- LOGIN
- MemberShip
- 2025-12-19 14:19:27
- Policy
- RSA Collateral calculation method under review
- by Jung, Heung-Jun Dec 11, 2025 08:39am
- The National Health Insurance Service (NHIS) is currently reviewing improvements to the collateral calculation method for the refund-type risk-sharing agreement.Setting collateral in risk-sharing contracts is a crucial safeguard to secure claims in case refund obligations are not met. While a formula exists for setting the collateral amount, shortcomings were identified in some newly established RSA types, prompting NHIS to review improvements.According to industry sources on the 9th, this year’s NHIS audit highlighted deficiencies in the collateral calculation method for certain RSA types. The NHIS was advised to establish alternatives that would secure unpaid refund amounts for risk-sharing types lacking a collateral calculation formula.The NHIS's collateral-related operations are governed by the “Detailed Operational Guidelines for Drug Price Negotiations under Risk-Sharing Agreements.” Article 13 of the guidelines stipulates that the NHIS must receive collateral from companies to ensure the fulfillment of contractual obligations.Furthermore, the collateral amount is calculated using a separate formula, and the amount can be adjusted based on the type, the expected reimbursement amount, and the level of uncertainty.The collateral calculation methods are broadly categorized and specified in the guidelines as: ▲Conditional sustained treatment and refund hybrid type ▲Total expenditure cap type ▲Refund type ▲Patient-Unit usage cap type. For example, the Total expenditure cap type sets collateral at expected claim amount × refund rate × 30%.Within the RSA refund type, ▲the outcome-based reimbursement type is a newly added category for which no standardized calculation method is defined in the guidelines.According to the NHIS, the type of guarantee calculation formula identified as inadequate during the audit is the ‘outcome-based reimbursement type’. The NHIS stated it is currently under internal discussion and plans to revise the guidelines if necessary.An NHIS official explained, "The guidelines lack a calculation formula for the outcome-based reimbursement type. Internal discussions are ongoing, and revisions will be made to the guidelines if necessary."The outcome-based refund type is a contract type in which the applicant refunds a certain percentage of the total claim amount to the NHIS if the treatment effect set for each treated patient is not achieved after tracking and observing the treatment effect over a specified period.The outcome-based refund type is applied to some ultra-high-priced drugs, including Kymriah and Zolgensma.
- Policy
- Korea’s pharma industry: 20 years of rebate competition
- by Lee, Jeong-Hwan Dec 10, 2025 08:49am
- An argument has been raised that even if generic drug prices are cut, fostering generic drug companies capable of achieving economies of scale in selected therapeutic areas will increase the likelihood of the domestic pharmaceutical industry's global expansion.The logic is that unless the industry structure, in which many pharmaceutical companies produce and sell a little bit of every ingredient's generic version in a multi-product, small-volume production model, is reformed, the repetitive, destructive rebate competition among pharmaceutical companies will inevitably continue.There was also a suggestion that government policy must follow to prevent generic drug price reductions from leading to supply instability for certain generics.On the 5th, Professor Sung-min Park of Seoul National University's Graduate School of Public Health expressed concern at a National Assembly forum on drug pricing policy reform, stating, “Korea’s generic price competition has been distorted for decades and has instead manifested as rebate competition.”Professor Park's view is that the problem, where a higher market share is gained by higher generic prices, resulting in low drug expenditure savings from generic use, has persisted for 20 years. Consequently, the means of generic competition continues to be rebates to prescribing physicians rather than price reductions.Professor Park pointed out, “As sanctions against illegal rebates intensified, the practice became more covert to evade detection. While the margin rate for general wholesalers is 6%, CSO commission rates range from 40% to 50%, and can even reach 100%. The structure requires sales practices that benefit prescribers to secure generic prescriptions.”He stressed, “Korean generic companies have no real competitive tools besides rebates, being forced into rebate wars. Rebate competitiveness is far easier to achieve than price or quality competitiveness. This leads to an increase in small and micro pharmaceutical companies.”Professor Park proposed that the government should focus on creating a generic industry structure where economies of scale operate as a solution to these problems.Professor Park's solution is to transform the domestic generic industry, currently characterized by domestic-focused, multi-item, small-volume production, into an export-driven industry producing consumer goods like cosmetics and automobiles.Professor Park explained, “In the sheltered environment without genuine price competition, Korea's generic industry has many companies producing a little of this and that for the domestic market. Generic companies may be highly competitive in terms of rebates because they work hard to win sales. However, rebate competition that drives domestic prescription is meaningless in the global market.”Professor Park elaborated, “Even if we build competitiveness by supporting companies through methods like paying 40-50% commissions to CSOs, giving special margins to wholesalers who pay upfront, donating to hospital-related foundations, or setting up booths and paying fees at medical conferences, exporting domestic generics overseas remains a distant prospect. For the generic industry to become an export industry, it must achieve economies of scale that allow for price and quality competitiveness.”He noted, "We should refer to Japan's Ministry of Health, Labour and Welfare's generic pharmaceutical industry policy. MHLW categorizes generic companies into two types: general trading company-type firms with high market share, numerous product lines, and overall improved productivity; and specialized domain-focused companies leading specific areas and concentrating on products where they have strengths to secure productivity. Japan concluded that limiting competition to about 5 companies per active ingredient is optimal for a stable supply.Professor Park added, “While lowering generic drug prices, we must foster generic companies to achieve economies of scale across numerous items or in specific areas of strength, enabling global expansion. We must also be cautious that generic drug price reductions do not lead to supply instability for certain generics. We must not repeat the major disruption caused by the acetaminophen shortage during COVID-19.”
- Policy
- Revaluations for herbal medicines begin in earnest
- by Lee, Tak-Sun Dec 10, 2025 08:48am
- Some herbal preparations are entering comparative clinical trials for equivalence reevaluations.This comes one year after the Ministry of Food and Drug Safety announced the reevaluation of herbal preparations’ reimbursement last December, indicating how long it took for clinical trial protocols to be approved.According to industry sources on the 9th, the MFDS recently approved two clinical trial protocols submitted by manufacturers of Pelargonium sidoides extract tablets for equivalence reevaluations.The original brand for Pelargonium sidoides is Hanwha Pharma’s Umckamin, used for acute bronchitis.The approved clinical trials are reportedly led by Dasan Pharma and Genuone Sciences.Currently, 30 Pelargonium sidoides tablet products maintain marketing authorization (excluding export-only products). Of these, 28 are subject to the equivalence reevaluation. Dasan Pharma’s trial is said to have the largest number of participating products.The clinical trial is expected to proceed to submit a final report in two years. The MFDS granted an additional six months beyond the initially planned duration. However, depending on trial progression, the submission deadline may be shortened or delayed.Unlike Pelargonium sidoides tablets, the generic versions of the gastritis treatment ‘Stillen Tab and the osteoarthritis reliever ‘Layla Tab, which are also subject to reevaluation, are reportedly still undergoing revisions to their clinical trial protocols.The herbal medicine equivalence reevaluations began upon the MFDS’ announcement in December last year. The MFDS stated that proving bioequivalence through standard BE testing was unsuitable for these formulations, and that comparative clinical trials would be required instead. This marks the first time equivalence reevaluation will be performed through full clinical trials.Comparative clinical trials are considered the most burdensome form of equivalence testing for companies, costing tens of billions of won and requiring more than two years. As a result, about half of the original 212 products subject to reevaluation have already withdrawn their marketing authorization or converted to export-only status.Upon the MFDS review announcement, companies submitted clinical trial protocols by June. A total of seven trials will be conducted (three for Stillen generics, three for Umckamin generics, and one for Layla generics). Poonglim Pharmatech will be conducting 2 trials for 2 Stillen generics; Mother’s Pharm 1 for Stillen generic and 1 for Layla generic; and Dasan Pharma and Genuone Scinces, Korea United Pharm will each lead 1 Umckamin generics trial.However, due to MFDS requests for revisions and companies’ extension requests, approvals for the trials have been repeatedly delayed.Consequently, the first trial plan approval came a full year after the announcement. The Umckamin generic companies whose plans were approved this time must submit their result reports by December 2027 to demonstrate equivalence with the original product.
- Policy
- First batch of Korean anthrax vaccine Barythrax Inj released
- by Lee, Jeong-Hwan Dec 10, 2025 08:48am
- GC Biopharma announced on the 8th that Barythrax Inj., the world’s first recombinant-protein anthrax vaccine that it had co-developed with the Korea Disease Control and Prevention Agency (KDCA), has been released domestically for the first time.This comes about 8 months after receiving marketing approval as Korea’s 39th homegrown new drug last April, marking the country’s transition from full reliance on imported anthrax vaccines to enabling self-sufficiency.The first batch shipped from the Hwasun plant will be supplied as reserve vaccines for the KDCA.Unlike existing vaccines that directly use non-pathogenic anthrax bacteria, Barythrax expresses and purifies only the Protective Antigen (PA) protein, a key component of anthrax toxin, offering a higher safety profile.Preclinical and clinical studies demonstrated Barythrax’s excellent safety and strong immunogenicity, and the platform allows rapid large-scale manufacturing when needed.Barythrax is produced at GC Biopharma’s vaccine plant in Hwasun, Jeonnam, which has the capacity to manufacture up to 10 million doses annually, sufficient for approximately 2.5 million people based on a four-dose regimen per person.GC Biopharma particularly emphasized that Barythrax is a vaccine developed entirely with domestic technology, making it highly significant in terms of securing national vaccine self-sufficiency.The KDCA expects this shipment to help secure the stable supply of essential national medicines. As a core material in the bioterrorism response system, anthrax vaccines have previously relied on overseas products, raising persistent concerns about supply disruptions.The KDCA's position is that securing a domestic production base strengthens vaccine sovereignty and enables a more systematic response to infectious disease and bioterrorism.KDCA Commissioner Seung-Kwan Lim said, “The first shipment of the domestically produced anthrax vaccine is an achievement made through close cooperation between government agencies and private companies. This case will serve as a turning point to elevate the technological capabilities and production base of Korea’s vaccine industry to the next level.”He added, “We will continue to pursue the domestic production of essential national vaccines and build a more robust vaccine stockpiling system for infectious diseases and bioterrorism preparedness.”GC Biopharma CEO Eun-chul Heo remarked, “We are pleased to be able to ship the first supply of a domestically developed anthrax vaccine that we jointly developed with KDCA. GC Biopharma will continue to strive to strengthen Korea’s disease prevention capabilities and achieve vaccine self-sufficiency.”
- Policy
- Changes to DUR criteria for pack unit drugs
- by Jung, Heung-Jun Dec 10, 2025 08:48am
- The changes to the drug utilization review (DUR) system criteria for pharmaceuticals sold in packs will be applied to duration of use, starting on December 11. The issue concerning confirmation of the actual duration of use due to the characteristics of pack units is expected to be improved.New regulatory standards will apply to 39 drug items involving 18 active ingredient codes, including treatments for allergic rhinitis, hormonal preparations, and COVID-19 therapies.On December 9, the Health Insurance Review and Assessment Service (HIRA) informed medical institutes of changes to the Drug Utilization Review (DUR) criteria. By incorporating the total duration of use, duplicate checking will become more thorough.For example, if a prescription for Climen is written for 1 tablet once daily for a 28-day supply, the pharmacy dispensing claim will now record as dose per administration: 0.0356 (1/28), times per day: 1, and total days of Supply: 28.DUR system checks for duplication only for a single day. However, there have been differences in unit size for cases such as a 21-tablet pack or a 30-tablet pack.From now on, the actual period of use will be displayed next to the total days of supply. For example, if the unit is a 28-tablet pack, the period of use will be recorded as 28. This change will make duplication checks easier for the actual 28-day duration of the pack-unit drug.Regarding the rationale behind the improvement, HIRA stated, "For pack-unit drugs, improvements to the review criteria were necessary to accurately reflect the actual duration of use, as unclear prescribing or packaging unit descriptions resulted in inaccurate monitoring."Furthermore, the change is also aimed at preventing drug misuse and abuse through accurate duplication checks of the same active ingredient.HIRA requested cooperation from healthcare institutions, asking them to "accurately record the total days of supply in accordance with the guidelines to ensure the supply of safe use information for pack-unit drugs."The total days of administration will also be reflected in claims for both treatments and dispensing. For example, if a prescription for Climen is written for 1 tablet once daily for a 28-day supply, the pharmacy dispensing claim will now record as dose per administration: 0.0356 (1/28), times per day: 1, and total days of Supply: 28.
- Policy
- DREC deems 42 drugs appropriate for reimbursement
- by Jung, Heung-Jun Dec 09, 2025 08:28am
- According to the Health Insurance Review and Assessment Service (HIRA), the Drug Reimbursement Evaluation Committee (DREC) deemed reimbursement appropriate for 42 drug items during the 12 meetings held this year.Among them, 30 cases involved new drug listings or expanded reimbursement indications, averaging about 2.5 approvals per month. Another 12 were approved for reimbursement when accepted at or below the evaluated price.Based on the results of the twelve meetings held by HIRA’s DREC on the 7th, Dailypharm examined the status of reimbursement appropriateness approvals by the DREC this year.Although final listing requires successful price negotiations with NHIS and subsequent review by the Health Insurance Policy Deliberation Committee, passing the DREC remains the most critical hurdle toward reimbursement listing in Korea.This year, Janssen Korea and Eli Lilly Korea appeared most frequently among the 42 approved items. Janssen led with four products, followed by Lilly with three, marking strong performance.Janssen Korea secured reimbursement approval for Balversa (erdafitinib), a targeted therapy for urothelial carcinoma. Darzalex (daratumumab) for multiple myeloma and Erleada (apalutamide) for prostate cancer were recognized as appropriate for reimbursement expansions.Additionally, Opsynvi (macitentan/tadalafil) for pulmonary arterial hypertension received conditional approval, making drug price negotiations critical.Lilly Korea received positive evaluations for Jaypirca (pirtobrutinib), a treatment for mantle cell lymphoma, and Mounjaro Prefilled Pen (tirzepatide) as an adjunct therapy for diabetes. Also, Ebglyss Autoinjector Inj (lebrikizumab) was conditionally approved at or below the evaluation price.Other multinational companies, including Novartis Korea, AstraZeneca Korea, GSK, and Sanofi, had 2 items approved each, including conditional approvals.Among domestic companies, Hanmi, Jeil Pharmaceutical, JW Pharmaceutical, HLB Pharma, GC Pharma, Shinpoong Pharm, and Samoh Pharmaceutical all received reimbursement adequacy approvals from DREC.Notably, Handok is the only domestic company with two items approved. Its bile duct cancer treatment, Pemazyre Tab (pemigatinib), received reimbursement adequacy approval, while its thrombocytopenia treatment Doptelet Tab (avatrombopag) received conditional approval. Both drugs were listed after price negotiations with the National Health Insurance Service.
- Policy
- Application submitted for salt change generic to 'Jakavi'
- by Lee, Tak-Sun Dec 09, 2025 08:28am
- Novartis' rare blood cancer treatment 'Jakavi'The first applications for a generic to Novartis's 'Jakavi (ruxolitinib phosphate)', used for rare blood cancers, have been filed in South Korea. Jakavi is facing generic competition ahead of the expiration of its domestic substance patent on January 14, 2027. Currently, Daewoong Pharmaceutical and Chong Kun Dang are actively seeking to circumvent a composition patent.According to the Ministry of Food and Drug Safety (MFDS), applications for different dosage variants of a salt form-changed generic to Jakavi were filed on the 24th and 27th of last month. In response, the MFDS notified the original patent holder, who had registered patents on the drug listing, of the generic applications, in accordance with the Patent-Approval Linkage System.The generic drug has a different salt form from the original Jakavi. While Jakavi is the phosphate salt, the generic drug uses the hemifumarate salt. This change in salt form is interpreted as a strategy to circumvent the patent.Currently, Daewoong Pharmaceutical and Chong Kun Dang are also working to circumvent the composition patent by filing suits for negative confirmation of the scope of right with the Korean Intellectual Property Trial and Appeal Board. If these suits are successful, they will be able to launch their generic drugs immediately after the substance patent expires on January 14, 2027.Another key characteristic of the generic drug applications is that they exclude the Graft-versus-Host Disease (GVHD) indication, which still has a remaining Post-Marketing Surveillance (PMS) period.Jakavi is indicated for the treatment for Myelofibrosis (MF), Polycythemia Vera (PV), and Graft-versus-Host Disease (GVHD). However, the GVHD indication was added in 2022 and has a remaining PMS period until May of next year (2026). During the PMS period, the filing of generic drug applications is generally prohibited.Generics to Jakavi are reportedly under development, besides those form Daewoong and Chong Kun Dang. Jakavi is a global blockbuster product, with worldwide sales reaching KRW 6.6 trillion as of 2024. Its sales in South Korea are rapidly rising after successfully securing reimbursement coverage for MF and subsequently for GVHD in 2023.Given that rare disease drugs often lack alternatives and carry high costs, analysis suggests that companies succeeding in an early launch of a generic drug can secure a stable sales performance.
- Policy
- Gvn’t ‘Drug reform benefits Korean companies’
- by Lee, Jeong-Hwan Dec 05, 2025 08:33am
- Ki-hyun Bae (Deputy Director) and Yeon-sook Kim (Director) of the Ministry of Health and Welfare’s Pharmaceutical Benefits Division explain the intent behind the new generic drug pricing reform. The ministry’s position is that the focus should be on significantly expanding price incentives for innovative pharmaceutical companies, firms with strong R&D, and manufacturers that ensure a stable supply of essential or exit-prevention medicines, and on advancing the post-listing price-reduction management system.The Ministry of Health and Welfare has emphasized that the purpose of this reform of the generic drug pricing system is to encourage domestic pharmaceutical companies' new drug research and development (R&D) and ensure the stable supply of essential medicines. It also stated that the advancement of the post-listing price-reduction management system reflects efforts to minimize unnecessary confusion or administrative burdens for pharmaceutical companies and establish a predictable environment for drug price reductions.This is a follow-up measure to the domestic pharmaceutical industry's strong resistance to the reform, which includes a substantial reduction in the generic drug pricing calculation rate from 53.55% to the 40% range.The Ministry of Health and Welfare stated that it intends to send a clear signal through this drug pricing system reform: both domestic and international pharmaceutical companies should strengthen their commitment to obtaining Korea Innovative Pharmaceutical Company certification, and even non-innovative pharmaceutical companies can receive preferential drug pricing if they invest in R&D or contribute to the production of essential medicines and drugs, preventing market withdrawal.On December 3, Director Yeon-sook Kim and Deputy Director Ki-hyun Bae met with the press corp and explained that the new pricing structure aims to reinforce the environment for new drug R&D and comprehensively overhaul the post-listing pricing evaluation and reassessment system.Kim stated, “The core of this reform is enhancing access to new drugs and establishing a clinical evidence-based reevaluation system. It's regrettable that this aspect seems largely unknown to the domestic pharmaceutical industry.”The drug pricing system improvement plan reported by the Ministry of Health and Welfare to the Health Insurance Policy Deliberation Committee last month includes applying preferential price increases of up to 68%, 60%, and 55% to innovative pharmaceutical companies and companies with high R&D investment ratios, respectively, and extending the existing one-year price premium period to three years or more.In particular, the ministry plans to overhaul post-listing reassessment into a unified, evidence-driven system focused on clinical utility, and to establish a fixed biannual schedule (April and October) for post-management.The Ministry of Health and Welfare states that this aligns the timing of drug price adjustments for frequently occurring reasons like ‘expanded usage scope’ and ‘price-volume linkage pricing’, enhancing predictability. This fully reflects the domestic pharmaceutical industry's demands.Kim stated, “The most important direction of this reform is not prioritizing health insurance savings, but minimizing policy judgment factors and shifting to an evidence-based approach. We will strengthen predictability by uniformly standardizing the post-approval management cycle, procedures, and evaluation items.”Furthermore, the Ministry clarified that the adjustment lowering the generic drug ceiling price to the 40% range in 2012 is a phased approach, starting sequentially with items already on the reimbursement list that have maintained a calculation rate of 50% or higher for over 13 years.While interpretations vary within the pharmaceutical industry regarding whether this applies only to drugs listed in the 2012 reimbursement list, Kim emphasized, “The approximately 3,000 items that are priced between the 53.55% and 50% level, and the approximately 4,500 items between 50% and 45% level are based on the 2012 reimbursement list criteria.”According to the government roadmap, approximately 3,000 items will be adjusted over 3 years starting in the second half of next year (2026). From the second half of 2027, the 1,500 items that maintained a rate of 45% or higher will be sequentially adjusted (reduced).Regarding the industry’s biggest concern—whether generics listed after April 2012 will also face price cuts—Kim explained, “We will gather industry feedback, and as outlined in the reform plan, we intend to establish a periodic reassessment framework, which may be discussed in connection with this issue. No immediate reduction or specific schedule has been finalized.”Kim further stated, “This restructuring should be viewed not as a policy differentiating global and domestic companies, but as a structural reorganization to ensure a stable supply of new drugs and essential medicines. Measures such as raising the designation criteria for exit-prevention drugs, adjusting the cost-compensation method, and providing incentives for using domestically produced raw materials are actions that broadly incorporate the pharmaceutical industry's research service results. Savings generated from the price cuts will ultimately return to benefit the domestic pharmaceutical industry.”Kim concluded, “For areas not yet finalized, we will make decisions after collecting further opinions. For this, we will continue communication and consultation with pharmaceutical associations and experts.”
- Policy
- 10th DREC members to be appointed next year
- by Jung, Heung-Jun Dec 05, 2025 08:33am
- The appointment of members for the 10th term of the Drug Reimbursement Evaluation Committee (DREC), which assesses the appropriateness of drug reimbursements, is expected to be delayed until next year.The 12th committee meeting held today (4th) will see the existing 9th-term members participate as usual. The Health Insurance Review and Assessment Service (HIRA) is currently conducting personnel verification procedures, including checking administrative disciplinary records, prior to appointing the 10th-term members, with appointments expected soon.Although the 9th-term members' official two-year term ended last September, their tenure has been extended due to delays in recommending and appointing the 10th-term members.DREC members are appointed after receiving around 70 recommendations from professional medical societies and organizations. The Korean Pharmaceutical Association may also recommend one member.The committee consists of approximately 105 members. Once the HIRA appointments are finalized, various subcommittees, such as the Pharmacoeconomic Evaluation Subcommittee and the Risk-Sharing Agreement Subcommittee, will also be newly reorganized.Seventy-six members were appointed for the 9th term. For the monthly DREC meetings, 20 members are randomly selected to participate.Among the recommended DRED members, the following are excluded: ▲Those currently performing pharmacoeconomic evaluation-related services for pharmaceutical companies ▲Officers, employees, or practicing physicians/pharmacists of the recommending medical/pharmaceutical organization ▲Those deemed unable to perform duties impartially during the pre-appointment ethics screening ▲ Individuals with administrative sanctions or legal penalties within the last 5 years under the Medical Service Act, Pharmaceutical Affairs Act, National Health Insurance Act, or Medical Benefit Act ▲ those who have served as a DREC member for two or more consecutive terms.Since HIRA is currently reviewing candidates’ administrative sanction histories, the committee may be fully reorganized with new members as early as January next year. The term of office is 2 years.Additionally, HIRA revised the Drug Evaluation Committee regulations last July, changing the chairperson election method from an election by committee members to appointment by the HIRA Director. The authority to form subcommittees and elect subcommittee chairs was also transferred from the committee chair to the HIRA Director, an issue criticized during the National Assembly audit.The number of individuals each organization (KMA, KPA, KSHP, etc.) can recommend for the candidate pool was also reduced from two to one..
- Policy
- MFDS announces revision to the ODD regulations
- by Lee, Tak-Sun Dec 05, 2025 08:32am
- From now on, Orphan Drug Designation (ODD) can be expedited without the need to submit documentation of significant improvement in safety and effectiveness compared to substitute drugs.The Ministry of Food and Drug Science (MFDS) (Minister Yu-Kyoung Oh) announced on December 4 that it has issued an administrative notice for the amendment to the 'Regulations on the Orphan Drug Designation' (MFDS Notice), expanding the criteria to provide diverse treatment opportunities for patients with rare diseases.The amendment is part of the 'The Top 50 Food and Drug Safety Tasks' and it will allow drugs used to treat or diagnose rare diseases to receive expedited designation as orphan drugs without having to submit data proving 'significantly improved safety and efficacy compared to alternative medicines.'A rare disease is one with a prevalence of fewer than 20,000 people, or one whose prevalence is unknown due to diagnostic difficulty, as designated and publicly announced by the Korea Disease Control and Prevention Agency (KDCA).The amendment enhances predictability by clearly specifying the documentation requirements that companies must submit when applying for Orphan Drug Designation, aligning them with the specific designation criteria.Since July of this year, the MFDS has been operating a 'Consultative Body for Improving the ODD System' to discuss various improvement measures, including the ease of designation criteria.The MFDS anticipates that this revision will help foster an environment in which patients with rare diseases can receive stable treatment and will contribute to the government's national agenda to fulfill a 'A Strong Welfare Nation Built on Solid Foundations'.Detailed information on the administrative notice for the regulation amendment can be found on the MFDS official website (www.mfds.go.kr) → Legislation/Data → Legislation Information → Legislation/Administrative Notice.
