter the global market by passing the pre-qualification examination by the WHO and confirming the efficacy of additional vaccinations. After securing core technologies by researching and developing vaccine candidate materials for COVID-19 as well as candidates for infectious diseases such as MERS and Zika virus, it supports rapid development of vaccines in case of crisis. In order to revitalize private investment worth 13 trillion won by 2026, including Samsung Biologics, Lotte Biologics, SK Bioscience, and EuBiologics, it will also provide support at the level of ministries. It will closely support licensing, location, and foundation creation, and quickly strengthen tax deductions, financial and policy funding support for each major related institution, and expansion of support limits. In a recently announced tax reform plan to promote investment in vaccines, the deduction rate for investment in national strategic technology facilities of large companies was raised from 6% to 8%. In order to develop innovative new drugs and secure vaccine autonomy, it will create a private joint "K-Bio and Vaccine Fund" worth 500 billion won that invests in pharmaceutical and bio companies within this year, and expand it to 1 trillion won in the future. It has also decided to provide 2.2 trillion won in research and development expenses, including 1.5 trillion won in state funds, to new drug pipelines that have entered the second phase of clinical trials in discovering effective substances. Regulatory innovation will also be carried out. Innovative medical devices such as AI and digital will be improved so that they can be used as non-reimbursement or Medical Benefits after licensing. In the case of innovative medical devices, the evaluation period required for them to be put into the medical field after minimum administrative measures after licensing will be drastically reduced from 390 days to 80 days. It will fully redesign regulatory systems suitable for high-tech product characteristics such as digital and high-tech bio to closely support entry into the global market, and establish a biohealth-specific regulatory sandbox that reflects the specificity of innovative technologies and services. Lee Ki-il, the second vice minister of the MOHW, said, "We will present a roadmap for bio-health regulatory innovation and actively resolve difficulties through continuous communication with the industry."
- Policy
- Outpatient tx 14.7 times a year per person in Korea
- by Kim, Jung-Ju Jul 28, 2022 05:54am
- In 2020, the number of outpatient treatments per capita in Korea was 14.7 times a year, the highest among OECD countries. This is 2.5 times the average 5.9 times of member states. As a result of evaluating drug sales per capita with Purchasing Power Parity (PPP) reflecting the price level of each country, $ 760.9 PPP was 1.4 times higher than the OECD average of $547.2 PPP. The MOHW analyzed and announced the level and status of Korea and each country by major indicators of "OECD Health Statistics 2022" announced by the OECD on the 4th. Among them, we looked at health care use and health care resources. ◆ Outpatient treatment, average number of days of hospitalization, examination, and current medical expenses = In 2020, the number of outpatient treatments per capita in Korea was 14.7 times a year, the highest among OECD countries, 2.5 times higher than the average of member countries (5.9). Japan (12.4) has the second highest number of outpatient treatments per person after Korea, while Costa Rica (1.9), Mexico (2.1), Chile and Sweden (2.2), Colombia (2.6) and Greece (2.7) have less than three. In 2020, the average number of hospitalization days per inpatients in Korea was 19.1, the second longest among OECD countries after Japan (28.3 days). The OECD average is 8.3 days. The average number of hospitalization days per inpatients for acute treatment was 7.8 days, longer than the OECD average (6.6 days). Over the past 10 years, the average number of hospitalization days per inpatients in Korea has been on the rise, but the number of patients treated in acute phase has been on the decline. The total number of hospitalizations increased by 1.9% annually, and acute treatment decreased by 2.5% annually. In 2020, Korea's MRI usage was 71.7 cases per 1,000 people, which was lower than the OECD average, and CT was 250.0 cases per 1,000 people, which was higher than the OECD average. Over the past 10 years, CT and MRI usage in Korea has continued to increase. CT usage increased by 8.3% annually, and MRI usage increased by 14.6% annually. Current medical expenses, which mean the total annual expenditure of the entire people spent on services and goods in the health care sector, were 8.4% of GDP in 2020, lower than the OECD average (9.7%). The per capita current medical expenses were $3,582.3, an annual average increase of 6.9% over the past 10 years, higher than that of the OECD (3.3%). The proportion of medical expenses (direct household burden) borne by households gradually decreased to 34.0% in 2010, 33.7% in 2015, and 27.8% in 2020. ◆ Number of beds and medical equipment = In 2020, the number of hospital beds was 12.7 per 1,000 people, the largest among OECD countries, and about 2.9 times the OECD average (4.3). Among them, 7.2 beds per 1,000 people were treated in acute phase, more than twice the OECD average (3.5). In 2020, Korea's number of MRIs was 34.2 per 1 million people and CT was 40.6 per 1 million people, which was higher than the OECD average (29.1 units). "OECD Health Statistics is important to use as basic data for policies to provide the quality of health care services that people can feel directly by analyzing and evaluating the level of health care in Korea in the international community," said Yang Kyung-jin, a policy statistics officer.
- Policy
- The revised COVID-19 in vitro diagnostic device guidelines
- by Lee, Hye-Kyung Jul 27, 2022 05:50am
- Due to the prolonged COVID-19, the in vitro diagnostic devices of the MFDS and the Korea Food and Drug Safety Evaluation Institute were very busy. Since the outbreak of COVID-19, the export performance of in vitro diagnostic medical devices has increased by 1.5 times, and the degree felt by in vitro diagnostic departments is said to be 10 times. Currently, in vitro diagnostic devices are operated on a small scale with four researchers and five examiners. However, five examiners are reviewing the workload for approval of in vitro medical devices from 800 companies. Jung Ho-sang, head of the in vitro diagnostic device division, said in a briefing to the journalists on the 26th, "Before COVID-19, there were many complaints about imported products of in vitro diagnostic devices used in hospitals." "However, after COVID-19, the development and permission management of product lines that used a lot and had a lot of complaints have decreased, and the situation has become to focus on COVID-19," he explained. He said, "The number of applications for permission from companies that have no experience in developing COVID-19-related devices has increased, resulting in a surge in complaints." "It is not easy to replenish manpower, so there are many difficulties," he said. Fortunately, applications for permission for new products have not increased despite the current COVID-19 resurgence. Foreign companies are reportedly putting in complaints for permission for cancer diagnosis and blood diagnosis devices, which have been stopped while focusing on developing COVID-19-related devices. Manager Jeong said, "Foreign companies are focusing on COVID-19 and restarting devices such as cancer diagnosis and blood diagnosis, which have rarely been developed. There are still many applications for permission for COVID-19-related devices, but foreign companies have completed the development of COVID-19 diagnostic test kits and are receiving a lot of complaints about devices that have already been developed or have now begun." There was also an explanation of the recently revised guidelines for the approval review of COVID-19 in vitro diagnostic devices. The MFDS deleted design restrictions that detected two or more genes only for COVID-19 gene test reagents, and added data on major mutation virus detection performance evaluation designated by the WHO as a prerequisite. He explained, "It is not true that the revision of the guidelines eased the criteria for approval of test reagents." Regardless of the revision of the guidelines, the COVID-19 gene test reagent must meet the same licensing criteria as before regardless of the number of detected genes, he said. "The clinical performance criteria with a sensitivity of 95% or higher and a specificity of 97% or higher are applied without change." In Korea, 46 gene test reagents have already been approved to detect two or more genes, and he added, "In accordance with the Korea Centers for Disease Control and Prevention's diagnosis guidelines, more than two genes are tested, so it does not affect the COVID-19 diagnosis system at all." However, as products targeting multiple genes are advantageous in detecting mutations in response to the new mutation virus, it is expected that the development of products targeting multiple genes will continue under the current epidemic and the Korea Centers for Disease Control and Prevention's diagnostic guidelines. Regarding the deletion of design restrictions on genetic test reagents, he said, "We decided that there was no need to limit the design of genetic test reagents anymore because many genetic test reagents were performing well at home and abroad." He said, "This is to promote the development of new products and additional product types according to changes in the COVID-19 quarantine situation."
