- LOGIN
- MemberShip
- 2026-06-06 09:06:00
- Policy
- "Fastest review in the world…K-bio global competitiveness"
- by Lee, Tak-Sun Jun 05, 2026 09:36am
- Minister Yu-Kyoung Oh of the Ministry of Food and Drug Safety (MFDS) highlighted milestones of her ongoing regulatory reform initiative, stating a robust commitment to driving the global expansion of the South Korean pharmaceutical-biotech sector. In an exclusive interview marking the anniversary of Daily Pharm, Minister Oh said 'regulation is not operational hurdles' but 'protective boundaries and a support system,' highlighting goals of establishing a virtuous cycle of patient safety and industrial growth.Addressing a long-standing industry bottleneck, the MFDS finalized its 'Medical Product Marketing Authorization and Review Innovation Plan,' which dramatically compresses the review timeline for novel drugs to a world-class standard of 240 days. The plan was officially enacted on June 1, Daily Pharm's founding anniversary. The initiative deploys 195 highly qualified new personnel across core technical divisions to significantly elevate review expertise.In accordance with the innovation plan, the MFDS began accepting applications for 'pre-submission face-to-face consultations' on June 1. Selected applications will be managed under the dedicated review teams. To maximize administrative efficiency, the MFDS is shifting away from legacy sequential review workflows, previously necessitated by workforce constraints, toward a concurrent, parallel review matrix where multiple specialists evaluate technical dossiers simultaneously across distinct disciplines.Furthermore, the MFDS is accelerating its digital transformation by integrating artificial intelligence (AI) into the complex, voluminous drug approval process. Following the establishment of the 'Food and Drug AI Transformation Task Force' in February, the MFDS launched a three-year, multi-phase initiative dedicated to constructing an advanced AI-driven regulatory review framework.The initial phase will be launched this October, utilizing AI tools to evaluate CMC (Chemistry, Manufacturing, and Controls) and quality data for both active pharmaceutical ingredients (APIs) and finished drug products, with plans to progressively expand AI utilization across the entire novel drug evaluation spectrum by 2028.Minister Oh emphasized that the international credibility of a domestic regulatory body directly correlates with a nation's industrial competitiveness. The MFDS recently achieved full functional listing on the WHO List of Authorities (WLA) register for both medicines and vaccines. Excluding traditional benchmark jurisdictions such as the US, EU, Canada, and Switzerland, South Korea's MFDS is the sole regulatory authority globally to provide comprehensive validation across all functional parameters for both therapeutic sectors.Based on this enhanced global reputation, the MFDS was recognized as a reference regulatory authority by the UAE in January and Lebanon in April, expanding South Korea's footprint to seven reference nations, which also include the Philippines, Paraguay, Egypt, Ecuador, and Nigeria.The following is a summary of the interview with Minister Oh.Q. The pharma-biotech industry holds high expectations for the MFDS's regulatory overhauls. What are the ongoing initiatives and public-private collaborative strategies for this year?The MFDS has consistently driven regulatory overhauls to fortify public trust while empowering commercial developers. It is encouraging to see positive feedback from the field. This year, we remain dedicated to actively capturing industry feedback and executing agile reforms that yield immediate, palpable results.Primarily, we have instituted a 240-day review cap for novel therapeutics, compressing what was historically a lengthy and frustrating process to match the fastest international standards, effective June 1.By expediting the review cycle for innovative drugs, biosimilars, and cutting-edge medical devices, we aim to expand patient access to treatment while significantly enhancing the global market standing of our domestic life sciences sector.Furthermore, the CDMO Act, designed to underpin the biomanufacturing ecosystem, will be implemented this December. The framework introduces a new export manufacturing registration registry to stimulate cross-border commerce, complemented by structured regulatory consultations on GMP compliance for contract manufacturing facilities to accelerate K-Bio's international expansion.The 'Innovative Product Pre-consultation Hotline' has also been operational since March, offering a streamlined, one-stop advisory portal that provides customized feedback and preliminary evaluations from early discovery through the formal filing stage.Additionally, we have improved orphan drug designation criteria to facilitate rapid market entry for rare disease therapeutics and expanded expedited import mechanisms for self-administered medications to ensure timely patient access to critical therapies.These systemic overhauls are fundamentally rooted in gathering public opinions. We continue to operate our policy-linking open forums to translate corporate and public feedback directly into regulatory directives, with a parallel focus on emerging entrepreneurs and small business operators.Since May, we have initiated a series of regional forums across six major domestic clusters to capture localized industrial needs. This feedback will be synthesized into a formalized regulatory roadmap slated for public disclosure this July.We plan to intensify our stakeholder-centric administrative model by ensuring absolute transparency in our policy implementation metrics and running continuous post-hoc audits to confirm that these reforms are operating successfully on the ground.Q. Following recent breakthroughs such as the WHO Listed Authorities (WLA) listing, the international stature of the MFDS has risen. What are your strategic plans for international engagement to further promote export growth?In the global market, commercial products are evaluated alongside the capabilities and scientific rigor of the regulatory bodies that oversee them. Because regulatory trust maps directly to asset valuation and national competitiveness, the MFDS has successfully become a premier global regulator.Achieving a comprehensive listing across all functional blocks on the WHO WLA register for both medicines and vaccines establishes South Korea as the only nation outside the traditional quad of the US, EU, Canada, and Switzerland to secure such a validation. This milestone serves as an objective, international endorsement of the expertise of our regulatory framework. Based on this global achievement, we secured reference authority status in the UAE and Lebanon this year, bringing our total to seven reference nations.This institutional credibility translates into reduced transactional friction, lower operational costs, and smoother market entry for domestic developers expanding overseas, demonstrating that regulatory diplomacy serves as a practical trade facilitator.Furthermore, South Korea's selection as host of the International Coalition of Medicines Regulatory Authorities (ICMRA) Summit this November reflects our growing leadership. We intend to spearhead international regulatory harmonization in emerging areas such as AI and advanced therapeutics, reinforcing our regulatory leadership to champion the global commercialization of K-Pharma actively.Q. To sustain the 240-day novel drug review mandate, 195 new personnel have been deployed. Are the core operational pillars, including the pre-submission face-to-face consultations launching this June, executing on schedule?The revised framework went live on June 1, structured around three core operational shifts designed to grant patients rapid access to innovative therapies while preserving safety margins.There are three main items to this innovation plan. First, we will introduce a preemptive regulatory support service starting from the 'submission dossier preparation phase' to support systematic data compilation by the industry. In the 'application submission phase', a new 'pre-submission face-to-face consultation' will be introduced to preemptively identify and resolve hurdles to marketing authorization, and a dedicated review team will be established to build a tailored, close communication system throughout the entire marketing authorization and review process. In the review phase, we plan to dramatically increase review speed by transitioning from sequential reviews, which were previously unavoidable due to limited review personnel, to concurrent and parallel reviews, where multiple reviewers evaluate dossiers simultaneously within their respective specialized disciplines.Starting June 1, the industry can apply for the 'pre-submission face-to-face consultation', and the submitted items can receive marketing authorization within 240 days through relevant procedures after the consultation.The MFDS will continue to promote innovation in medical product marketing authorization and review without a hitch, ensuring greater safety while accelerating review speed to the fastest in the world, thereby spearheading the global competitiveness of the K-Bio industry and expanding treatment opportunities for the public.Q. What is the current status of integrating AI technology to shorten the marketing authorization review timeline, and what are the countermeasures regarding data security concerns?The MFDS established an Information Strategy Plan (ISP) last year to preemptively utilize AI in massive and complex pharmaceutical marketing authorization and review workflows, and created the 'Food and Drug AI Transformation Task Force' this February to centralize its capabilities.A project to construct an AI-driven review system will be executed for three years starting this year, launching services this October with CMC and quality (drug substance, drug product) evaluation data for novel drugs, and progressively expanding the scope to cover comprehensive novel drug reviews by 2028.We anticipate that reviewers will be supported during the marketing authorization and review process by AI functionalities, such as large-scale document translation, summarization, historical precedent searches, and draft generation of review reports, enabling a more meticulous yet expedited review process.Furthermore, the AI review system will install AI servers and models within the secure internal government network to prevent the leakage of proprietary submission data and ensure impeccable security management.The MFDS will lay the foundation for securing international-standard review quality by optimizing marketing authorization and review workflows using AI, such as automating simple, repetitive tasks in real time.Q. Achieving two objectives of 'ensuring safety' and 'industry revitalization' concurrently does not seem easy. As the longest-serving Minister, we would like to hear about your expertise and the challenges you face.It is common for people to view regulation as a financial cost or an operational hurdle. Indeed, there were such aspects in the past, and the logic that emphasizing safety directly translates into a barrier to industrial development used to prevail. However, with technological innovations like AI increasingly part of daily life, the regulatory paradigm is shifting.Sustainable industry growth is only possible when it is backed by safety. We frequently observe historical cases in which a failure to secure safety downstream has led to catastrophic risks, such as large-scale product recalls or severe erosion of brand equity. Safety is like a perimeter fence. When the fence is strong, the industry can grow healthily within it. We are striving to ensure that MFDS regulatory validation guarantees product credibility and translates into product competitiveness, serving as a springboard to clear global regulatory barriers.Another point I would like to emphasize is that when novel technologies like AI emerge, the industry can easily fall into disarray if there are no laws or frameworks in place. Preemptive codification of rational baselines by the regulator is necessary to enable market players to operate with confidence.The MFDS is supporting the formation and challenges of new industries by proactively providing benchmarks, such as enacting the world's first Digital Medical Products Act and publishing review guidelines for generative AI-driven medical devices.Furthermore, if domestic standards converge with global standards, they can serve as a powerful promotional mechanism to drive international market expansion. To this end, the MFDS is broadening the horizon of regulatory diplomacy by leading the Asia-Pacific Food Regulatory Authority Summit (APFRAS), hosting the 'International Coalition of Medicines Regulatory Authorities (ICMRA) Summit (November), and driving the launch of the Global Cosmetics Regulatory Authority Summit (GCORAS) this September.The MFDS will ensure that creative innovation can occur freely within the protective boundary of safety. We will cultivate a rational regulatory ecosystem where regulation opens pathways for innovation to advance safely.Q. Lastly, Daily Pharm was founded on June 1, 1999, and marks its 27th anniversary this year. The objectives pursued by a specialized media outlet like Daily Pharm, public health enhancement and industrial development, seem to parallel your own considerations. Could you offer your advice on the future direction and role of specialized pharmaceutical journalism?First, I extend my sincere congratulations to Daily Pharm on its 27th anniversary. Over the past 27 years, Daily Pharm has dedicated itself to enhancing public health and advancing the pharmaceutical industry. It has served as a benchmark for specialized media, delivering information from a balanced perspective so the public can easily understand the rapidly changing pharma-biotech industry and the institutional frameworks driven by advanced technology.The opinions and sharp analysis from the pharmaceutical industry are a major asset to the MFDS's policy formulation, and you continue to perform your role as a constructive critic. In particular, functioning as a policy microscope that does not overlook even the minor issues that might go unnoticed, you are helping the MFDS draw closer to the public.We hope Daily Pharm will continue elevating the public's right to know by professionally identifying the latest trends in the pharmaceutical industry, at a level the public can understand. The MFDS will also collaborate with Daily Pharm through communication to collectively build a world where food and drug safety becomes an everyday reality.
- Policy
- Accelerated review may attract first-ever global new drug filings in Korea
- by Lee, Tak-Sun Jun 05, 2026 09:36am
- Could a paradigm shift be underway in which global pharmaceutical companies submit new drug applications to Korea's Ministry of Food and Drug Safety (MFDS) before filing in the United States or Europe? Expectations are rising as the MFDS launches a major regulatory service reform aimed at shortening review timelines for new drugs and biosimilars to 240 days, potentially positioning Korea as a preferred first-filing market.The MFDS, led by Commissioner Yu-Kyoung Oh, announced that it has implemented a comprehensive ‘Medical Product Approval and Review Innovation Plan,’ effective June 1, to accelerate patient access to innovative therapies while supporting the global expansion of Korea's biotechnology industry.A key component of the initiative is a comprehensive regulatory support framework covering the entire development process—from early-stage product preparation through final approval. To support this effort, the MFDS recruited approximately 200 additional reviewers and established dedicated review teams by specialty area. The agency also introduced a ‘simultaneous and parallel review system’ designed to significantly improve efficiency.Previously, due to limited personnel, the initial request for additional information typically occurred 87 days after submission (60 working days). Under the new system, the first feedback is expected to be provided within 25 days of submission, enabling companies to identify and address deficiencies much earlier in the review process.MFDS officials expect the new review framework to work in tandem with the recent elimination of the CCP requirement, which had long been viewed as a barrier for imported medicines entering the Korean market.During a press briefing held on June 2, Young-Joo Kim, Head of the Regulatory Science Policy Promotion Division, said, “With the CCP requirement removed, shortening review timelines for new drugs could become a true paradigm shift. We may soon see global pharmaceutical companies submitting applications simultaneously in the U.S., Europe, and Korea—or even choosing Korea as the first country in the world for regulatory filing. Given that possibility, our review organization feels a significant sense of responsibility and pressure.”On the 2nd, the Ministry of Food and Drug Safety held a briefing with journalists regarding innovation plans for medical product approval and review. (From the left) Young-joo Kim (Head, Regulatory Science Policy Promotion Team), Seung-ryeol Ryu (Director, Advanced Medical Device Division), Kyung-seung Shin (Director, Medical Device Approval Division), Hyun-jung Park (Director, Biopharmaceutical Approval Division), Nam-soo Kim (Director-General, Pharmaceutical Approval Management Division), So-hee Kim (Director, Cardiovascular and Neurology Products Division), Ho-Jung Kim (Director, Recombinant Protein Products Division), Yong-seok Koh (Director, Advanced Drug Quality Division II)Efforts to improve communication and reduce trial-and-error throughout the review process will also be significantly strengthened. A pre-submission checklist outlining key requirements prior to filing will be provided, while the existing consultation process, which was previously limited to a single meeting, will be formalized into Pre-NDA Meetings, guaranteeing at least two opportunities for discussion before submission.At the briefing, Nam-Soo Kim, Director-General of the Pharmaceutical Approval Management Division, explained, “The checklist will be particularly valuable for venture companies and small-to-medium-sized pharmaceutical firms that often have limited regulatory resources. Even before the official implementation date, companies with products that are sufficiently prepared and request a Pre-NDA Meeting will receive support with the goal of completing the review within 240 daysHowever, challenges do remain. The expertise of the massively increased personnel needs to be elevated in a short period. Regarding this, Kyung-seung Shin, Director of the Medical Device Division, stated, "It is a fact that it is difficult to immediately deploy new personnel to review new drugs. As we have selected highly experienced reviewers with extensive backgrounds in pharmaceutical companies, we will quickly deploy them to the field through thorough training and internal mentoring to fill the gap."The pharmaceutical industry and patient groups also seem to actively welcome this improvement in the system. Yeon-hong Noh, Chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, said, "This plan is an innovation that fundamentally changes the structure of the approval and review system beyond a simple race for speed. The industry will also cooperate so that the system can settle in the field by increasing the completeness of application materials." Ki-jong Ahn, representative of the Korea Alliance of Patient Organizations, also said, "I hope that an environment will be created where patients in urgent need of treatment can return to their daily lives as soon as possible."The MFDS began accepting applications for Pre-NDA Meetings for new drugs, biosimilars, and novel medical devices on June 1. The full 240-day review timeline will officially apply to applications submitted on or after October 1.
- Policy
- Novo Nordisk discontinues Victoza Pen supply in Korea
- by Lee, Tak-Sun Jun 02, 2026 08:55am
- Novo Nordisk Korea will discontinue the supply of its type 2 diabetes treatment, Victoza Pen 6 mg/mL (liraglutide), in the Korean market. The move follows the reimbursement listing of its successor product, Ozempic (semaglutide), in February and appears to be part of a broader portfolio optimization strategy aimed at replacing older-generation therapies with next-generation products.According to industry sources, Novo Nordisk Korea recently decided to discontinue Victoza Pen under its product portfolio integration and enhancement strategy and officially reported the decision to the Ministry of Food and Drug Safety on June 1.Victoza Pen, which was approved in Korea in 2010, is a first-generation GLP-1 receptor agonist for diabetes. Unlike Victoza, which required daily administration, Ozempic, which recently secured reimbursement coverage, demonstrated superior glycemic control and weight-loss benefits despite requiring only once weekly administration. Under pressure to make way for newer and more effective products, Novo Nordisk appears to be accelerating its portfolio transition in earnest with Ozempic’s inclusion in the national health insurance reimbursement.The company emphasized that extensive measures have been established to ensure that patient care is not disrupted by the discontinuation. A company official stated, “Supply will be discontinued as part of our portfolio integration efforts to provide stable treatment options to a greater number of patients. We will provide transition guidelines until supplies are completely cut off to ensure continuity of care for existing patients."The representative added, “We will carefully manage existing inventory until stocks are exhausted and maintain close communication with healthcare professionals to prevent any impact on patient treatment. Based on current inventory depletion forecasts, the likelihood of a sudden supply shortage or widespread stockout situation is low.”Novo Nordisk plans to recommend Ozempic Prefilled Pen as an alternative treatment option for patients currently receiving Victoza. The company noted, “Treatment transitions will be carried out appropriately based on healthcare professionals’ clinical judgment and each patient’s individual health status.”The medical community largely views the discontinuation as an expected development. One endocrinology professor at a university hospital commented, “The market is currently transitioning from once-daily liraglutide (Victoza) to once-weekly semaglutide (Ozempic), as it offers improved convenience and clinical utility. Since Ozempic entered the reimbursement system earlier this year, I believe the transition will be relatively smooth, as the patients’ financial burden will also be reduced.”
- Policy
- Price negotiations begin for Padcev and Keytruda
- by Jung, Heung-Jun Jun 02, 2026 08:55am
- Astellas Korea’s Padcev (enfortumab vedotin) and MSD Korea’s Keytruda (pembrolizumab) have entered reimbursement price negotiations with the National Health Insurance Service (NHIS) for combination therapy in urothelial carcinoma.At the same time, Keytruda is also under separate negotiations for reimbursement expansion in gastric cancer, placing MSD in a pricing defense dilemma.According to industry sources on June 2, negotiations have begun for Padcev and Keytruda with the NHIS for urothelial carcinoma. In April, Padcev was recognized by the Drug Reimbursement Evaluation Committee (DREC) as being adequate as a first-line treatment for adult patients with locally advanced or metastatic urothelial carcinoma.However, the requirement to negotiate jointly with MSD represented a significant hurdle. Unlike Padcev, Keytruda reportedly joined the negotiations only after considerable deliberation, even after receiving a favorable DREC recommendation.The challenge stems from the fact that when a company participates in reimbursement negotiations for its drug in combination with a drug developed by another manufacturer, it may be forced to repeatedly defend a price that has already been reduced, or may soon be reduced, through prior reimbursement expansions.In January, Keytruda accepted a price reduction following reimbursement expansions across 11 indications, including endometrial cancer, breast cancer, and biliary tract cancer.Subsequently, the company has also pursued reimbursement expansion for Keytruda to dMMR/MSI-H metastatic gastric adenocarcinoma and gastroesophageal adenocarcinoma, following requests from the medical community. The indications passed DREC review in March and are currently under NHIS negotiation.As a result, MSD faces the difficult task of negotiating both the Padcev-Keytruda combination therapy for urothelial carcinoma and reimbursement expansion for gastric cancer during the same period.Industry observers view this as a clear example of the limitations inherent in negotiating reimbursement prices for multi-indication drugs, and stressed the need for an indication-based pricing system.The government is currently reviewing the validity and effectiveness of indication-based pricing. The NHIS plans to complete a research project by the end of this year and may consider implementation if deemed necessary. Factors under review include pricing equity across different cancer types and the administrative burden associated with drug management.Because indication-based pricing remains at the evaluation stage, the key question is whether a breakthrough can be achieved in these negotiations.A Korea MSD official commented, “Although it was not intentional, we ended up conducting the two negotiations simultaneously. We believe this case highlights the need for institutional improvements, such as indication-based pricing. However, since the negotiations have only just begun, further discussion will be necessary.”
- Policy
- "Phase 3 trial waiver·review shortcut"…for K-biosimilar
- by Lee, Tak-Sun Jun 01, 2026 09:04am
- AI-generated imageThe competitiveness of Korean biosimilars is projected to strengthen as the Ministry of Food and Drug Safety (MFDS) pursures regulatory reform that waive the requirement to submit therapeutic confirmatory clinical trial (Phase 3) data during the marketing authorization application process for biosimilars, provided that comparability in quality and non-clinical data is demonstrated.In addition to the 'Biosimilar Review Innovation Plan (reducing the review timeline to up to 240 days)' recently introduced by the MFDS to bolster global competitiveness, this measure is expected to create a powerful synergistic effect, significantly lowering the development burden on domestic biotech companies and accelerating their entry into global markets.A 'Two-Way Synergy' between Phase 3 clinical trial waivers and the 240-Day review In the biosimilar development pipeline, Phase 3 clinical trials have been the greatest hurdle, consuming the most time and requiring astronomical costs. Under the reform plan, developers can be exempted from Phase 3 trials if they successfully demonstrate comparability to the reference product in terms of quality, non-clinical data, and pharmacokinetic (PK) profiles.Notably, this is closely linked to the MFDS's recently announced initiative to reduce the biosimilar review timeline to up to 240 days. When promising biosimilar pipelines, already significantly truncated during the clinical trial stage, are placed on the MFDS's innovative and expedited review track, the overall commercialization cycle is projected to be advanced by several years compared to legacy timelines.Industry experts evaluate that companies will now have a springboard to secure 'first-mover' advantages or early price competitiveness in the global market, not only by reducing clinical development costs but also by minimizing administrative review bottlenecks.The benefits of shortened development timelines and accelerated review speeds will also translate directly to patients. As safe and effective biosimilars capable of substituting for high-cost original biologics are rapidly introduced to the market, the financial burden on patients is expected to ease significantly. It is expected to have a positive impact on safeguarding the fiscal soundness of the national health insurance fund.Through this reform, the MFDS has cleared a path to waive not only Phase 3 clinical trials but also the submission of non-clinical 'repeated-dose toxicity study data,' provided that analytical comparability in terms of quality and pharmacological profiles with the reference product is established. Consequently, companies will be able to gain momentum starting from the early candidate validation phase, substantially accelerating overall pipeline development efficiency.Notably, the public notice ensures that the revised regulations can be applied even to products whose marketing authorization or variation applications have already been submitted to the MFDS and are currently under review at the time of enforcement. The pharma-biotech industry is actively welcoming this 'surprise retroactive application' and the MFDS's consecutive forward-looking regulatory innovations, given that products awaiting approval could have immediate benefits.The MFDS plans to gather opinions from institutions, organizations, and individuals through an administrative notice period ending on June 19, after which the reform plan will be finalized and enacted. Attention is focused on whether the MFDS’s comprehensive deregulation spanning the entire life cycle of development (Phase 3 waiver) and review (240-day reduction) will activate a sluggish investment market and serve as a catalyst to further solidify South Korea’s status as a global biosimilar powerhouse.
- Policy
- Govn’t seeks to upgrade 'Overseas AE safety monitoring network’
- by Lee, Jeong-Hwan Jun 01, 2026 09:04am
- The Korean government plans to strengthen Korea’s national and public support policies to resolve frequent drug shortages caused by production or supply discontinuation from poor profitability. At the same time, it intends to modernize the system for collecting overseas safety information on imported medicines through the Korea Orphan & Essential Drug Center (KODC).As the government expands administrative measures that provide essential medicines not supplied or manufactured by domestic private pharmaceutical companies through the KODC, it aims to ensure that information regarding adverse events and side effects associated with overseas medicines can be identified and addressed more rapidly and accurately.On May 31, the Ministry of Food and Drug Safety (MFDS) announced plans to establish a system for collecting safety information and building a database for medicines supplied through the KODC, while also securing a framework for analyzing and reviewing overseas drug safety information.The MFDS will also assess the level of human and material resources required to build and operate a database covering overseas medicines imported through KODC.In Korea, when the supply of a drug manufactured or imported by a private pharmaceutical company is discontinued, or when marketing authorization is withdrawn and no domestic alternative is available, the MFDS uses its emergency import program through the KODC to directly purchase and supply overseas medicines and support patient-specific imports for self-treatment purposes.The Lee Jae-myung administration has been promoting policies to expand emergency-import medicines this year in order to address essential medicine supply disruptions and recurring shortages. As a result, the proportion of medicines supplied through public channels via the KODC is expected to continue to increase.Accordingly, the need to establish a system for collecting, analyzing, and rapidly responding to overseas safety information on medicines distributed by the KODC has become increasingly important.The MFDS will launch a policy research project to establish the scope and methodology for gathering information on medicines supplied through the KODC. The study will examine regulatory approvals, safety information, recalls, and sales suspensions from advanced regulatory agencies such as the US FDA, the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).The ministry will also conduct research on creating a database capable of accumulating, managing, and utilizing overseas safety information, while developing a user-friendly system designed to maximize accessibility and practical use.In addition, it plans to establish update cycles, standards, and data display methods to ensure rapid mutual sharing of overseas safety information and real-time incorporation of the latest safety updates.To establish an advisory and review framework for overseas safety information, the MFDS will develop a process for collecting opinions from medical and pharmaceutical experts regarding whether the supply of a medicine should be continued when safety concerns arise.The MFDS intends to define the requirements for expert consultation, develop standardized advisory forms incorporating those requirements, identify appropriate academic societies and organizations to participate, and establish formal consultation procedures.In effect, Korea will be building a physician-pharmacist advisory panel system to enhance domestic responses when overseas drug safety issues emerge.Based on the results of this consultation, a review process will be established to determine whether to continue supply, analyze potential measures such as the emergency introduction of alternative products or suspension of supply.To identify the human and material resources necessary for these new responsibilities, the MFDS will analyze comparable overseas cases and assess its current staffing structure. It will then calculate the appropriate workforce size and personnel costs required for the new tasks and define the roles of individual staff members.An MFDS official explained, “We need a process to collect and build a database of drug safety information originating from overseas regarding medicines supplied and supported by KODC, and to establish measures for gathering expert advice and taking action when issues arise. At the same time, we will identify the human and material resources necessary to carry out these functions.”
- Policy
- Lilly’s Verzenio passes CDDC review for reimbursement
- by Jung, Heung-Jun May 29, 2026 09:14am
- Eli Lilly Korea’s Verzenio Tab (abemaciclib) passed the Cancer Drug Deliberation Committee (CDDC), moving one step closer toward expanded reimbursement coverage for early breast cancer.Meanwhile, Curocell’s CAR-T therapy ‘Rimqarto Inj’ (anbalcabtagene autoleucel), which had attracted significant attention, failed to secure reimbursement criteria.On the 27th, the Health Insurance Review and Assessment Service released the results of the 5th Cancer Drug Deliberation Committee meeting. The committee reviewed reimbursement decisions and the expansion of reimbursement criteria for a total of 5 products. Among them, two products passed the initial reimbursement hurdle.AbbVie Korea’s ovarian cancer therapy ‘Elahere Inj’ (mirvetuximab soravtansine) was the only new drug to receive reimbursement criteria.The criteria apply to adult patients with folate receptor alpha (FRα)-positive, platinum-resistant high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received one to three systemic therapies.Lilly Korea’s Verzenio Tab was approved for reimbursement expansion for use ‘in combination with endocrine therapy as adjuvant treatment in adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, lymph node-positive early breast cancer at high risk of recurrence.’Outcomes diverged for early breast cancer reimbursement expansion. Novartis Korea’s Kisqali Tab (ribociclib succinate) attempted to expand reimbursement for HR-positive, HER2-negative Stage II and III early breast cancer patients at high risk of recurrence, but reimbursement criteria were not established.Roche Korea’s Alecensa Cap (alectinib hydrochloride) also attempted reimbursement expansion as adjuvant therapy following tumor resection in ALK-positive non-small cell lung cancer patients, but failed to pass the CDDC review.Among the new drugs, Curocell’s CAR-T therapy ‘Rimqarto Inj’ failed to establish secure reimbursement coverage for the treatment of adult B-cell lymphoma patients, leaving the company seeking reimbursement again in the future.
- Policy
- Fast-track listed rare disease drugs need to demonstrate performance
- by Jung, Heung-Jun May 28, 2026 10:27am
- The government will lower drug prices starting in the fourth year if rare disease treatments fail to meet their targets following post-marketing evaluation, following fast-track listing.Evaluations will be based on real-world evidence (RWE), but if pharmaceutical companies fail to collect and submit the required data, the drugs may be removed from reimbursement coverage altogether.Sook-hyun Lee, Director of New Pharmaceutical Benefits Listing Division at the Health Insurance Review and Assessment Service (HIRA)On the 27th, Sook-hyun Lee, Director of the New Drug Listing Division at the Health Insurance Review and Assessment Service (HIRA), explained specific operational plans for the system during a public hearing on “Fast-Track Listing Strategies to Improve Access to Rare Disease Treatments.”Until now, rare disease treatments underwent a 150-day approval negotiation process at HIRA and a 60-day process at the National Health Insurance Service (NHIS) following approval by the Ministry of Food and Drug Safety (MFDS) before official notification by the Ministry of Health and Welfare.Under the revised drug pricing system, the review periods at both HIRA and the NHIS will be shortened to one month each. Instead, post-listing management will be strengthened through follow-up evaluations after reimbursement listing.A general scope for drugs eligible for the fast-track listing pilot program has also been established. Drugs will be selected based on: ▲availability of alternative treatments ▲severity of the disease ▲need for rapid introduction ▲fiscal impact. The pilot project plans to begin by selecting two to three items based on these criteria.Director Lee explained, “The primary criteria for selecting target drugs are treatments for rare diseases that have already received approval or are listed in at least three of the A8 countries.”A performance-based evaluation model will be operated using real-world evidence (RWE) and linked to electronic medical records (EMR). Before reimbursement, pharmaceutical companies must submit clinical outcome evaluation plans for review by HIRA. The plan must include details such as ▲target patients and drugs ▲outcome measures ▲evaluation cycle and duration ▲reimbursement adjustment plan ▲methods for calculating clinical performance evaluation results ▲data collection procedures and quality control methods.Afterward, pharmaceutical companies will be required to collect annual data during years one through three, and evaluations will be conducted based on those results. The findings will then be reported to the Drug Reimbursement Evaluation Committee.Data collection and validation will continue for three years after fast-track listing, and reimbursement adjustments will begin in year four according to evaluation outcomes. Data collection and verification will be conducted for three years following fast-track listing, and reimbursement will be adjusted starting in the fourth year based on the evaluation results.Lee stated, “If pre-established targets are not achieved, drug prices will be reduced, and if data are not submitted, we are reviewing measures to convert reimbursement to full out-of-pocket payment.” Obligations related to post-evaluation plans and follow-up measures based on results will also be included in fast-track reimbursement contracts.The National Health Insurance Service will apply expenditure cap agreements to fast-track listed drugs. Negotiations will be conducted based on total expenditure figures proposed by pharmaceutical companies, and after one year of listing, actual claims will serve as the benchmark.The expenditure cap mechanism is expected to prevent rapid increases in financial burden caused by the expansion of fast-track reimbursement listings.Pricing standards are expected to be stricter than those applied to drugs exempt from pharmacoeconomic evaluations. Drug prices are expected to be negotiated at around 90% of the lowest price among the A8 countries.
- Policy
- Bayer's new antifungal cream Canesten wins nod…"once-daily"
- by Lee, Tak-Sun May 28, 2026 10:27am
- Bayer Korea is expanding its market presence by introducing a new product projected to shift the over-the-counter (OTC) anti-fungal market in South Korea.In contrast to existing Canesten products, the new product is a topical formulation that requires only once-daily application.On the 27th, Bayer Korea secured marketing authorization from the Ministry of Food and Drug Safety (MFDS) for 'Canesten Once Daily Cream', a once-daily topical anti-fungal. This new product differs from Bayer's existing anti-fungal product, 'Canesten Cream', in both its active pharmaceutical ingredient (API) and its usage.Differentiation from existing products...Re-entering the Korean Market with the API 'bifonazole'The key feature of 'Canesten Once Daily Cream' is its updated API. While existing Canesten products utilize clotrimazole, this new product features bifonazole as its primary API. Although both substances are classified as azole-based anti-fungals, products containing bifonazole have vanished from the domestic market. Bayer's strategy is to successfully re-establish bifonazole in the Korean market through this approval.The usage has also been dramatically improved. While the existing Canesten Cream required application 2 to 3 times a day, the new product is effective with just a single daily application (preferably before bedtime), thinly applied and rubbed onto the affected area.However, a pharmaceutical industry employee said, "Because the name includes 'Once,' it is easy for consumers to confuse it with single-application athlete's foot treatments that have high brand awareness, such as 'Lamisil Once External Solution' (terbinafine hydrochloride)," and added, "'Canesten Once Daily Cream' is not a single-application treatment. It is a product that must be applied consistently once every day throughout the designated treatment duration."Currently, the domestic topical anti-fungal market involves market competition between the traditional powerhouse 'Lamisil' series and 'single-application (Once) formulations' driven by domestic pharmaceutical companies.Amid this competition, Bayer Korea's introduction of 'Canesten Once Daily Cream' is interpreted as a strategic move to aggressively expand the Canesten brand equity into the traditional tinea (dermatomycosis) market. The Canesten brand currently spans vaginal tablets, powders, and other formulations, utilized not only for tinea but also for vulvovaginal candidiasis and vaginitis.In particular, the enhanced convenience of a 'once-daily' application is expected to improve treatment adherence (the degree to which a patient follows prescribed medication guidelines) among busy modern consumers. Analysis suggests that the product has an advantage in capturing male tinea patients, where the penetration rate of existing products has been low.It is important to note that the treatment duration varies depending on the specific clinical indication. For dermatomycosis and cutaneous candidiasis, treatment lasts 2 to 3 weeks, whereas for tinea versicolor and erythrasma, it lasts 2 weeks. Therapy must be continued even if symptoms subside mid-treatment to prevent fungal recurrence.An industry insider stated, "Bayer has reintroduced bifonazole, which had vanished from the domestic market, with its 'once-daily' product. It will be interesting to see whether Canesten, with its powerful brand recognition, can shift the landscape of the domestic tinea treatment market with this new product."
- Policy
- Boehringer begins drug price negotiations for stroke therapy Metalyse
- by Jung, Heung-Jun May 27, 2026 04:10pm
- Boehringer Ingelheim Korea has entered drug price negotiations with the National Health Insurance Service for Metalyse Inj (tenecteplase), a treatment for acute ischemic stroke in adults.In addition, negotiations have also begun for Meditip’s vasculitis treatment Tavneos Cap (avacopan) and Guerbet Korea’s X-ray contrast agent Elucirem Inj (gadopiclenol).According to industry sources on the 26th, Metalyse 25mg, which was recognized as appropriate for reimbursement by the Drug Reimbursement Evaluation Committee in April, has now entered drug price negotiations, bringing it one step closer to reimbursement listing in Korea.Metalyse, a thrombolytic agent, received domestic approval last October. It garnered attention as the first new treatment option for acute ischemic stroke in approximately 20 years following the indication expansion of Actilyse (alteplase).While Actilyse is a second-generation thrombolytic agent, Metalyse is a third-generation thrombolytic agent with PAI-1 resistance, which inhibits thrombolysis.At the end of last year, the National Assembly also raised the need to introduce third-generation thrombolytics that are already reimbursed overseas, specifically mentioning the rapid reimbursement listing of Metalyse.Meditip’s Tavneos Cap 10mg, which was reviewed alongside Metalyse by DREC in April, is also undergoing price negotiation procedures. At the time, the committee determined the drug was appropriate for reimbursement for the ‘treatment of severe granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).’However, side effects have become a concern following recent reports of deaths and other adverse events overseas. The Ministry of Food and Drug Safety (MFDS) stated that while the product was supplied to some patients prior to market launch, no adverse event reports had been received. Safety management is expected to influence the price negotiation agreement as well.Negotiations are also underway for Guerbet Korea’s X-ray contrast agents Elucirem Inj and Elucirem Prefilled Syringe Injection, as well as Bracco Imaging Korea’s Vueway Inj.These products had previously been recognized as eligible for reimbursement as “MRI contrast agents for adult and pediatric patients aged 2 years and older,” provided they are accepted at or below the assessed price.As the pharmaceutical company has accepted the term, detailed negotiations with the National Health Insurance Service regarding expected claims costs and related matters are expected to take place thereafter.
