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- 2026-05-17 00:03:43
- Policy
- Finding ways to utilize the Patent-approval linkage system
- by Lee, Hye-Kyung Mar 10, 2022 05:53am
- The MFDS plans to prepare a collection of data so that domestic pharmaceutical companies can pioneer the Chinese pharmaceutical market by utilizing the Patent-approval linkage system within the first half of this year. The MFDS recently announced research services for "Overseas the Patent-approval Linkage System Survey and Domestic Impact Analysis." Following the signing of the Korea-U.S. FTA in 2007, the Pharmaceutical Affairs Act has been fully implemented in Korea since March 2015 through the revision of the Pharmaceutical Affairs Act twice in 2012 and 2015. The study was designed to identify recent overseas systems and trade agreements related to the Patent-approval linkage system and to support pharmaceutical companies' development of overseas markets in the future, and will run until October 31 with 55 million won in project costs. The core of this study is a plan to utilize the Patent-approval linkage system in Korea under the recently revised Chinese patent law. Since June 1 last year, China has been fully implementing the Patent-approval linkage system. This study identifies not only the size and status of the Chinese pharmaceutical market, but also the Chinese pharmaceutical market, including Korea's exports to China, and recently investigates the organization, system, and implementation status of Chinese pharmaceuticals. Based on this, the MFDS plans to prepare a data book by July to support domestic pharmaceutical companies to explore the Chinese pharmaceutical market. Investigation and analysis of international agreements are also conducted not only in China but also in relation to the Patent-approval linkage system. Through this study, the MFDS plans to investigate the recent issues and trends of countries subscribed to the agreement by comparing the background and operation status of comprehensive and progressive CPTPP, and commonalities and differences with other trade agreements such as the Korea-U.S. FTA. Based on the results of the survey, the impact analysis on the Patent-approval Linkage System, which is expected when Korea joins the CPTPP, and countermeasures of domestic pharmaceutical companies to enter overseas markets will be presented together.
- Company
- Keytruda for esophageal cancer indications is imminent
- by Eo, Yun-Ho Mar 08, 2022 06:08am
- Keytruda, an immuno-cancer drug, is expected to be able to be prescribed for esophageal cancer. According to related industries, the MFDS has finally reviewed the first round of local progressive or metastatic esophageal cancer (GEJ), in which PD-1 inhibitory immuno-cancer drug Keytruda (Pembrolizumab) of MSD is non-resectable. Permission is expected as early as the second quarter. Following colon cancer in June last year and triple negative breast cancer in July last year, the area of indications is rapidly expanding. Keytruda's indications for esophageal cancer and gastroesophageal junction cancer were approved by the U.S. FDA in March last year and the European EMA in June last year. Keytruda's effectiveness for esophageal cancer has been proven through a phase 3 clinical KEYNOTE-590 study. Keytruda, 5-FU, and Cisplatin combination therapy demonstrated statistically significant OS and PFS improvements over 5-FU+cisplatin in all pre-designated study groups. Keytruda, 5-FU, and Cisplatin reduced the risk of death by 27% compared to 5-FU+Cisplatin, and the risk of disease progression or death by 35%. In the patient group with a PD-L1 expression rate of 10 or higher, Keytruda and 5-FU+Cisplatin reduced the risk of death by 38% and the risk of disease progression or death by 49%, compared to 5-FU and Cisplatin. In patients treated with Keytruda, 5-FU, and Cisplatin combination therapy, the objective response rate (ORR) was 51.1%, of which the CR ratio was 5.9% and the PR ratio was 45.2%.
- Company
- Generation shift of ALK targeted drugs... rise of Alecensa
- by Mar 08, 2022 06:08am
- The targeted cancer therapy market for patients with ALK mutations has been restructured around second-generation drugs. The share of the first-generation drug Xalkori, which used to occupy 2/3 of the market fell to 20%, and the representative second-generation drug ‘Alecensa' took over the market. However, Alunbrig, a latecomer into the second-generation treatment market, has been rapidly chasing the market leader Alecensa that has currently occupied over half of the market. According to the pharmaceutical research institution IQVIA on the 8th, the Anaplastic Lymphoma Kinase (ALK) tyrosine kinase inhibitor (TKI) market recorded ₩54.4 billion last year, which was an 11.9% and ₩48.6 billion increase from the previous year. The ALK TKI market, whose doors were first opened by ‘Xalkori (crizotinib),’ is used to treat patients with ALK-positive non-small-cell lung cancer (NSCLC). With the introduction of next-generation drugs that have demonstrated improved efficacy, a total of 5 drugs are currently present in the market. In addition to second-generation drugs ‘Zykadia (ceritinib),’ ‘Alecensa (alectinib),’ ‘Alunbrig (brigatinib),’ a third-generation drug ‘Lorviqua (lorlatinib)’ has also entered the market last year. Compared to 2017, the market transition from first-generation to second-generation drugs is quite clear. In 2017, Xalkori had an oligopoly over the market as the only ALK TKI option and accounted for 86% of the market. Its sales had recorded nearly ₩36.5 billion that year, followed by the first second-generation drug, ‘Zykadia,' which made ₩5.1 billion, then Alecensa's ₩1.1 billion. However, in 4 years in 2021, the landscape had completely shifted with the proof that second-generation drugs have a better effect in patients with brains metastasis. With doctors opting for second-generation drugs in the first line, Alecensa’s market share rose to 60%. Shares of another second-generation drug, Alunbrig, took over 15% of the market, making ₩8 billion in sales. Xalkori’s sales fell to 24%, making ₩13.1 billion. Roche’s Alecensa and Takeda’s Alunbrig are representative second-generation ALK TKIs. By market entry, Alecensa entered the market 2 years earlier than Alunbrig. Alecensa expanded its indication to the first-line in 2018 and was granted reimbursement in December of the same year to quickly replace Xalkori. In 2018, Alecensa sold ₩10.4 billion, which was 1/4 of the sales made by Xalkori (₩49.6 billion). After receiving reimbursement in 2019, Alecensa sold ₩22.1 billion and exceeded the Xalkori's ₩20.3 billion in sales. Alecensa's sales increased to ₩29.3 billion in 2020 and ₩32.7 billion in 2021. Alunbrig, which was approved in December 2018, aimed to rapidly enter the market and catch up with Alecensa. As soon as it was approved for the first linein August 2020, the company applied for its reimbursement and succeeded in expanding its reimbursement in only 7 months. With the reimbursement approval as a first-line treatment that was granted in April last year, the company is working to expand its share in the market. Sales in 2020 were ₩3.9 billion won, far short of that of Alecensa and Xalkori, sales increased 102.9% to ₩8 billion after the reimbursement expansion. On the other hand, the first second-generation drug, Novartis’s Zykadia, has been going down a completely different path. Zykadia’s sales which had surged to ₩5.1 billion in the past had started to fall sharply with the introduction of Alecensa. It sold ₩2.2 billion in 2018, ₩0.9 billion in 2019, and only ₩0.5 billion last year. The anlaysis is that this rapid drop in sales is due to the relatively higher instance of side effects compared to Alecensa or Alunbrig. The first third-generation ALK TKI was introduced last year. Xalkori’s developer Pfizer had introduced the first-ever third-generation drug Lorviqua. Lorviqua was first to be approved as a second-line treatment for ALK-positive NSCLC in July last year and rose as a new alternative due to its ability to manage the resistance developed after first-line treatment. Lorviqua can manage the resistance caused by G1202R mutation, as well as those by F1174L (Zykadia), I1171T/N/S (Alecensa), E1210K (Alunbrig). Lorviqua is not listed for reimbursement yet and is expected to generate sales in earnest after passing the National Health Insurance Service’s Drug Reimbursement Evaluation Committee and drug negotiations with the authorities. In particular, as Lorviqua is attempting to expand its territory into first-line treatment for ALK-positive patients, its its competition with second-generation drugs are also being expected to arise soon. The drug already owns a first-line indication for ALK-positive NSCLC in the US and Euope.
- Company
- Domestic production of Sputnik V was delayed
- by Kim, Jin-Gu Mar 08, 2022 06:08am
- Due to the war between Russia and Ukraine, shipments of domestic companies that consignment produce the COVID-19 vaccine Koruspharm developed by Russia are also being postponed indefinitely. Koruspharm said in a telephone interview with Dailypharm on the 4th, "We are continuously talking to the Russian side via e-mail or phone call even after the war broke out," adding, "For now, product shipments have been stagnant due to the Ukrainian crisis." According to Koruspharm, the company has currently produced Sputnik undiluted solutions for 10 million people, of which 5.3 million have completed the production of finished products. This means that the quantity that can be shipped immediately amounts to 5.3 million people. Koruspharm originally planned to supply the finished vaccine to Southeast Asia, the Middle East, and South America in line with the Russian order. Administrative procedures for shipment have also been completed. However, orders from Russia have been delayed day by day, and shipments have not been expected recently due to the outbreak of war. Koruspharm is looking for buyers directly through its own network. The company explained that it has even confirmed its intention to purchase from some Middle Eastern countries. An official from Koruspharm said, "Iit is true that Russia lacked marketing capabilities. We are looking through our own network and have confirmed our intention to purchase from some places." He went on to say, "Russia and the country must officially sign contracts in order to lead to actual shipments. When the contract between the two countries is signed, we plan to ship it immediately, he said. "We have concluded discussions with Russia to ship the rest of the vaccines in this way in the future." Regarding the payment for consignment production of vaccines, he said, "Uncertainty has grown in the collection of payments as the U.S. and Europe imposed massive economic sanctions against Russia." "To solve this problem, we are discussing with the Russian side how to receive payments directly from vaccine buyers instead of Russia," he said. Koruspharm signed a "Sputnik V consignment production contract" with RDIF in September last year. Since then, Koruspharm has formed a consortium with six companies and one institution, including Binex, Boryung Biopharma, ISU Abxis, Chong Kun Dang Bio, Quratis, and Andong Animal Cell Demonstration Support Center. The consortium plans to build production facilities of more than 100 million doses per month.
- Policy
- The fatality rate of Omicron is low
- by Lee, Jeong-Hwan Mar 08, 2022 06:08am
- The quarantine authorities announced a full-fledged easing of distancing, saying that it is becoming clearer that the COVID-19 Omicron mutation has a lower severity and fatality rate than the delta mutation. From the 5th to the 20th, the 22 o'clock operating hours limit, which will be applied to groups 1, 2, and 3, will be increased by 1 hour to 23:00, but the next adjustment of distance will be eased. In particular, the quarantine authorities urged government agencies to actively participate in blood donation and spread the voluntary participation of the people, citing the continued stage of interest in domestic blood reserves of more than 3 days and less than 5 days. On the 4th, Lee Ki-il, the first controller of the Central Disaster and Safety Countermeasure Headquarters, made the remarks at a regular COVID-19 briefing. The quarantine authorities explained that it is not enough to keep a recently relaxed distance to resolve the difficulties of self-employed and small business owners. Considering that the quarantine system is being reorganized around the management of high-risk groups, the intention is to further ease distancing. Accordingly, the quarantine authorities will adjust the distance measure, which was originally scheduled to be applied by the 13th. The quarantine authorities analyzed that unlike Delta, it is becoming increasingly clear that Omicron has a low severity and fatality rate, and that the effectiveness and efficiency of distancing are decreasing due to its high propagation power. Based on this, the 22-hour operation time limit, which is applied to some facilities of groups 1, 2, 3 and other groups, will be eased by 1 hour from the 5th to the 20th until 23:00. Private gatherings maintain standards that allow up to six people nationwide regardless of whether they are vaccinated or not. The quarantine authorities plan to lower the level of distance in earnest after this easing. Pre-recommendations are also implemented for all inpatients with quasi-severe and moderate symptoms. As of the 4th, 731 patients with COVID-19 quasi-severe and moderate hospitalization who have passed 10 days from the date of sample collection are advised in advance to move to general beds. If the medical staff determines that additional quarantine treatment is necessary and submits explanatory data on all recommendations, if the need for additional quarantine is recognized through consultation, they can continue to receive treatment in the same hospital room without all or lost. If treatment is needed for an underlying disease, pt will move to a general bed and continue to receive treatment. The quarantine authorities also requested blood donation to stabilize blood supply and demand. Recently, the stage of interest in blood retention of more than 3 days and less than 5 days continues. In order to stabilize blood supply and demand, government agencies will take the initiative for a month in March and conduct group blood donations through a "Continuing Blood Donation Event." More than 1,600 employees from 31 organizations, including the Ministry of Employment and Labor, the MOHW, the Ministry of National Defense, the Maritime Police Agency, and the Ministry of Public Administration and Security, will participate in the event. In addition, the quarantine authorities asked the public to participate in blood donation at a blood donation house or a blood donation cafe close to them.
- Policy
- DREC rejects reimb of neurofibromatosis drug ‘Koselugo'
- by Lee, Tak-Sun Mar 08, 2022 06:08am
- The new neurofibromatosis drug ‘Koselugo (selumetinib),’ failed to receive reimbursement benefits in Korea. The Health Insurance Review and Assessment Service decided the drug as a ‘non-benefit' after deliberation on the adequacy of providing medical benefit for the drug at the 3rd Drug Reimbursement Evaluation Committee that was held this year. The drug, which is sold by AstraZeneca Korea, is used to treat neurofibromatosis type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas in pediatric patients over the age of 3. In the past, patients had to rely on symptomatic treatment due to the lack of appropriate treatment options. This was why expectations were high for Koselugo as the new treatment option in an area with a dire unmet need. Around half of the neurofibromatosis type 1 patients have plexiform neurofibroma (PN), and it may appear anywhere in the body. Depending on the position and size, it may limit the range of motion or bring pain or external deformity in patients, The internally developed tumors may pressure the internal organs. Most rumors are positive and grow relatively slow, but some progress into malignant tumors and can lead to an increased risk of developing breast cancer in women. The prevalence is about 1 in 3,000. The drug was approved by the MFDS in May last year based on the Phase II SPRINT study. In the study, 68% of the patients who were administered Koselugo saw a decrease in tumor volume by over 20% and achieved its primary efficacy endpoint, the objective response rate (ORR). Also, 82% of the patients who showed partial response showed saw a duration in their response of over 12 months. Compared to how only half of the untreated patients experienced disease progression after 1.5 years, only 15% of the patient who used Koselugo experienced disease progression in 3 years. As the drug costs ₩200 million a year, the demand for its reimbursement had been quite strong, but the company was unable to even pass DREC deliberations, the 1st gate to reimbursement in Korea.
- Company
- Changes in the lung cancer treatment market are detected
- by Mar 07, 2022 05:50am
- Changes are detected in the EGFR targeted anticancer drug market, which Tagrisso dominated. Tagrisso sales stagnated for the first time due to sluggish primary treatment benefits. Leclaza, the only domestic new drug in the market, is threatening Tagrisso. According to IQVIA, a pharmaceutical research institute, on the 5th, the size of the domestic EGFR TKI market last year was 156.4 billion won, up 2.8% from 152.1 billion won a year earlier. Compared to the growth trend so far, it has slowed down somewhat. The market surged from 55.4 billion won in 2017 to 104.3 billion won in 2018 and 132.2 billion won in 2019. Tagrisso's sales stood at 106.5 billion won last year, the same as the previous year. Tagrisso, which had been increasing sales at a frightening pace for four years since its approval in 2016, suffered a stagnation for the first time last year. Tagrisso is the first third-generation EGFR-TKI in Korea. It is a next-generation targeted anticancer drug following the first generation Iressa, Tarceva, and second generation Giotrif and Vizimpro. Tagrisso was first listed in December 2017 after being approved as a secondary treatment in May 2016. Sales of Tagrisso jumped from 2.3 billion won in 2016 to 10.3 billion won in 2017, and surged to 59.4 billion won in 2018. It surpassed 100 billion won for the first time, raising 106.5 billion won in 2020 following 79.2 billion won in 2019. However, it did not exceed 100 billion won last year. This is in contrast to a 16% increase in global sales from $4.3 billion to $5 billion last year. This is analyzed as a result of reflecting the specificity of the Korean market. Tagrisso obtained a primary treatment indication for EGFR mutated non-small cell lung cancer in December 2018 and began to expand the benefit, but failed to pass the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service for three years. Since then, AstraZeneca has appealed for Asian effects by submitting FLAURA China data for Chinese people, but failed to pass the Cancer Disease Review Committee in November last year. Another factor that caused congestion was the emergence of a new domestic drug Leclaza. Leclaza is a third-generation EGFR TKI developed by Yuhan Corporation. In January of last year, it was approved as the 31st new drug in Korea and was listed in July of that year. It was registered 165 days after the permit while quickly applying for insurance registration. Leclaza is also the only domestic treatment in the EGFR targeted anticancer drug market. Leclaza quickly entered large hospitals and made full-fledged sales in the second half of last year. Sales for the first six months amounted to 4.1 billion won. This is the highest sales in the past six months among new anticancer drugs developed in Korea. Yuhan Corporation is chasing Tagrisso by entering a global phase 3 with the aim of indicating Leclaza's primary treatment. Beringer Ingelheim's Giotrif stood at 22 billion won last year, up 18.4% from 18.6 billion won the previous year. Giotrif is steadily increasing its sales to 10.9 billion won in 2017, 13.6 billion won in 2018, and 16.6 billion won in 2019. Iressa fell 14.1% from 19.6 billion won in 2020 to 16.8 billion won last year. Tarceva also fell 23.6% from 7.3 billion won to 5.6 billion won. First-generation EGFR-TKI, which once accounted for 80% of the market, gave way to next-generation drugs, falling to 14%.
- Company
- Immuno-oncology drugs make ₩400 billion after 7 years
- by Mar 07, 2022 05:49am
- The immuno-oncology drug market exceeded ₩400 billion in annual sales only 7 years since its debut in Korea. With Keytruda in the lead making over ₩200 billion in sales, the latecomers Tecentriq and Imfinzi are chasing the lead with its rapid growth. According to the market research institution IQVIA on the 4th, the total immuno-oncology treatment that consists of 6 immuno-oncology drugs in Korea has made ₩407 billion last year, a ₩285.6 billion increase and a 42.5% YoY increase from the previous year. This record was made in 7 years since the first immuno-oncology drug Yervoy (Ipilimumab) was approved in December 2014. The release of Yervoy marked the start era of immuno-oncology treatments in Korea. Since then, Ono Pharamcueitals’ Opdivo (nivolumab), MSD’s Keytruda (pembrolizumab), Roche’s Tecentriq (atezolizumab), AstraZeneca’s Imfinzi (durvalumab), Merck’s Bavencio (avelumab) followed, recording a total of 6 immuno-oncology drugs to be sold in the Korean market. ◆'Keytruda’s sales exceed ₩200 billion… ‘Opdivo’ shows later growth ' Half of the ₩400 billion immuno-oncology drug market is currently occupied by Keytruda. Keytruda made ₩200.1 billion to top pharmaceutical sales in Korea last year. This is the second consecutive year Keytruda has topped the leaderboard since it first recorded took the lead in 2020. Looking back on its sales for the past 5 years, Keytruda first sold ₩12.2 billion in 2017, then rose 476.2% the next year after reimbursement to make ₩70.3 billion in 2018. In 2019 it made ₩124.8 billion, then ₩155.7 billion in 2020, a 77.5% and 24.8% YoY growth, respectively. Then, the drug’s sales exceeded ₩200 billion for the first time last year. With its reimbursement applied to first-line treatment in NSCLC, its sales are again expected to show rapid growth this year. The 2nd place was Opdivo, which recorded ₩85 billion in sales last year. This is a 27.4% YoY increase from the previous year. Opdivo’s sales jumped from ₩12.5 billion to ₩57.5 billion after it was listed for reimbursement in 2017, then slowed down to maintain the ₩67 billion range in 2019 and 2020, then again gained growth last year. However, Opdivo has made relatively slow growth compared to Keytruda, which received approval on the same day. Opdivo is seeking external growth by increasing its indications. After receiving approval in the first-line for non-small cell lung cancer in December 2020, it also added a first-line indication for gastric cancer last year and became the first immuno-oncology drug to add a first-line indication in the field. The company also added 5 more indications this year. ◆Latecomers Tecentriq and Opdivo succeed by targeting unattended markets The relative latecomers Tecentriq and Opdivo are intently chasing the leaders at a rapid pace. The drugs, which have entered the market 2-4 years later than Ketruda·Opdivo, have rapidly penetrated the unattended markets. Tecentriq, which made ₩0.7 billion the first year, recorded ₩4.4 billion the following year. In 2019, its sales rose 238.6% to record ₩14.9 billion. Also, Tecentriq’s sales rose over twofold last year to ₩37 billion in 2020. Last year, its sales rose 81.6% to record ₩67.2 billion. Tecentriq was the first PD-L1 immuno-oncology drug to be introduced to Korea. The drug was first indicated for bladder cancer (urothelial carcinoma), an area that Keytruda and Opdivo hadn’t entered at the time. Also, the drug was the first to enter the field of triple-negative breast cancer. It was also relevantly quickly introduced into the reimbursement setting, in one year since its approval. The company embraced the government’s ‘'performance-based reimbursement proposal' in 2019 to accelerate reimbursement expansion for its drug. Imfinzi, which was approved in December 2018, also made over ₩50 billion in annual sales only 3 years after its release. Imfinzi’s sales which recorded ₩3.4 billion in 2019, jumped 7 times to record ₩24.6 billion in just a single year. Last year, its sales grew 91% to record ₩47.1 billion.
- Company
- Organon is focusing on expanding the women's health lineup
- by Mar 07, 2022 05:49am
- The demand for unmet diseases related to women's entire life cycle was relatively high. Organon will focus on improving treatment accessibility so that all women can enjoy healthier daily lives." At a press conference held by Organon for the first time since its launch at The Plaza Hotel in Jung-gu, Seoul on the morning of the 2nd, CEO Kim So-eun made the remarks about the company's vision. Kim Soeun, CEO of Oganon Korea Organon, which spun off from MSD, was officially launched in June last year. Founded in the Netherlands in 1923, Organon was merged with Organon and absorbed into MSD. After about a decade, it was separated from MSD again. Organon, headquartered in New Jersey, USA, has subsidiaries and six manufacturing facilities in more than 60 countries around the world. More than 60 products are supplied to 140 countries. Organon focuses on three areas: women's health, chronic diseases, and biosimilars. Women's health includes women's inherent diseases or diseases that can have a significant impact on women. In chronic diseases, it has about 50 treatments for cardiovascular, respiratory, dermatology, musculoskeletal system, and urinary system. Biosimilars have five products in cooperation with Samsung Bioepis. Fosamax, Atozet, Cozaar, Propecia, etc. are representative. The chronic disease sector accounts for the majority with 70%. CEO Kim said, "We plan to expand our portfolio by identifying women's health needs that are not met in all women's life cycles such as pregnancy and childbirth, and we plan to explore new indications and expand our lineup in chronic diseases." Since its actual launch, Organon has aggressively expanded its portfolio. In June last year, it acquired Alydia Health, a women's health medical device company. Alydia is a company that developed the JADA system, a postpartum bleeding solution. In July, it signed a global license agreement with ObsEva, which developed a premature birth treatment solution. In December, it then acquired Forendo, which has a pipeline of endocrinology-related treatment solutions such as endometrium. CEO Kim said, "We are working on commercializing postpartum bleeding solutions and endocrine treatments outside the United States, and we will make sure that new solutions can be accessed as soon as possible." Organon is preparing for competition of generic for Atozet, which accounts for the largest portion of sales. CEO Kim said, "Generics for Atozet were released last year. We plan to make efforts to expand sales. "We plan to introduce JADA, which was released first in the U.S., in Korea in the near future, and we are looking for new opportunities such as expansion and introduction of indications in other chronic diseases."
- Opinion
- [Reporter's view] Consistency in the post evaluation
- by Lee, Tak-Sun Mar 07, 2022 05:49am
- Re-evaluation of drugs is underway. The move is aimed at preventing waste of health insurance benefits due to insufficient drugs to verify efficacy. Accordingly, the MFDS is playing a leading role in re-evaluating clinical trials and the HIRA is playing a leading role in re-evaluating the adequacy of benefits. The problem is that there is no consistency in selecting the target drug as the re-evaluation is carried out separately. The MFDS goes through clinical re-evaluation procedures if it fails to prove that it is currently not used in developed countries, the United States, the United Kingdom, France, Italy, Japan, Germany, Switzerland, and Canada, called A8 during the license renewal process. The HIRA is also based on the benefit performance of A8 countries. However, compared to the MFDS, it is excluded from the re-evaluation only if there are two or more countries' performance. However, the HIRA started re-evaluating the adequacy of benefits from the 2020 Choline alfoscerate, a brain function improvement drug. In addition, it targets ingredients worth more than 0.1% of the annual claims and about 20 billion won, so there are not many ingredients subject to revaluation per year. Six ingredients were selected this year and eight next year. The agency in charge of drug approval and registration conducted re-evaluation on different criteria, making it impossible to ensure consistency in the results. Of course, the MFDS verifies the efficacy and the HIRA evaluates the appropriateness of benefits, but basically, it is the same to determine whether the drug is effective or not. The verification of 'clinical usefulness' is the most important indicator for both institutions. Enteron, which went through a re-evaluation last year, was recognized for its appropriateness in treating ophthalmic disorders such as retinal and choroid circulation. The MFDS is also conducting a clinical re-evaluation of the indications, and in the process, the efficacy and effect were limited due to eye disorders in diabetic patients. Streptokinase and Streptodornase, which are subject to revaluation this year, are expected to produce clinical revaluation results next year. This is also a situation where we cannot guarantee the results of this year and next year. Basically, if the MFDS grants a drug license, the HIRA will establish standard based on the license. However, this basic procedure is ignored in the revaluation. Whether the MFDS verifies its efficacy through clinical re-evaluation or not, the re-evaluation will be conducted separately. Conversely, clinical re-evaluation proceeds regardless of clinical usefulness in re-evaluation. It is meaningless for drugs that have not been recognized for their clinical usefulness in revaluation and have been expelled from benefit to be recognized for their efficacy in clinical revaluation. Pharmaceutical companies with Streptokinase and Streptodornase, which are undergoing clinical re-evaluation, are worried about this. Some think that the HIRA is an affiliated organization of the MOHW, and the MFDS is a different independent ministry, so each of them tried to demonstrate their capabilities in the re-evaluation. It is unlikely that the problem will be solved because there is no ministry to adjust this. Anyway, drug licensing and benefit evaluation should be done by an independent institution to be a better choice for national health. The important thing is to keep the basics. The MFDS determines the exact efficacy of the drug, and the HIRA determines whether to pay based on this and applies it to post-reevaluation.
