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- 2026-04-03 13:34:14
- Policy
- MFDS to improve essential drug designation standard
- by Lee, Hye-Kyung Apr 25, 2025 05:58am
- The Ministry of Food and Drug Safety will conduct a study to improve the standards for designating essential medicines. When the national essential medicine system was first implemented in 2017, the designation focused on government stockpiles, but there have been continuous calls to expand the list to include items that require stable supply in the private medical setting. This was announced in the “Proposal Request for Research on Classification of National Essential Drugs and Measures for Stable Supply” announced by the Ministry of Food and Drug Safety on the 23rd. The MFDS designates and manages essential medicines that need a stable supply because they are necessary for medical use, such as disease control and radiation disaster prevention, Efforts have been made to ensure a stable supply of essential medicines, including improving the designation criteria, introducing a reevaluation system, providing administrative support for expedited approval, and revising laws. The study plans to review cases from other countries to develop measures to improve the current system. Following the recruitment of researchers, KRW 50 million will be invested over a period of 6 months to conduct the following: ▲survey and compare the operation and utilization of essential medicine systems in major countries; ▲analyze the current status of national essential medicine operations and explore directions for improvement; and ▲analyze the current status of utilization and explore directions for improvement to ensure the stable supply of national essential medicines. First, the study will examine the purpose of essential medicine management in other countries, classification methods (product characteristics, uses, etc.), selection criteria and procedures, and consultation processes. It will also investigate the current status of policy support and preferential measures for stable supply. In addition, the study will derive key considerations for designating national essential medicines based on the characteristics of each item and prepare proposals for improving the standards for designating national essential medicines. The study will also review the classification methods for national essential medicines by use, referencing the WHO Model List of Essential Medicines, to revise the list. The list will be revised based on a comprehensive review of the necessity of each item within the category when designating or reevaluating national essential medicines. In addition, the purpose of the national essential medicines system and the need to distinguish it from similar systems will be considered, and the scope of designation and exclusion of national essential medicines be reviewed. This study will also establish a reorganization and operational plan for the Stable Supply Council and Subcouncil to facilitate discussions on the designation and stable supply of national essential medicines. The study will identify government policy tools and collaboration requirements with relevant ministries and agencies to ensure that stable supply policies decided through the council are implemented, and will review measures to strengthen human and material infrastructure for the stable supply of essential medicines. The MFDS stated, “The supply of essential medicines continues to be an ongoing issue, and we expect the government to play a stronger role in improving the national essential medicines system and ensuring a stable supply in response to environmental changes in various fields.”
- Company
- SK Bioscience wins patent nullity trial against Moderna's
- by Kim, Jin-Gu Apr 24, 2025 06:01am
- SK Bioscience researcher conducting an experiment related to mRNA (photo by SK Bioscience) SK Bioscience reported on April 23 that it won patent nullity against Moderna's mRNA manufacturing technology patent. Moderna’s use patent is the only mRNA manufacturing technology patent registered in Korea. Korea's Intellectual Property Trial and Appeal Board recently issued a decision in favor of SK Bioscience in an invalidation trial against Moderna’s patent titled 'Modified nucleosides, nucleotides, and nucleic acids and their uses.' Moderna did not file a petition to cancel that decision within the allotted time. As a result, the first-instance ruling has been finallized, giving SK Bioscience’s victory. Moderna’s patent has served as core technology for mRNA vaccine production. In South Korea, Moderna’s use patent is the sole registered patent covering mRNA manufacturing methods. SK Bioscience filed the invalidation trial against that patent in 2023. The company determined that the patent is granting undue priority and excessive exclusivity, thereby hampering mRNA vaccine technology development, and brought the suit. After about two years of proceedings, the Korea's Intellectual Property Trial and Appeal Board found that the patent’s appropriatness, priority claim, and inventive step were all invalid. This patent will apply to SK Bioscience’s Japanese encephalitis vaccine candidate 'GBP560' and others in development. With this ruling, SK Bioscience expects its global clinical trials of GBP560 to gain momentum. SK Bioscience began global Phase 1/2 clinical studies of GBP560 in February. These trials are evaluating immunogenicity and safety following GBP560 administration in 402 healthy adults in Australia and New Zealand. The company anticipates interim results will be available next year. SK Bioscience's mRNA vaccine development began in 2022 under an agreement to receive USD 40 million in initial R&D funding from CEPI (Coalition for Epidemic Preparedness Innovations). Once it enters late-stage development after completing Phase 1/2 trials, CEPI will provide up to an additional USD 100 million to SK Bioscience. SK Bioscience spokesperson stated, "We secured a competitive edge in global mRNA vaccine development through this patent case," and added, "While many global firms are still undergoing patent disputes with Moderna, SK Bioscience has led the way in dismantling patent barriers and advancing its proprietary technology." "By reducing patent risk for domestic mRNA developers, we expect to contribute significantly to establishing vaccine sovereignty," the spokesperson emphasized. "SK Bioscience plans to establish an mRNA vaccine platform capable of addressing a broad range of diseases beyond pandemic response and to build new pipelines to achieve global competitiveness," he added. According to the global market research firm Nova One Advisor, the mRNA therapeutics market is anticipated to grow at a 17% compound annual rate, reaching USD 58.9 billion (approximately KRW 84 trillion) by 2033.
- Policy
- Psychotropic drug etomidate will be discontinued in KOR
- by Lee, Hye-Kyung Apr 24, 2025 06:01am
- The domestic supply of etomidate, a psychotropic drug scheduled to be newly designated this year, is expected to be discontinued. According to the Ministry of Food and Drug Safety's list of discontinued and shortage drugs, B. Braun Korea reported on the 21st that it would discontinue the supply of ‘Etomidate-lipuro Injection.’ B. Braun Korea explained, “The drug is scheduled to be designated as a psychotropic substance, which will result in the termination of the current sales contract with the domestic distributor by the end of this year. At this time, the possibility of renewing the contract or entering into a new contract for the drug is unclear, with the future import and supply of the drug plan also undecided.” The MFDS conducted a public consultation until the 10th regarding the “Revision of the Enforcement Decree of the Act on the Control of Narcotics” on whether to newly designate etomidate as a psychotropic drug. Etomidate has been illegally administered or misused in some medical institutions, and the MFDS announced that it will proactively designate it as a narcotic and actively manage it to ensure its safe use in Korea. B. Braun Korea explained, “The medication in question is an injection containing etomidate, and there are no other products with the same ingredient. However, medications with similar efficacy and effects, such as propofol, ketamine, and midazolam, are currently in circulation in the country.”
- Company
- Tuberculosis drug Dovprela lands in Big 5 hospitals in Korea
- by Eo, Yun-Ho Apr 24, 2025 06:01am
- ‘Dovprela,’ the first new drug introduced in the field of tuberculosis in half a century, can now be prescribed at general hospitals in Korea. According to industry sources, Viatris Korea's multidrug-resistant tuberculosis treatment Dovprela (pretomanid) passed the Drug Committees (DCs) of the Big 5 tertiary hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Asan Medical Center. Dovprela, which was first approved in September 2019 in the US and in October 2021 in Korea, is indicated in combination with bedaquiline and linezolid to treat adult patients with extensively drug-resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) pulmonary tuberculosis (TB). It was listed for reimbursement in January 2023. Pretomanid is the first new drug introduced in the field in 50 years. The field of TB has been neglected by front-line pharmaceutical companies due to its lack of economic feasibility. In fact, Viatris developed the drug in collaboration with a non-profit organization, ‘TB Alliance,’ rather than a general pharmaceutical company. Multi-drug resistant tuberculosis is a type of tuberculosis that cannot be treated with two or more TB treatments including isoniazid and rifampicin, the two most effective anti-TB treatments due to intolerance. Its cause can be divided into primary resistance and acquired resistance. Primary resistance develops when a patient is infected with drug-resistant MTB or during the course of treatment due to arbitrary discontinuation of therapy or irregular administration, etc. Treatment success rate of multi-drug resistant tuberculosis is around 50%, it has low treatment efficiency, and second-line drugs used for its treatment bring more side effects than first-line drugs. Moreover, due to its longer treatment period of 18 to 24 months, the cost burden is high and may even require surgical operations to remove lesions. Also, the seven-drug combination therapy that includes bedaquiline (Bdq) which is used as the current standard treatment for multidrug-resistant tuberculosis, is not well used in Korea due to its high drug resistance rate and long treatment period of 9 to 12 months. Due to the long period, the 7-drug combination is difficult to manage and has a high failure rate. Meanwhile, Dovprela demonstrated its efficacy through the Phase III Nix-TB trial. Dovprela, in combination with bedaquiline and linezolid (BPaL), demonstrated a 92% effect in patients with treatment-intolerant or nonresponsive multidrug-resistant TB and an 89% effect in patients with extensively drug-resistant TB within 6 months and demonstrated its potential as a new short-term combination therapy in the field. Also, it reduced the treatment period from 18-24 months to 6 months, and almost all patients with treatment-intolerant or nonresponsive multidrug-resistant TB and extensively drug-resistant TB were found to be sputum culture-negative within 16 weeks. As the first ready-to-use combination that consists solely of oral treatments, the BPaL regimen reported a 90% cure rate in patients with extensively drug-resistant tuberculosis when used for 6 months compared to the standard treatment that recommends the use of at least 4 drugs in the initial intensive phase.
- Company
- 1 out of 2 multinational firms saw SG&A expenses ratio↓
- by Son, Hyung Min Apr 24, 2025 06:01am
- It was reported that multinational companies reduced their selling, general, and administrative (SG&A) expenses (hereafter referred to as SG&A expenses). Analysis suggests that the recent medical dispute in South Korea impacted the sales and R&D activities. In contrast, pharmaceutical companies with increased SG&A expenses saw a surge in severance payment ratio due to early retirement plans (ERP). According to the Financial Supervisory Service (FSS) on April 24, SG&A expenses for 30 major multinational pharmaceutical companies’ Korean subsidiaries totaled KRW 1.8373 trillion last year, a 0.8% increase from the year before. Among those 30 companies, 17 increased their SG&A expenses, while 16 saw their expense-to-revenue ratios decline. Selling, general, and administrative (SG&A) expenses of major multinational companies in KOR (unit: KRW 1 million) Lilly Korea’s SG&A expenses amounted to KRW 37.2 billion, down 2% year-on-year (YoY), and its expense to sales ratio declined by 6%. R&D expenses, which include academic research and ongoing trial costs, dropped 25%, from KRW 6.4 billion in 2023 to KRW 4.7 billion last year. As Lilly supplies new drugs for oncology and biologics to tertiary hospitals, medical-government disputes significantly affected Lilly's R&D expenses. MSD Korea cut its SG&A expenses by 11%, from KRW 104.9 billion in 2023 to KRW 93.6 billion. The company had a significant reduction in R&D spending. MSD Korea's research expenses dropped 48% from KRW 9.2 billion to KRW 4.8 billion. Both lower research budgets and workforce reduction likely affected this shift. GSK Korea also reduced its current research expenses by 72%, from KRW 8.9 billion to KRW 2.5 billion, and Novartis Korea, which had the highest SG&A expenses last year, saw a reduction in SG&A expenses from KRW 29.6 billion to KRW 28.0 billion, a 5% decrease. Salaries spending impacted changes in SG&A expenses Changes in salaries, severance payments, and retirement benefits, also affected expense changes in several companies. AstraZeneca Korea's SG&A expenses fell 26% to KRW 107.5 billion. Its expense ratio dropped 5% from that of 2023. The company's base salaries, retirement benefits, severance, and welfare outlays all decreased. AstraZeneca conducted an ERP following the withdrawal of Forxiga from South Korea in 2023. The severance costs amounted to KRW 25.7 billion in 2023 but declined to KRW 0.081 billion last year. The total payroll dropped 14% from KRW 37.1 billion to KRW 31.8 billion. In contrast, Kyowa Kirin Korea's ERP drove SG&A expenses higher. The company recorded a total payroll of KRW 8.2 billion, and severance payouts amounted to KRW 26.1 billion. The payroll declined by 15%, but severance payouts surged by 1,410%. Kyowa Kirin Korea conducted an ERP last year. The company sold its Asia-Pacific unit last year, China operations to Hong Kong's Winhealth Pharma, and regional promotional and distribution arms to DKSH last month. Janssen Korea's SG&A expenses increased due to increased payroll and retirement benefits. The company saw a 13% rise in SG&A expenses from the previous year to KRW 88.0 billion. Its total payroll rose 9% to KRW 27.4 billion, and retirement benefits increased 24%. As the company's KRW 3.8 billion severance cost from 2023 was reflected on the audit report, the SG&A cost surged.
- Company
- AbbVie’s workforce↑ MSD↓ due to business restructuring
- by Son, Hyung Min Apr 24, 2025 06:01am
- Various factors, including the sale of drug rights, early retirement programs (ERP), and the launch of new drugs, have affected the number of employees at Korean subsidiaries of multinational pharmaceutical companies. AbbVie Korea doubled its workforce over 4 years through the Allergan merger. BMS Korea, Merck, and Novo Nordisk Korea saw significant increases in staff upon the launch of their innovative new drugs and business expansion. MSD Korea had the largest number of employees as of last year, but this decreased by 200 in four years due to the sale of Januvia rights and the implementation of ERP. Pfizer Korea, Janssen Korea, AstraZeneca Korea, and Novartis Korea also saw a decrease in the number of employees due to the adoption of ERP. According to an analysis of the audit reports of 30 multinational pharmaceutical companies in Korea disclosed on the Financial Supervisory Service's electronic disclosure system on the 23rd, the total number of employees last year was 7,389, an increase of 68 from 7,321 the previous year. Compared to 7,192 in 2020, this is an increase of 197 in four years. The company with the largest increase in employees compared to 2020 was AbbVie Korea. The number of employees at AbbVie Korea last year was 340, a 17 increase from the previous year. The company's employee count rose significantly from 170 in 2020 to 323 in 2023. AbbVie Korea acquired 100% of the shares of Allergan Korea on February 1, 2023. On April 30 of the same year, it absorbed Allergan Korea, and from the following day, Allergan Korea's performance began to be reflected in AbbVie Korea's results. The merger and acquisition at the headquarters level was carried out in 2019. On June 25, 2019, AbbVie acquired Allergan for USD 63 billion (approximately KRW 73 trillion). Allergan owns the original botulinum toxin product “Botox.” Merck, Novo Nordisk, and BMS Korea saw a significant increase in their number of employees with the launch of innovative new drugs. BMS Korea surpassed 200 employees for the first time last year. The company's workforce reached 209 employees last year, a 24 increase from the previous year. The company has consistently expanded its workforce while supplying immunotherapy drugs such as Opdivo, heart failure treatment Camzyos, anticoagulant Eliquis, and leukemia drug Sprycel in Korea. In addition, BMS Korea signed a joint promotion agreement with Yuhan Corporation last year for the psoriasis treatment of Sotyktu and the ulcerative colitis treatment of Zeposia. As a result, the company established a new Immunology Sales Department and hired additional clinical team members, leading to an increase in the number of employees. The number of employees at Merck Korea increased by 39.4% from 345 in 2020 to 481 last year. This means that 136 new employees were hired over the past four years. Looking at the numbers by year, the number of employees steadily increased from 360 in 2021 to 409 in 2022 and 444 in 2023, reflecting the company's strategy to expand its business in Korea. Merck has achieved remarkable results in various fields, including infertility treatments and anticancer drugs. In April last year, Merck's Pergoveris Inj for ovulation induction was granted reimbursement for infertility. In addition, the company is expanding its business by supplying the non-small cell lung cancer treatment Tepmetko and the bladder cancer treatment Bavencio in Korea. Novo Nordisk also showed a clear upward trend, increasing its number of employees from 169 in 2020 to 291 in 2024, which was a 72 increase. This is believed to be related to the growth of GLP-1 (glucagon-like peptide-1) class obesity and diabetes treatments in the domestic market. Novo Nordisk has launched not only GLP-1 new drugs containing liraglutide, such as Saxenda and Victoza but also diabetes drug Ozempic and obesity drug Wegovy containing semaglutide in the domestic market. Wegovy, which entered the market in the fourth quarter of last year, surpassed KRW 60 billion in sales in just one quarter. Sales right transfers, withdrawal from the Korean market, and ERP lead to layoffs On the other hand, some companies have reduced their workforce due to the impact of sales, withdrawal from the Korean market, and ERP. Last year, MSD Korea had 505 employees, which was a 201 decrease from 2020. The biggest factor affecting this reduction of workforce was the spin-off of Organon. Organon was spun off from Korea MSD in 2021 and officially launched in June of the same year. Organon sells chronic disease treatments such as Propecia for hair loss, Cozaar for hypertension, and Atorvastatin for dyslipidemia, which was previously sold by MSD. MSD Korea has transferred the Januvia family to Chong Kun Dang and reorganized its chronic disease business division. The company transferred the rights for Januvia (sitagliptin), Janumet (sitagliptin and metformin), Janumet XR (sitagliptin and metformin), and other Januvia family products, as well as the diabetes drugs Steglatro and Steglujan to Chong Kun Dang in May 2023. At the same time, it closed down its General Medicine (GM) division. The number of employees at Pfizer Korea decreased by 50 from 454 in 2023 to 404 last year. The honorary retirement benefits paid last year amounted to KRW 5.33526 billion, a 279.9% increase from the previous year's KRW 1.4453 billion. Pfizer carried out global restructuring in 2023 and last year. This was due to a sharp decline in sales of vaccines and treatments such as Comirnaty and Paxlovid following the COVID-19 pandemic. This decision also affected the reduction in staff at the Korean branch. Novartis Korea had 466 employees last year, a decrease of 68 in the past four years. Novartis underwent a large-scale restructuring at the headquarters level in 2022. In response, Novartis Korea reorganized its respiratory division in 2022. Novartis Korea's respiratory treatments include Enerzair, a triple combination asthma treatment, and Atectura, a once-daily fixed-dose combination medication. Xolair, Novartis Korea's best-selling asthma treatment, was not included in the restructuring as it was an immune disease division product. In addition, Novartis Korea's generic drug division, Sandoz, was spun off and then withdrawn from the Korean market in 2023. In the same year, Novartis Korea began restructuring its portfolio by implementing ERP for its ophthalmology division. AstraZeneca Korea is one of the companies that has experienced significant fluctuations in the number of employees. The company's workforce increased by 18 employees from 393 in 2020 to 411 last year. However, compared to 439 employees in 2023, last year's figure represents a decrease of 28 employees. The increase in AstraZeneca Korea's workforce was attributed to its business expansion. AstraZeneca acquired Alexion, a company specializing in the development of rare disease treatments, in 2020. Alexion holds rare disease drugs Soliris and Ulotrimis, which are used for conditions such as paroxysmal nocturnal hemoglobinopathy and severe myasthenia gravis. AstraZeneca Korea began domestic sales of the drugs in February 2023, leading to an increase in the number of employees in the rare disease division. Meanwhile, the primary reason for the decrease in the number of employees at AstraZeneca Korea last year was the withdrawal of the SGLT-2 inhibitor-based diabetes treatment drug Forxiga from the Korean market. The company implemented an ERP for the CVRM (Cardio Vascular Renal Metabolism) division, which previously housed the Forxiga sales department.
- Company
- 'One year anniversary of Adtralza's launch in KOR'
- by Son, Hyung Min Apr 23, 2025 06:12am
- Shin Jung-bum, CEO of Leo Pharma Adtralza, which debuted in the market last year, has been shown to improve the quality of life for atopic dermatitis patients during its first year of domestic launch. Experts note that its effectiveness in areas such as the head and neck, where symptoms are more visible, could lead to broader applications. On the 22nd, LEO Pharma held a press conference at the Andaz Hotel in Apgujeong-dong, Gangnam-gu, Seoul, to celebrate the first anniversary of Adtralza’s launch. Adtralza is a biological agent that selectively acts on interleukin (IL)-13 and was approved for reimbursement in May last year as a treatment for chronic severe atopic dermatitis in adults and adolescents. IL-13 is a key cytokine that triggers symptoms and signs of atopic dermatitis, including immune regulation and skin barrier dysfunction. It is known to be overexpressed in the skin with atopic dermatitis symptoms and is associated with the disease severity. Previously, Dupixent, which inhibits IL-4 and IL-23, and Rinvoq, a JAK inhibitor, were primarily used to treat atopic dermatitis. However, the introduction of Adtralza has expanded treatment options. Given that atopic dermatitis is a chronic condition with no cure and a long treatment duration, diverse treatment options are essential. In particular, since March, switching between JAK inhibitors and biological agents has been approved for reimbursement, leading to predictions that the use of Adtralza may increase in the future. Adtralza has demonstrated efficacy and safety in the Phase III ECZTRA3 and ECZTEND studies. The ECZTRA3 trial compared Adtralza with placebo in patients aged 18 years and older with moderate-to-severe atopic dermatitis who had previously failed to respond adequately to topical therapy or required systemic treatment. The primary endpoints were the proportion of patients achieving an improvement in the Validated Investigator Global Assessment scale for Atopic Dermatitis (IGA) to 0 or 1 at Week 16, and the proportion of patients achieving EASI-75 (75% or greater reduction in the Eczema Area and Severity Index (EASI) score from the baseline) The clinical results showed that Adtralza achieved an EASI-75 response rate of 56.0%, an improvement compared to 35.7% in the placebo group. The proportion of patients with an IGA score of 0 or 1 at Week 16 was 38.9% in the Adtralza group and 26.2% in the placebo group. The ECZTEND study evaluated the long-term efficacy of Adtralza. In the clinical trial, 84.5% of patients treated with Adtralza for 4 years achieved EASI-75. Adtralza also demonstrated efficacy in patients with atopic dermatitis in the difficult-to-treat head and neck area. A key advantage of Adtralza is its convenience of administration. While Dupixent requires administration once every two weeks, Adtralza can be administered once every four weeks in patients with clear or almost clear skin after 16 weeks of treatment, based on the judgment of a healthcare professional. Currently, LEO Pharma is conducting clinical studies on patients with hand eczema and pediatric patients aged two years and older. The company also plans to add a pen-type formulation to further improve patient convenience. Dong-Hoon Lee, professor of Dermatology at Seoul National University Hospital Dong-Hoon Lee, professor of Dermatology at Seoul National University Hospital, said, “Adtralza showed consistent efficacy in real-world studies, as in clinical trials. In particular, it showed improved symptoms in patients who switched to Adtralza from existing treatments.” He added, “Treatment is particularly difficult when atopic dermatitis occurs on the hands or head and neck, but symptoms improved in these patients as well when treated with Adtralza.” Ji-Hyun Lee, professor of dermatology at Seoul St. Mary Ji-Hyun Lee, professor of dermatology at Seoul St. Mary's Hospital, said, “Although biological agents have emerged for atopic dermatitis, lesions often remain in the head and neck area, such as the face and neck. It is known that 17% of patients who are treated with Dupixent experience conjunctivitis. This remains an unmet need for patients who must continue with their social lives.” She added, “Adtralza has been confirmed to reduce EASI scores uniformly across various body areas, including the head and neck and limbs. If visible lesions do not improve, this can significantly impact the quality of life. Since Adtralza has a low incidence of conjunctivitis as a side effect, it may be considered as an alternative to existing treatments like Dupixent if conjunctivitis occurs during their use.” Professor Lee noted, “Currently, there is limited active switching between treatments. However, some patients may benefit from switching, so I anticipate that this will become more common in the future.”
- Opinion
- [Reporter's View] Reimb criteria for cancer therapy
- by Whang, byung-woo Apr 23, 2025 06:11am
- The Ministry of Health and Welfare (MOHW) has recently issued an administrative notice announcing an improvement to the National Health Insurance-covered reimbursement criteria for combination cancer therapy. The revised policy states that the patient's co-payment will remain the same as the previously initiated treatment regimen, even if a new cancer therapy approved by the Ministry of Food and Drug Safety (MFDS) is combined with a drug previously approved for reimbursement. Until now, the system has been unfavorable to patients. When an individual uses a new drug in combination with existing therapy, the existing drug becomes non-reimbursed. Therefore, the patient was responsible for the entire treatment course out-of-pocket. The industry and patients welcomed the current measure, but a bigger issue related to new drug-new drug combination therapy remains unresolved. In fact, almost 48% of 70 cases of combination cancer therapy that the MFDS approves falls into the category of new drug combination therapy. Now that discussions about expanding reimbursement for combination therapies have been initiated, the focus has shifted to improve new drug combinations. However, the interests of the government and the industry still do not align perfectly. The government must consider a finite National Health Insurance fund, thereby demanding careful approach before green‑lighting high‑cost anticancer drugs. Patient demand for innovative therapies is high, but broadened coverage could strain the National Health Insurance fund. Pharmaceutical companies aim to quickly commercialize their products after the value of a new drug is acknoweldged. The rationale behind this is to secure profits that meet global standards, compensating for the substantial investment in R&D. Consequently, companies tend to pushback during price negotiations with the government or reluctance to supply detailed cost‐effectiveness data. Pharmaceutical companies stress the significance of a 'patient‑centric' value and vision, declaring patient access improvement a core mission. As they emphasize societal duties, critics say they must also accept the consequences during discussions for expanded reimbursement. The recent measure to improve reimbursement criteria for combination therapy has prompted calls for companies to adopt a more forward-looking partnership. At times, the pharmaceutical industry has placed the blame for new‑drug patient access issues on the government’s stringent approval criteria and low-price proposals. Of course, a fundamental difference exists between a government that must respect budgetary constraints and companies driven by profit motives. However, some critics argue that a company with a 'patient-centric' operation as its company core value must also proactively participate in improving the system that obstructs patients from receiving new drug benefits. Several opinions suggest that the health authorities should reciprocate such efforts by fast‑tracking reimbursement decisions for therapies with proven benefits. If each side defers responsibility to the other, the patients may be affected. If pharmaceutical companies truly prioritize patients, they must fulfill their role as partners in improving policy to help solve remaining issues. The government must also balance fair compensation and sustainable fund management in line with the evolving treatment landscape. The issue of reimbursing new drug combination therapy is a complex challenge that can only be met through government-industry partnerships. The government and pharmaceutical companies must be in the same boat for collaborating and have mutual responsibility toward this goal. The recent improvements to the reimbursement criteria have opened the door to change. We hope that the remaining issues will be resolved quickly and improvements will be made continuously.
- Policy
- MFDS 'Review time shortened after the GIFT introduction'
- by Lee, Hye-Kyung Apr 23, 2025 06:11am
- Following the introduction of the Global Innovative products on Fast Track (GIFT) for global innovative products by the Ministry of Food and Drug Safety (MFDS) last year, the time it takes to review pharmaceuticals for severe disease has shortened significantly from the average of 115 days to 62.9 days. Furthermore, the number of approved cases for innovative new drugs increased by 3.1-fold, from 8 to 25, compared to 2022. According to the 'GIFT Monitoring and Plans' unveiled by the MFDS on April 22, the number of cases designated as GIFT increased from 6 cases in 2022 to 16 cases in 2024. The number of approved innovative new drugs also surged. (left) Number of cases designated as expedited review (right) Number of approved innovative news drugs Notably, proactively running the system has enabled short review time, which falls within 75% of the regulatory review period (within 120 days). The review period reportedly takes 62.9 days. During the regulatory review period, the time it takes to submit document supplementation is not included. An expedited review also excludes the document supplementation period. The MFDS has been operating the expedited review system since August 2020. It has introduced the GIFT for severe disease in 2022. To date, 65 cases have been designated for expedited review system, with 29 cancer drugs and 21 COVID-19 vaccines ranked by highest. In addition, the MFDS has expanded GIFT program criteria to include advanced biopharmaceuticals. For new drugs developed by innovative pharmaceutical companies, the MFDS supports early entries to the GIFT program. Notably, as the Health Insurance Review and Assessment Service (HIRA) revised the 'Specific evaluation criteria of new drugs and medicines in consideration for negotiation,' GIFT-designated new drugs are now acknowledged for 'innovativeness of new drugs' during the ICER value evaluation during the reimbursement evaluation. Furthermore, the 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,' aimed at the swift supply of severe rare diseases treatments, also considers GIFT-designated products for their program. Recordati Korea's Qarziba, the 13th GIFT-designated drug for rare cancer in children, took 89 days until marketing authorization review, and it was approved for reimbursement listing six months after approval. This year's '2nd Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations' includes the 24th GIFT drug 'Winrevair,' the 30th GIFT drug 'Fintepla,' and the 33rd GIFT drug 'Rimqarto.' The MFDS stated, "In March, the MOHW revised the pharmaceutical evaluation criteria and newly established drug pricing evaluation for GIFT-designated new drugs developed by innovative pharmaceutical companies," and added, "Criteria for evaluating cost-effectiveness are newly established, such as providing benefits for new drugs when their clinical effectiveness is comparably improved than a substitute drug."
- Policy
- ‘Govt will resolve the supply issue of rare disease drugs’
- by Lee, Jeong-Hwan Apr 23, 2025 06:10am
- A private-public policy consultative body will be established to discuss support measures for manufacturers and sellers of rare disease drugs, medical devices, and special foods. The Korea Disease Control and Prevention Agency announced that a partial amendment to the Enforcement Decree of the Rare Disease Management Act, which provides the basis for the formation and operation of the “Consultation Body for Rare Disease Support Policies,” was approved at the Cabinet Meeting on the 22nd. The amendment was prepared to provide administrative and financial support to manufacturers and distributors to ensure a stable supply of drugs, medical devices, and special foods related to the diagnosis and treatment of rare diseases. Key provisions include the establishment and operation of a “Consultative Body for Rare Disease Support Policies” comprised of relevant central administrative agencies and related institutions to determine necessary matters such as the scope, procedures, and criteria for administrative and financial support for manufacturers and sellers of rare disease medications, medical devices, and special foods. The consultative body will be chaired by the Director-General of the Chronic Disease Control Bureau of the KDCA and consist of no more than 10 members, including officials from relevant central government agencies such as the Ministry of Economy and Finance, the Ministry of Agriculture, Food and Rural Affairs, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety, as well as other officials from relevant organizations and groups. The task force will discuss and coordinate matters such as: ▲preparing and reviewing detailed support measures for administrative and financial support; ▲sharing and utilizing information on the current status of support for rare diseases among relevant agencies; and ▲determining the scope, procedures, and other necessary matters related to administrative and financial support for the diagnosis and treatment of rare diseases. KDCA Commissioner Young-mi Jee said, “We hope that practical support for those who produce and sell medicines, medical devices, and special foods for the diagnosis and treatment of rare diseases will be strengthened. We will continue to expand cooperation with relevant ministries and private organizations to establish a management system for the entire process that includes the diagnosis, treatment, and support for patients with rare diseases.”
