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2026-04-16 21:14:34
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Company
Immunotherapies tap on SCLC treatment area for more options
by
Eo, Yun-Ho
Jun 23, 2020 06:21am
One after another, immunotherapies are tapping into the unexplored small cell lung cancer (SCLC) treatment area. According to the pharmaceutical industry sources on June 20, AstraZeneca’s Imfinzi (duvalumab), following Tecentriq (atezolizumab) by Roche, has been indicated as a first-line treatment for SCLC by Korea’s Ministry of Food and Drug Safety (MFDS) Imfinzi’s SCLC indication was cleared in Korea for the third time in the world after the approval in Singapore and the U.S. SCLC was considered to be ‘hopeless’ for new drug as there was no treatment option other than chemotherapy for last two decades. The aggressive SCLC shows poor prognosis with five-year survival rate of just 6.5 percent, about a quarter of patients with non-small cell lung cancer. The Phase III CASPIAN study tested efficacy and safety of Imfinzi against existing standard of care in patients with SCLC from 22 countries around the world, who have not received any treatment. The study confirmed statistically significant improvement in overall survival (OS) in the arm receiving Imfinzi combined with etoposide and either carboplatin or cisplatin chemotherapy, compared to the control arm treated with six cycles of chemotherapy followed by optional Prophylactic Cranial Irradiation (PCI). The Imfinzi combination therapy reduced the risk of death by 27 percent against the standard of care, and demonstrated median OS of 13.0 months, which was 2.7 months longer than the standard of care. And other endpoints like progression free survival and objective response rate have indicated Imfinzi combination therapy shows enhanced efficacy against the standard of care. As for another immunotherapy Tecentriq, the Phase III IMpower133 study confirmed Tecentriq’s meaningful efficacy by comparing 403 patients with SCLC either treated with Tecentriq combined with chemotherapy (etoposide and ecarboplatin) or the chemotherapy alone. The study result found the patient group treated with Tecentriq combination therapy reached the medial OS of 12.3 months, whereas the chemotherapy alone reached 10.3 months. Compared to the control group, the Tecentriq combination group had 30 percent lower risk of death. Also 51.7 percent of the patients in Tecentriq combination group survived after a year, but only 38.2 percent of the chemotherapy only group survived after a year.
Policy
Minister Choi said, COVID-19 treatment may come out
by
Lee, Jeong-Hwan
Jun 23, 2020 06:20am
Choi Kiyoung, Minister of Science and ICT, said that as soon as possible, COVID-19 treatment could be developed within two months. Minister Choi said that the development of treatments through the ‘drug repositioning method’ to discover the effect of COVID-19 treatment of already-approved drugs has been revealed, not through the approval of new drugs through new clinical trials. However, vaccines is expected to require a relatively long time because it is impossible to apply the drug repositioning method and clinical trials are required. On the 19th, Minister Choi said on Kim Hyun-jung's News Show(CBS Radio). Minister Choi said "The Ministry of Science and ICT is collaborating with the MOHW and the KCDC. The Ministry of Science and Technology mainly conducts basic research on sources." Minister Choi explained that clinical trials take a long time, but the drug repositioning method can target drugs that have already been clinically developed, which can significantly speed up drug development and the drug repositioning is the use of a drug that has been previously approved for other uses as COVID-19 treatment." In particular, when asked about the timing of the development of COVID-19 treatment, he said "As soon as possible, the treatment may come out within 2 months, but it is not a medicine targeting COVID-19, but the effect may be reduced." It was diagnosed that the vaccine development time would require a lot of time compared to treatment. He said that vaccines are not able to reposition a drug, so it can take a very long time. Fortunately, many people around the world have researched and some vaccines are in clinical trials. It will be released in the first half of next year as soon as possible, and it is possible to come out in Korea in the second half of next year."
Policy
Generic for Daxas was applied
by
Lee, Tak-Sun
Jun 23, 2020 06:20am
Generic for Daxas (Roflumilast, AZ), which was approved in Korea, was first applied. Particularly, the generic that has been applied are noted because they also contain low doses (250 mcg). According to the MFDS on the 19th, Generics for DAXAS (Roflumilast), were applied for approval as of the 5th and notified to patent holder AstraZeneca. The generic includes 250 mcg dose, as well as 500 mcg dose, which are the same as Daxas. Daxas 250 mcg is available abroad, but is not sold in Korea. The domestic patent right of Daxas is valid until February 19, 2023. In last March, Sama Pharmaceutical succeeded in evading the patent right through a passive judgment on the scope of rights. In last August, Sama was approved for a bioequivalence test that compares the bioequivalence between Daxas and its generic. However, it was not disclosed whether Sama applied for this license or not. Daxas is used as a maintenance therapy for severe chronic obstructive pulmonary disease with chronic bronchitis with a history of worsening symptoms. Adults over the age of 18 take one tablet a day, regardless of meals. As of last year's IQVIA, sales amounted to ₩1.5 billion. Generic for Daxas has not been approved in Korea so far.
Company
Daewoong wins first patent dispute in Belkyra after 2 years
by
Kim, Jin-Gu
Jun 22, 2020 06:10am
BelkyraDaewoong has passed the first gateway for the release of generic for Belkyra (Deoxycholic acid), which targets and eliminates fat cells under the chin. Daewoong won the patent dispute that has been leading for two years with Allergan. The IPT ( Intellectual Property Trial and Appeal Board) made a trial decision on the 19th at Daewoong Pharmaceutical's passive judgment on the scope of the right to claim Belkyra's formulation patent. The patent dispute related to Belkyra was triggered in March 2018 when Daewoong Pharmaceutical filed an invalidation trial on the formulation patent. Subsequently, in April, a trial to confirm the passive scope of rights was raised against the same patent. The dispute lasted more than two years. In this process, Allergan used a “time wasting” strategy through patent splitting. In January, two new patents were registered by removing some of them from existing patents. Daewoong Pharmaceutical also challenged each of the two split patents. Penmix, a subsidiary of Kuhnil Pharmaceutical, joined here. This trial is the conclusion of the passive judgment of the scope of rights raised in 2018. The result of the invalidation trial filed in the same year has not yet been announced. However, the Patent Judge has notified that the hearing will be closed in March, so it is expected that the result of this trial will be released soon. According to the industry, Daewoong Pharmaceutical analyzed that it raised a dispute with the aim of 'preemptive defense for the development of its own products' rather than 'early launching generics through patent evasion' from the beginning. Daewoong Pharmaceutical is currently developing a submandibular fat improvement injection under the name 'DWJ211'. Since March of last year, it has entered a phase III clinical trial in 150 patients at Konkuk University Hospital and Chung-Ang University Hospital. The indication is 'improvement of moderate and severe submandibular fat', which is the same as that of Belkyra. When development is finished, Allergan may file a patent infringement lawsuit. At this time, the trial is expected to be properly used for defense purposes. Even if the development of DJW211 is torn down, Daewoong Pharmaceutical will be able to release generics after August 24, 2023. Belkyra's patent expiration date is August 23, 2031, and the PMS expiration date is August 23, 2023. However, the generic release date is delayed if Allergan appeals. Belkyra is the only subcutaneous fat injection to be approved by the U.S. Food and the FDA. Belkyra’s indications include moderate to severe protrusions in adults or excessive submandibular fat improvement. It was released in Korea in early 2018. Belkyra contains Deoxycholic acid, a 100% chemical compound that is not derived from humans or animals. Injection of this substance subcutaneously irreversibly destroys the fat cell membrane and causes new collagen production at the treatment site.
Company
Big 5 DC pass HIV treating two-drug regimen Dovato
by
Eo, Yun-Ho
Jun 22, 2020 06:08am
General hospitals in Korea are reviewing the prescription of GlaxoSmithKline’s (GSK) Dovato, a two-drug regimen indicated to treat HIV-1 infection. The pharmaceutical industry sources reported the drug committees (DC) at the Big Five general hospitals like Seoul National University Hospital and Severance Hospital have passed Dovato (dolutegravir/ lamivudine) after it was listed for reimbursement from early June. The healthcare reimbursement is granted for using Dovato in patients with HIV-1 infection with and without AIDS-related symptoms, who tests baseline CD4 cell count below 350/㎟, exceeds viral load of 100,000 copies /㎖, or is acknowledged by an infectious disease specialist to be prescribed with the drug. Moreover, the drug’s reimbursement would be provided for a pregnant person with HIV infection, infant born from HIV-infected mother, healthcare provider exposed to HIV infection, and spouse (partner) of a person with HIV infection for preventive purpose. In Phase III GEMINI1 and GEMINI2 trials, the drug was used to treat adult patients with HIV infection, and they confirmed the drug’s safety and antiviral effect equivalent to other triple-drug regimen (dolutegravir, tenofovir disoproxil fumarate and emtricitabine). And in TANGO trial, adult patients, who maintained viral suppression for at least six months on a tenofovir disoproxil fumarate (TAF)-containing triple-drug regimen, demonstrated a similar level of viral suppression effect after switching to the two-drug regimen. Recommended to administer a single tablet once-daily, 18,528 won per tablet Dovato would cost 555,840 won, monthly. The drug’s pricing is equal to the existing single-drug regimen option Tivicay (dolutegravir), which is at about 72 percent of the triple-drug regimen Triumeq (abacavir/ dolutegravir/ lamivudine).
Policy
26 million flu vaccines will be released this year
by
Lee, Tak-Sun
Jun 22, 2020 06:08am
It is expected that 26 million flu vaccines will be released this year. The MFDS is planning to cooperate closely with the industry in preparation for an increase in demand for inoculation due to the prevalence of COVID-19 and the flu at the same time in the second half of the year. On the 18th, the MFDS announced that it will hold a briefing on the lot release of flu vaccines in 2020 for domestic vaccine manufacturers and importers. The main contents of the briefing are ▲ Amendments to the lot release approval regulations ▲ Precautions when preparing a summary of manufacturing and quality control ▲ Plan for procurement of vaccination for public use. Influenza vaccine planned for domestic distribution in 2020 An official from the MFDS said, "We expect the country's seasonal flu (influenza) vaccine to be approved for the lot release this year at about 26 million. And plans to work closely with the KCDC." The MFDS said that it would pay attention to the condition of COVID-19 ooutbreak, and will promptly approve the lot release so that seasonal flu vaccines can be supplied smoothly, and closely monitor supply and demand in cooperation with the KCDC.
Company
Yuyu Pharma exports FDA-approved COVID-19 test kit
by
Lee, Seok-Jun
Jun 22, 2020 06:08am
CEO Yu Wonsang of Yuyu Pharma (left) and CEO Lee Hyo-keun of SD Biosensor In partnership with SD Biosensor, Yuyu Pharma is to export COVID-19 test kit. At SD Biosensor headquarters office in Suwon on June 17, two companies signed a supply deal on real time polymerase chain reaction (RT-PCR) test kit for COVID-19. SD Biosensor’s COVID-19 test kit has received the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) in April. As a result, USD 5.2 million worth of 300,000 kits were supplied to the U.S. Federal Emergency Management Agency (FEMA) as well. The RT-PCR kit, named 'STANDARD M nCoV Real-Time Detection Kit.,' amplifies and detects specific nucleic sequence to diagnose COVID-19 infection through human nasopharyngeal swabs and throat swab samples. SD Biosensor is one of six Korean companies that received EUA from FDA and one of seven companies Korea Centers for Disease Control and Prevention (KCDC) approved EUA for. CEO Yu Wonsang of Yuyu Pharma stated, “Using the company’s global network, the COVID-19 testing kit would prioritize export to the U.S. first and later expand out to other countries.”
Company
Outpatient Rx amount for major chronic diseases decreased
by
Chon, Seung-Hyun
Jun 22, 2020 06:08am
Prescriptions for chronic diseases such as hyperlipidemia, hypertension, and diabetes, which have the largest sales due to COVID-19, have been reduced by half. According to UBIST, a drug research agency on the 17th, the outpatient prescription size was ₩2,360 billion in April and May, a 9.0% decrease from the same period last year. In April, the outpatient prescription amount fell 8.7% from the same period last year, and the prescription amount decreased 9.4% last month. Prescriptions for major chronic diseases that form a large market have declined. The prescription amount for statin drugs used in the treatment of dyslipidemia was April and May, at 1618 billion won, a 4.0% decrease from the same period last year. Considering that the prescription amount of statins in April and May rose 7.1% year-on-year, the decline was large. In the first quarter, the outpatient prescription for statin drugs in the first quarter was ₩247 billion, an increase of 3.0% compared to the same period last year, but turned downward from April. The prescription amount for statin drugs in April was ₩82 billion, a 2.8% decrease from the previous year, and decreased by 5.1% in May. The prescription amount for hyperlipidemic drugs in the first quarter was ₩120 billion, up 26.0% from the previous year, but the prescription amount in April and May increased by 15.2%. Recently, Rosuvastatin or Atorvastatin and Ezetimibe combined drugs increased explosively as the preference increased, but growth has been slow since April. Monthly outpatient Rx Amount for major chronic disease treatments (Unit: ₩100 million, Source: UBIST) It is analyzed that a full-scale prescription difference occurred in the second quarter as patients with chronic diseases received long-term prescriptions in advance in February and March when the number of COVID-19 infected patients surged. In fact, when the number of COVID-19 infected patients surged, it was reported that the number of patients receiving prescriptions for 3 to 6 months in advance increased significantly. The large chronic disease prescription market, such as hypertension or diabetes, has a similar pattern. The April/May prescription for 'ARB+CCB' combination, the most commonly used hypertension drug, increased 2.3% compared to the same period last year. Compared to last year's April and May prescriptions, an increase of 7.1% over the previous year, growth has slowed. In the first quarter, the prescription size of outpatients was ₩198 billion, an increase of 10.0% from the same period last year. ‘ARB+CCB' is a combination drug of calcium channel blocker (CCB) and angiotensin II receptor blocker (ARB). The prescription amount of 'ARB+CCB' combination in the first quarter of last year was ₩180 billion, an increase of 9.2% over the previous year. However, the growth rates in April and May were reduced to 3.2% and 1.4%, respectively. In April and May, prescription amount for ARB-based drugs were ₩64.1 billion, a 3.3% decrease from the same period last year. The prescription amount in April and May last year increased by 7.2% from the previous year, but this year it decreased. Prescription amount for ARB-based drugs decreased in April and May by 2.8% and 4.9% YoY, respectively. The size of the April/May prescription for the 'DPP4-inhibitor + Metformin' combination, which is the most widely used diabetes treatment, was ₩30.7 billion, a 1.4% decrease from last April & May (₩30.5 billion). The prescription amount of 'DPP4-inhibitor + Metformin' in the first quarter rose 6.9% from last year. Monthly outpatient Rx amount for major antibiotics (Unit: ₩100 million, Source: UBIST) The amount of antibiotic prescription was significantly reduced in the major prescription market. The prescription amount of Cephalosporins in April and May was ₩29.6 billion, a 39.2% decrease from the same period last year. Prescriptions for oral Cephalosporins fell 1.3% year-on-year, but fell sharply after April. It decreased by 41.2% in April compared to the same period last year, and decreased by 37.1% in May. Prescription amount of oral Penicillins decreased 11.9% in the first quarter compared to the previous year, but fell 57.0% in April and May. It is analyzed that the decrease in antibiotic prescription is closely related to the decrease in the number of patients. This is because after the spread of COVID-19, external activities contracted and personal hygiene management, such as washing hands and wearing a mask, strengthened, and the incidence of infectious diseases such as cold decreased. According to statistics released by UBcare last month, prescriptions for acute nasopharyngitis in April were 71% less than in the same period last year. In April, the amount of prescriptions for children and adolescents decreased by 52% from the previous year, and the number of prescriptions dropped by 76%.
InterView
EASY-ON opens up new opportunity to Xarelto amid COVID-19
by
Eo, Yun-Ho
Jun 19, 2020 06:24am
PM Jung Changho COVID-19 has brought dramatic changes to our lives. Witnessing these changes, scholars stress the importance of responding and planning for the prospective changes in the post-coronavirus era. And many pharmaceutical companies are also seeking for new changes in business model amid COVID-19 pandemic. For the pharmaceutical industry, the novel infectious disease has been increasingly limiting the conventional sales activity, which highlighted the importance of non-contact multi-channel marketing. Now the online-based marketing tools are emerging as an answer, and companies are taking the cue to expand various non-contact sales channels like one-on-one detailing service, web symposium and e-catalogue. In March, when COVID-19 was spreading fast in Korea, Bayer Korea launched non-contact detailing service ‘EASY-ON’ and swiftly tackled on the changes in the society’s trend. EASY-ON is an online video consulting solution that provides latest clinical findings and anti-coagulant prescription related medical information for primary healthcare institutes like private clinics to better manage chronic atrial fibrillation. The program has specialized nurse with clinical experience as a consultant to engage with the healthcare providers. .Daily Pharm interviewed Product Manager (PM) Jung Changho, who led the EASY-ON project launch, for the story of the present and future of non-contact sales .Bayer -Please give us a short introduction to yourself for the readers Started as a medical representative in the cardiovascular sector since 2009, I joined the Xarelto sales division in 2016 .Currently, I am in charge of planning and operating the EASY-ON project in the marketing team, and it has been over a year being the PM for Xarelto team .-Marketing and sales around the world are largely obstructed by the COVID-19 pandemic .What kind of changes have you experienced after the outbreak, and how is the Xarelto team responding to the situation ? The non-contact marketing and sales back in the day used to lack the drive .Of course, many pharmaceutical companies have been continuously working on remote multi-channel marketing before, but after the outbreak, the companies are more eager to diversify the communication channels and try them in real life .As the conventional sales are deeply rooted in face-to-face engagement, I was always skeptical of other channels and their effect .But, with the recent incident, I have learned the clients are more ready to accept the new system than how we expected, and that they are more open and positive to review a new communication channel .-Apparently, EASY-ON program launch was planned before the COVID-19 ? Actually, the plan for EASY-ON predates the COVID-19 outbreak—it was initially planned to improve the atrial fibrillation patient management .And the project took the momentum as the outbreak started in the time of the launch .The objective of the EASY-ON is to inform private clinic healthcare providers to adequately manage atrial fibrillation patients, and to fixed imbalanced information caused when using an anticoagulant .Unlike general hospitals, private clinics have contacted the company through various channels to query prescription related information, which shows the information asymmetry between the two .And this is how EASY-ON came about .The ultimate goal of the project is to educate the healthcare providers for patients to truly benefit from treatment options .-How is the program generally operated ? The first and the most important benefit of EASY-ON is having seasoned specialist nurse to give consultation via video conference call .The second benefit is that the program focuses on atrial fibrillation, which tends to require more intricate care and treatment compared to other chronic disease .The healthcare providers can access relevant in-depth information, because EASY-ON specializes in atrial fibrillation and relevant treatment information, .About three months since the launch in March, approximately 200 healthcare providers have joined the program so far .It constantly provides scheduled consulting service to the members .The EASY-ON platform offers overall ten basic learning materials based on basic information of the health condition, which is accessible on demand after the consulting session .-General hospital and private clinic healthcare providers are torn between the prescription options of non-Vitamin K antagonist oral anticoagulants (NOAC) like Xarelto and initial care .Between the two clientele, which does Bayer tries to put more focus on ? Most importantly, no patient should be left behind by any one of them .So both are very important channels we need to take care of .At the moment, general hospitals are encouraging patients to be diagnosed at general hospital and to manage the condition at clinics .And clinics anticipate contributing in the initial anticoagulant treatment in atrial fibrillation patients .Bayer’s biggest mission is to have the patients with atrial fibrillation to receive adequate treatment, regardless of general hospital or clinic, and to manage the condition properly .-Any memorable anecdote with the EASY-ON to share ? A private clinic in a hard to access remote region gave a quite memorable feedback .Despite the needs for the anticoagulant treatment information, the healthcare provider there did not have a good and efficient access to the information .But in the end they expressed gratitude for our EASY-ON program when basic information and key information needed for seeing a patient were provided through a video call platform .-What’s next for EASY-ON ? The project is aiming to secure 2,000 members within this year .Although the service has been reactively responding, the company is preparing a channel to academically engage with general hospital professors in real time for their unmet needs .For the EASY-ON clients, web symposium consisting of specialized consulting webinars would be organized to talk about differences in each clinical trial and solution in each case .And other informative materials like FAQ or newsletter would be disseminated to the EASY-ON members to answer their queries on NOAC .
Policy
What is the solution for Remdesivir/generic competitiveness?
by
Lee, Tak-Sun
Jun 19, 2020 06:21am
Kim Young-ok, director of pharmaceutical safety bureau at the MFDS There was no communication between the MFDS and the pharmaceutical industry due to the COVID-19 crisis that began in Korea from the end of January. Since the 'Director of pharmaceutical safety bureau at the MFDS-CEO Meeting in 2020' was postponed indefinitely on February 12, the news of the MFDS was only occasionally available through data and articles. The 'Online Video Conference between the MFDS and the factory managers in the pharmaceutical industry' held on the 2nd and 9th attracted attention as it was a place of communication after a long time. The MFDS says it will continue to expand such non-face-to-face video conferencing and investigation. Officially met with reporters this year, Kim Young-ok, director of pharmaceutical safety bureau at the MFDS, also selected keywords of the MFDS as a solution to non-face-to-face environmental changes and generic competitiveness measures after the COVID-19 outbreak. In addition to the reporter's meeting with director Kim Young-ok held on the 16th, there was also a story about the homework facing the MFDS in COVID-19 crisis. These include, for example, special imports of Remdesivir and clinical trials of COVID-19 treatments. The following is a summary of the meeting with Director Kim Young-ok. After COVID-19 incident, how will the factory survey be conducted? "As the non-face-to-face environment becomes common, it is inevitable to change. Some are already doing so. For example, if there is a due diligence report from the PIC/s member countries, it replaces the actual investigation. I'm going to try a method that I can see even if I don't go, and I think I can connect to the company and employees through video equipment to look at facilities, equipment, etc. Korea has good IT technology and networks, If it goes well, I think these things will be enlarged and become everyday." Will the policy briefing sessions proceed in a non-face-to-face manner in the future? "I recently had a videoconference with the factory manager of a pharmaceutical company, and I plan to expand it in the future because it was a place where I could communicate with the field without face-to-face. There are several technical and unfamiliar parts. There are many effective aspects. The policy briefing session is also looking for ways to make it non-face-to-face, and it is also considering ways to post content on Youtube and so on, so that it does not end in one time. Counseling is also being prepared so that the videoconference can proceed as much as possible." In this non-face-to-face situation, can clinical trials of COVID-19 treatment be conducted properly? "The clinical trials for new drug development should also prepare for system maintenance according to non-face-to-face. Change has already begun.. In the case of COVID-19 treatment, it is difficult for clinical trial operators to contact and even obtain consent. The agency has made improvements to ensure that clinical trials can be carried out smoothly. As a result, 12 clinical trials related to COVID-19 treatment and 2 vaccines have been approved." How is the public-private partnership to strengthen the competitiveness of generic drugs? Paradoxically, international confidence in medical products in Korea has been increasing a lot since COVID-19. I think Korean medicine should enter the global market with this opportunity. It is discussing strengthening international competitiveness of generic drugs through public-private councils in this regard. There are two main objectives. The first is to provide accurate information to the people, and the second is to make 'K-Generic' grow into the future industry. In order for these things to work, we need to help them enter the global market. The MFDS is planning to proceed with international cooperation with local governments so that Korean companies can obtain product approvals quickly from overseas countries. The public-private council plans to announce the final conclusion in late June." How is the cause of NDMA detected in Metformin being investigated? “We plan to draw a final conclusion through the NDMA investigation committee. We are investigating with the manufacturer with the detected item. We went through due diligence to understand the situation. When the data is gathered in the committee, it seems that scientific conclusion will be reached. However, it seems difficult to complete the cause investigation within a short period of time because there are various facts (causes) in the process.” How is the discussion of accident compensation due to the NDMA case going on? "This issue is also being discussed through the public-private council. However, I think we should see the lawsuit result in the Valsartan case. I intend to participate if it goes through legislative assembly with regard to personal contributions." How is the proceedings of special import for Remdesivir going? "We are in the process of discussing with Gilead and the KCDC. The timing and quantity of supply will be decided in a consultation process. Gilead is also actively negotiating. These drugs need to be approached in that respect because the company has more publicity than taking private profits. Gilead knows well." Isn’t the reevaluation of Choline alfoscerate formulations too late? “We are going at our own pace. The schedule of the MFDS was in June, and it seems to be going as it was. In the meantime, there were data limitations, and thus, manufacturers were asked for additional data. Some experts reviewed it internally, and some evaluations were conducted by the evaluation agency. Currently, Pharmaceutical Affairs Review Committee’s meeting is scheduled to be held and it will be asked if a special reevaluation is appropriate. If a special reevaluation is conducted, it is planned to seek advice on how appropriate it is. When the results are announced, we will take steps to organize the position of the MFDS and publish it soon. However, the Committee is not a deliberative body, but an advisory body.”
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