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- 2025-12-24 03:00:06
- Policy
- AZ has applied for domestic approval of COVID-19 vaccine
- by Lee, Tak-Sun Jan 05, 2021 05:18pm
- The MFDS announced today (4th) that AstraZeneca Korea's application for item approval for COVID-19 vaccine (code name: AZD1222) has been received. This vaccine is a 'viral vector vaccine' manufactured by putting COVID-19 surface antigen gene into a chimpanzee adenovirus vector. Viral vector vaccines are manufactured by inserting viral antigen genes that cause infectious diseases into other viral genes used as carriers and mass-producing them. AstraZeneca vaccine uses adenovirus, which only infects chimpanzees, as a carrier to deliver COVID-19 surface antigen gene into human cells, and the delivered COVID-19 antigen gene synthesizes antigen proteins in the body to induce the production of neutralizing antibodies. US Johnson & Johnson (Janssen) vaccine was developed using a viral vector method. The expected target of AstraZeneca’s vaccine is 18 years of age or older, and the expected dosage is administered twice 4 to 12 weeks after one vaccination. This is the same as indications and dosages approved for emergency use in the UK, and the storage conditions are 2-8℃. AstraZeneca is currently conducting phase III clinical trials in 10 countries including the UK, Brazil and the US. The clinical trial was discontinued (September 6, 2020) due to an unexpected AEFI (one case of transverse myelitis). As a result of safety review, clinical trials were resumed (October 23, 2020, USA, and September 12, 2020, UK) because there was no direct relationship with the vaccine. Transverse myelitis is an inflammatory syndrome that affects the spinal cord and can be caused by a viral infection. However, no direct association with the vaccine was found in this study. The UK confirmed the preventive effect of 11,636 people in the vaccine clinical trial of AstraZeneca and made an Emergency Use Authorization on December 30, and the European Medicines Agency (EMA) has been conducting a preliminary review since October last year. AstraZeneca Korea applied for the approval for products that are consigned to SK Bioscience, a domestic pharmaceutical company, and for products manufactured overseas such as Italy. Item approval/examination data include non-clinical trials, clinical trials, quality, risk management plans, and manufacturing/quality control data. Non-clinical data is a verification of toxicity and effectiveness through animal testing prior to administration of a drug to humans. Clinical trial data confirm the effectiveness and safety when administered to humans. Unlike the clinical evaluation of general medicines that show therapeutic effects, it is important to evaluate the effectiveness of vaccines to prevent infection after vaccination in healthy people. The prophylactic effect (%) in the clinical trial is calculated based on the proportion of infected people who developed each after vaccination in the vaccination group and placebo group. For example, in a phase III clinical trial in which 10,000 people each vaccinated and placebo vaccinated, 10 confirmed cases out of the vaccinated group and 100 confirmed cases out of the placebo vaccinated group occurred, the probability of infection of the vaccinated group Is 1/10 compared to the placebo group, so the effect of preventing COVID-19 infection is calculated as 90%. Looking at the WHO's considerations for COVID-19 vaccine evaluation, it is recommended that the standard of preventive effect of COVID-19 vaccine be at least 50%. The safety is checked and evaluated whether abnormal cases occur after vaccination, and the safety of the vaccine is collected through long-term tracking such as serious abnormal cases. In the 'Guidelines on clinical evaluation of vaccines' by the WHO, it is recommended to follow up for at least 6 months for general vaccines and at least 12 months for vaccines containing immune boosters. It is recommended to perform follow-up observation for at least 1 year in the case of COVID-19. Quality data are data related to the manufacturing process control of the drug and'standards and test methods' for quality control. In addition, the risk management plan (RMP) is data on a comprehensive safety management plan that includes measures to minimize the occurrence of hazards for safety management after marketing. Risk Management Plan (RMP) refers to a comprehensive safety management activity plan that is carried out to collect, investigate, test, and minimize risk occurrence of information on safety and effectiveness over the entire cycle before and after drug approval and marketing. GMP implementation status evaluation data are 10 kinds of data, including facility·environmental management and quality assurance system related to the item for which the license is applied. Good Manufacturing Practice (GMP): Refers to the standards that pharmaceutical manufacturers must comply with throughout facilities, equipment and production processes in order to manufacture excellent pharmaceuticals with guaranteed quality. In addition to general GMP evaluation data, AstraZeneca’s vaccine will be evaluated according to the characteristics of the virus carrier vaccine, such as management of biological raw materials and genetically modified organisms used in manufacturing, and biological safety level (BSL), the MFDS explained. AstraZeneca’s vaccine is planned to be produced in the US, UK, and Italy, as well as SK Bioscience in Korea. As for the quality data, SK Bioscience is currently submitting additional quality data on the original vaccines and finished drugs produced in Korea under consignment from AstraZeneca Company to the AstraZeneca headquarters. AstraZeneca, the original developer, reviews the data to analyze and verify the quality equivalence between the vaccine used in the clinical trial and the vaccine consigned to SK Bioscience in Korea. AstraZeneca prepares data including the results of quality equivalence evaluation between manufacturing sites, and AstraZeneca Korea plans to quickly submit the data to the MFDS. Among the clinical trial data, additional data obtained by collecting and analyzing vaccine adverse events through a planned 12-month follow-up will be submitted, which is the same worldwide. The clinical trial data submitted by AstraZeneca are data from phase I to III being conducted in the UK and Brazil, and the trial is still ongoing for the safety evaluation of the vaccine and is expected to be completed in September 2021. The safety evaluation method of the vaccine is applied to other vaccine methods in the same way, and Pfizer’s vaccine and Moderna’s vaccine will be equipped with additional long-term safety data through follow-up. The MFDS has announced that it will thoroughly verify the safety and effectiveness through the screening of experts in each field and external experts of COVID-19 vaccine and treatment license examination team so that the public can receive a safe and effective COVID-19 vaccine. The MFDS aims to shorten the existing processing period (180 days or more) and process it within 40 days for the rapid approval and review of COVID-19 vaccine and treatment, including the product for this approval. The MFDS is conducting a preliminary review on non-clinical and quality data (non-clinical 10.6~, quality 12.18~) at the request of AstraZeneca Korea and requested data supplementation for nonclinical data. In addition, it is reported that the AstraZeneca vaccine, commissioned and manufactured by SK Bioscience, is preparing for the nation's lot release the fastest. It is explained that the manufacturer's detailed test method was obtained at the end of August last year, and the test method was established at the end of December after receiving reagents such as standard products in November. Vaccines used in the pandemic of infectious diseases are subject to rapid lot release and will be treated preferentially over lot release drugs in other countries, and they plan to quickly complete the national lot release within 20 days, which usually takes 2-3 months or more.
- Policy
- Generics for Arcoxia are coming soon
- by Lee, Tak-Sun Jan 04, 2021 05:58am
- Generic for Arcoxia, COX-2 anti-inflammatory analgesic is expected to be released soon. As the PMS ended on the 22nd of last month, it was confirmed that the generic company received the application on the 23rd, the next day. Since generic companies have already confirmed patent avoidance, they are expected to market their products as soon as they go through approval and reimbursed procedures. According to the MFDS on the 3rd, generic companies for Arcoxia (Etoricoxib) received applications on the 23rd. This drug is used to relieve symptoms or signs of osteoarthritis (degenerative arthritis). MSD Korea's Arcoxia obtained a domestic approval on December 23, 2014. The MFDS ordered a re-examination (PMS) for 6 years, and the end of the re-examination was on the 22nd of last month. Generic companies have been preparing for the market step by step. It succeeded in evading the patent with the remaining term. A trial was filed to confirm the scope of passive rights to evade crystalline patent of Arcoxia, and the claim was finalized in May last year. Participating pharmaceutical companies were Theragen Etex, Hana Pharm, Union Korea, Aju, Arlico, Reyon, Daewoopharm, Boryung Pharmaceutical, Hutecs, and Guju. A bioequivalence test was also conducted for product approval. Three companies of Theragen Etex, Aju, and Arlico conducted a bioequivalence test using Arcoxia as a reference drug. Accordingly, it seems that it succeeded in demonstrating the equivalent of the original drug and applied for permission immediately after the end of PMS. Arcoxia(Etoricoxib) is a nonsteroidal anti-inflammatory analgesic (NSAID) family of selective COX-2 inhibitors. In particular, it attracted attention that it is a follow-up item made by MSD of Vioxx (Rofecoxib), which was removed from the market due to cardiovascular risk as a COX-2 inhibitor. Arcoxia directly conducted clinical trials in Korea to resolve the safety controversy. However, there were fewer recognized indications than the competitive product Celebrex (Celecoxib). Arcoxia is only approved for osteoarthritis, whereas Celebrex has five indications, including ankylosing spondylitis, rheumatoid arthritis, and primary menstrual pain, as well as osteoarthritis. This leads to differences in performance in the market. Looking at the amount of outpatient prescriptions based on UBIST in the first half of last year, sales of Celebrex was ₩20.1 billion, whereas sales of Arcoxia were ₩1.7 billion. Large pharmaceutical companies except for Boryung analyzed that generics for Arcoxia were not very attractive in that they had limited indications for Arcoxia and generics for Celebrex were released after 2015. However, it is expected that the generics applied for approval this time will be able to produce new product effectiveness as they are the first generics that have successfully evaded patents.
- Policy
- Contract for 20 million people with Moderna was completed
- by Lee, Jeong-Hwan Jan 04, 2021 05:55am
- The government officially announced today (31) that it has signed a contract to purchase 20 million COVID-19 vaccines with Moderna, a US pharmaceutical company. As a result, Korea has secured the quantity of Moderna vaccines before the end of this year. This amount exceeds 100% of the population of Korea, and it is evaluated that it is sufficient for the formation of domestic collective immunity. On this afternoon, KDCA Commissioner Jung Eun Kyeong said at a briefing held at the KDCA located in Cheongju, North Chungcheong Province, "We have signed a contract to purchase COVID-19 vaccine for 20 million people with Moderna, and will be supplied to Korea from the second quarter." The government has been negotiating with Moderna for vaccine supply since July. In particular, on the night of the 28th, President Moon Jae-in and Moderna's CEO, Stéphane Bancel agreed on the timing and expansion of the vaccine supply through video calls. At the time, President Moon reached an agreement to supply 20 million people in the second quarter of next year, twice the amount of 10 million people originally secured by the government. Since then, the vaccine purchase contract between the health authority (the KCDA) and Moderna is proceeding smoothly. She said, "This contract was concluded through follow-up negotiations after the agreement to supply a vaccine for COVID-19 in a video call between President Moon and CEO Bancel for 20 million people. The vaccine purchased by the government is for a total of 56 million people, It exceeds 100% of the population. Enough to secure normal population immunity.” She said, "Because there are 30 million people who are eligible for the first vaccination, they must be vaccinated sequentially. In addition, (per person) they need to be vaccinated twice. Therefore, the vaccination starts from the first quarter, but the first vaccination is completed at the end of the third quarter," "We are preparing a plan to finish the second vaccination over a certain period of time." Currently, the MFDS is working on a preliminary review of the Moderna vaccine. The KCDA is planning to announce the current vaccination plan in the next month. The MFDS plans to complete the license/national lot release within 60 days when a pharmaceutical company applies for a license. Vaccination has already begun in the United States and the United Kingdom, and US Armed Forces in Korea has also begun vaccinating Moderna from the 29th. The government secured AstraZeneca’s vaccine for 10 million people, Pfizer for 10 million people, Janssen for 6 million people, COVAX Facility for 10 million people and Modena for 20 million people. With this, Korea will have a total of 56 million COVID-19 vaccines.
- Policy
- GBP510 by SK Bioscience has been clinically approved
- by Lee, Tak-Sun Jan 04, 2021 05:55am
- Another COVID-19 vaccine developed by SK Bioscience has been approved for clinical trials in Korea. The MFDS announced on the 31st that it has approved the clinical trial of the domestically developed COVID-19 vaccine GBP510. GBP510 is a vaccine candidate being developed by SK Bioscience and is different from NBP2001, which was clinically approved in November. This clinical trial is to evaluate the safety and immunogenicity of GBP510 in healthy adults, and phase II will be sequentially conducted after phase I. Immunogenicity refers to the rate of increase in neutralizing antibody that eliminates or lowers viral infectivity. GBP510 is a recombinant vaccine made using gene recombination technology of surface antigen protein of COVID-19. The preventive principle is that the surface antigen protein of the vaccine stimulates immune cells to form neutralizing antibodies to induce an immune response, and when COVID-19 invades, the antibody removes COVID-19. SK Bioscience's recombinant vaccine NBP2001, which was approved clinically on the 23rd of last month (Phase I), induces an immune response with the surface antigen protein of COVID-19, and GBP510 is a surface antigen protein that has a nanostructure (icosahedral particle). There is a difference in inducing an immune response by binding to a specific protein that forms. Novavax in USA is conducting phase III clinical trials of a COVID-19 vaccine using genetically modified technology. The MFDS said, "We plan to do our best to ensure that our people can receive treatment opportunities by supporting necessary matters so that a safe and effective COVID-19 treatment and vaccine can be developed quickly."
- Policy
- Review of new evaluation index for innovative certification
- by Lee, Jeong-Hwan Dec 31, 2020 06:20am
- When the MOHW is certified as an Innovative Pharmaceutical Company, it is expected to initiate a reorganization of the system to create new evaluation indicators that take into account the characteristics of overseas pharmaceutical companies. The goal is to establish a pharmaceutical and bio environment that provides a basis for domestic investment through certification as an innovative pharmaceutical company by a multinational pharmaceutical company. On the 30th, Minister Kwon Deok-chul responded to the written inquiry of Miae Kim, a member of People Power Party of the National Assembly Health and Welfare Committee. The information was answered just before Kwon was appointed, and it shows the direction of policy improvement in the future. Miae Kim inquired to Kwon Deok-chul to "tell your opinoin on the need to provide a basis for domestic investment as an Innovative Pharmaceutical Company certification of a foreign pharmaceutical company." Her inquiry seems to be based on criticism that the Korean government's certification of Innovative Pharmaceutical Company has focused on domestic pharmaceutical companies relatively compared to overseas pharmaceutical companies. The Innovative Pharmaceutical Company certification system has been operated since 2012 as a system to certify and support companies with high R&D proportions and excellent performance. Minister Kwon explained that the system certifies not only domestic pharmaceutical companies, but also multinational pharmaceutical companies that have contributed to the development of the domestic pharmaceutical industry, thereby activating open innovation and technology exchange and cooperation within the industry. It is said that three companies, Janssen Korea, AstraZeneca Korea, and Otsuka, have obtained certification and are applying a fair evaluation method without discrimination between domestic and foreign companies. Minister Kwon said that he would prepare for reorganization, including the establishment of new evaluation indicators that take into account the characteristics of multinational pharmaceutical companies. Minister Kwon said, "The environment of the domestic and foreign pharmaceutical industry is changing and domestic investment by foreign companies is expanding." He replied, "We are reviewing the reorganization of the direction of establishing a new evaluation index considering the characteristics of foreign companies."
- Policy
- Item management of accelerated approval is strengthened
- by Lee, Tak-Sun Dec 31, 2020 06:20am
- The MFDS has established a policy that it will not approve the extension of the deadline if the clinical trial is unsatisfactory for phase III accelerated approval item. Periodic reports should be submitted in the middle of Phase III, and surveys will be conducted if necessary for items with no results. It was to supplement this by creating an internal management guideline for the MFDS in response to the fact that the management of items was insufficient during the last National Assembly audit. According to industry sources on the 29th, the MFDS recently prepared an amendment to the 'Guidelines for approval and management of drugs with conditions related to clinical trials' and began to collect industry opinions. Items subject to phase III accelerated approval are applied to ▲life-threatening or serious serious diseases, ▲no alternative drugs, or products with significant clinical benefit compared to existing drugs. This guideline focuses specifically on the management of accelerated approval items. In particular, detailed information on post-licensing management such as changes in conditions such as clinical trials and submission of periodic reports were included. Although it is possible to change the conditions of approval given earlier, for example, the deadline for submitting the final clinical trial or the number of patients to be tested, it has been decided not to approve the extension of the deadline for submitting items that are unfaithful to the clinical trial. Phase III conditional permit items are notified of the necessity of fulfilling the conditions and actions taken in case of non-compliance 1 month before the approval of the plan and 1 year before the submission of the result report. It monitors the clinical trial progress and distribution status of the item within the deadline of the license conditions, and if there is no performance, the measures taken if the license conditions are not fulfilled. If the Accelerated Approval item does not submit the final clinical trial results or periodic report data, we plan to cancel the item or delete the indication according to the Pharmaceutical Affairs Act. According to this guideline, the management of phase III conditional licensed items after approval is expected to be strict. In particular, it is expected that the Ministry of Food and Drug Safety can actively intervene and take action in the process of clinical trials through regular reports. On the other hand, at the National Assembly audit held in October, it was pointed out that the management of Accelerated Approval items was insufficient. In particular, it was pointed out that the MFDS was passive about the situation in which Accelerated Approved Riavax was revoked due to failure to complete the phase III conditions. Baek Jong-heon, a member of the People Power Party, said that eight out of 32 clinically accelerated applications in Phase III over the past five years have no production performance. This guideline seems to accept these comments and clarify the conditional implementation process. Currently, it is known that Baek Jong-heon plans to initiate a bill to legislate accelerated approval.
- Policy
- Benlysta is about to be listed as RSA (Refund·Expenditure)
- by Kim, Jung-Ju Dec 31, 2020 06:19am
- Benlysta (Belimumab), a new treatment for systemic lupus erythematosus by GSK, can be listed on the ‘Pharmaceutical Benefit List and Upper Limit Price List’ in February next year as soon as the administrative procedures are carried out sequentially. According to the pharmaceutical industry on the 28th, the government will promote insurance benefits for Benlysta 120mg and Benlysta 400mg. Benlysta is an injection approved by the MFDS for “the treatment of adult patients with autoantibody-positive active systemic lupus erythematosus being treated with standard therapy.” The number of domestic patients subject is about 835. In June 2013, after obtaining the approval of the MFDS, discussions took place in earnest at the Pharmaceutical Benefit Evaluation Committee following the application for insurance registration in May this year. As a result of negotiating drug prices with the NHIS in September, the pharmaceutical company agreed to refund a certain percentage of the initial amount of treatment and drug charges and the excess of the estimated cap to the NHIS during the RSA. According to the industry, Benlysta 120mg will be set at ₩182,696 and Benlysta 400mg will be set at ₩608,988. If applied, it is expected that the listing will be possible as early as February.
- Policy
- Generic for Teribone was approved & the competition began
- by Lee, Tak-Sun Dec 30, 2020 06:02am
- Dong-A ST As a treatment for osteoporosis, generics have begun to be released in the latest bone formation promoting agents. Following Lilly's Forsteo, Dong-A ST's Teribone was also a generic version. The MFDS approved Terrosa 56.5μg (Teriparatide acetate) from BMIKOREA on the 28th. Terrosa is a generic of Teribone subcutaneous injection 56.5 μg and the same ingredient (Teriparatide acetate), which was approved by Dong-A ST in November 2015. This is the first time Generic for Teribone has been licensed. Teribone is a partially synthesized formulation of parathyroid hormone involved in bone formation, and is a product introduced in Korea by Dong-A ST from Asahi Kasei Pharma in Japan. In a clinical trial in Japan, it showed a fracture inhibitory effect that reduced the incidence of vertebral fractures to 78.6% compared to the placebo group. In particular, in Korea, it is treated like IMD because of improved ease of administration than Lilly's Forsteo (Teriparatide), which was licensed in 2002. Forsteo should be injected subcutaneously once a day, whereas Teribone can be injected once a month. In December 2016 by Forsteo and January 2017 by Teribone, benefits were recognized for patients who were ineffective or unable to use existing bone resorption inhibitors. Therefore, it has been in the domestic market in less than four years. Generic for Forsteo was released for the first time and was in competition. In October of last year, Forsteo's biosimilar'Terrosa cartridge' by Daewon was approved. This product was developed by Richter-Helm, a Hungarian-German pharmaceutical joint venture, and was given a re-examination for four years (until October 28, 2023) in recognition of its equivalence with the original. With BMIKOREA's approval of generic for Teribone this time, the number of promoting bone formation drugs of Teriparatide increased to four. Forsteo and Teribone's IQVIA sales last year were 21.7 billion won and 2.9 billion won, respectively. The gap between Forsteo and Teribone is widening. If generics such as BMIKOREA's Teria are sold in earnest following Daewon's Terrosa, it is believed that it will affect the market structure. Terrosa was released last May.
- Policy
- Vaccination will be given for medical staff and the elderly
- by Lee, Jeong-Hwan Dec 29, 2020 06:09am
- The Democratic Party of Korea, the government, and Cheongwadae have decided to start vaccinating COVID-19 from February of next year. On the 27th, the Party, the government, and Cheongwadae held a party government council at the National Assembly to discuss support measures for COVID-19 damage, measures to secure treatment and isolation facilities, and vaccine contracts. The Chief Presidential Secretary Noh Young-min said, "We have already secured enough COVID-19 vaccines to protect our people." He said, "Vaccinations for medical staff and the elderly will begin by February next year. " He said, "Countries around the world will start vaccinating the general public in the second quarter of next year. We will begin vaccinating the general public at a similar time." He explained, "The timing of the formation of group immunity will be similar to that of foreign countries, or it will be faster. The government is making all-out efforts to accelerate this period and is making progress." Lee Nak-yon, Leader of Democratic Party of Korea said, "We will mobilize all available means for the disaster damage subsidy to be executed from January in order to further help COVID-19 victims. We will focus on overcoming COVID-19 outbreak, stabilizing people's livelihood, and recovering the economy.” Kim Tae-nyeon, floor leader, asked, "Financial authorities have an extraordinary awareness of the war situation and drastic financial execution. I request that the government's customized emergency damage subsidies be expanded from '₩3 trillion + α." Prime Minister Chung Sye-kyun said, "We will promote rental support and income preservation measures for small business owners and the underprivileged. We will prepare necessary beds in advance with the possibility of worsening COVID-19."
- Policy
- What are the major systems of the MOHW, the MFDS, & the KCDA
- by Kim, Jung-Ju Dec 29, 2020 06:08am
- From next year, medical expenses for rare diseases and diseases subject to the exempted calculation will be expanded. In addition, the national infrastructure necessary for rapid introduction and verification of the safety and effectiveness of COVID-19 vaccines and treatments using high-tech new technologies will be expanded. The Ministry of Economy and Finance announced on the morning of the 28th a summary of the government's business plan for 2021, which will have a great impact on the public among all government ministry projects next year. In the health care and pharmaceutical industry sectors, reinforcement of coverage for rare and essential targets and reduction of entry into essential medical care and advanced and precision technologies are typical. ◆Ministry of Health and Welfare = Diseases subject to the exempted calculation of health insurance will be expanded from January. The exempted calculation is a type of guarantee that reduces the estimated copayment rate to 10%. The targets for promotion are patients with severe incurable diseases, rare diseases such as keratoconus patients, or 68 rare diseases such as hydranencephaly and severe atopic dermatitis. Newly designated as a disease subject to exempted calculation. For these diseases, the current hospitalization co-pay rate is 20% and the outpatient co-pay rate is 30-60%, and from next month, the inpatient and outpatient co-pay rates will be 10%. In August 2017, health insurance coverage for chest (breast) and echocardiography will be expanded according to measures to strengthen health insurance coverage. The MOHW will expand and apply echocardiography in order from the first half of next year to the chest (breast) and from the second half of next year. Until now, the government has completed health insurance coverage. Beginning with the upper abdomen in April 2018, ultrasound examinations in the lower abdomen and the urinary system in February 2019, the emergency and critically ill patients in July of the same year, the male genitalia in September of the same year, the female genitalia in February this year, and the ophthalmology sector in September will be expanded. In the meantime, despite the high cost-effectiveness of ultrasound, insurance has been applied mainly to patients with four major serious diseases (cancer, heart, cerebrovascular, rare intractable teeth) due to financial burden, but from now on, the disease is affected by the medical judgment of the doctor. Health insurance benefit will be expanded if there is a need for examination due to a disease or suspected disease. The government announced that it plans to discuss specific insurance coverage and medical cost reduction effects, and to prepare related legal procedures later with the medical community. The government has been expanding responsible medical institutions in each region in order to close the gap in essential medical care between regions since last November. This is a project to strengthen cooperation in essential medical services centered on public hospitals, focusing on 15 regionally responsible medical institutions such as national university hospitals, and 35 regionally responsible medical institutions such as local medical centers. The main goal is to establish a system of direct and essential medical cooperation. In addition, the business area in the essential medical field is expanded step by step to develop a cooperation model and carry out the project. It also promotes referrals and transfers between partner organizations. The MOHW is carrying out a project to revitalize medical referrals with the main focus of improving the reimbursement rate system so that exchange of medical information can be activated through an electronic method such as electronic record. This is a method in which a medical institution in a non-capital region increases the fee when it is requested above the general hospital level (including specialized hospitals) in the same city. As a result, the government is expecting to establish the function of each type of medical institution and to ease the focus of patients in large hospitals. In addition, patient treatment and image information will be exchanged through an electronic method so that patient’s referrals can be made. The government explained that this will increase patient safety by ensuring continuity of treatment at the time of referral and return, and increase patient convenience as patients do not have to submit treatment information directly. In addition, it added that it is possible to expect efficient use of medical resources and savings in health insurance finances by reducing duplicate examinations and imaging. In addition, the reimbursement rate system will be improved so that medical institutions in non-metropolitan areas can induce referrals to general hospitals, general hospitals, and specialized hospitals within the same city (17 administrative districts) to strengthen the connection of medical institutions within the local community. A plan is also underway to shorten the period of entry into the medical field with new medical technologies through regulatory innovation of medical devices. The MOHW expanded the targets for the evaluation of innovative medical technologies from last November so that cutting-edge medical technologies such as digital therapeutics and precision medicine can enter the medical field early. Specifically, the number of innovative Health Technology evaluation targets has been expanded from 6 to 9, and the disease group, which was limited to 4 fields, has been abolished, enabling the use of advanced medical technology for various diseases with a large impact on society. ◆The KCDA = The KCDA will expand supportable diseases such as medical expenses for rare diseases from January next year. The KCDA announced a list of additionally designated rare diseases in October this year, and plans to increase support for rare diseases such as medical expenses support and expansion of target diseases for diagnosis next year. From January, the number of diseases subject to the medical expense support project for rare diseases has expanded from 1,014 to 1,078, supporting health insurance copayment. In accordance with the designation of new rare diseases, the number of diseases subject to “genetic diagnosis support for rare diseases” will also be expanded from 126 to 175. Online applications for medical expenses support for people with rare diseases will also be expanded. The scope of the online application for the “medical expense support project for people with rare diseases,” which started in March this year, will be expanded from next September. Specifically, it will expand from low-income health insurance subscribers who do not currently have a support obligation to all low-income household health insurance subscribers, medical benefit patients, and the next higher-ranking out-of-pocket patients who are eligible for deductible deductions regardless of whether they are obligated to support or not. In addition, from next month, free vaccinations for the elderly pneumococcal (PPSV23) will be expanded from the current public health center to a consigned medical institution. The government is temporarily expanding operation of vaccination institutions to consigned medical institutions from June 22 to the end of this year in response to COVID-19 by public health centers this year. If it is expanded to entrusted medical institutions, about 14,000 sites will be added from 256 existing ones. In addition, the KCDA strengthens the protection of personal information exposure of patients with infectious diseases. In the event of an infectious disease crisis, personal information such as the name and detailed address of residence that are not related to the prevention of infectious disease should be excluded when disclosing the route of movement of the patient with an infectious disease. This project will be applied from the 30th of this month. ◆The MFDS = The MFDS will support education and training to nurture experts in regulatory science to strengthen the safety supply of biohealth products and domestic industrial competitiveness from next year. The government explained that it is essential to develop safety technologies that can evaluate product safety, effectiveness, quality and performance in order for biohealth products to which future technologies (AI, application of big data, etc.) are applied to the market quickly. Accordingly, the MFDS will select five excellent universities in Korea and provide more than ₩500 million per year to each university for five years in order to cultivate professional researchers who research safety technology while learning legal knowledge about the licensing of biohealth products In addition, universities that have received applications are planning to cultivate more than 600 new researchers and field experts by establishing master's and doctoral degrees in regulatory science in the field of food and medicine at graduate schools. Product development and safety management for COVID-19 will also be strengthened. The MFDS is planning to reinforce infrastructure, such as verification of the safety and effectiveness of COVID-19 vaccines and treatments using state-of-the-art new technologies, and national testing equipment necessary for rapid domestic supply. All vaccines, including the COVID-19 vaccine, must undergo a lot release from the MFDS after reviewing data on manufacturing and quality control and verification tests for domestic supply. Accordingly, for the rapid and safe national lot release of COVID-19 vaccine, advanced analysis equipment will be added and newly introduced, and a special laboratory will be built. In addition, in order to accelerate the development of a vaccine and treatment for COVID-19, the country plans to designate an “IRB” for rapid review. It shortens the entry period for clinical trials by conducting an integrated review (one time) by IRB for approval of clinical trials conducted by various medical institutions. To this end, the MFDS will regularly review major new information such as side effects of clinical trial drugs to prevent harm to patient safety in advance. In addition, it will provide a platform that can be used for new drug development by transparently disclosing information from clinical trial approval to results, and release a lot of vaccines quickly and safely to successfully overcome COVID-19. In addition, a design for the expansion of patient treatment opportunities and the rights, safety and welfare of clinical trial participants will be established. Mandates education to prevent recidivism in people who commits a crime related to narcotics. Since the 4th of this month, the MFDS has been convicted by a court or notified of a summary order as a mandatory education to prevent recidivism of people who commits a crime related to narcotics has been implemented. The crime related to narcotics is a policy that compulsory completion of an order to attend education or rehabilitation programs necessary to prevent recidivism within 200 hours. In addition, safety inspections for overseas direct purchases will be further expanded. Even though the rate of nonconformity such as overseas fast-purchased food is very high, there are only about 1600 purchase inspections as of this year, and there is a possibility of domestic inflow of hazardous food, and the government inspects it at twice the level of the previous year (3,000 cases) from next year. It plans to expand the number of cases. In particular, the MFDS plans to reinforce the safety management of foods purchased directly from overseas by diversifying inspection targets such as foods of vulnerable groups and foods that are domestic issues from the existing tests focused on improving sexual function, strengthening muscles, and diet food. The MFDS also implements an innovative medical device software manufacturing company certification system to promote rapid commercialization of innovative medical device software. Innovative medical device software refers to a software-only product among medical devices with significantly improved safety and effectiveness compared to existing medical devices by applying advanced technologies such as artificial intelligence (AI) and virtual reality (VR). When manufacturing licenses for innovative medical device software of certified companies, some of the submitted data will be exempted so that innovative products can be quickly released to the market. The special exceptions for certification and permitting of manufacturing enterprises will be implemented within the first half of next year when the relevant regulations are revised.
