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- 2026-04-17 15:11:30
- Policy
- Early market entry of Gabsmet salt-modifying drugs are noted
- by Lee, Tak-Sun Jan 06, 2020 06:21am
- The salt-modifying drug 'Galvusmet', a DPP-4 inhibitory diabetes drug, applied for approval for the first time in Korea on the 24th of last month. It is therefore noteworthy whether it will be released to the market early. According to the MFDS on the 24th, Vildagliptin HCl-Metformin HCl combination was applied for the first time to the patent holder, Novartis. The salt is different from the original 'Galvus', which is a combination of Vilagliptin-Metformin HCl. Therefore, the industry has made an observation that Hanmi which has been developing Galvus salt modification drugs, has applied for a license. Hanmi also reportedly filed an application for a license for the Vildagliptin HCl formulation, a Galvus' monolithic salt change product, in July. However, it has not yet obtained a product license. On November 22, last year, Anguk received the first approval of generic drugs and obtained a exclusivity for generic product following the successful patent challenge. However, since the company succeeded in invalidating part of the extended period of the patent, the exclusivity for generic product of sale is not applied immediately, and it is enforced for nine months from August 30 2021. Galvusmet's salt-modifying drug, one of material patent is also likely to be on the market at this time. This is because Anguk and Hanmi have succeeded in invalidating patents that survive after August 29, 2021. Nevertheless, Galvusmet, a latecomer of DPP-4 diabetes, is expected to be the fastest case to enter the market. Galvus recorded outpatient prescriptions of ₩9 billion on UBIST basis in 2018, and Metformin-included Galvusmet is a blockbuster drug with a record earnings of ₩35.1 billion. If first-latecomers enter the market early through patent challenge, they will benefit from the preemptive effect.
- Company
- SK gets world’s first quadrivalent flu vaccine PQ by WHO
- by Lee, Seok-Jun Jan 06, 2020 06:20am
- For the first time in the world, a quadrivalent influenza vaccine passed prequalification (PQ) by the World Health Organization (WHO). SK Bioscience announced on Jan. 2 WHO has completed the seven-month long PQ evaluation and granted a certification of PQ on its Sky Cellflu Quadrivalent. This marks the first time in the world history for a cell-cultured quadrivalent influenza vaccine to pass WHO’s PQ evaluation procedure. Even including egg-based vaccines, only three quadrivalent influenza vaccines, except Sky Cellflu Quadrivalent, have passed the PQ. WHO’s PQ evaluation follows strict set of criteria to verify safety and efficacy of vaccine by assessing the finished pharmaceutical product’s manufacturing procedure, quality and clinical trial outcomes. The evaluation procedure includes technical document review of clinical trial and quality test data, sample quality test, and due diligence on GMP and quality control system. A company with PQ certification is eligible for international bidding for vaccine procurement called by UN-affiliated UNICEF and Pan American Health Organization (PAHO). As of last year, the PAHO’s market volume for influenza vaccine has reached about USD 700 billion (about 81.4 billion won). Sky Flucell Quadrivalent is a vaccine preventing four types of influenza viruses. Unlike typical egg-based vaccinea, the Korean-made quadrivalent vaccine is produced with top-of-the-line aseptic culture system, which does not require preservative. With the unique qualities, the vaccine has less risk of allergic reaction or adverse reaction from egg or antibiotics when administered. Besides, the vaccine can be manufactured quickly as its production time is close to a half of other vaccine’s. Since its split from SK Chemical in July 2018, SK Bioscience has been specializing in vaccine production. The company’s vaccine portfolio includes Korea’s first trivalent cell-cultured influenza vaccine ‘Sky Cellflu,’ the world’s first quadrivalent cell-cultured influenza vaccine ‘Sky Cellflu Quadrivalent,’ the world’s second shingles vaccine ‘Sky Zoster’ and the second Korean-made varicella vaccine, ‘Sky Varicella.’
- Company
- Nexavar reimbursement cleared for severe HCC patients
- by Eo, Yun-Ho Jan 06, 2020 06:20am
- From this year, reimbursed prescription would be granted on liver cancer treatment Nexavar treating patient with severe liver dysfunction. According to the new pharmaceutical listing, reimbursement on Nexavar (sorafenib) would be provided for a patient, including pediatric patient, with advanced hepatocelluar carcinoma (HCC) who is unable to undergo local treatment like surgery or transarterial chemoemoblization (TACE), and qualifies condition of being classified as class A or B7 according to Child-Pugh scoring; in Stage III or more advanced; or classified as Grade 0 to 2 of ECOG Performance Status. Provided by the newly revised listing, treatment access to Nexavar has been expanded not only for patients with good liver condition graded by Child-Pugh scoring, but also for patients with HCC with severe liver dysfunction. The coverage expansion has been decided based on the safety profile confirmed in the GIDEON study incorporating HCC treatment guideline from home and abroad and numerous HCC patients classified in class B7 by Child-Pugh scoring. With 3,371 participants around the world with unresectable HCC, GIDEON study evaluated safety of sorafenib by treating the subgroup patients with 800 mg of sorafenib daily, reduced when necessary. The study found consistent safety profile in over 70 percent of the participants, specifically in Child-Pugh A patient group (61 percent) and Child-Pugh B7 patient group (11 percent). Consistent incidences of adverse events were reported from Child-Pugh A and Child-Pugh B7 patients groups with 69 percent and 67 percent, respectively. Commonly reported drug-related adverse reaction from Child-Pugh B7 group was diarrhea (27 percent), hand-foot syndrome (20 percent) and fatigue (16 percent). And in the subgroup analysis of GIDEON on 482 Korean patients, the safety profile was consistent in Child-Pugh A patient group (56.8 percent) and Child-Pugh B patient group (21.8 percent). The subgroup analysis found overall patient group treated with sorafenib (n=482), including Child-Pugh B patients, reached median overall survival of 8.5 months, which was not too far off from the median overall survival of 10.2 months in Child-Pugh A patients only group. Commonly referred by cancer academics, the U.S. National Comprehensive Cancer Network (NCCN) Guidelines (Version 3.2019) and HCC Treatment Guideline in Korea (2018) recommends Nexavar as systemic treatment for HCC patients with specific tumor condition including Child-Pugh A and B7 class of liver function. Professor Kim Yoon Jun of Gastroenterology Department at Seoul National University Hospital commented, “Preserving the liver function is crucial in HCC treatment, but patients with already dysfunctional liver or cancer-damaged liver had not have many treatment option. However, even the patients with severe liver condition, who used to be inaccessible to systemic anticancer therapy, can now access to higher level treatment option with expanded reimbursement.”
- Policy
- Announcement of drug price reform is delayed
- by Kim, Jung-Ju Jan 04, 2020 08:47pm
- The reform of the drug price system, which the government plans to announce last month, is delayed somewhat. The pharmaceutical industry is all on edge because of the reorganization of generic drug prices, improved risk-sharing contract (RSA), economic exemption system, and insurance policy supplementary agreement (sub-contract). ◆Generic price restructuring= Among the many cases where drug price restructuring is expected, the focus of the industry is on the final revision of the 'Determination and Adjustment Criteria for Drug Price Revision', which contains the generic price restructuring. The government planned to announce the final announcement no later than last month, but it was slightly delayed, with some revisions to the earlier this month. It is essential to calculate this system by linking the MFDS' item permission to the Ministry of Health and Welfare’s drug price system. It is largely divided into generic cascade drug price reform and cut line system. The requirement for a cascading drug price reform is to conduct its own bioequivalence test and to meet the registered use of the Drug Master File (DMF). If both criteria are met, the price is estimated at 53.55% of the cost of the original drug (before generic listing). However, if one or not met, then the price is multiplied by 0.85 based on 53.55%, depending on the level of fulfillment of the criteria. They are cut by 15%. In addition, the 'cut line system' is a price condition that is lowered separately from the permit linkage. Starting from the 21st order of health insurance, the drug price is estimated at 85% of the lowest price regardless of whether the criteria are met. For example, the 21st generic is estimated at 85% of the lowest price in 20 products, while the 22nd generic is 85% of the 21st generic price. The government has announced that the drug price reform will be finalized by the middle of this month and planned to be implemented in July. ◆Completion of RSA, reimbursement decision, the economic evaluation exemption system and additional contract creation subjects=In the current drug price system, issues that require expansion or reorganization of the reimbursement gateway stage are also overhauled. The government has continually improved the drug price system without changing the fundamentals of the system since the implementation of the positive list system. However, as the groundbreaking reinforcement of security continued, the awareness of the need to reorganize and upgrade the positive list system continued. The improved drug price system can be divided into: ▲expanding the scope of RSA coverage ▲complementary details of reimbursement determination ▲complement of economic evaluation exemption system ▲expansion of generics for writing subsidies when reimbursement listed. First of all, in the case of RSA improvement, one of the new drug listing tracks, it is important to expand the gateway to be able to apply the RSA target criteria that could be applied only to the current selection drugs. In the meantime, drugs that have the same therapeutic position but have not been covered by RSA just because of late-release drugs will have a wider benefit opportunity. In addition, high-priced drugs that are subject to phase III conditional approval are considered to have greater uncertainty, and thus, improvements are made in the direction of raising benefits by reimbursed them within the framework of the RSA. In the case of reimbursement determination, some socially disturbing reimbursed priorities are supplemented. The government is currently making reimbursement in consideration of medically feasible or medically significant materiality and treatment effects, as well as patient costs and social benefits. In the future, it will be added to determine detailed principles or priorities in consideration of the financial status of health insurance. In other words, it reflects the decision of reimbursement to the financial level that health insurance can cover, along with the characteristics of pharmaceuticals and the necessity of the times. The economic evaluation exemption system will also be supplemented. The government plans to improve the system by adding antibiotics, tuberculosis treatment, and emergency detoxification drugs, which are difficult to evaluate, to reflect the voice of expanding the scope of drugs that are difficult to evaluate. Lastly, it is a revised plan that includes a generic agreement that is included when insurance is listed. The contracting parties are the Korea Health Insurance Corporation and pharmaceutical companies. The main contents of the contract are to fulfill supply obligations and accept price cuts when disposing of rebates. The government aimed to implement the midterm this year after outlined this month's reorganization plan based on improving the positive list system and promoting administrative notice. Evaluation adopted by the government during the maintenance of the list of registered agreements from 2007 to 2011 ◆Re-evaluation of listed drugs=The government is currently setting up a 'post-evaluation of pharmaceuticals', that is, a re-evaluation guideline for already listed reimbursed drugs and collecting expert opinion. The evaluation is based on the revised List of Contracts, which was carried out 12 years ago, but the standard is expected to be more detailed. Reevaluation targets are selected from anti-cancer drugs, rare disease drugs, and drugs of uncertain clinical usefulness. Of these, ▲drugs that need to confirm clinical usefulness through effects re-evaluation ▲drugs that need to be managed due to increase in population structure and usage ▲other drugs that require evaluation taking into account social impacts and other effects on health care at ex post evaluation Sub-committees become standards. The government plans to announce the final reassessment soon and finalize the system within the year.
- Opinion
- [Reporter’s View] At least a guideline for ‘class effect’
- by Eo, Yun-Ho Jan 03, 2020 06:33am
- ‘Recognizing expected efficacy of drugs with same mechanism of action.’ It is definitely an unresolved conundrum. Experts have clashing opinions and each pharmaceutical company has different interests. In the end, what it comes down to is ‘case by case.’ Not that it needs an answer key, but obviously the prescribing doctor’s decision based on experience and medical knowledge is important. The problem is consistency in applying healthcare insurance reimbursement. For some classes, the effects are recognized regardless of the approved label and equivalent reimbursement criteria are applied, but some other classes have different scope of labels approved. Reimbursement expansion on combination therapy of sodium-glucose cotransporter-2 (SGLT-2) inhibitor, currently pending without much of progress from 2018, would be a good example. As Korean Diabetes Association (KDA) failed to settle a dispute over expanding reimbursement on off-label anti-diabetic combination therapies including SGLT-2 inhibitor, dipeptidyl peptidase-4 (DPP-4) inhibitor and thiazolidinedione (TZD), the government that initially had intention to expand reimbursement on the off-label use, is now hesitant to take a further step. An odd phenomenon of the doctors opposing on expanding reimbursement is happening because of the dispute over class effect. Originally, it was the medical industry that started the discussion of providing reimbursement on anti-diabetic combination therapy. Apparently, doctors had experiences of confusion in prescribing as each drug in same class had different indications, and eventually had reduced reimbursement. In 2013, expanding reimbursement on combination therapy with DPP-4 inhibitor and TZD went through the same ordeal. However, the results were different. The medical industry valuing clinical evidence and expert’s judgment over approved label and financial impact was unprecedented as well. Class effects of DPP-4 inhibitor and SGLT-2 inhibitor, as stated by Korea’s reimbursement standard on orally taken anti-diabetic treatment, have been polarized so far. However, the possibility is still out there. Some expects positive outcome of a former professor at Seoul St. Mary’s Hospital, Yoon Kun-ho, elected as the president of KDA. The former professor used to actively demand for reimbursement on the combination therapy in 2013. We are talking about prescription drug. It doesn’t hurt to be careful. Some might say it better be rather careful. But, if their agenda is to recognize the class effect, then they should set a guideline on ‘required time for properly building up prescription experience, or prescription volume.’ There may be an expectation in the current situation, but there is no promise. If properties of disease are different, then a manual on class effect by each disease is essential. There is no need for the government to worry about the industry getting too confident about class effect and lazy on clinical trial. They know very well that abundant academic data is more powerful in the field than qualifying for reimbursement criteria.
- Policy
- Only 6 out of 9 reimbursed use of Spinraza approved
- by Lee, Hye-Kyung Jan 03, 2020 06:31am
- Only 66.6 percent of preliminary approval applications for reimbursement submitted last month was cleared for the use of spinal muscular atrophy (SMA) treatment Spinraza (nusinersen). Six out of nine applications were approved, and other three applications were rejected with conditional approval, disapproval and required supplementary data. On Dec. 31, Health Insurance Review and Assessment Service (HIRA, President Kim Seung-taek) officially disclosed outcomes of reimbursement review on four items—Spinraza, Soliris, ventricular assist device (VAD), and hematopoietic stem cell transplantation—deliberated by Healthcare Review & Assessment Committee in November 2019. Spinraza has been listed for reimbursement since last Apr. 8, but a healthcare institute intending to use super-high-cost treatment priced at 92.36 million won per 5 ml has to apply for a preliminary approval for reimbursement. For reimbursement on the treatment, a patient has to qualify for all conditions of lacking 5q SMN-1 gene or being diagnosed with gene mutation; SMA related clinical symptoms and signs onset from age younger than three; and not in use permanent ventilator. A well-known unapproved case was a 14-year-old male patient with SMA, who could not clearly prove his age of SMA-related symptom and sign onset was younger than 36-month-old according to the submitted data. The committee did not approve the application without proper objective data. A conditional approval was granted on 24-year-old female patient with a record of scoliosis surgery as her myelogram result proved she is able to take continuous administration into her dura mater with lumber puncture. However, the approval condition was submission of the confirmed number of SMN2 copy with the monitoring report. Soliris (eculizumab) was available for preliminary approval for reimbursement prior to Spinraza, and had six applications submitted for treating atypical hemolytic uremic syndrome (aHUS). But only one was approved out of all. A 49-year-old male patient was approved with reimbursed use of Soliris as he had recurrent thrombotic microangiopathy and kidney dysfunction, despite he had conservative treatment after ABO-incompatible kidney transplantation. Although HIRA found, reviewing his medical record, thrombotic microangiopathy has occurred after the kidney transplantation and using immunosuppressant, it approved of the reimbursed use because the patient had clinical symptoms of aHUS and also continued to show thrombotic microangiopathy symptoms with no apparent response to hemodialysis and therapeutic plasma exchange. But the patient has been ordered to submit genetic testing result and two-month monitoring report. His feasibility of maintained reimbursement would be deliberated depending on the clinical result.
- Company
- Daewoong launches 'Nabota' Phase III clinical trial in China
- by An, Kyung-Jin Jan 02, 2020 11:26pm
- On the 28th, Sung-soo Park , Director of Nabota Business Division, Daewoong Pharm. Co., Ltd (Third left in front row) is taking commemorative photos with the researchers such as Yu-ri Pan, professor of dermatology (Fourth left in front row) of Zhejiang Provincial PeopleNabota, a botulinum toxin preparation developed by Daewoong Pharm. Co., Ltd (CEO Seung-ho Jeon), has begun preparations for clinical trials in China. Daewoong Pharm. Co., Ltd announced on the 31st that it held a researcher meeting for Nabota's phase III clinical trials in China at the Pullman Skyway Hotel in Shanghai on the 28th. Daewoong Pharm. Co., Ltd aimed to release the product in 2022 after acquiring Nabota's moderate to severe frown lines improvement indications in China. Daewoong Pharm. Co., Ltd plans to demonstrate non-inferiority and safety by comparing Nabota with the reference drug for 16 weeks in 500 patients with moderate or higher frown lines. The clinical trials will be conducted in 12 institutions, including the 9th Hospital of Shanghai Jiao Tong University, which is famous for its plastic surgery in China. Around 60 people attended the meeting, including professors in the 9th Hospital of Shanghai Chung-Ang University Hospital including the chief clinical officer of China, Chung Bong Lee, clinical researchers and hospital staff. In addition to the announcement of China's Phase III trial plan and questions and answers, Nabota products and clinical trial experiences were introduced. In order to improve understanding of the product and clinical trials, Dr. Won-Woo Choi, a dermatologist of the Wells Dermatology Center, conducted a training program to assist in the launching of clinical trials such as the method for evaluating the frown lines. Chung Bong Lee, Professor of the 9th Hospital of Shanghai Chung-Ang University Hospital said, “2020 is the most anticipated time of change in the medical beauty market. Many people are looking forward to new products, and Nabota will strive to become a successful importer of botulinum toxin in China”. Sung-Soo Park, director of Nabota Business Division, Daewoong Pharm. Co., Ltd, said, “China has the largest number of patients in the world, while its market penetration rate is as low as 2%. The market is expected to grow the most in the future because there are only two licensed drugs. If a high-quality, reasonably priced product, such as Nabota, is officially approved and supplied to the market, Chinese potential patients will be able to receive botulinum toxin procedures more easily and safely”.
- Policy
- Rare cancer reoccurred in patients with Allergan’s implants
- by Lee, Tak-Sun Jan 02, 2020 11:21pm
- Another patient with rare cancer developed after breast augmentation with Allergan’s coarse surface implants. This is the second time since it was first reported in Korea on August 14th. The Minister of Food and Drug Safety, Eui-Kyung Lee and the Korean Society of Plastic and Reconstructive Surgeon(Chairman, Kwang Seog Kim) announced on the 26th that an additional patient with breast implant-related anaplastic large cell lymphoma (BIA-ALCL) was reported on the 24th. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare cancer associated with the immune system that is separate from breast cancer. Suspicious symptoms include changes in the size of the breast caused by serousomas, lumps or skin rashes on the skin. The patient, a woman in her 40s, underwent breast enlargement using rough surface implants from Allergan in 2013. After swelling in the chest recently, a pathology examination was performed at a university hospital. The patient was diagnosed with BIA-ALCL and reported to the MFDS and the Korean Society of Plastic and Reconstructive Surgeon. The patient visited the medical institution promptly and received the BIA-ALCL test in accordance with safety information, such as how to respond to suspected BIA-ALCL symptoms reported by the MFDS and medical institution. On the 26th after final confirmation with BIA-ALCL, additional tests such as positron emission computed tomography (PET-CT) confirmed that BIA-ALCL did not spread to other sites. The MFDS explained that the patient is currently working on a treatment plan, including removal of the implant. Meanwhile, according to the compensation plan for patients with rough surface breast implants on Sep 30, Allergan will pay medical expenses for the patient. The MFDS and the Korean Society of Plastic and Reconstructive Surgeon are conducting patient registration studies to minimize the difficulty of patients with breast implants and improve safety, and will continue to implement more rapid measures through continuous monitoring of adverse event information. In addition, They have repeatedly asked patients with breast implants to visit and see a medical professional if they have any suspected symptoms, such as a sudden change in breast shape.
- Policy
- Reimbursed Dupixent requires prior prescription record
- by Kim, Jung-Ju Jan 02, 2020 11:20pm
- The reimbursement criteria for patients taking now listed Sanofi Aventis Korea’s severe atopic dermatitis treatment Dupixent Pre-filled syringe 300 mg (dupilumab) were officially disclosed. Reimbursement on the treatment is granted for an adult patient age over 18 with chronic and severe atopic dermatitis symptoms continuing over three years, who has a record of topical treatment and systemic immunosuppressive therapy within six months. And when the patient has to resume treatment after a hiatus with a medical reason would also be granted with reimbursement under certain circumstances. Korea’s Ministry of Health and Welfare (MOHW) recently announced partially revised ‘National Health Insurance Reimbursement Listing Criteria and Method’ reflecting the details of the newly listed atopic dermatitis treatment. Dupixent is a first non-anticancer or rare disease treatment in Korea to have signed the risk sharing agreement (RSA) with the government. However, patients requesting for National Health Insurance reimbursement on the treatment have to qualify for a list of conditions. ◆ Patient condition = According to the announcement, the treatment is listed for treating chronic severe atopic dermatitis patient over the age of 18 with symptoms continuing over three years. Also, the adult patient should have symptoms unable to be managed after four-week topical treatment (corticosteroids or calcineurin inhibitor) as first-line treatment, and not showing more than 50 percent decrease of Eczema Area Severity Index (EASI) score after three-month systemic immunosuppressant therapy (cyclosporine or methotrexate), and have EASI score over 23 before administrating the treatment. Also, the patient has to have a record to receiving topical treatment and systemic immunosuppressant therapy within past six months. ◆ Reimbursement evaluation = Reimbursement is granted for six months more after 14 weeks of administration and the patient showing more than 75 percent decrease of EASI score at week 16. From then on, reimbursement would be granted continuously when the result of initial evaluation response is maintained in EASI evaluation every six months. By principle, the reimbursement is limited to in-patient prescription only, and an outpatient prescription for a patient discharged from hospital covers four-week of dose of the treatment at most. However, for patients demonstrating stable disease activity and no adverse reaction at week 24 after the initial administration, their outpatient prescription can cover up to eight to 12 weeks of dose. To confirm a patient’s self-injection record during the administration period, the patient has to document ‘daily administration log’ and their healthcare institute has to confirm and oversee the daily log. A doctor specializing in atopic dermatitis related department like a department of dermatology or allergy has to prescribe the treatment, and objective data of the prescribed patient and their response assessment result of multiple dose administration (past treatment record, EASI evaluation result, photos of patient body with symptoms) should be handed in. ◆ Reimbursement when resuming treatment after hiatus = Patients needs to pass a certain condition to receive reimbursement again when resuming the treatment after a hiatus for medical reason. Patients, who had a hiatus before the first response assessment at week 16, may receive reimbursement for resumed treatment if the patient qualifies for the initial administration standard (EASI score over 23). On the other hand, two conditions apply for a treatment-resuming patient, who took hiatus after the initial response assessment followed by multiple dose treatment. Resuming after a hiatus shorter than three months would be considered continuous administration. But a patient would have pass the initial administration standard (EASI score over 23) to receive the reimbursement again if the hiatus was longer than three months. MOHW plans to collect public opinion until Jan 30, and to finalize the revision on Jan 31. Contact Pharmaceutical Management Department of Health Insurance Review and Assessment Service (HIRA) for inquiries on the details of the announcement.
- Policy
- ₩2.8 billion will be invested in AI drug development
- by Kim, Jung-Ju Jan 02, 2020 06:09am
- The government will greatly strengthen investment in innovation growth in the biohealth sector, which is called the future food industry, such as the pharmaceutical industry and increased the budget by 13% to ₩527 billion, and doubled the budget by building big data, new drug development platform, and support for the development of the pharmaceutical industry this year. The MOHW responded to pending questions on the Korean Special Press Association. First, this year's total budget is ₩82.5 trillion, an increase of 13.8% from last year. Among them, the MOHW’s budget increased ₩1.35 trillion by 11.7%. Looking at the biohealth sector, which includes pharmaceuticals, investment for innovation growth in the pharmaceutical, medical data, and medical device sectors will be greatly strengthened. This year's major R & D budget for health care is ₩527.8 billion, up 13% from ₩466.9 billion last year. The amount increased by 60.9 billion won. The government will establish a new drug development platform utilizing the 4th Industrial Revolution technology and discover core experts in pharmaceutical and biotechnology. The AI drug development platform was set at ₩2.8 billion, up ₩300 million(11.1%) from last year's ₩2.5 billion. In order to innovate biohealth technology, the budget of ₩15 billion was also reflected in the development of big data platform for genome and medical clinical information. Bio big data development is a pan-government project in connection with the Ministry of Welfare, the Ministry of Science and ICT, and the Ministry of Trade, Industry and Energy. In addition, the government invest ₩9.3 billion, will newly select and support five medical data-centric hospitals. As the Advanced Renewable Bio Act comes into effect in August, a budget will be invested in establishing a regenerative medical safety management system. The Ministry of Health and Welfare decided to reflect the budget of ₩1.2 billion to establish a clinical research system for rare and intractable diseases and to establish a safety management system. In the case of medical devices, the MOHW decided to support R&D to commercialization and expand investment to strengthen industrial competitiveness. A total of ₩30.2 billion was newly organized for full-cycle R&D development, and a budget of ₩8.6 billion was increased by ₩3.9 billion(82.4%) year-on-year to strengthen industrial competitiveness. In addition, the cosmetics industry plans to raise ₩7.74 billion to support localization of materials and development of technology to respond to market diversification to foster sustainable future growth engines.
