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- 2026-04-12 10:11:26
- Policy
- The MFDS will gradually disclose the results of GMP survey
- by Lee, Hye-Kyung May 20, 2022 06:11am
- The MFDS has decided to disclose the results of the drug GMP survey on its website in the future. The MFDS has prepared a plan to disclose information on the results of the drug GMP survey based on the discussions discussed through the Public-Private Consultative Body on the Results of the GMP Survey. As a PIC/S member country, the results of the survey will be disclosed at the level of the U.S. and Europe, but in consideration of the need to prepare legal grounds, it will gradually disclose detailed information after the revision of the Pharmaceutical Affairs Act in the first stage. Subject to the disclosure are pharmaceuticals and herbal medicines under the jurisdiction of the Drug Safety Bureau, and the results of a survey on the status of the licensing stage, regular monitoring, and overseas manufacturing plants. Advanced biopharmaceuticals such as biological drugs are excluded. As a result of the fact-finding survey, the disclosure time is within 6 months after the approval and report of the item, the regular monitoring of the post-authorization stage is within 6 months after the issuance of the GMP conformity report, and the overseas manufacturing plant survey is within 6 months after the report. The MFDS will go through the process of inquiring opinions of the company and disclose it on the website only for summary information. If the company does not agree to disclose the results of the survey, the survey related to the company among the disclosure contents will be shaded. The scope of disclosure is a level that summarizes the outline and points of the fact-finding survey by referring to the current status of the United States and Europe, and is limited to item information in the case of the fact-finding survey. The MFDS is planning to expedite the disclosure of the results of the GMP test in May in line with the current evaluation for WLA registration.
- Policy
- Green light to Sprycel's reimb with indication expansion
- by Lee, Tak-Sun May 20, 2022 06:11am
- The chronic myeloid leukemia treatment ‘Sprycel tab (dasatinib, BMS Korea)’ has received the green light to expand its reimbursement. The Health Insurance Review and Assessment Service announced that it had set the reimbursement standards for Sprycel in pediatric patients with acute lymphoblastic leukemia (ALL) at the 5th Cancer Disease Deliberation Committee meeting that was held on the 18th. Based on the set standards, Sprycel can now progress to the next step in expanding its reimbursement to the indication set above. The drug will now undergo Drug Reimbursement Evaluation Committee review, drug pricing negotiation with the National Health Insurance Service, then receive final deliberations for reimbursement. The specific indication for Sprycel that was approved in the reimbursement standard is for ‘the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.’ Deliberation results of HIRA CDDC that was held on the 18th The other 3 drugs failed to establish reimbursement standards on the same day. Lilly Korea’s ‘Retevmo capsule (selpercatinib)’ that is gaining attention as a tumor-agnostic anticancer drug, Pfizer Korea's ‘Mylotarg injection (gemtuzumab ozogamicin),’ and Novartis Korea's ‘Jakabi tablet (ruxolitinib) all failed to establish reimbursement standards. Retvmo’s reimbursement standards were failed to be set for all its indications: ▲treatment of advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; ▲ treatment of patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or Lenvatinib treatment experience, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy; and ▲ treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC). In the case of Mylotarg, which had failed to expand reimbursement to newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults, and Jakabi which failed to expand its reimbursement standard to the treatment of patients with intermediate or high-risk myelofibrosis, the drugs are now left to reattempt reimbursement expansions at this stage.
- Opinion
- The Minister should be appointed to lead policy continuity
- by Lee, Hye-Kyung May 20, 2022 06:11am
- On the 13th, the Yoon Seok-yeol government announced the appointment of vice ministers, ministries, and commissioners. However, as the head of the Ministry of Food and Drug Safety was excluded from the list of appointments, many talks were exchanged about the background. The most credible argument was that the appointment of the head of the affiliated agency would not have been easy at a time when the appointment of the MOHW was not made. Candidate for Minister of Health and Welfare Chung Ho-young has yet to be appointed since the personnel hearing. Some say they are trying to trade for the confirmation of Prime Minister nominee Han Duck-soo and the resignation of Minister of Health and Welfare candidate Chung Ho-young. In this situation, attention is also being paid to who will become the head of the regulatory agency, the MFDS. Oh Yoo-kyung, dean of Seoul National University College of Pharmacy, Kim In-kyu, former head of Gyeongin Office, Yoon Hyung-joo, and Seo Kyung-won, head of safety evaluation, were mentioned as candidates for his successor. All candidates seem to have the advantage of being able to maintain policy continuity and consistency as internal personnel of the MFDS. It is unclear whether the head of the MFDS, who is first appointed by the Yoon Seok-yeol government, will also be able to exceed the average tenure. The MFDS is a regulatory agency for pharmaceutical and food safety management, and frequent replacement of the head of the MFDS does not seem desirable to maintain continuity and consistency. Yoon Seok-yeol, the first head of the government's MFDS, who will be appointed soon, should be empowered to lead policies such as rapid approval of medical products such as medicines and support the development of COVID-19 treatments.
- Policy
- HIRA plans to improve the overall management system
- by Lee, Tak-Sun May 20, 2022 06:11am
- Lee Jin-soo, chairman of HIRAWith the launch of Zolgensma, the HIRA plans to improve the overall management system of the pre-approval system. Accordingly, it has been confirmed that internal research is being carried out. The HIRA allows benefits for ultra-high-priced drugs such as Soliris and Spinraza or some medical procedures through a pre-approval system. However, some items have been pre-approved for a long time, and as ultra-high-priced drugs subject to pre-approval are expected to increase in the future, they are reportedly considering adjusting the target items. Lee Jin-soo, chairman of the HIRA Medical Review and Assessment Committee, made the announcement at a meeting with the Korea Special Press Association on the 17th. Chairman Lee explained, "Recently, demands for higher-priced drugs have continued to increase, and medical institutions are also expected to actively use the pre-approval system," adding, "We will improve the overall management system of the pre-approval system." Currently, hematopoietic stem cell transplantation, Soliris (subject to PNH, aHUS diseases) 'ICD&CRT, VAD, and Spinraza are allowed to administer or perform pre-approval systems. Among them, hematopoietic stem cell transplantation is under consideration. Chairman Lee said, "In the case of hematopoietic stem cell transplantation, the pre-approval system has been applied since 1992. At the beginning, it was a high-risk and high-cost act, but now it is cheaper than other expensive drugs, so I think we can go to a post-examination." However, in the medical community, there is a high opinion that it should be maintained. Hematopoietic stem cell transplantation benefited 3,323 people through preliminary screening last year, costing a total of 127.6 billion won. This is a much higher cost than other items. Soliris, an ultra-high-priced drug, cost 36.7 billion won and Spinraza 41.6 billion won last year. The number of people subject to approval is also higher. Chairman Lee said, "Hematopoietic stem cell transplantation has been a learning training for medical institutions since pre-examination was introduced for 30 years, so the approval rate is far higher than other items. However, we are considering withdrawing internally in consideration of manpower and screening capacity." The new drug to which the pre-approval system will be applied is Zolgensma, a treatment for spinal muscular dystrophy. Zolgensma was recognized of benefits on the condition of prior approval of medical care benefits at a review of the Drug Benefit Evaluation Committee held on the 12th. The Medical Review and Assessment Committee is currently considering coordinating the Spinraza review division with the same indication if Zolgensma is confirmed to be subject to the pre-approval system. "In order to improve the system, the review and evaluation laboratory is conducting internal research on the systematic operation of the pre-approval system," Chairman Lee said. "We will analyze the operation status and collect domestic and foreign cases to come up with specific improvement measures." The preliminary review department of the Medical Review and Assessment Committee plans to expand the application of the pre-approval system for severely incurable diseases who need high-risk and high-cost medical services and strengthen management. Chairman Lee said, "Last year, the number of pre-approval items increased from eight to nine, and we received about 280 billion won in medical expenses."
- Company
- The standard of Xospata is very disappointing
- by Eo, Yun-Ho May 19, 2022 05:51am
- Insurance benefits for the new leukemia drug Xospata have been applied, but clinics are expressing regret. Acute Myeloid Leukemia (AML) treatment Xospata has been reimbursed since March. Looking at the benefit criteria of this drug, remission-induction therapy is recognized in patients with FLT3 mutant acute myeloid leukemia who are refractory to conventional treatment or can transplant homologous hematopoietic stem cells. Considering the preparation period for the transplantation of homologous hematopoietic stem cells, additional administration of 2 cycles is required only if the transplantation of homologous hematopoietic stem cells is approved in advance. Xospata's administration is limited to up to 4 cycles. In general, when the drug administration cycle is limited in the benefit standard, it is based on the design of clinical research of the drug or authoritative overseas guidelines. Blood cancer treatments such as Besponsa and Blincyto have limitations on benefit administration, all of which are based on evidence. In the case of Xospata, there is no specific reason to limit the dosage cycle. According to Xospata's ADMIRAL study, it was designed without any limitation on the administration period, and the NCCN guidelines recommend it as "Category 1" without any limitation on the period. Lee Je-hwan, chairman of the Korean Society of Hematology, said, "I'm not sure why the four-cycle restriction was made. Currently, Xospata benefits are recognized in A7 countries such as the United States and the United Kingdom and Canada without restrictions on the treatment cycle, he said. In addition, "targeted treatments such as Xospata are virtually difficult to prescribe unless they are reimbursed." If the treatment period is limited, it will have a great adverse effect on the patient's treatment," he stressed.
- Company
- Samsung Bioepis makes ₩199.1 bil in Q1
- by Chon, Seung-Hyun May 19, 2022 05:51am
- Samsung Bioepis is off to a smooth start this year with a sharp rise in its biosimilar sales. According to the Korea Financial Supervisory Service, Samsung Bioepis recorded ₩199.1 in Q1 sales this year, a 19.4% increase compared to the same quarter of the previous year. Also, the company’s net profit increased 11.5% to ₩31.9 billion. This is the largest amount of sales ever made by the company in the first quarter. However, compared to the ₩271 billion in Q3 and ₩221.8 billion in Q4 it had made last year, the growth rate seems to have slowed down somewhat. In Q3 last year, the company had recorded its largest-ever sales with the milestone it received with the approval of its biosimilars abroad. In August last year, the company’s Lucentis biosimilar ‘Byooviz’ that it developed received marketing authorization from the European Commission (EC) and from the U.S. Food and Drug Administration (FDA) a month later. The biosimilar products developed by Samsung Bioepis have continued to show strong growth abroad. Most of Samsung Bioepis’ sales are generated by overseas sales of its biosimilars. Samsung Bioepis had succeeded in commercializing biosimilars of 6 original products - Enbrel, Remicade, Herceptin, Humira, Avastin, and Lucentis. All its 6 products were approved in Europe, and 5 products less the Avastin biosimilar received marketing authorization in the US. The 5 biosimilars of Samsung Bioepis’ raised $292,300,000 (approx.. ₩350 billion) in sales in Q1 this year. This is a 2.5% YoY increase from the $285,100,000 made in Q1 last year. Biogen’s sales of Samsung Bioepis’ 3 autoimmune disease treatments recorded $194,300,000 (approx. ₩240 billion), and Organon also sold $98,000,000 (approx. ₩120 billion) with Samsung Bioepis’ 3 autoimmune disease treatments and 2 anticancer drugs. Samsung Bioepis’ biosimilars are sold abroad by its partners Biogen and Organon. Samsung Bioepis, which had been established in 2012, first generated sales of ₩43.7 billion in 2013. Its sales then reached ₩147.5 billion with the start of its full-fledged penetration of overseas markets with its biosimilars in 2016, and have continued to grow ever since. Samsung Bioepis has recorded cumulative sales of ₩3.484 trillion since its launch in 2012. The company has been accelerating market penetration with a series of biosimilar products recently. This year, the company plans to release its Lucentis biosimilar ‘Byooviz’ in the US market. Pursuant to a global license agreement entered into with Genentech, Samsung Bioepis will have the freedom to market the drug in the United States as of June 2022, i.e., before the expiration of Genentech’s applicable SPC (Supplementary Protection Certificate). The company has also been accelerating the expansion of its biosimilar pipeline in Korea as well. Samsung Bioepis received approval from the Ministry of Food and Drug Safety to market Lucentis biosimilar, ‘Amelivu (ranibizumab).’ Amelivu is the first Lucentis biosimilar to be approved in Korea. With Amelivu’s approval, Samsung Bioepis is now approved for a total of 6 biosimilars in Korea. The company had first entered the domestic biosimilar market after receiving approval for its ‘Enbrel’ biosimilar ‘Etoloce’ in 2015. In the same year, the company also received approval for its ‘Remicade’ biosimilar ‘Remaloce,’ and then for the ‘Humira’ and ‘Herceptin’ biosimilars ‘Adaloce’ and ‘Sampenet’ in 2017. Last year, it also acquired approval for its ‘Avastin’ biosimilar, ‘Onbevzi.’ Its competitor Celltrion has acquired approval for the biosimilars of Remicade, Herceptin, Mabthera, and Humira. The approval of Samsung Bioepis’ biosimilars in Korea is expected to lead to financial savings for the National Health Insurance. In principle, the Korean drug pricing system mandates the ceiling price of original drugs to be discounted by 30% compared to its price before patent expiry with the introduction of its biosimilars. Prices of original drugs and their biosimilars that are ‘items developed by Innovative Pharmaceutical Companies, equivalent companies, or domestic companies that have signed joint agreements with multinational pharmaceutical accompanies; or items that were first-ever approved in Korea; or items manufactured in Korea’ are ensured a price set at 80% of the original’s price before patent expiry. Avastin’s insurance ceiling price fell with the listing of Onbevzi last year. In October last year, the ceiling price for Avastin 0.1g/4mL fell 30% from ₩330,387 to ₩231,271. Price of Avastin 0.4g/16mL also fell 30% from ₩1,077,531 to ₩752,746. According to the market research institution IQVIA, Avastin’s sales fell 23.8% YoY in Q4 last year to record ₩22.6 billion. This was a 27.2% drop from the ₩30.9 billion made in just the previous quarter, Q3 last year.
- Company
- Samsung Bioepis’s Lucentis biosimilar approved in Korea
- by Lee, Seok-Jun May 18, 2022 10:42pm
- Samsung Bioepis became the first company to receive approval for a Lucentis biosimilar in Korea with ‘Amelivu (ranibizumab).’ Lucentis is a treatment developed by Genetech for ophthalmologic diseases such as macular degeneration and macular edema. With Amelivu’s approval, Samsung Bioepis is now approved for a total of 6 biosimilars in Korea. The company is selling 3 types of autoimmune disease treatments that treat rheumatoid arthritis, etc – ‘Etoloce (Enbrel similar),’ ‘Remaloce (Remicade similar),’ and ‘Adaloche (Humira similar)’ – with Yuhan Corp. Its other two drugs, which are anticancer drugs ‘Sampenet (Herceptin similar),’ and ‘Onbevzi (Avastin similar)’ are sold jointly with Boryung Pharmaceutical. Amelivu’s approval in Korea holds significance in two ways. On the surface, Amelivu will be entering the domestic Lucentis biosimilar market worth 30 billion won as the ‘first drug’ introduced to the market, and will be able to gain market dominance before its competitor, Chong Kun Dang’s ‘CKD-701’ as its review is still in process. From a broader perspective, the approval may act as momentum in penetrating overseas markets. In addition to Korea’s approval this May, Amelivu has been approved in August and September last year in Europe and the US, which allows the company to accumulate real-world prescription data on the drug in various countries. Acquisition of such actual prescription data may facilitate easier approval in other countries in the future. Also, the accumulated evidence (data) can also contribute to the creation of a virtuous cycle that leads to an increase in actual prescriptions in global markets such as the US and Europe. Amelivu’s approval in each country is also directly related to the future of Samsung Bioepis. The company has been recently expanding its business to ophthalmology, endocrine system, and blood diseases. In ophthalmology, in addition to Amelivu, Samsung Bioepis has completed a Phase III trial of its biosimilar for Eylea(SB15), the drug that has been bisecting the market for macular degeneration with Lucentis. An official from Samsung Bioepis said, “We can now expand our business to ophthalmic disease treatments in earnest with our approval of Amelivu in various countries.” Global clinical trial on 705 patients Meanwhile, Amelivu was approved in each country based on the large-scale Phase III study. Samsung Bioepis conducted a global Phase III study comparing SB11 (Korean brand name: Amelivu) with the original from March 2018 to December 2019 in 705 patients with wet (neovascular) AMD. Analysis of the 634 patients among the 705 that continued to receive treatment up to week 52 showed that Amelivu was equivalent (non-inferior) to the original in terms of its efficacy, safety, pharmacokinetics, and immunogenicity. Based on the results, Samsung Bioepis received marketing approval for the drug in Europe in August, in the US in September, and in Korea this May. SB11 will be sold under the brand name ‘Byooviz’ in Europe and the US by Biogen, and its marketing partner and release date in the Korean market is yet unknown. Pursuant to a global license agreement entered into with Genentech, Samsung Bioepis will have the freedom to market the drug in the United States as of June 2022, i.e., before the expiration of Genentech’s applicable SPCs, and elsewhere in other territories after the expiration of Genentech’s SPCs. Increasing macular degeneration market… Epis preoccupies market The blockbuster macular degeneration treatments are ‘Lucentis’ and ‘Eylea.’ Lucentis’s patent is set to expire in July 2022 in Europe, and June 2020 in the US. In the case of Eylea, its patent is set to expire in May 2025 in Europe and in June 2023 in the US. Lucentis is currently sold by Roche and Novartis and has raised 4.4 trillion won in global sales last year. Samsung Bioepis is the first company in the world to receive marketing approval for a Lucentis biosimilar and is competing with European countries including Germany and Sweden in the global market. In Korea, Chong Kun Dang has also conducted a Phase III trial on domestic patients and is being reviewed by the Ministry of Food and Drug Safety. An industry official said, “Samsung Bioepis developed its biosimilar for the two major AMD treatments Lucentis and Eylea in time of their patent expiry. In the case of Lucentis, the company will be able to gain market dominance as it owns the ‘premium’ of being the first approved in Europe, the US, and Korea.”
- Policy
- 34 new global drugs, including Beleodaq, are urgently needed
- by Lee, Tak-Sun May 18, 2022 05:52am
- A study has been released that 34 new drugs, including the peripheral T-cell lymphoma treatment Beleodaq, are urgently needed to be introduced in Korea. These new drugs have not been introduced because they are judged to be insufficient in marketability due to domestic screening permits. KoNECT announced that it will select 34 new drugs that are urgently needed to be introduced in Korea and release them online on the 18th for the 2022 KoNECT Brief 1. KoNECT derived priorities through preliminary analysis of 244 in Korea. As a result, Beleodaq (peripheral T cell lymphoma treatment), Palynziq, Zinplava (lostridium difficile recurrence reduction effect), Artesunate (severe malaria treatment), and Xerava (complex abdominal infection treatment antibiotic) were the top drugs to be reviewed. Poteligeo (Fungi and Cezali Syndrome Treatment), Elzonris, Tecartus (CAR-T Cell Blood Cancer Treatment), Yescarta (CAR-T Cell Blood Cancer Treatment), Obizur (Instinctive Post-Cellular Blood Cancer Treatment), and Trumenba. The third-priority drugs mentioned by the association as urgent and unmet demand diseases were BEXSERO (menopausal bacteria serum type B vaccine), Alofisel (treatment of complex anal fistula of Crohn's disease patients), and Raxibacumab (first aid drug for anthrax). Top 4 drugs that need high introduction but require attention are Provenge (prostate cancer vaccine using cells from autologous choroid blood), Zanosar (treatment of malignant neoplasms of the pancreas), Cablivi (acquired thrombocytopenia), Audenz (immune cell-based influenza and anti-viral drugs), Audenz, Rukobia, Trogarzo, Krintafel, Nuplazid, and Apokyn. The last drugs appeared as Steboronine (BNCT), - Scenesse (erythrocytic protorphyria), Mepsevii, Ravicti, Lamzede, Myalept, Egaten (fascioliasis parasite infection treatment), Tpoxx (natural greenhead treatment), Solosec, Voraxaze, and Idenfirix. KoNECT analyzed that the main reason for the delay or non-introduction of global new drugs in Korea is to determine marketability such as whether to exempt ▲ bridge test, ▲ whether to register benefit, and ▲ product price, etc. In particular, whether to be exempted from PE system in the stage of determining drug prices is also important, and it was pointed out that blind spots exist in new drugs for rare diseases that are exempted from economic evaluation. For example, the MFDS' rare drugs and rare diseases of the KCDA are designated based on less than 20,000 people, but the HIRA's rare disease treatment system is limited to less than 200 people. KoNECT stressed the need for a specialized institution to introduce global new drugs in Korea along with the expansion of the "Expended Access Program (EAP)" and the national essential drug system, a program that provides drugs for clinical trials that have not yet been sold on humanitarian grounds. Bae Byung-joon, chairman of the National Clinical Trials Foundation, said, "Korea's drug price policy has been stingy in recognizing the innovative value of global new drugs, while generic prices are higher than the cost to protect domestic industries."
- Opinion
- [Reporter’s View] New govnt signals expanded PE exemptions
- by Eo, Yun-Ho May 18, 2022 05:52am
- The inauguration of a new government brings hope and anticipation to each and every industry. The same goes for multinational pharmaceutical companies. In the pharmaceutical industry, hopes are rising for the expanded eligibility of the pharmacoeconomic evaluation exemption scheme. Although many agendas remain in need of resolution, such as improvement of drug prices for each indication and the pre-listing post-evaluation scheme, etc., the industry believes the improvement of the PE exemption system is most realistic. This seems plausible from the third person's perspective as well. In fact, Yoon Suk-Yeol’s administration plans to promote the accelerated listing of anticancer drugs and treatments for severe and rare diseases that have no alternatives to improve patient access to such treatments. However, due to the conservative stance held by the relevant ministries such as the Ministry of Health and Welfare, Health Insurance Review and Assessment Service, and the National Health Insurance Service in improving drug prices for each indication and the application of the pre-listing post-evaluation system, no drastic change may be possible even with the administration change. But there still lies hope for improvement in the PE exemption system, as this special system that was introduced as an exception by the Korean government is still being well utilized, and the request for its improvement has been continuously raised for some time. Strangely enough, new drugs with low profitability due to a small number of eligible patients and drugs that have difficulty demonstrating cost-effectiveness even after overcoming developmental difficulties are becoming a trend and being actively introduced to the market. It may be due on one part because drugs for almost all other diseases have already been released, but still, the addition of these new treatment options cannot be bad for mankind. The industry has been requesting expanding eligibility of the pharmacoeconomic evaluation exemption scheme. The industry requested a more flexible application of the system, under which the PE exemption system is applied to drugs with no alternatives that have been approved with placebo-controlled data or be applied the same eligibility standards for the patients, etc. However, from the government’s perspective, it is difficult to open up its pockets upon every request as it has to pay the expenses from a limited budget. This is why the rumor that the PE exempted drug’s price will be set at ‘80% of the lowest A7-adjusted price’ had turned the industry upside down last year. PE exemptions are the only option for necessary drugs deemed difficult to receive pharmacoeconomic evaluations. It contains various fiscal management devices and has incorporated the ‘expenditure cap’ design ever since its implementation to protect fiscal sustainability. It’s just that with more drugs introduced to the market, more flexible management of the system may now be required for the right treatment to be prescribed to patients at the right time. In this context, on what picture the new administration has prepared to address this issue remains a focus of attention.
- Policy
- MFDS promotes RWD analysis of COVID-19 vaccines & txs
- by Lee, Hye-Kyung May 18, 2022 05:51am
- The MFDS (Director Kim Kang-rip) will push for a benefit and risk assessment study from May this year based on data actually used in medical sites after the COVID-19 vaccine and PO treatment were introduced in Korea. This study was prepared to analyze safety information such as the incidence of side effects, vaccine defense effects, and hospitalization/death change rates by using RWD and RWE of COVID-19 vaccines and eating treatments. The results of practical data studies will be used to examine the benefits and risks of drugs along with the results of clinical trials, and will be used to verify the causality of major adverse reactions or to establish a safety information monitoring system in the future. The main contents of the study include developing a technology to evaluate the mechanical relationship among ▲ vaccination and adverse reactions, ▲ vaccine developing criteria to evaluate the effectiveness and safety of vaccines, and ▲ therapeutic agent)analysis of domestic patients. Overseas regulatory agencies such as the United States, Europe, and Japan are also promoting various studies on COVID-19 vaccines and treatments using data actually used. The MFDS said, "We will continue to activate various studies to verify the safety and effectiveness of drugs based on scientific evidence and do our best to ensure that the public can use them with confidence based on regulatory science."
