- LOGIN
- MemberShip
- 2026-07-22 03:12:16
- Product
- Which drugs will fill Fotagel and Stavic’s void?
- by Kang, Hye-Kyung Jul 21, 2026 08:26am
- The market disruption that arose following the removal of pediatric indications for dioctahedral smectite products is beginning to subside in Korea.According to local pharmacies and industry sources, supplies of alternative products that experienced a surge in demand after Fotagel and Stavic Suspension were barred from use in children and adolescents have largely returned to normal.Supplies of Hidrasec, which had temporarily gone out of stock following increased demand after the pediatric indication for dioctahedral smectite products was withdrawn, have now stabilized.Both the prescription drug Hidrasec and the OTC product Seolmum Chew, which experienced temporary shortages because of the sudden spike in demand, have also normalized.Samjin Pharm, which distributes Abbott Korea's Hidrasec, said, "Temporary supply instability occurred due to a sudden increase in orders, but both the 10mg and 30mg strengths are now being supplied normally."Seolmum Chew, which also experienced temporary shortages in line with Hidrasec, has likewise returned to normal supply.More than 80,000 units of Hanmi Pharmaceutical's Seolmum Chew are currently in stock in the company's HMP Mall, indicating stable supply.Industry closely watches the shift in demandThe industry is closely watching how demand will be redistributed.The key question is which alternatives for patients under 19 years of age, who can no longer use dioctahedral smectite products, will benefit the most.Pharmacist communities expect prescriptions for Hidrasec (racecadotril) to increase.AI-generated imageA local pharmacist said, "Since Fotagel and Stavic can no longer be prescribed for children and adolescents, prescriptions for Hidrasec are increasing. As it can be used from 6 months of age, it is effectively the only prescription antidiarrheal available for pediatric patients."Products containing polycarbophil calcium, including Wellcon, Hylcon, Recxil, Silcon, Carcon, and Pilcon tablets, are approved for children aged 6 years and older and are expected to cover much of the market for patients aged 6 to 18 years.According to the Ministry of Food and Drug Safety, imports of Hidrasec totaled KRW 984.11 million in 2024 (10mg KRW 377.04 million, 30mg KRW 607.07 million)Among OTC products, demand is also expected to rise for Baekcho Syrup (licorice extract, gambir 20% ethanol extract, Coptis/Cortex Phellodendri 50% ethanol extract, ginseng fluid extract, cinnamon bark 70% ethanol tincture, Scutellaria root soft extract, and gentian ethanol extract) and Seolmum Chew (berberine tannate, Scopolia extract powder 33%, ursodeoxycholic acid, and bismuth subnitrate), both of which can be used in younger age groups.A pharmacist practicing near a pediatric clinic said, "With the pediatric indication for dioctahedral smectite removed, the antidiarrheal market is becoming segmented by age group. Even when customers are looking for an over-the-counter antidiarrheal, we now first recommend Baekcho Syrup or Seolmum Chew because they can be used in younger patients."
- Product
- Korea first to recommend cuffless blood pressure monitors,
- by Hwang, byoung woo Jul 20, 2026 08:51am
- Cuffless blood pressure monitors, which measure blood pressure without inflating a cuff around the arm, have been included in Korea's hypertension treatment guidelines for the first time. The Korean Society of Hypertension (KSH) has become the first in the world to recommend cuffless blood pressure monitors for out-of-office blood pressure measurement, establishing a clinical framework for their use.The move is expected to accelerate clinical adoption, which is already increasing following reimbursement coverage, by reducing patient discomfort associated with conventional ambulatory blood pressure monitors and easing equipment burdens on healthcare providers. The society also plans follow-up clinical studies to strengthen the recommendation.At a press briefing on July 17, the KSH introduced the major updates in its sixth edition of the 2026 Korean Society of Hypertension Guidelines and their clinical implications.(from the left) Seonghoon Choi, Director of Public Relations at KSH (Hallym University College of Medicine); Kwang-il Kim, Chairman of KSH (Seoul National University Hospital); Sang-Hyun Ihm, Chair of the KSH Guideline Committee (The Catholic University of Korea College of Medicine); Eun Mi Lee, Secretary of the KSH Guideline Committee (Dongguk University College of Medicine)First positive recommendation…opens door to clinical useThe updated guidelines retain the existing recommendation to use validated cuff-based blood pressure monitors for office, home, and ambulatory blood pressure measurement while newly adding cuffless monitors as an option for out-of-office monitoring.Its use received a Class IIb recommendation with Level B evidence, meaning it may be considered in practice. This differs from U.S. and European guidelines, which do not recommend cuffless devices for clinical use.The society emphasized that this is the world's first positive recommendation for cuffless blood pressure monitors. While international discussions continue regarding their accuracy and appropriate use, the recommendation reflects growing validation data and real-world clinical experience accumulated in Korea.Kwang-il Kim, Chairman of KSH and professor at Seoul National University College of Medicine, explained, "There were concerns from overseas academia that Korea might be moving too quickly, but others viewed it as taking the lead in a new field. This is the first positive recommendation for cuffless blood pressure monitors anywhere in the world."In Korea, Sky Labs' CART BP, a ring-type blood pressure monitor, has already undergone validation against conventional 24-hour ambulatory blood pressure monitoring and is being used in clinical practice. Moving beyond being just a simple wearable device, its use has broadened as a clinical tool for ambulatory blood pressure monitoring.Major changes in the KSH hyperlipidemia treatment guidelinesSang-Hyun Ihm, Chair of the KSH Guideline Committee (Catholic University of Korea), said, "Given that the device is already being used in Korean patients and supporting evidence has accumulated, we concluded it would not be appropriate to classify it as a technology that should not be used. Although it has not reached Class I or IIa, we introduced it as a Class IIb recommendation that may be considered in clinical practice."Adoption expands following reimbursement…use expands across primary care clinicsThe inclusion of cuffless monitors in the guidelines is also expected to support the growing use of the technology following reimbursement coverage.Eun Mi Lee, Secretary of the KSH Guideline Committee, said, "We understand that the use of cuffless blood pressure monitors has increased significantly since its reimbursement listing. The convenience for both patients and healthcare professionals serves as a clear advantage."She noted, however, that additional validation is needed in certain patient populations, including those with thick finger joints, improperly positioned sensors, arrhythmias, or pregnancy.The society attributed the increase in use partly to broader adoption by primary care clinics. Traditional 24-hour ambulatory blood pressure monitoring requires dedicated equipment and repeated cuff inflation, placing burdens on both providers and patients. This had limited its use in smaller clinics.Seonghoon Choi, Director of Public Relations at KSH (Hallym University College of Medicine), said, “The rate of ambulatory blood pressure monitoring using conventional cuff-based devices has remained around 0.5% in Korea. The growing use of cuffless monitors suggests that primary care physicians, not just tertiary hospitals, are now participating in out-of-office blood pressure monitoring."Choi added, "The society has long emphasized that treatment decisions should not rely on a single office blood pressure measurement. The expansion of ambulatory blood pressure monitoring in primary care is therefore a very encouraging development."Cuffless monitors were newly introduced in practiceCan monitor blood pressure at night and in daily life… expands treatment dataOne of the main advantages of cuffless monitors is their ability to measure blood pressure during sleep and daily activities without repeated arm compression.Conventional ambulatory monitors inflate every 15 or 30 minutes, allowing patients to anticipate measurements and complain about sleep disturbances or discomfort during the night.Ring-type cuffless monitors can measure blood pressure more frequently without compressing the arm, potentially enabling more comprehensive monitoring beyond nighttime to routine daily activities.KSH President Kim said, "Conventional ambulatory monitors measure blood pressure every 15 or 30 minutes, whereas cuffless devices can collect readings at many more time points. They also offer advantages for nighttime and prolonged monitoring that exceeds one day."The technology may also benefit patients who have difficulty wearing arm cuffs, such as those undergoing hemodialysis or those who experience discomfort from repeated cuff inflation.For now, KSH sees the primary clinical role of cuffless monitoring in the follow-up of patients already diagnosed with hypertension, using the devices to assess treatment response, nighttime blood pressure, and diurnal variation while establishing interpretation criteria specific to cuffless measurements.Large clinical study involving over 1000 patents planned…. To prepare data to elevate the recommendation levelThe KSH is preparing an investigator-initiated clinical trial to strengthen the recommendation in future guideline updates.Chairman Kim said, “Whereas previous studies focused mainly on whether cuffless devices produced measurements comparable to cuff-based monitors, the next phase will evaluate whether treatment guided by cuffless blood pressure readings improves blood pressure control and patient outcomes."The evidence showing that cuffless monitors can generate values comparable to conventional ambulatory monitors supported the current Class IIb recommendation. Going forward, we need to demonstrate whether treatment based on cuffless measurements leads to better outcomes and predicts prognosis more accurately than existing methods."He added, "A single meaningful study could support a Class IIa recommendation, and consistent findings from both domestic and international studies could eventually lead to a Class I recommendation. Class IIb does not indicate a problem with the device -- it marks the beginning of a new clinical field."The planned study is expected to enroll more than 1,000 patients, with the final sample size depending on participating institutions and whether primary care clinics are included. The KSH aims to launch the study later this year after completing institutional reviews and protocol evaluations.The recommendation is not limited to any specific product. According to the KSH, any cuffless monitor that demonstrates sufficient accuracy and clinical evidence may receive the same level of recommendation.The updated guidelines also introduce isolated diastolic hypertension as a new category, strengthen blood pressure targets for high-risk patients, classify single-pill combination therapies, establish diagnostic and treatment algorithms for resistant hypertension, and emphasize more proactive management of hypertensive disorders of pregnancy. In particular, hypertensive disorders of pregnancy were identified as an area requiring efforts to bridge the gap between the guidelines and clinical practice, as the number of patients continues to increase while treatment options available in Korea remain limited.Chairman Kim said, "Gestational hypertension not only impacts maternal health but also the health of the child. The society will continue exploring policy solutions and providing the information needed to improve care."
- Product
- Discussion on hADM safety…traceability tracking from the donation phase
- by Hwang, byoung woo Jun 29, 2026 09:42am
- The Symposium of the Korean Society for Anti-Aging DermatologyAmid growing interest in human-derived extracellular matrix (ECM), the industry is also focusing on its safety profile. Currently, ECM is reported to be properly regulated through rigorous validation protocols.Human acellular dermal matrix (hADM) used in aesthetic and reconstructive fields is supplied to patients through a strict full project lifecycle management system that spans from donor consent and infectious disease screening to processing, sterilization, quality review, and traceability tracking.At the 16th Summer Symposium of the Korean Society for Anti-Aging Dermatology held on June 28, Faith P. Case, a tissue bank expert, introduced the ethical standards, regulatory compliance, and safety validation frameworks of US tissue banks during a session titled 'hADM, The center of the ECM era, Their similar yet different stories.'Case is an American Society for Quality (ASQ) Certified Quality Manager and an American Association of Tissue Banks (AATB) Certified Tissue Bank Specialist, currently serving as the Vice Chair of the AATB Accreditation Committee. She also has extensive experience conducting inspections and audits for the US Food and Drug Administration (FDA) and the South Korean Ministry of Food and Drug Safety (MFDS).The hADM safety management system initiates from donor consentCase emphasized that human-derived tissue allografts, such as hADM, fundamentally differ from synthetic biomaterials from their very origins. She noted that a donor's decision precedes the manufacturing process, serving as the critical first step in safety management.Faith P. Case, a tissue bank expert"Human tissue does not originate in a laborator. It begins with a human decision to donate," she stated. "This decision leads to a moral responsibility to manage the donation process with absolute transparency."The ethical foundation of the US tissue banking system is the Uniform Anatomical Gift Act (UAGA). This legislation serves as the legal bedrock for voluntary tissue donation and informed consent protocols. Donors or their families provide explicit authorization for which specific tissues may be recovered and the exact clinical fields, such as reconstructive or aesthetic purposes, in which they may be used.Case explained, "Securing high-caliber tissue and maintaining rigorous safety standards is not merely a regulatory compliance, but a pledge to honor the donor's intent," and added, "When public trust is protected, the continuity of sustainable therapeutics for patients is guaranteed."Case further explained the structurally integrated relationship between donor consent and FDA regulations. While the donor's authorization serves as the trigger for tissue recovery, FDA regulations provide the mechanism to validate whether the recovered tissue meets the standards required for patient administration."Donation is merely the starting point. It does not automatically guarantee the production of an allograft," Case said. "If a donor fails to pass the initial safety screening protocols, the process stops at that stage, and no tissue is recovered."Only validated tissues reach patients following infectious disease screening and aseptic recoveryFollowing recovery, the timeline proceeds through infectious disease screening, aseptic recovery, and validated processing and sterilization.According to Case, US tissue banks review donors' medical and behavioral histories and use Nucleic Acid Amplification Testing (NAT) to minimize the risk of acute asymptomatic infections. The screening panel comprehensively covers HIV, Hepatitis B, Hepatitis C, Syphilis, HTLV, and West Nile Virus, among others.Case highlighted that the regulatory directions of the US FDA and the Korean MFDS converge on the singular goal of patient protection."While the FDA and the MFDS may vary in procedural and administrative actions, their ultimate destination is identical, which is absolute patient protection," Case said. "The core safety values demanded in donor screening and infectious disease testing remain fundamentally aligned."Regarding safety validation, operational environmental control was proposed as a key factor. Case stressed that "Microorganisms do not read documentation. They react to the environment. Tissue safety validation must function as a multi-layered defense system that actively mitigates contamination risks across every single phase of the tissue lifecycle."Contamination risks are strictly controlled from the recovery phase onward, after which processing eligibility is determined through formal evaluations by physicians and the tissue bank's medical director. The processing phase operates under a strict protocol in which only one donor's tissue is processed in a designated zone at any given time, supported by cleanroom environments, HEPA filtration, validated sterilization protocols, and cold-chain management.Finished products are never distributed immediately. A dedicated quality professional must independently review the medical director's release determination, donor testing records, processing logs, and sterilization data before the tissue can finally advance to the patient administration phase.Completing safety validation via unique ID-based traceability systemsCase detailed traceability as another core benchmark that substantiates hADM safety.Every donor is assigned a unique identification number, which remains seamlessly linked from tissue recovery through processing, storage, international logistics, and final clinical administration at the point of care. This system ensures that if an adverse event or issue arises, the system can trace the lineage back to the initial donation phase or pinpoint exactly which patient received a specific tissue unit.Case mentioned, "The true sophistication of modern allografts does not lie merely within the clinical application itself, but within the invisible safety nets that ensure patient safety." "Tissue banking is ultimately about honoring the gift of donation and protecting the patients who receive it," Case added. "This responsibility is sustained through error-proof operating systems and precise accountability frameworks."Concluding the session, the chairperson tied the lecture's implications directly to the broader discussion on ECM safety. The chair evaluated, "This lecture provided a clear, scientific evidence-based understanding of the ethical considerations and safety concerns previously raised by some regarding ECMs, based on validated international management and regulatory standards."
- Product
- Mounjaro 12.5 mg and 15 mg land in Korea
- by Kim JiEun Jun 02, 2026 08:55am
- The final high-dose formulations of the obesity treatment Mounjaro (tirzepatide) are set to enter the Korean market. With the completion of the phased expansion of dosage options that has been underway since the launch of the low-dose product last year, expectations are rising among obesity and diabetes treatment prescribers for gaining broader prescribing options.Lilly Korea announced that it plans to launch Mounjaro single-use prefilled pens in 12.5 mg and 15 mg strengths on June 10.Mounjaro was first launched in 2.5 mg and 5 mg formulations in August of last year, followed by 7.5 mg in October and 10 mg in November. The introduction of the new high-dose products completes the supply lineup for all domestically approved dosage strengths.The timing of the high-dose launch has been the subject of significant speculation among healthcare professionals and pharmaceutical distributors. Medical institutions specializing in obesity treatment have reportedly received numerous patient inquiries regarding the availability of high-dose prescriptions, and distributors have also been closely monitoring launch schedules since last month.As Mounjaro has emerged as one of the leading competitors to Wegovy in the rapidly expanding obesity treatment market, the availability of higher-dose products has been regarded as a major issue of market interest.Lilly stated, “Clinical results showed progressively greater weight-loss effects at higher doses. In the SURMOUNT-1 study involving adults with obesity, weight reduction at week 72 reached 16% in the 5 mg group, 21.4% in the 10 mg group, and 22.5% in the 15 mg group.”Industry observers believe that even if the product is launched on the 10th, it will take some time for the higher-dose products to actually reach the market.One pharmaceutical distribution executive explained, “While orders are expected to be accepted starting on the 10th, considering the allocation of inventory quantity confirmations, wholesale inventory is likely to arrive around 20 days later.”As a result, widespread prescribing of the high-dose formulations is expected to begin sometime after mid-June.Some observers have expressed concerns that the introduction of higher-dose products could lead to dose-splitting practices similar to those reported with Wegovy. However, Lilly emphasized that Mounjaro’s product design makes such misuse considerably more difficult.A Lilly representative explained, “Multi-dose pens allow patients to adjust doses themselves, which may have enabled some degree of dose splitting. In contrast, Mounjaro uses a single-use prefilled pen that is discarded after one injection, making it difficult for patients to arbitrarily alter the dose.”
- Product
- Regulatory sandbox for OTC drug vending machines revisited
- by Kim JiEun May 18, 2026 09:11am
- Discussions surrounding a regulatory sandbox pilot exemption for “smart vending machines for over-the-counter essential medicines,” which has remained unresolved for years, have recently resumed. With the expert committee under the Ministry of Trade, Industry and Energy’s Regulatory Exemption Deliberation Committee convening again after about 2-3 years, debate over permitting unmanned sales of OTC essential medicines appears to be reigniting.In particular, it is reported that a heated debate ensued during this meeting, with the industry strongly advocating for the pilot exemption by emphasizing the need for installation in medically underserved areas and technological advancements, while the Korean Pharmaceutical Association and the Ministry of Health and Welfare clearly stated their opposition, as they have in the past.According to multiple sources on the 15th, the Ministry of Trade, Industry, and Energy held the “5th Expert Committee Meeting of the Regulatory Rationalization Committee” at the end of last month to discuss a proposal for a pilot exemption regarding smart vending machines for over-the-counter medicines.This marked the first reopening of discussions on the issue in approximately two to three years after deliberations had effectively been suspended. It was reported that attendees included representatives from the Korean Pharmaceutical Association, the Ministry of Health and Welfare, the Ministry of Trade, Industry and Energy, the applicant company Urban Sharing Economy, as well as legal and academic experts.The core of this proposal is to allow the sale of over-the-counter medicines through unmanned smart vending machines. Previously, the company had applied for a regulatory sandbox, proposing a smart vending machine model that integrates biometric authentication and remote control systems based on 13 over-the-counter medication items currently sold at convenience stores.At the time, the Korean Pharmaceutical Association strongly opposed the proposal, expressing concern that the unmanned sale of medications could expand gradually following the approval of video-based dispensing machines. As discussions failed to reach a conclusion for an extended period, the matter remained effectively on hold.However, during this latest meeting, the Ministry of Trade, Industry, and Energy reportedly emphasized that “a conclusion needs to be reached on the issue that remained unresolved for 5 years,” strongly advocating for the necessity of a pilot exemption.It is reported that the company presented an additional plan to focus installations on medically underserved areas, such as remote islands and mountainous regions, where access to pharmacies and convenience stores is limited, in addition to its existing proposal.It is also reported that they emphasized the stability of the technology, noting that biometric authentication and control systems had been further refined during the period when discussions were suspended.On the other hand, the Korean Pharmaceutical Association and the Ministry of Health and Welfare reaffirmed their opposition. They reiterated the existing logic that pharmaceutical sales should be premised on face-to-face medication guidance and safety management systems, and that expanded unmanned sales could lead to misuse and safety concerns.During the meeting, a heated debate reportedly continued over whether to proceed with the pilot exemption.An official who attended the meeting stated, “Toward the end of the meeting, the atmosphere even reached the point where we were about to decide on proceeding with the exemption via a show of hands, but the debate between supporters and opponents continued for a long time. Ultimately, the Ministry of Trade, Industry and Energy decided to refer the matter to the next expert committee.”At the meeting, ministry officials reportedly stated that a sixth expert committee meeting would be convened within 1-3 months to make a final decision on whether to proceed with the pilot exemption.Within and outside the industry, some observers believe a partially positive sentiment toward the project is forming inside the Ministry of Trade, Industry, and Energy. In fact, several participants at the meeting reportedly expressed opinions sympathetic to the need for pursuing the pilot project.However, given the continued strong opposition from the Ministry of Health and Welfare and pharmacy organizations, as well as the possibility that allowing unmanned pharmaceutical sales could expand into a broader social controversy, significant conflict is expected before a final conclusion is reached.
- Product
- Obesity drugs 'all-season market'…preference for high dose
- by Kim JiEun Apr 07, 2026 07:22am
- Injectable obesity treatments such as Wegovy and Mounjaro are shifting the market landscape. Moving away from the previous pattern in which demand spiked during specific seasons, a stable year-round demand is emerging, while short-term supply instability is emerging, particularly for high-dose products.According to local pharmacies and the wholesale industry, the obesity treatment market previously was defined as a 'seasonal market,' with prescriptions concentrated during the New Year for weight-loss resolutions or in the period leading up to summer. However, since the launch of Wegovy and Mounjaro, this pattern has been changing rapidly.An official from the wholesale industry explained, "In the past, demand was concentrated in specific seasons, but recently, a steady sales trend has continued regardless of the season," and that "A key characteristic of these items is that sales volatility has not been significant since their launch."Increasing demand for high-dose products is being observed even on pharmacy-exclusive online malls. Preference for the 5mg dose of Mounjaro and the 2.4mg dose of Wegovy is prominent, and at times, supply instability, such as temporary stockouts, has occurred.An official from a pharmacy-exclusive online mall stated, "While the overall sales trend for Wegovy remains stable, demand for high-dose products is particularly high," adding, "There have been instances where temporary supply-demand imbalances appeared."However, critics point out that the distribution structure remains heavily skewed toward hospitals and clinics. Aside from some large-scale pharmacies, many neighborhood pharmacies are giving up on carrying the products altogether.Furthermore, analysis suggests that the trend of patients flocking to clinics is intensifying as rumors regarding 'reimbursement status' for Mounjaro have recently spread.According to industry sources, these rumors appear to have originated from Mounjaro's diabetes indication obtaining 'reimbursement adequacy'. As news spread that it passed the initial hurdle for listing on the reimbursement schedule by passing the Pharmaceutical Reimbursement Evaluation Committee, cases of people misinterpreting this as actual reimbursement have increased.However, the drug is currently at a stage where follow-up procedures, such as price negotiations and deliberations by the Health Insurance Policy Deliberation Committee, remain. Thus, it has not been reimbursed.A pharmacist in Gangnam, Seoul, said, "For pharmacies that haven't previously carried the drug, securing the product itself is not easy," and that "Since nearby clinics are actively prescribing and selling, there isn't much incentive for pharmacies to handle it."The pharmacist added, "As rumors of Mounjaro's reimbursement circulate, demand for direct purchase at hospitals seems to have increased," and that "This trend is concentrating patients at clinics."
- Product
- Wegopro, Mounjung? Warning over supplements resembling medicines
- by Kim JiEun Mar 03, 2026 09:21am
- The Korean Pharmaceutical Association (President Young-hee Kwon) has urged consumers to exercise caution regarding health functional foods and general food products that may be confused with prescription medicines.The KPA emphasized, “As the distribution of general foods that are classified as other processed goods with names and appearances similar to pharmaceuticals increases in the market, there is a growing risk of treatment delays, misuse, and other health harms. This is not merely a matter of product choice but an issue directly linked to public health and safety, requiring special caution.”The association noted that cases have recently been identified in which health functional foods and general foods are being sold with names and appearances similar to prescription drugs.In particular, products using names reminiscent of diabetes or obesity treatments are being distributed, raising concerns that consumers may mistake them for medicines.Some products reportedly mimic pharmaceutical packaging colors and design layouts, further increasing the risk of confusion.The KPA mentioned that it had previously raised the issue during a National Assembly Health and Welfare Committee audit last year.Rep. Bo-yoon Choi pointed out that distinctions among pharmaceuticals, quasi-drugs, and health functional foods are not clearly conveyed to consumers. She cited examples such as Ursa–Ursaji, Jeil Cool Pap–Jeil Pap Cool, and Madecassol–Madecassol Care, where similar names and packaging may blur distinctions.At the time, Rep. Choi stated, “Even if the legal distinction is clear, if identical display and similar packaging persist, consumers inevitably perceive them as the same drug,” pointing out the resulting risks of delayed treatment and side effects.Eun-gyo Kim, Director of Health Functional Foods at the Korean Pharmaceutical Association, said, “Pharmaceuticals are therapeutic products whose safety and efficacy are verified through clinical trials and regulatory approval by the Ministry of Food and Drug Safety, whereas health functional foods and general foods are supplementary products that cannot replace medicines. Selling products with similar names or that exploit the recognition and social interest in treatments for specific diseases poses a high risk of misleading consumers.Meanwhile, the KPA urged consumers to always verify the distinction between pharmaceuticals, health functional foods, and general foods, along with their labeling information, when purchasing products. It also stated that it will continue monitoring similar cases and actively pursue policy improvements to protect public health.Furthermore, it stressed the need for: ▲ Establishing prior review and restriction criteria for products using names closely resembling medicines ▲ Creating new regulatory standards for packaging and designs that evoke pharmaceuticals ▲ Strengthening mandatory distinction labels and warning statements to prevent confusion ▲ Enhancing inspection and management of advertising and online promotional practices that imply disease treatment effects.
- Product
- Pharmacies express discontent over Xigduo distribution
- by Kang, Hye-Kyung Feb 05, 2026 07:48am
- ChatGPT-generated image.As the distribution of a widely prescribed pharmaceutical product has shifted from a manufacturer-led model to a wholesaler-led model, supply blind spots have emerged, leaving pharmacies that do not have a direct contract with the wholesaler unable to secure the drug.Pharmacies claim they are effectively forced to enter direct trading agreements with the specific distributors to receive products, facing unprecedented inconvenience.The product in question is AstraZeneca's diabetes drug, Xigduo XR (metformin hydrochloride, dapagliflozin propanediol monohydrate).Until last year, HK Inno.N was in charge of its sales and supply. However, as of January 1 this year, sales and supply were transferred to AstraZeneca Korea. In the process, a large domestic wholesaler (Wholesaler A) secured exclusive pharmacy distribution rights for the product.The problem is that since Company A secured the pharmacy distribution rights, supply to other wholesalers became impossible. In other words, pharmacies can only receive the drug if they have a direct trading relationship with Wholesaler A.One pharmacist said, “None of our four primary wholesalers can source the product from Wholesaler A, and it shows as out of stock across online wholesale platforms. For pharmacies like ours that do not have a direct trading relationship with Wholesaler A, securing inventory is impossible. It is unfair for a single wholesaler to effectively monopolize the sale and supply of a prescription drug.The pharmacist added that the product should at least be made available to other wholesalers through secondary wholesale channels.Another pharmacist noted, “When we checked why Xigduo XR was unavailable, we found that it could only be purchased through Wholesaler A. According to the sales representative, distribution to other wholesalers will only take place after distribution rights and inventory are fully reorganized.”In response, Wholesaler A stated that the policy is unavoidable given current supply conditions, citing limited inventory as a key constraint.A representative from Company A stated, “Due to limited market inventory, we are prioritizing supply to our contracted pharmacies. Secondary wholesale distribution is physically not feasible at this time.”The official added, “We currently have trading relationships with approximately 80% of pharmacies nationwide. Pharmacies with direct trade agreements can secure inventory as long as they meet the minimum order requirement.”However, this leaves around 20% of pharmacies facing significant hurdles, as initiating a new trading relationship requires meeting an initial minimum order threshold.Critics point out that pharmacies with low order volumes or long-standing relationships with other primary wholesalers are unlikely to open a new account solely to secure Xigduo XR—particularly when doing so may require purchasing several million wons worth of products upfront to meet initial order requirements.
- Product
- MOHW to unveil list of 4K items subject to price cuts in JAN
- by Kim JiEun Dec 19, 2025 09:09am
- The South Korean government plans to pre-release a list of approximately 4,000 pharmaceutical products subject to price reductions effective January 1, 2026. The price reduction is due to the adjustment of the ceiling price of the actual transaction price.On December 17, an official from the Ministry of Health and Welfare (MOHW) confirmed to DailyPharm that the list of related items and their respective reduction rates will be provided to relevant associations within this week.Earlier this month, the MOHW issued an official notice, announcing 'a temporary allowance for paperwork-only returns when reporting of supply records following the price cuts', to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KBPMA), the Korea Pharmaceutical Distribution Association, and the Korean Pharmaceutical Association.The notice also informed that the ceiling prices of insurance price tags of approximately 4,000 pharmaceutical products are subject to price reductions effective January 1, 2026.However, concerns have been raised across the industry after the announcement. With less than 15 days remaining until the massive price cut of 4,000 pharmaceutical products takes effect, pharmacies and distributors lacked the specific data, such as exact items, quantities, and reduction percentages, needed to prepare.In response, the MOHW decided to provide the pre-list, including items subject to price cuts due to the actual transaction price ceiling price increase and the reduction rate, to minimize field confusion. Although the price reduction is scheduled to be officially announced on December 24, the MOHW plans to provide the list five days ahead, on December 20.An MOHW official said, "We are aware of the related issue in the distribution industry and pharmacies," and added, "For actual transaction price reduction, the MOHW plans to take administrative response in a way that minimize the field confusion."The official further added, "The affected documents are according to the official notice, but the MOHW will pre-lease the list of affected products to institutions," and added, "It will be announced by this Friday."In 2023, when over 7,600 items were subject to price reductions, the MOHW similarly pre-released the list after the field confusion.At that time, affected organizations, including the Korea KBPMA, the Korea Pharmaceutical Distribution Association, the Korean Pharmaceutical Association, and HIRA, received the pre-lease list files. Pharmacies could verify affected stocks through billing software integration and prepare for the financial impact well in advance.Meanwhile, affected organizations have argued that this pre-release of data to affected parties should be formalized, given the recurring large-scale price reductions.Regarding this issue, the MOHW announced that it is preparing to reform the current actual transaction price-based price reduction system. The ministry acknowledged that the current system imposes an excessive administrative burden on the field relative to its actual impact on health insurance financial savings, primarily because of the vast number of affected items.An MOHW official explained, "In the case of an actual transaction price survey, the number of products subject to investigation is immense, yet the predictability regarding which specific drugs will actually face a price cut is low, which appears to be confusing the field," and added, "For the actual transaction price investigation, we are looking to redesign the entire system of drug pricing and post-management instead of the current method of simple price reductions. We expect this will enhance predictability for the field."
- Product
- Resolving patient data transparency
- by Jung, Heung-Jun Dec 03, 2025 08:42am
- Starting March next year, when the Integrated Care Support Act comes into effect, pharmacists participating in the polypharmacy management program will be able to access real-time medication histories for eligible patients.This addresses a previously noted limitation by enabling access to real-time patient information. Until now, information has been based on claims data, resulting in a time lag compared to actual prescription and dispensing information.Access to DUR-based real-time data is expected to mark a major turning point for multidisciplinary team-based care involving pharmacists.On the 26th, the Seoul Pharmaceutical Association co-hosted a National Assembly policy discussion forum with the offices of Democratic Party lawmakers Yoon Kim and In-soon Nam, focusing on medication management services in a super-aged society.During the general discussion session, the need to expand access to real-time patient information and increase pharmacist participation in multidisciplinary teams was raised to strengthen pharmacists’ medication management services.Jin-mi Jang, Director of the Seoul Pharmaceutical Association, said, “A government-led public data-based medication management system needs to be established. The issue can be resolved by enabling easy access to the excellent data held by the National Health Insurance Service and the Health Insurance Review and Assessment Service. Patient information must be viewable before visits.”Jang added, ” Sharing medication counseling results with medical institutions is also crucial. In the community-based model, prescription intervention through communication with medical institutions is impossible. System improvements are clearly needed."Jang also suggested expanding eligibility to basic livelihood security recipients and high-risk patients who receive prescriptions from multiple hospitals.Park Sang-won, CEO of Neulpum Value, who participated in Gwanak-gu’s integrated care pilot project, highlighted the need for robust data integration and the pharmacist’s role within multidisciplinary teams. Park said, “The patient's medication list is not being brought to the integrated support meetings. This makes it difficult for pharmacists to play their role within the meetings. Medication management must be part of the case review from the beginning.”Park also noted that integrated care frequently involves socially vulnerable individuals who are severely immobile or have limited health literacy, meaning pharmacists must be thoroughly prepared.Park added, “Data often differs from reality. Therefore, pharmacists' roles are essential on-site. Furthermore, managing performance indicators will be crucial starting next year, so we must determine how to demonstrate that pharmacist counseling contributed to patient health outcomes.”The National Health Insurance Service (NHIS), the operational agency for the polypharmacy management program, also recognized the need for patient information verification.Hyang-jung Park, Director of Health Support Programs at NHIS, stated, “We will link DUR-based medication history data to public MyData, enabling consulting pharmacists to access real-time information starting in March next year.”Park emphasized, "We need many pharmacists with advanced expertise. There is a specialized pharmacist for integrated medication management (in the national specialist pharmacist subjects). If it becomes reimbursable, qualifications may be required for fee-for-service pricing. We will communicate with relevant departments at the Ministry of Health and Welfare and strive to make the polypharmacy management project a pilot reimbursement program,“ and asked for pharmacists’ active participation.Hyun-jin Kang, Deputy Director at the Ministry of Health and Welfare’s Pharmaceutical Policy Division, commented: “We agree on the importance of comprehensive medication management. However, we must continue discussing how to standardize and institutionalize it,” adding that the ministry will review the forum’s proposals with relevant departments.
