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- 2026-03-10 07:55:17
- Policy
- Three-month import suspension for Pfizer’s Prevnar 20
- by Lee, Tak-Sun Jan 13, 2026 06:58am
- Pfizer’s pneumococcal vaccine ‘Prevnar 20 Prefilled Syringe’ is subject to a three-month import suspension in Korea.The administrative action was imposed for importing and selling products that differed from the product specifications and standards described in the marketing authorization.On the 12th, the Ministry of Food and Drug Safety (MFDS) announced that it will suspend the import operations of Prevnar 20 Prefilled Syringe (Pneumococcal Diphtheria CRM197 Protein Conjugate Vaccine) for three months, from today through April 11.The MFDS explained that the action was taken because the company imported and sold products that differed from the product standard and specifications described in the marketing authorization.In June last year, the MFDS issued a safety letter and temporarily suspended the use of Prevnar 20 products that were supplied with injection needles that did not match the approved specifications.The vaccine is designed to be administered by attaching the enclosed needle to the syringe. While the approved needle length is 25 mm, the enclosed needles supplied were shorter, at 16 mm.At the time, the action was taken shortly after the product had entered the market. The current administrative penalty is understood to be a follow-up action based on the results of that investigation.Prevnar 20 is Pfizer’s first new pneumococcal vaccine in 14 years. It adds seven serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F, 33F) to the existing Prevenar 13 vaccine.
- Policy
- Lee administration’s bio-industry support plan revealed
- by Kang, Shin-Kook Jan 12, 2026 03:58pm
- The government is launching large-scale investment and policy support for the bio industry this year as part of its efforts to restore economic growth and secure future growth engines.On January 9, the government held the 2026 National Economic Growth Strategy Public Briefing at the Chungmu Room of the Blue House, presided over by President Jae-myung Lee, where it finalized and announced this year’s national growth strategy.Under the bio-industry development policy, the government will establish a National Bio Innovation Committee under the Prime Minister and announce a provisional Bio Industry Policy Roadmap in the first quarter of this year.President Jae-myung Lee is attending the 2026 National Economic Growth Strategy Public BriefingThe National Bio Innovation Committee will integrate and operate the National Bio Committee (chaired by the President) and the Bio-Health Innovation Committee (chaired by the Prime Minister).To support new drug development and commercialization, the government will expand regulatory review staff and accelerate approval timelines for medical products, while simplifying clinical trial and data submission procedures.The government's plan is to reduce the current approval review periods—420 days for new drugs, 406 days for biosimilars, and 398 days for new medical devices—to 240 days. Furthermore, criteria for exempting biosimilars from Phase III trials will be established this year.Comprehensive support measures covering finance, R&D, regulation, and location will also be implemented to help bio companies expand their global reach. First, ‘Bio Sector Mega Project’ will be established and promoted through the National Growth Fund. R&D support will also be provided for the entire lifecycle (development-clinical trials-approval) of advanced medical devices in six promising fields (medical robots, implants, etc.).Support for open innovation will be expanded to promote joint technology development between pharmaceutical companies and biotech ventures. The government will also pursue the enactment of a provisional Digital Healthcare Act to enhance the use of healthcare data and will upgrade existing bio-health clusters, such as advanced medical complexes, through infrastructure sharing and joint research.Furthermore, it will apply regulatory exemptions for data utilization to AI bio innovation hubs and establish a National Bio Data Integration System to lay the groundwork for data sharing and utilization. To this end, it will also push for the enactment of the proposed Bio Data Act.
- Policy
- Max ICER for cancer drugs exceeds KRW 50 million
- by Jung, Heung-Jun Jan 09, 2026 08:36am
- As a result of cost-effectiveness evaluations of drugs submitted for economic assessment, the median incremental cost-effectiveness ratio (ICER) for anticancer drugs has remained relatively stable at around KRW 40 million over the past 10 years.However, over the last four years, the maximum ICER has exceeded KRW 55 million, suggesting that the ICER threshold is declining depending on the drug.According to the 'Cost-effectiveness results of drugs submitted for pharmacoeconomic assessment' released by the Health Insurance Review and Assessment Service (HIRA) on January 8, the median ICER for anticancer drugs has not fluctuated significantly, even after the acceptance limits were raised in 2014.Median ICER values for anticancer drugs: The median ICER for anticancer drugs from 2014 to 2021 was KRW 45.32 million. For the 2018–2022 period, it was KRW 39.99 million; for 2019–2023, KRW 39.93 million; and for 2020–2024, KRW 42.94 million.Since 2022, HIRA has announced the median, minimum, and maximum ICER values for general drugs, anticancer drugs, and orphan drugs across four reporting cycles.The median ICER for anticancer drugs from 2014 to 2021 was KRW 45.32 million. For the 2018–2022 period, it was KRW 39.99 million; for 2019–2023, KRW 39.93 million; and for 2020–2024, KRW 42.94 million.overlapping periods, the median ICER for anticancer therapies is consistently in the low-to-mid KRW 40 million range.Notably, the maximum ICER value, which had never previously exceeded KRW 50 million, surged to KRW 55.36 million in the 2020–2024 data. This suggests that the authorities are flexibly recognizing the cost-effectiveness of essential anticancer drugs and strengthening coverage.Maximum ICER values for anticancer drugs.The anticancer ICER data for 2020–2024, announced last month, covers eight active ingredients. The drugs that broke through the KRW 50 million ceiling are likely those subject to 'flexible threshold application,' such as Enhertu or Trodelvy, before and after innovative ICER standards were introduced.Given the timing and pricing, Enhertu, a targeted therapy for breast cancer, appears to be the most likely candidate for the record-high maximum value.Upward trend of ICER values over the past decade is also observed in orphan drugs. Specifically, the minimum ICER for rare disease drugs has increased sharply. This reflects the growing prevalence of high-priced orphan drugs compared to the past.The minimum ICER for rare disease drugs rose from KRW 23.16 million (2014–2021) to KRW 39.97 million (2020–2024). The cost-effectiveness of orphan drugs is now approaching KRW 40 million, with a strong upward trajectory.In the 2020–2024 ICER evaluation results, the median for orphan drugs was not disclosed because it included only three rare disease drug active ingredients, which could have led to the identification of specific products.
- Policy
- AZ’s gMG candidate ‘gefurulimab’ receives GIFT designation
- by Lee, Tak-Sun Jan 09, 2026 08:36am
- AstraZeneca's ‘gefurumab,’ its new drug candidate for myasthenia gravis, has been selected for fast-track review support by Korea’s Ministry of Food and Drug Safety (MFDS).This designation is expected to accelerate its commercialization.On the 5th, the MFDS announced that AstraZeneca’s gefurulimab had been designated as the 63rd product under the GIFT (Global Innovative product on Fast-Track) program.GIFT is a fast-track review program operated by the MFDS since September 2022 to provide patients with new treatment opportunities through expedited product development support.Products eligible for GIFT designation include drugs for life-threatening diseases, rare diseases with no existing treatment alternatives, and innovative new drugs developed by certified innovative pharmaceutical companies.The MFDS designates GIFT products through a comprehensive evaluation of factors such as innovative therapeutic benefit, contribution to public-health crisis response, and the developer’s R&D efforts.Selection into GIFT reduces the review period by at least 25% (from 120 working days to 90 working days).This is achieved by applying a rolling review process, where submitted data are reviewed first, and close communication between reviewers and developers, which is facilitated through product briefings and supplementary explanations. Additionally, companies receive various supports for rapid commercialization, such as specialized regulatory consulting.AstraZeneca announced positive results last July from the Phase III PREVAIL trial, which evaluated the use of gefurulimab in adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG). Gefurulimab met the primary endpoint and all secondary endpoints in the trial.Gefurulimab is a terminal complement inhibitor that selectively binds to both complement protein C5 and serum albumin. It is a novel bispecific nanobody drug candidate optimized for self-administered subcutaneous injection to treat anti-acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG).Generalized myasthenia gravis is a chronic autoimmune neuromuscular disorder, a rare disease causing muscle function loss and severe muscle weakness.Gefurulimab has been favorably evaluated for its convenience, as it allows once-weekly self-administration, compared with existing treatments for adult myasthenia gravis, such as Ultomiris and Soliris.AstraZeneca Korea's status as a Korean Innovative Pharmaceutical Company influenced gefurulimab’s selection for the GIFT program.This drug has not yet received approval from advanced overseas regulatory agencies such as the US FDA, Europe’s EMA, or Japan’s PMDA. The Ministry of Food and Drug Safety (MFDS) applied its fast-track review program ahead of these overseas agencies.However, the US FDA has designated this drug as an orphan drug and is providing support. The MFDS also designated this drug as a development-stage orphan drug this month.To date, 49 of the drugs designated as GIFT have received marketing authorization.
- Policy
- Plan to waive Phase 3 for comb therapies for HTN and DYS
- by Lee, Tak-Sun Jan 08, 2026 07:31am
- Ministry of Food and Drug Safety (MFDS)The Ministry of Food and Drug Safety (MFDS) has announced an exemption for Phase 3 clinical trials of combination therapies targeting hypertension and dyslipidemia, provided the components do not mutually interfere with efficacy or safety. This exemption is also expected to extend to triple-combination therapies that include diuretics.However, the MFDS explained that Phase 3 data will be waived only if meta-analysis data confirm that treatments for hypertension and dyslipidemia do not affect each other’s therapeutic effects or safety profiles.The MFDS has prepared a revision to the 'Guidelines for Clinical Trials of Combination Drugs' and is collecting industry feedback through January 13.The new addition outlines a plan to rationalize data submission requirements for developing combination drugs intended for comorbid conditions, organized in a Q&A format within the guidelines.According to the guidelines, the MFDS stated, "Regarding combination drugs for the treatment of comorbid hypertension and dyslipidemia, we have determined that therapeutic confirmatory clinical trials (Phase 3) can be exempted for specific drug classes based on the results of meta-analysis performed on accumulated domestic clinical trial data."The MFDS added, "To date, hypertension + dyslipidemia combinations developed in Korea have primarily consisted of ARBs (Angiotensin II Receptor Blockers) or CCBs (Calcium Channel Blockers) for hypertension, and Statins or Ezetimibe for dyslipidemia," and explained," Meta-analysis of previously submitted clinical results indicate that these hypertension and dyslipidemia treatments do not mutually affect therapeutic efficacy or safety."Based on these findings, the MFDS has finalized a policy to exempt therapeutic confirmatory clinical trial data for companies developing combination drugs composed of ARB or CCB and Statin or Ezetimibe. Nevertheless, the MFDS noted that even within these classes, toxicological patterns or pharmacokinetic profiles may vary by specific active pharmaceutical ingredient (API).The MFDS explained that a therapeutic confirmatory clinical trial may be requested in some cases because the toxicity profile and pharmacokinetics may vary depending on APIs. The MFDS stated, "Developers must present a review of the impact on safety and efficacy based on trial data regarding absorption, distribution, metabolism, and excretion (ADME), as well as pharmacokinetic drug-drug interaction studies," the MFDS added. "If significant drug-drug interactions are observed in pharmacokinetic studies and are judged to potentially affect safety or efficacy, a therapeutic confirmatory clinical trial may be requested."Regarding triple-combination drugs that include a diuretic in addition to these two components, the MFDS explained that while Phase 3 data submission is the general rule, exemptions are possible under specific conditions.The MFDS stated, "For hypertension-dyslipidemia combinations containing drugs in addition to the mentioned classes (e.g., diuretics), therapeutic confirmatory clinical trials must be submitted as before. However, if meta-analysis data for the specific drug class being developed confirms that the hypertension and dyslipidemia treatments do not influence each other's efficacy and safety, the requirement for Phase 3 data may be waived."In cases where the combination includes a new drug ingredient or involves changes to dosage and administration, additional safety and efficacy data will be required. The MFDS advised, "If a new drug is included in the proposed combination or if it deviates from the approved labeling (dosage, administration, etc.) of the individual treatments, additional safety and efficacy evaluations may be necessary," and added, "We encourage companies to consult with the Ministry in advance."
- Policy
- ImmuneOncia, Merck, and Bayer receive orphan drug designation
- by Lee, Tak-Sun Jan 07, 2026 08:46am
- Three new drug candidates, including ImmuneOncia's lymphoma treatment candidate danverstotug, have been designated as orphan drugs in Korea.Designation as orphan drugs increases the likelihood of expedited approval through fast-track review, potentially accelerating the commercialization of these products.On January 2, the Ministry of Food and Drug Safety (MFDS) announced the designation of three new drug candidates, danverstotug, mirdametinib, sevabertinib, as orphan drugs.Danverstotug is a novel lymphoma drug candidate being commercialized by ImmuneOncia, Yuhan Corporation's immune-oncology subsidiary.As an immunotherapy targeting relapsed/refractory NK/T-cell lymphoma, it demonstrated efficacy in a domestic Phase II clinical trial, based on which the company applied for orphan drug designation to the MFDS last July.According to the company, the Phase II study in patients with relapsed or refractory NK/T-cell lymphoma who had failed first-line therapy showed an objective response rate (ORR) of 79% and a complete response (CR) rate of 63%.The median progression-free survival (PFS) was 29.4 months, while overall survival (OS) rates were 85% at one year and 78% at two years. Adverse reactions were mostly mild, and 40% of all patients completed the two years of long term treatment.The company has completed the commercial manufacturing technology transfer for this drug to Lonza, a global contract development and manufacturing organization (CDMO). ImmuneOncia aims to launch the drug before 2030.Mirdametinib is a drug used for neurofibromatosis with plexiform neurofibroma that received US FDA approval in February last year. The drug is expected to compete with Koselugo (selumetinib, AstraZeneca), an existing therapy for neurofibromatosis.Mirdametinib was developed by US-based biotech SpringWorks Therapeutics, which was acquired by Merck (Germany) in April last year for USD 3.9 billion.Bayer’s sevabertinib is an investigational therapy for HER2-positive non–small cell lung cancer, an area with limited treatment options. The drug is gaining attention as a potential alternative for patients who do not respond to existing therapies. The US FDA has granted the drug accelerated approval status and is conducting a priority review.When designated as an orphan drug, data submission required for approval is simplified, allowing exemptions from bridging studies, conditional approval, and fee reductions. It also enables a fast-track approval process through priority review. The Ministry of Food and Drug Safety (MFDS) recently relaxed the requirements for orphan drug designation, lowering regulatory barriers. Previously, data demonstrating improved efficacy over existing alternatives was required, but under the revised rules, such data are no longer mandatory for orphan drug designation.
- Policy
- NHIS publicly discloses RSA Refund-type drugs
- by Jung, Heung-Jun Jan 06, 2026 08:25am
- Going forward, fewer patients are expected to miss out on refunds simply because they are unaware of refund-eligible drugs under Korea’s Risk-Sharing Agreement (RSA) system.On the 2nd, the National Health Insurance Service (NHIS) disclosed the “List of Risk-Sharing Refund-Eligible Drugs.” The aim is to improve information accessibility for patients who are prescribed refund-type drugs.There have been demands in the past from the National Assembly for information on refund-type reimbursed drugs. During the NA audit the year before the last, concerns were raised that patients were missing out on reimbursements due to a lack of information.Previously, lists of RSA drugs had been shared with medical institutions for the purpose of supporting patients subject to full out-of-pocket payments. However, this marks the first time the NHIS has directly disclosed the list of refund-type drugs to the general public.An NHIS official stated, “Starting in January this year, we plan to disclose the list of refund-type drugs on a monthly basis. This was a frequent request from patients, and addressing that need is the primary purpose. Following requests from the National Assembly, we reviewed the matter and decided on regular disclosure.”According to the refund-type RSA drug list released by the NHIS, there are 61 drugs under refund-type RSA contracts. These drugs are from 26 multinational companies and 3 domestic companies.When classified by dosage, the number of refund-eligible drug items reaches 112. Among them, AstraZeneca Korea (AZ) accounted for the largest share with 14 items.When categorized by dosage, 11 of the 112 refund-type items are from domestic companies. Multinational companies account for over 90% of the refund-type contract drugs.Domestic companies with refund-type RSA drugs include Yuhan’s Leclaza (lazertinib), JW Pharmaceutical’s Hemlibra (emicizumab), Handok’s Defitelio Inj (defibrotide), Vyxeos Liposomal Inj, and Pemazyre Tab (pemigatinib).Domestic companies are divided into those with domestically developed new drugs and those with overseas new drugs introduced to Korea, where they hold the local marketing rights. Among the refund-type drug list, domestically developed new drugs like Leclaza and multiple new drugs marketed by Handok stand out.Among multinational companies, AZ and Novartis Korea each had the most drugs, with 6 each. When including dosage distinctions, AZ accounted for 14 items.AZ has refund-type contracts for Tagrisso, Lynparza, Imfinzi, Koselugo, Strensiq, and Fasenra, while Novartis’ refund-type drugs include Kymriah, Kisqali, Zolgensma, Luxturna, Ilaris, and Lutathera.Other companies with multiple refund-type drugs include: ▲Pfizer Korea (Ibrance, Lorviqua, Vyndamax Cap, Paxlovid) ▲Eli Lilly Korea (Verzenio Tab, Cyramza Inj, Jaypirca Tab) ▲BMS Korea (Yervoy, Onureg, Camzyos, Inrebic).The reduction in drug expenditure through the RSA refund-type contracts has been largely concentrated on high-priced anticancer drugs and rare disease treatments from multinational pharmaceutical companies.
- Policy
- Rare disease drugs to be reimbursed within 100 days
- by Lee, Jeong-Hwan Jan 06, 2026 08:25am
- Starting in the new year, the government will shorten the timeline for National Health Insurance (NHI) reimbursement listing of rare disease treatments from the current 240 days to 100 days, strengthening patient access to medicines.To address frequent shortages of essential medicines, the government proposed ‘activating made-to-order manufacturing’ by establishing a public production and distribution network through collaboration between the government, pharmaceutical/distribution/medical associations, and pharmaceutical companies.Under this model, the government requests production of frequently out-of-stock drugs from manufacturers and purchases the entire output for supply.By expanding the emergency import of treatments and contract manufacturing, the government aims to create an environment where patients can obtain treatments without difficulty, even if private supply ceases due to low demand.In addition, patient co-insurance payments under the NHI special reimbursement calculation scheme for rare and severe intractable diseases will be further reduced.On the 5th, the Ministry of Health and Welfare (MOHW), the Ministry of Food and Drug Safety (MFDS), and other relevant agencies jointly announced measures to strengthen support for rare and severe intractable diseases. Rare Drugs to be listed within 100 days… approval-evaluation-pricing parallel review to continueFrom the new year, the government will significantly reduce the time required for NHI listing of rare disease treatments from within 240 days to within 100 days.Furthermore, the government will continue its pilot program for ‘parallel approval-evaluation-price negotiation’ for rare disease drugs, where it is difficult to establish robust efficacy and safety evidence due to extremely small patient populations. This program reduces the time required for drug price approval and listing from the current 330 days to 150 days, a reduction of 180 days.The first pilot program included Qarziba and Bylvay Cap, while the second pilot program is currently underway with three selected drugs.Prices for rare disease treatments will be set at a certain level relative to the average price in reference countries.Expansion of emergency import and made-to-order manufacturing for rare essential and shortage drugsFurthermore, to ensure access to treatments even if pharmaceutical companies halt manufacturing or imports due to low demand, the government is expanding emergency imports and custom manufacturing.First, medications for self-treatment that patients previously had to purchase directly overseas will be converted into emergency import items for at least 10 products starting this year to stabilize supply.Emergency import refers to a system in which the government directly procures drugs from overseas and supplies them when the domestic supply is disrupted.While an emergency import system already exists through the Korea Orphan and Essential Drug Center, ultra-low-demand products have often been excluded. Expanding the scope of emergency imports aims to address these limitations.If an emergency import drug was previously eligible for reimbursement, reimbursement price applications will be prioritized, and existing emergency import drugs will also be allowed to apply for reimbursement.In particular, to ensure a stable domestic supply of essential medicines at risk of discontinuation, the government will activate made-to-order manufacturing through a public production and distribution network involving the government, pharmaceutical companies, distributors, medical associations, and industry groups.Last year, KRW 810 million was allocated to manufacture 7 drugs through made-to-order manufacturing. This year, an additional KRW 500 million will be allocated to expand production to two more drugs.Under this system, the government shares information on drugs scheduled for supply discontinuation with the pharmaceutical industry. The Korea Orphan and Essential Drug Center analyzes prescription and supply history, demand, and regulatory issues, after which pharmaceutical companies decide whether to proceed based on production intent and required budget. Public production projects are then implemented through product transfer, new approvals, or manufacturing contracts.The government plan is to expand from the current 7 items to 17 items by 2030, adding 2 items annually starting this year.This would mean 25% of the 40 essential drugs requested for emergency import by the medical field would be converted to public production.When expanding emergency import and made-to-order-manufactured items, priority will be given to treatments for rare diseases.Reduced patient co-insurance costs through enhanced special reimbursement supportTo reduce the financial burden of high-cost care for patients with severe diseases, the government will strengthen special reimbursement schemes that lower NHI co-insurance payment rates.For high medical expenses related to rare and severe intractable diseases, the patient's co-insurance payment rate will be further reduced from the current 10%.Taking into account factors such as the need for continuous treatment and management and the burden of high medical costs, a reduction plan will be prepared in the first half of this year, followed by approval by the Health Insurance Policy Deliberation Committee, with implementation scheduled for the second half of the year.Furthermore, starting this January, 70 additional diseases, including congenital functional short bowel syndrome, will be added to the list of rare diseases eligible for special billing exceptions, with continuous expansion planned.The re-registration process for rare and intractable diseases will also be reorganized to be more patient-centerd. Until now, the government required separate test results for 312 specific rare and intractable diseases upon re-registration.Reflecting field feedback that additional testing is unnecessary given the incurable nature of these conditions, unnecessary testing requirements will be eliminated during re-registration.Support for low-income patients through the rare disease medical expense assistance program will also be expanded.The income and asset criteria separately applied to households with dependent family members will be phased out starting in 2027, expanding support for low-income individuals.Customized medical nutrition support based on disease-specific needs will continue to expand. The government currently provides special formula milk and low-protein instant rice to rare disease patients requiring dietary management. Since September last year, it has additionally provided special corn starch for patients with glycogen storage disease.This year, based on a survey of the current status of special diet usage and additional demand, the government plans to review expanding the range of supported items and support the development of new products.
- Policy
- Industry asks NHIS to defer February vote on drug price cuts
- by Lee, Jeong-Hwan Jan 06, 2026 08:25am
- The pharmaceutical industry is voicing concerns that the government's plan to push through a drug pricing system, which includes price cuts for domestically produced generic medicines, for approval by the Health Insurance Policy Deliberation Committee (HIPDC) next month (February), represents overly hasty administration.Industry consensus is that because the government failed to adequately collect industry opinions when it announced the reform plan late last November—lowering the pricing benchmark for generics from 53.55% of the originator price to the “40% range”—it is necessary to resume consultations in the new year before obtaining the approval of the Health Insurance Policy Deliberation Committee, and then set a new implementation date for the drug pricing system reform plan.The demand is that postponing or deferring the timing of the generic drug price reduction from July this year to next year or later is necessary to ensure domestic pharmaceutical companies' management predictability and the normal execution of their business plans.Some members of the National Assembly’s Health and Welfare Committee are also paying close attention to these concerns, raising questions over whether changes will occur in the government’s administrative timetable.According to domestic pharmaceutical industry sources on the 5th, the Ministry of Health and Welfare (MOHW), the government agency responsible for the drug pricing system reform plan, has not yet initiated a formal process to gather opinions from pharmaceutical companies regarding the reform plan, including generic drug price cuts and pricing incentives.On November 28 last year, the MOHW reported the reform plan to the HIPDC, publicly announcing its intention to reduce the generic pricing benchmark from 53.55% of the original drug’s price to the 40% range.At the same time, the ministry disclosed plans to finalize the reform through a HIPDC vote in February this year and to fully implement the revised pricing system and price reductions starting in July.At the time, domestic pharmaceutical companies reacted strongly, criticizing the ministry for abruptly announcing the plan without providing sufficient prior explanation regarding the specific pricing rate, the scope of generics subject to price cuts, or the targets and methods for pricing incentives.Pharmaceutical companies are criticizing the Ministry for failing to show any signs of reviewing or partially reflecting the industry's demands even now, over a month after the Health Insurance Review and Assessment Service report and into the new year.Industry stakeholders complain that the ministry has not retreated even marginally from its unilaterally disclosed proposal, instead adhering strictly to the government plan—creating an environment in which meaningful dialogue between the MOHW and the pharmaceutical industry cannot take place.In fact, Jeong-Kee Hong, Executive Director of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), strongly appealed for a deferral of implementation during a National Assembly policy forum on the drug pricing reform held last December, pointing out how the proposed timeline was excessively tight, undermining predictability, and that insufficient analysis had been conducted on the reform’s negative impact on the pharmaceutical industry.At the time, Executive Director Hong stated, “When pursuing drug price reductions, prior evaluation and analysis of the long-term impact on the pharmaceutical industry must be conducted first, and the effects on employment, production bases, and supply chains must also be examined. Notifying the industry of price reductions just 7 months before the system implementation makes it difficult for pharmaceutical companies to establish business plans and ensures no predictability.”Despite these industry appeals, the MOHW has shown little indication of establishing a consultation channel until now, prompting growing skepticism within the pharmaceutical sector regarding the plan to finalize the reform at the February HIPDC meeting.Against a backdrop of mounting uncertainty in the pharmaceutical industry—driven by the COVID-19 pandemic and rising trade barriers imposed by major economies such as the United States—industry voices warn that the MOHW’s focus on cutting health insurance expenditures, rather than regulatory innovation to support domestic new drug R&D, could ultimately threaten national security and pharmaceutical sovereignty.Accordingly, the pharmaceutical industry is expected to intensify calls for the MOHW to moderate the pace of its drug price cut measures.Mr. A, a drug pricing manager at a top domestic pharmaceutical company, stated, “We need to critically assess whether cutting generic drug prices to save KRW 1 trillion in health insurance funds is truly the top administrative priority the Ministry should pursue, given Korea's current situation. Throughout the prolonged COVID-19 pandemic, conflicts over medical policies and healthcare gaps, pharmaceutical companies have dedicated their management efforts to new drug R&D amid significant uncertainty. At this point, reducing generic prices to the 40% range is difficult to understand in terms of urgency or appropriateness.”Mr. B, another executive from a top pharmaceutical company, also stated, “While the Minister of Health and Welfare and the Vice Minister in charge of the pharmaceutical industry have consecutively published opinion pieces in media outlets expressing strong strong commitment to generic drug price reduction and strengthening the sustainability of the national health insurance finances, there has been no visible effort to establish a discussion table for collecting industry feedback on their strong opposition. Rather than repeating and reinforcing the government's drug pricing system reform plan already reported to the HIPDC, what is needed now is a consultative approach that proactively accommodates industry demands and promises the possibility of revising the reform plan.”As industry opposition persists, the National Assembly is closely monitoring the MOHW’s handling of the pricing reform.Some members of the Health and Welfare Committee are questioning the rationality of rushing implementation without sufficiently accommodating industry concerns, and there is a growing sense that legislative mediation may be necessary if government–industry tensions escalate.An official from a ruling-party lawmaker’s office on the committee remarked, “There is concern that the policy of applying differential pricing to generics for domestic pharmaceutical companies that have expanded investment in new drug R&D was not sufficiently reflected in this drug pricing system, and we partially share that view. We are currently communicating with the pharmaceutical industry to determine whether the MOHW’s drug pricing system reform truly sends a policy signal encouraging competition based on innovation rather than rebates.”The official continued, “It's difficult for the National Assembly to hastily take on the legislative branch's mediation role before conflicts even arise. The domestic pharmaceutical industry has sufficiently voiced its opposition to the policy, and since the consultation process with the government is still ongoing, we need to observe the situation a bit longer. If the government implements the drug price reduction reform plan quickly and the resulting shock to the pharmaceutical industry is significant, then some level of incentive measures should follow to offset it to a certain extent."
- Policy
- MFDS establishes dedicated division to accelerate biosimilar reviews
- by Lee, Tak-Sun Jan 05, 2026 10:39am
- The establishment of a dedicated division for biopharmaceutical approvals is expected to accelerate the review process for domestically developed biosimilars.The Biopharmaceutical Approval Division has been formally incorporated into the Biopharmaceuticals and Herbal Medicine Bureau. With the Biologics Approval Task Force (TF), which began operations in 2024, having been elevated to a permanent division, the review of related products is expected to gain momentum, alongside last year's increase in biosimilar fees.According to the Ministry of Food and Drug Safety (MFDS) on the 1st, the Biopharmaceutical Approval Division was newly established as of the 30th of last month. Hyun-jung Park, a senior civil servant who previously led the TF, has been appointed as division director.Notably, the Biopharmaceutical Approval Division is expected to focus on shortening biosimilar review periods by organizing dedicated teams to review each product.The biosimilar approval review fee was raised last September from the previous KRW 8.03 million to KRW 310 million. The MFDS has stated that it aims to significantly reduce approval timelines using the additional resources secured through the fee increase.Hyun-jung Park, Director of the Biopharmaceutical Approval DivisionDuring a recent presidential policy briefing, MFDS Minister Yu-kyoung Oh announced plans to reduce the average review period for new drugs and biosimilars to 240 days. The current average review timelines are 420 days for new drugs and 406 days for biosimilars. If achieved, this would effectively cut review periods by nearly half.The key to shortening review timelines lies in operating dedicated review teams. By concentrating reviews on a per-product basis, the MFDS aims to eliminate unnecessary delays. The Biopharmaceutical Approval Division is expected to play a central role in this effort.The Ministry of Food and Drug Safety (MFDS) introduced a new expedited review system last year alongside increased fees for new drugs. This system involves forming dedicated product teams (18 members) incorporating specialized personnel for new drug approvals, prioritizing the review of Good Manufacturing Practice (GMP) reviews, and providing customized face-to-face meetings both before and after marketing authorization applications.The establishment of the Biopharmaceutical Approval Division is widely interpreted as an effort to extend this expedited review framework to biopharmaceuticals. All 13 members of the former Biologics Approval TF have been transferred to the new division.Since 2024, the Biologics Approval TF has been responsible for handling approval-related petitions, including preliminary reviews, coordination requests (covering GMP, review processes, risk management plans, and patent issues), issuance of requests for additional data, and approval of extensions for response periods when necessary, and coordination of responses from relevant departments.
