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- 2026-03-10 07:55:17
- Policy
- Adstiladrin receives expedited review in Korea
- by Lee, Tak-Sun Mar 09, 2026 08:53am
- The gene therapy for bladder cancer ‘Adstiladrin,’ developed by Swiss company Ferring Pharmaceuticals, has been selected for Korea’s GIFT program, enabling expedited regulatory review by the Ministry of Food and Drug Safety (MFDS).The drug is the world’s first gene therapy for bladder cancer and received U.S. FDA approval in 2022.The MFDS announced on the 6th that Adstiladrin (nadofaragene firadenovec) has been designated as a drug eligible for fast-track review. The designation date was February 4th.The therapy has been submitted for approval in Korea for the treatment of high-risk non–muscle-invasive bladder cancer (NMIBC) that is Bacillus Calmette-Guerin (BCG)-unresponsive with carcinoma in situ (CIS), with or without papillary tumors.The MFDS designated the drug for fast-track review, citing improved efficacy compared with existing treatments. It had previously also been designated as an orphan drug.Adstiladrin also underwent fast-track review during the U.S. FDA approval process, leading to its accelerated approval. The therapy exerts its antitumor effect through the expression of the interferon alpha-2b (IFNα2b) gene delivered via a non-replicating adenovirus vector, administered intravesically.The GIFT program is a Global Innovative products Fast-Track Review Program designed to support the development of innovative medical products in Korea and has been in operation since September 2022.Eligible products include innovative medicines targeting life-threatening diseases, rare diseases with no existing treatment alternatives, and new drugs developed by certified Korea Innovative Pharmaceutical Companies.The MFDS conducts a comprehensive evaluation of the candidates’ innovative therapeutic benefits, contributions to addressing public health crises, and the developer’s efforts, among other factors.Adstiladrin has been designated as GIFT No. 65. Among the 50 products approved under the GIFT program so far, 42 are orphan drugs.
- Policy
- Health and Welfare Committee to conduct inquiries on pending issues next week
- by Lee, Jeong-Hwan Mar 09, 2026 08:53am
- The ruling and opposition party leaders of the National Assembly's Health and Welfare Committee have agreed to hold a plenary session on the 10th of next week to receive this year's (2026) business reports and conduct inquiries on pending issues.The committee plans to hold the First and Second Subcommittees for Legislations on the 11th and 12th, respectively, to process pending legislation. Following this, the bills are expected to be approved during a plenary session on the 13th and forwarded to the Legislation and Judiciary Committee.Key issues to be highlighted during next week's plenary session include the findings regarding contaminated COVID-19 vaccines and the proposed restructuring of the drug pricing system, which includes price cuts for generics and preferential pricing for innovative pharmaceuticals.Other pressing topics include policies to strengthen regional, essential, and public healthcare, such as increasing medical school quotas, establishing new regional·public medical schools, and implementing a regional physician system.The opposition, led by the People Power Party, is expected to take issue with Minister of Health and Welfare Jung Eun Kyeong's failure to publicly announce cases of COVID-19 vaccines containing mold or foreign substances during her previous leadership as Commissioner of the Korea Disease Control and Prevention Agency (KDCA). They are likely to demand a parliamentary investigation.Rep. Kim Mi-ae, the executive secretary of the committee, along with Rep. Na Kyung-won and Rep. Shin Dong-wook, are strongly calling for Minister Jung’s immediate resignation. They are also demanding that the government drop its appeals against vaccine-related lawsuits and initiate a parliamentary investigation into the contaminated vaccines.Lawmakers from the Democratic Party also plan to question the announcement regarding the contaminated vaccine issue during next week's session. As the majority party, they are expected to counter the opposition's criticisms by emphasizing the necessity of vaccinations during the peak of the COVID-19 pandemic.Regarding the drug pricing restructuring, which the Ministry of Health and Welfare (MOHW) plans to implement in July following approval by the Health Insurance Policy Deliberation Committee this month, inquiries are expected to focus on whether the system adequately encourages and fosters innovation within the domestic pharmaceutical and biotech industry.In fact, Rep. Kim Yoon of the Democratic Party previously criticized the MOHW's plan as "too mechanical" and insufficient for rewarding the innovativeness of domestic pharmaceutical companies, and subsequently demanded the submission of a revised proposal.Despite persistent protests from the Korean pharmaceutical industry against the restructuring plan, the MOHW is maintaining its position in its policy to secure Health Insurance Policy Deliberation Committee approval in March.The MOHW plans to hold a one-point subcommittee meeting on the drug pricing restructure next week, followed by a final vote at the plenary session at the end of the month. Detailed calculation rates for generic drugs and preferential pricing measures for innovative pharmaceutical companies are expected to be finalized within this month.The MOHW has proposed reducing the generic pricing rate from the current 53.55% to the 40%, while the pharmaceutical industry views 48% as their bottom line or maximum acceptable cut.Furthermore, the industry argues that the criteria and mechanisms for preferential pricing must be significantly revised to reflect contributions to the development of the domestic industry and to the manufacturing, production, and distribution of high-quality medicines, in order to achieve the Ministry's policy goals.An official from a Health and Welfare Committee member’s office commented, "Since the New Year's business reports have been delayed and the bill subcommittees have not met properly for months, holding the standing committee in March is essential," adding , "The People Power Party has agreed to participate, and I understand that pending issues like the COVID-19 vaccine contamination played a role in that decision."
- Policy
- GSK’s Nucala-Omjjara enters pricing negotiations for reimb in Korea
- by Jung, Heung-Jun Mar 09, 2026 08:53am
- [GSK Korea’s new myelofibrosis drug Omjjara (momelotinib) and the eosinophilic disease treatment Nucala Autoinjector (mepolizumab) have entered drug price negotiations with the National Health Insurance Service (NHIS).In addition, Janssen Korea’s new multiple myeloma treatment, Darzalex SC injection (daratumumab), is also proceeding with price negotiations, the final stage of reimbursement listing.According to industry sources on the 6th, new drugs that passed the Drug Reimbursement Evaluation Committee (DREC) in January have entered the negotiation process with the NHIS.Both Omjjara and Nucala passed the DREC with the condition that reimbursement would be accepted only if the price is set below the committee’s evaluation amount. AI-generated imageOmjjara Tab (100, 150, and 200 mg) was deemed adequate for reimbursement as a treatment for intermediate- or high-risk myelofibrosis in adults with anemia. Nucala Inj was deemed adequate for reimbursement as an add-on maintenance therapy for the treatment of severe eosinophilic asthma in adults and adolescents that is inadequately controlled with existing treatments.With GSK receiving reimbursement approval for two new drugs simultaneously, expectations are rising on the possibility of their concurrent listing.Omjjara passed the Cancer Disease Deliberation Committee review last March but faced delays in reaching the DREC due to issues such as the selection of comparator drugs, requiring a resubmission. It cleared the DREC hurdle approximately 10 months after resubmission.Meanwhile, the Nucala Autoinjector, a new formulation of the drug, is a self-injectable device that allows patients to administer the treatment at home. If reimbursement coverage is expanded to include the self-injection formulation, Nucala’s prescription market presence is expected to grow.At the previous DREC meeting, both Omjjara and Nucala were approved with the condition that reimbursement is appropriate only if the company accepts a price below the evaluated amount. Since the pharmaceutical company has accepted this condition, negotiations with the NHIS are expected to focus on details such as the projected claims amount.Meanwhile, Janssen Korea’s Darzalex SC Inj was recognized as appropriate for reimbursement for ‘combination therapy with bortezomib, cyclophosphamide, and dexamethasone in newly diagnosed light-chain amyloidosis patients.’Unlike Omjjara and Nucala, Darzalex did not receive the “below evaluation price” condition from DREC, allowing it to proceed directly to price negotiations.Following its approval by the CDDC in the latter half of last year, the subcutaneous injection formulation of Darzalex is steadily gaining access to tertiary hospitals in Korea.
- Policy
- Pharmaceutical Act prohibiting non-face-to-face wholesaling
- by Lee, Jeong-Hwan Mar 09, 2026 08:53am
- The amendment to the Pharmaceutical Affairs Act, prohibiting non-face-to-face care platforms from concurrently operating as pharmaceutical wholesalers, is expected to be passed in its original form without revisions.Analysis suggests that related personnel, including Representative Choo Mi-ae, Chairperson of the Legislation and Judiciary Committee, and Representative Han Jeoung-ae, Chair of the Democratic Party's Policy Committee, have maintained a firm commitment to the original bill, which had been stalled at the plenary session for several months after being initially scheduled for processing late last year.The legislation had previously passed the Health and Welfare Committee and the Legislation and Judiciary Committee with agreement between both parties. However, it was repeatedly excluded from the plenary agenda due to opposition from certain lawmakers and the Ministry of Small Businesses and Startups.According to officials from the National Assembly and the pharmaceutical industry, the Pharmaceutical Act prohibiting non-face-to-face care platforms from concurrently operating as pharmaceutical wholesalers is likely to pass the National Assembly plenary session this month.The amendment is aimed at preventing conflicts of interest that arise when a non-face-to-face platform also acting as a wholesaler. If a platform acts as an intermediary for non-face-to-face treatment while also functioning as a wholesaler, a conflict of interest can arise. This is because the platform would be directly involved in prescribing, preparing, and distributing the medications it manages. Additionally, this setup raises concerns that the system could be misused as a method for providing rebates on illegal medications.Some Representatives characterized the bill as the "Doctor Now Prevention Act" and argued it would stifle innovation in the telemedicine sector. Accordingly, this bill was delayed for the National Assembly consideration.In this process, a sharp difference in positions between the relevant government agencies, the Ministry of Health and Welfare (MOHW) and the Ministry of SMEs and Startups, emerged, leading to suggestions that mediation by the Prime Minister's Office and the Office of the President was necessary.However, Ministry of Health and Welfare Minister Jung Eun Kyeong maintained firmly on passing the original version to ensure institutional safety and block market distortions. Within the Democratic Party, voices grew to maintain the original bill, with leadership emphasizing that revised proposals should not compromise the legislative process.In fact, ruling party lawmakers, including Democratic Party Chairman Jung Cheong-rae and Rep. Choo Mi-ae, visited the General Assembly of the Korean Pharmaceutical Association and promised to pass pharmacy-related legislation, including a bill to prevent intermediary platforms from concurrently operating wholesale businesses. Consequently, it is likely that the bill will be considered and processed during this month's plenary session.An official from a Democratic Party lawmaker’s office commented, "From the start, the bill that passed the Legislation and Judiciary Committee was not a matter where amendments should have been discussed, or its tabling in the plenary session was repeatedly excluded without a specific reason." The official added, "While there were some differing opinions within the party, the floor leadership stayed committed to passing the original version."
- Policy
- Rezurock, Fetroja reimbursed through Refund-type RSA
- by Jung, Heung-Jun Mar 06, 2026 08:44am
- The number of domestic pharmaceutical companies entering refund-type risk-sharing agreements (RSA) is gradually increasing. Following GC Biopharma’s Livmali solution in January, Jeil Pharmaceutical's Fetroja Inj has now signed a reimbursement contract.This brings the total number of domestic pharmaceutical companies that have signed Refund-type RSA contracts with the National Health Insurance Service (NHIS) to five, including Yuhan Corp, JW Pharmaceutical, and Handok.As of January and February this year, the number of domestic companies participating in Refund-type RSA has reached five. AI-generated imageAccording to the list of drugs eligible for refund-type RSA released by the NHIS this year, three new active ingredients signed contracts in January and February.In January, GC Pharma’s Livmarli solution (maralixibat chloride) for pruritus associated with Alagille syndrome signed a refund-type RSA contract. In February, Jeil Pharmaceutical’s gram-negative antibiotic Fetroja Inj (cefiderocol tosylate sulfate hydrate) and Sanofi Aventis’s third-line treatment for chronic graft-versus-host disease, Rezurock Tab (belumosudil mesylate), also entered refund-type RSA agreements.The listed prices were KRW 29,002,835 for Livmarli solution, KRW 210,097 for Fetroja Inj, and KRW 424,742 for Rezurock Tab.With additional refund contracts signed this year, the number of RSA refund-target drugs has reached 64 ingredients, or 115 products when dosage strengths are counted separately.Domestic companies that had previously signed refund-type agreements include Yuhan Corp for Leclaza (lazertinib), JW Pharmaceutical for Hemlibra (emicizumab), and Handok for Defitelio Inj (defibrotide), Vyxeos liposomal Inj, and Pemazyre Tab (pemigatinib).Among domestic companies, all except Yuhan Corp’s Leclaza are imported new drugs. The remaining 59 ingredients under refund agreements belong to drugs from 26 multinational pharmaceutical companies.With the addition of Rezurock, Sanofi now holds 5 RSA refund-type drugs, including four dosage forms of Dupixent and Rezurock.Among multinational pharmaceutical companies, AstraZeneca holds the largest number of RSA refund-type drugs, including Tagrisso, Lynparza, Imfinzi, Koselugo, Strensiq, and Fasenra. When dosage strengths are counted separately, AstraZeneca has 14 products under RSA refund contracts.
- Policy
- Padcev–Keytruda combo receives orphan drug designation for bladder cancer
- by Lee, Tak-Sun Mar 06, 2026 08:44am
- The Padcev–Keytruda combination therapy for bladder cancer has been designated as an orphan drug in Korea. Since orphan drug designation enables expedited review by the Ministry of Food and Drug Safety (MFDS), the timeline to commercial approval is expected to be shortened.On the 4th, the MFDS announced that it has designated three drugs, including the enfortumab vedotin–pembrolizumab combination therapy for bladder cancer, as orphan drugs.Enfortumab vedotin is the generic name of Padcev, an antibody-drug conjugate (ADC) developed by Astellas. Pembrolizumab is the generic name of Keytruda, the immuno-oncology drug developed by MSD.The newly designated orphan indication is muscle-invasive bladder cancer in the perioperative setting for patients ineligible for cisplatin-containing chemotherapy (limited to cases where both components are administered in combination).This indication was approved by the U.S. FDA in November last year. Results from the KEYNOTE-905 clinical trial, which evaluated the combination therapy of the two drugs for bladder cancer, showed that the combination of Padcev and Keytruda improved event-free survival (EFS) by 60% compared to the control group (NR. vs 15.7 months; HR 0.40; 95% CI 0.28–0.57; P<.001), and overall survival (OS) improved by 50%. The pathological complete response rate (pCR) was also significantly higher in the Padcev-Keytruda combination group.It appears that the company applied for domestic approval following FDA approval. If the combination therapy receives commercial approval, patient access to treatment is expected to improve substantially.The orphan drug designation also includes nirogacestat (tablet) and tovorafenib (oral formulation).Nirogacestat is a drug indicated for the treatment of desmoid tumors, marketed under the brand name Ogsiveo by Merck.SpringWorks Therapeutics, a healthcare affiliate of Merck, received approval for the oral gamma-secretase inhibitor Ogsiveo from the European Commission (EC) in August last year as monotherapy for adults with progressing desmoid tumors requiring systemic treatment.Ogsiveo is the first and only therapy approved in the European Union for the treatment of desmoid tumors.Tovorafenib is a treatment for pediatric low-grade glioma (pLGG). It is a type II BRAF inhibitor developed for pediatric low-grade glioma patients with BRAF gene mutations. Marketed as Ipsen's ‘Ojemda,’ the drug received U.S. FDA approval in 2024. It is expected to provide a new treatment option for pediatric brain tumor patients who have failed existing therapies.Designation as an orphan drug shortens the approval period through expedited review. Beyond conditional approval and fee reductions, submission requirements are simplified, including exemptions from bridging studies, and a fast-track approval process is conducted through priority review.
- Policy
- Implementation of the drug price reform may be delayed to next year
- by Lee, Jeong-Hwan Mar 05, 2026 05:30pm
- The Ministry of Health and Welfare plans to finalize its drug pricing reform proposal that focuses on lowering prices of already-listed generics while granting pricing incentives to innovative pharmaceutical companies through a special one-point meeting of the Health Insurance Policy Deliberation Committee (HIPDC) review in early to mid-March.However, the government is reportedly considering postponing the implementation timeline from the originally planned July this year to January next year.The significant backlash from the domestic pharmaceutical industry against the drug pricing reform plan appears to be the reason the MOHW decided in February to postpone submitting it to the HIPDC subcommittee and plenary session, and is now reviewing whether to defer the implementation date from July this year to next year.Nevertheless, the MOHW remains steadfast in its plan to submit the drug pricing system reform proposal, which contains specific generic drug calculation rates, to the HIPDC this month (March) to finalize the drug pricing policy direction.A ministry official said on the 3rd, “It is true that we are reviewing a plan to postpone the implementation of the drug pricing system reform plan until next year, but we will complete the submission and vote on the reform proposal at the HIPDC this month.”In effect, even if implementation is delayed, the policy framework itself is expected to be finalized soon. This means the calculation rate for generic drug price reductions and the detailed regulations for preferential pricing for innovative pharmaceutical companies will be determined at this month's meeting.Currently, the ministry has proposed lowering the price calculation ratio for already-listed generics from the current 53.55% to the 40% range. The reform proposal also includes pricing incentives depending on whether a company is certified as an “innovative pharmaceutical company,” while allowing non-certified firms to receive preferential pricing based on their clinical trial performance and contribution to supplying drugs with unstable supply.Domestic pharmaceutical companies have criticized the proposal, arguing that it fails to adequately reward firms that invest in facilities for high-quality drug production and in innovative R&D for new drugs. They contend that it instead imposes the same level of price reduction shock on companies that have made no such investments and focused solely on generating revenue through contract generic production.Particularly regarding the MOHW's decision to finalize the drug pricing system reform plan at the March HIPDC meeting and postpone its implementation from July this year to next year, the domestic pharmaceutical industry is criticizing that “the specific policy content matters far more than delaying the implementation date.”They argue that if the government reduces the generic pricing ratio to the 40% range, companies may abandon the production of low-margin drugs, leading to job losses and reduced capacity for new drug R&D.Based on the current 53.55% generic drug pricing rate, the position of most domestic pharmaceutical companies is that the MOHW must set the rate at a minimum of 48% to allow them to maintain reasonable operations without changing their current business status.In particular, mid-sized and top-tier pharmaceutical companies, including those certified as Korean innovative pharmaceutical companies, state that the Korean pharmaceutical and biotech industry can only grow if drug prices for companies that have sustained value-based investments for decades are preserved, while prices for contract-manufactured generic-focused companies that have made no investments are significantly reduced.In other words, they insist the reform must move away from across-the-board mechanical price cuts and adopt a differentiated system reflecting actual investment and contribution.This is why attention is rising on whether the reform will include measures that foster innovative R&D environments crucial to the growth of the Korean pharmaceutical industry.As a result, the pharmaceutical industry is closely watching the detailed direction and revisions of the reform proposal expected to be presented at the one-point HIPDC meeting in early to mid-March.In the National Assembly, lawmakers like Yoon Kim of the Democratic Party of Korea have pointed out the incompleteness of the MOHW's drug pricing reform plan and called for a revised plan.While praising the Lee Jae-myung administration for deciding on the first significant overhaul of the domestic drug pricing system since the 2012 blanket generic price cuts, Rep. Kim also raised the need for a ‘more refined reform plan’.He argued that generic drug prices should be adjusted more carefully by therapeutic class, referencing price levels in 8 countries already being referenced by Korea.However, the drug pricing system reform plan announced by the MOHW on November 28 last year involves a blanket adjustment of approximately 40% for drugs whose prices have seen little change since the 2012 blanket price cuts.Rep. Kim has urged the MOHW to submit a revised proposal that sets differentiated reduction rates by therapeutic class instead of applying uniform cuts.Rep. Kim stated, “To enhance the innovation of the pharmaceutical industry through drug pricing policy, drug price reform should not be a standalone policy but part of a package policy that can foster innovative pharmaceutical companies. The core issue is not simply price cuts but addressing excessive marketing competition through CSOs, curbing the proliferation of generics, and identifying price distortions created by competition centered on selling and administrative expenses.”The pharmaceutical industry points out that the MOHW's approach of simply assigning different drug price premiums and preferential rates based solely on whether a company is certified as an innovative pharmaceutical company is overly crude and risks creating a distorted pharmaceutical industry landscape.The point is that promoting innovative R&D should not automatically translate into preferential treatment solely for companies with official certification.A drug pricing manager at a mid-sized domestic pharmaceutical company expressed, “The MOHW's drug price reform plan concentrates all benefits on certified innovative pharmaceutical companies. Ultimately, these innovative pharmaceutical companies are defined by the proportion of new drug R&D relative to total sales. It's questionable whether the standard for innovation can be determined solely by the R&D ratio.”This manager added, “It is highly inappropriate to select innovative pharmaceutical companies and grant benefits exclusively to them based on this criterion when the government and the pharmaceutical industry have not mutually agreed on the definition or standards of innovation. The reform plan must adequately reflect that pharmaceutical companies not certified as innovative are also striving for the development of the domestic pharmaceutical industry and overseas exports through high-value-added new drugs or improved new drugs. As it stands, it is unfair.”Another pricing executive at a large pharmaceutical company commented, “The current proposal effectively cuts prices uniformly without distinguishing between companies that invested in high-quality generic production and those that generated profits through contract generics and aggressive marketing without real investment. If the goal is to reward companies that contribute through new drug R&D, high-quality manufacturing, or stabilizing supply, the reform must introduce a differentiated pricing system that significantly lowers prices for companies that make no such contributions.”
- Policy
- ‘Forcing 40% generic drug price cut will kill the industry’
- by Lee, Jeong-Hwan Mar 05, 2026 05:30pm
- “If the generic price calculation rate is cut to 40%, companies will inevitably halt new drug research and development (R&D). Also, they will also stop producing medicines that are not profitable, even if they are designated as essential medicines or market-withdrawal prevention drugs. Companies will likely proceed with workforce restructuring to remove what they see as unnecessary personnel, which will worsen employment instability. While the pharmaceutical industry understands the government’s goal of strengthening the sustainability of the national health insurance system, , the absolute limit we can accept is 48%. Even lowering the current rate of 53.55% by more than 5 percentage points will cause considerable management losses and shock.”Although the MOHW has decided to postpone the implementation of its drug pricing system reform plan that focuses on generic drug price cuts and preferential pricing for innovative pharmaceutical companies until next year, the pharmaceutical industry has emphasized the need for revisions, stating that ‘the details matter more than the timing.’Multiple pharmaceutical companies have criticized the MOHW's proposed reform plan, arguing it fails to create a structure that properly values companies that have consistently invested in producing high-quality medicines, improving R&D capabilities for incrementally modified drugs and new drugs, and contributing to the stable supply of pharmaceuticals.In particular, while the industry understands the government’s intention to reduce drug prices to cut healthcare spending, many companies suggest that the maximum acceptable generic pricing rate would be 48%.This represents a 5.55 percentage point reduction from the current 53.55% calculation rate, equivalent to a roughly 10% drug price reduction when the generic calculation price is set at 100. The intent is to indicate that, while maintaining current operations and accepting the MOHW's policy, they can only tolerate a price reduction level of up to 10% when calculating the administrative shock impact on sales revenue and other factors.On the 4th, pricing managers at domestic pharmaceutical companies did not offer particularly positive assessments upon hearing that the MOHW is considering delaying the implementation of the drug pricing system reform plan until January next year.This is because, even looking at the implementation plan for the drug pricing system reform announced on November 28 last year, it was foreseeable that the timing for major policy implementations, such as drug price reductions, would be next year.Industry officials say that the specific details of the reform to be finalized at this month’s Health Insurance Policy Deliberation Committee (HIPDC) are far more important than the implementation schedule.The industry criticizes that the reform plan confirmed by the HIPDC must include measures that can fundamentally improve the domestic pharmaceutical industry's structure. They argue that the drug price preferential criteria and generic drug price reduction methods proposed by the MOHW thus far are essentially irrelevant to pharmaceutical industry innovation.Companies also say the government must significantly refine the criteria and tools used to evaluate a pharmaceutical company’s “innovation.”They argue that simply ranking companies based on whether they are certified as an “innovative pharmaceutical company or their R&D expenditure ratio relative to sales revenue to grant preferential drug pricing, or uniformly lowering generic drug prices, fails to accurately gauge the value of each company's true level of innovation.Pharmaceutical companies propose that the MOHW must establish and implement a drug pricing system reform plan that employs a multi-layered innovation assessment tool. They argue this would naturally lead to the elimination of ‘paper companies’ that contribute little to the development and innovation of the domestic pharmaceutical industry, while favoring drug prices for companies that diligently pursue value-based investment and sound management. This, they contend, would achieve the goal of pharmaceutical industry innovation.Furthermore, observations of advanced countries indicate that lowering the generic drug pricing rate to 40% may trigger the abandonment of domestic pharmaceutical production.Analyzing the cases of Japan and France, where the generic drug pricing levels are 40-50%, similar to the level proposed by the MOHW, Japan saw supply shortages and production discontinuation of 4,064 items (23.1% of generic items). Even in the French case published by the European Medicines Agency (EMA), only 15% of new generics are produced in France, and only 30% of all generic drugs are produced in the country.Given these precedents, the industry strongly advocates 48% as the maximum acceptable generic pricing rate, representing a 5.55 percentage-point reduction from the current 53.55% rate, but still significantly higher than the ministry’s proposed level in the 40% range.A representative from domestic pharmaceutical company A stated, “Contrary to the policy goal of prioritizing innovation value in the pharmaceutical industry, the MOHW's drug pricing system adopts a blanket price reduction approach. This structure means that companies with larger sales volumes and greater investment scale will incur proportionally larger absolute losses. A revised proposal must be developed to ensure that pharmaceutical companies that have contributed to the industry's development through clinical trial achievements, expansion of high-quality drug manufacturing facilities, advanced quality control, and hiring research personnel can gain a clear competitive advantage over paper companies.”Another official from pharmaceutical company B said, “If the government truly wants to build an innovative ecosystem for the pharmaceutical industry and strengthen health security, it must create clear criteria to identify companies that genuinely contribute to those goals and provide appropriate pricing incentives. If the generic pricing rate is reduced to the 40% range, this would cause immediate operational losses for pharmaceutical companies, creating shockwaves severe enough to prevent them from fulfilling new drug development, stable supply of essential medicines, and maintaining employment. Maintaining a minimum calculation rate of 48% is essential to ensure management is capable of sustaining innovation.”
- Policy
- Voluntary recall announced of Bayer's contrast agent 'Gastrografin'
- by Lee, Tak-Sun Mar 05, 2026 05:30pm
- Bayer Korea's GastrografinBayer Korea's contrast agent Gastrografin (amidotrizoic acid, meglumine, sodium hydroxide) is being recalled for its commercially distributed units due to concerns over excessive impurity detection. Bayer has suspended supply in South Korea as a preemptive measure.Gastrografin is a contrast agent used for gastrointestinal examinations, with an import value of $139,636 (KRW 206.18 million) as of 2024.The Ministry of Food and Drug Safety (MFDS) announced on the 26th of last month that it issued an operator recall for commercially distributed units of certain batch numbers of Bayer Korea's Gastrografin due to concerns over the detection of the impurity N-Nitroso-Meglumine exceeding permissible limits.The batch numbers subject to recall are MA04TPB, MA04RUS, MA04NK2, MA04NDM, MA04JX3, MA04H8X, MA048E7, MA043KK, MA040LT, and MA03VLL.Bayer stated, "During recent post-marketing stability testing, the potential formation of N-Nitroso-Meglumine, a nitrosamine byproduct, was identified. While this component was not detected during quality testing at the shipping stage, post-marketing stability results for some manufacturing units confirmed levels exceeding the European Medicines Agency (EMA) Acceptable Daily Intake (ADI) standards (calculated based on conservative guidelines for nitrosamine byproduct management)."The company added, "Bayer has decided to stop production immediately and voluntarily recall all manufacturing units currently in circulation (Class II) as a preemptive measure. Depending on clinical judgment, alternative use of broadly approved low-osmolality iodinated contrast agents is possible."Furthermore, they explained, "The cause of the component's formation is under investigation, and production of new batches will be temporarily suspended until the investigation is complete. At this point, it is difficult to predict when the supply of Gastrografin will resume."Additional products are being recalled due to excessive impurity levels. CMG Pharm's Tratol Inj (tramadol hydrochloride) has been recalled for batch numbers 23001, 23002, 23003, 24001, 24002, 24003, 24004, 24005, and 24006. The official announcement date was the 27th of last month.Tratol Inj is used for severe and moderate acute or chronic pain (such as various cancers) and for pain following diagnosis and surgery. Its production performance in 2024 was 49.82 million KRW.Meanwhile, certain units of Samchandang Pharm's S-Porin Eye Drops 0.05% (cyclosporine) are being voluntarily recalled following the discovery that the outer packaging and the contents differ.The batch number for the recalled product is 25004. The production performance of this product in 2024 was KRW 1.2 billion. The recall was officially announced on the 27th of last month.Additionally, Jeil Pharmaceutical's diabetes treatment, Linatin Tab (linagliptin), has been recalled voluntarily due to deviations from standards in certain categories (active ingredient content) during post-marketing stability testing. The MFDS announced this as of March 3.The recalled batch numbers are FLEA601, FLEA602, FLEA603, FLEA701, FLEA702, FLEA703, FLEA704, FLEA705, and FLEA801. The production performance of this product in 2024 was KRW 651.16 million.
- Policy
- MFDS ‘GMP revocation system reform and ongoing litigation are separate matters’
- by Lee, Tak-Sun Mar 04, 2026 05:41pm
- AI-generated imageAs the Ministry of Food and Drug Safety (MFDS) moves forward with legislative revisions to the GMP certification revocation system in cooperation with the National Assembly, it has clarified that the changes will not apply to pharmaceutical companies that previously had their GMP certifications revoked.The ministry also drew a clear line regarding companies currently engaged in litigation, stating that the institutional reform is separate from ongoing lawsuits.According to the MFDS on the 3rd, the proposed amendment to the Pharmaceutical Affairs Act, jointly introduced on the 27th of last month by Rep. Jong-heon Baek (People Power Party) and Rep. Mi-hwa Seo (Democratic Party of Korea), reflects findings from last year’s research on improving the GMP certification revocation system.The GMP revocation system, implemented in December 2022, is a so-called “one-strike out” rule under which the MFDS revokes GMP certification for manufacturing sites that seriously violate Good Manufacturing Practice standards or repeatedly falsify manufacturing and quality records.The MFDS revokes GMP certification or changes compliance determinations if they were obtained through ‘false or fraudulent’ means or if manufacturing/quality management records were ‘repeatedly’ falsified or incorrectly documented.Additionally, it issues a ‘correction order’ if there is a risk of quality impact due to the lack of detailed standards or procedures for GMP compliance.The industry has previously argued that penalties under this system are excessively harsh, while also pointing out that criteria such as ‘repeated’ within the legally stipulated regulations lack clarity.Therefore, this amendment to the Pharmaceutical Affairs Act introduces intermediate regulations that allow for the suspension of GMP certification for up to 6 months and corrective orders to be issued, depending on the severity of the violation, when simple errors occur in GMP record-keeping or when there are minor issues in GMP compliance or operation.Furthermore, a new regulation has been established stipulating that pharmaceutical companies that fail to create or retain GMP records will have their certification immediately revoked, similar to cases of false or fraudulent certification. This aims to prevent deliberate failure to prepare GMP records to evade certification revocation.Since the revocation system took effect, GMP certification revocations were notified to 8 companies as of last October, beginning with Hutecs Korea. Of these, 5 companies are currently pursuing administrative litigation, while penalties for 3 have been finalized.An MFDS official stated, “In principle, the amendment to the Pharmaceutical Affairs Act cannot be applied retroactively. Companies currently involved in litigation may submit opinions regarding the amendment, but legislative changes and lawsuits are separate matters.”This suggests that the MFDS intends to continue defending its position in court against companies that have filed lawsuits.The MFDS official stated, “We understand that once this revised Pharmaceutical Affairs Act is promulgated, it is expected to take effect one year later. Accordingly, we plan to proceed with revising the details in accordance with the legal provisions through amendments to the Prime Ministerial Decree (Regulations on the Safety of Pharmaceuticals).”The reason opposition lawmaker Jong-heon Baek of the People Power Party joined the MFDS in pursuing this amendment is that, after Baek spearheaded and passed the initial Pharmaceutical Affairs Act amendment addressing the revocation of GMP compliance certifications, the industry flooded the MFDS with requests for further revisions.In response, Rep. Baek’s office requested that the MFDS conduct research on potential improvements, ultimately leading to the current legislative proposal. The amendment is jointly sponsored by Rep. Mi-hwa Seo of the Democratic Party of Korea, reflecting bipartisan support for refining the system.
