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- 2026-04-06 18:37:23
- 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.”
- Company
- Pharma exports to the Middle East reach $570M
- by Kim, Jin-Gu Mar 05, 2026 05:30pm
- AI-generated image As military tensions in the Middle East escalate following the United States’ attack on Iran, the pharmaceutical and biotech industry is closely monitoring developments.While export volumes to Iran and other directly involved countries remain limited, concerns are emerging that major export markets, including Türkiye, could contract if the conflict spreads to neighboring regions. Observers also note that indirect burdens could increase due to heightened volatility in energy prices and exchange rates.According to the Korea Customs Service on the 3rd, exports of Korean pharmaceuticals to 15 Middle Eastern countries (Syria, Bahrain, Saudi Arabia, United Arab Emirates, Yemen, Oman, Jordan, Iraq, Iran, Israel, Egypt, Qatar, Kuwait, and Türkiye) totaled USD 569.07 million (approximately KRW 830 billion) last year.Since 2018, annual pharmaceutical exports to the Middle East have consistently exceeded USD 500 million. Exports peaked at USD 723.79 million in 2020 before entering a gradual decline. Last year’s figure marked a 4.3% decrease compared to the previous year.As of last year, the Middle East accounted for 6.5% of total Korean pharmaceutical exports. This represents a steady decline from 15.7% in 2018. The trend reflects stagnant exports to the Middle East alongside expanding exports to the United States and Europe.Exports to Iran remain minimal. Last year, shipments to Iran totaled just USD 3.17 million (approximately KRW 4.6 billion). Iran has long been subject to secondary sanctions by the United States. Direct transactions may restrict access to dollar settlements and U.S. financial networks, leading Korean companies to rely primarily on indirect export channels.Similarly, exports to neighboring countries where retaliatory actions by Iran have been confirmed or anticipated, including the United Arab Emirates, Bahrain, Jordan, Kuwait, Qatar, and Saudi Arabia, each amounted to less than USD 50 million, indicating relatively limited exposure.However, if the conflict spreads to neighboring countries, it could directly impact pharmaceutical export performance. Türkiyestands out as a key variable. Türkiyewas the seventh-largest destination for domestic pharmaceutical exports last year. A full 67.5% of exports to the Middle East are concentrated in this country. Last year's exports alone reached USD 384.28 million (approximately KRW 560 billion). Under these circumstances, any disruption in shipments to Türkiye could translate into an overall decline in pharmaceutical exports.Heightened alert over indirect impacts, such as rising costs and exchange ratesThe pharmaceutical industry is also closely watching the potential indirect effects of a prolonged conflict. While short-term export disruptions may be limited, uncertainty across cost structures and supply chains could increase.In particular, concerns are mounting over rising energy costs amid the growing possibility that Iran could block the Strait of Hormuz. If crude oil prices increase, this could trigger a chain reaction affecting not only factory operating expenses but also the prices of intermediate goods and raw materials.For the pharmaceutical industry, which heavily relies on petrochemical-based raw materials, this could lead to increased manufacturing cost burdens. If the situation prolongs, there is an analysis suggesting delays in the supply schedules for some equipment, reagents, and raw materials.Increased volatility in foreign exchange markets is another burden factor. Should the strength of the U.S. dollar persist, upward pressure on the won–dollar exchange rate is expected. The Korean pharmaceutical industry is heavily dependent on imported active pharmaceutical ingredients (APIs), meaning that a weaker won directly raises production costs. Although a significant share of APIs is sourced from China, transactions are typically settled in U.S. dollars, leaving companies vulnerable to exchange-rate fluctuations.On the 28th of last month (local time), the United States and Israel launched a large-scale airstrike targeting missile bases and command centers within Iran. Iran has warned of a major retaliation, especially following the death of Supreme Leader Khamenei, a core figure of the Iranian regime. Iran has initiated retaliatory airstrikes against nearby U.S. bases and announced a policy of mobilizing all means, including the closure of the Strait of Hormuz.
- 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.
- Company
- IgA nephropathy drug Vanrafia soon to be introduced to Korea
- by Eo, Yun-Ho Mar 05, 2026 05:30pm
- Vanrafia, a new treatment for the rare kidney disease IgA nephropathy, may soon enter the Korean market.According to industry sources, Novartis Korea recently submitted a marketing authorization application to the Ministry of Food and Drug Safety (MFDS) for Vanrafia (atrasentan), a treatment for adults with primary IgA nephropathy (IgAN) with a urinary protein-to-creatinine ratio (UPCR) of 1.5 g/g or higher.Vanrafia was designated an orphan drug in Korea in August last year and previously received accelerated approval from the U.S. Food and Drug Administration (FDA).The drug is a once-daily oral non-steroidal therapy that can be used in combination with supportive treatment, including renin–angiotensin system (RAS) inhibitors, and may also be used in combination with sodium-glucose cotransporter-2 (SGLT-2) inhibitors.Vanrafia demonstrated efficacy in an interim analysis of the Phase III ALIGN study. However, the study has not yet confirmed whether the drug can slow the decline of kidney function in IgAN patients.In the ALIGN study, patients receiving Vanrafia in combination with RAS inhibitors experienced a clinically meaningful and statistically significant 36.1% reduction in proteinuria compared with the placebo group. This effect was observed as early as 6 weeks and was sustained for 36 weeks.The effect of Vanrafia on UPCR was consistent across subgroups in the primary study cohort, including differences in age, sex, race, estimated glomerular filtration rate (eGFR), and baseline proteinuria.IgA nephropathy is a progressive, rare autoimmune kidney disease in which the immune system attacks the kidneys, often causing glomerular inflammation and proteinuria.Up to 50% of IgAN patients with persistent proteinuria progress to kidney failure within 10 to 20 years after diagnosis, eventually requiring maintenance dialysis or kidney transplantation. Treatment responses can vary among patients.
- 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.
- Company
- Amvuttra for multiple neuropathy now prescribed at hospitals
- by Eo, Yun-Ho Mar 04, 2026 05:41pm
- A RNAi-based drug, 'Amvuttra,' currently seeking reimbursement listing, has entered the prescription area of general hospitals.According to industry sources, the new drug Amvuttra, a treatment for hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN), introduced to the Korean market by Medison Pharma Korea, has passed the drug committees (DC) of tertiary general hospitals, including Seoul Samsung Medical Center and Sinchon Severance Hospital.Medison Pharma is currently negotiating with the National Health Insurance Service (NHIS) for the drug price. Accordingly, once this drug is listed, it is expected to proceed quickly to prescription. Amvutra previously passed the Health Insurance Review and Assessment Service's (HIRA) Drug Reimbursement Evaluation Committee in December last year.Furthermore, Medison Pharma is currently operating Amvuttra's Expanded Access Program (EAP) for patients.Amvutra was designated as an orphan drug by the Ministry of Food and Drug Safety (MFDS) in November 2023 and received final approval in November last year.Amvutra is administered by subcutaneous injection once every 3 months. This drug targets and silences specific messenger RNA (mRNA), thereby blocking the production of both wild-type and mutant transthyretin (TTR) protein.The efficacy of Amvutra was demonstrated through the HELIOS-A Phase 3 study. The Phase 3 trial enrolled 164 patients with hATTR-PN and polyneuropathy across 22 countries. These patients were randomly assigned to either the Amvutra group (122 patients), receiving 25mg via subcutaneous injection every three months, or the 'Onpattro (patisiran)' group (42 patients), receiving 0.3mg/kg via intravenous injection every three weeks.Amvutra's efficacy was assessed by comparing its data with placebo data from the APOLLO study, which evaluated the efficacy and safety of Onpattro in a patient population similar to that in HELIOS-A.As a result, during the 9-month treatment period, the Amvutra group experienced less severe neurological impairment and showed improved quality of life compared to the placebo group. In the 10-meter walk test, which assesses a patient's walking speed and motor ability, the time taken by the vutrisiran group showed almost no change. NT-proBNP, a biomarker used to evaluate cardiac function, also showed improvement.Meanwhile, hATTR-PN, which affects approximately 1 in 100,000 people, is a disease caused by mutations in the transthyretin gene. It is characterized by systemic multiple autonomic neuropathies, including cardiac, gastrointestinal, and ophthalmic. Vyndaqel stabilizes the transthyretin protein.Generally, symptoms such as pain, paresthesia, and paralysis begin in the lower extremity nerves, where abnormal proteins tend to accumulate, eventually spreading to the upper body and affecting other organs, such as the heart, kidneys, and eyes. Life expectancy is 7 to 12 years on average from the onset of symptoms.
- InterView
- [Reporter’s View] Polypharmacy management no longer a pilot project
- by Jung, Heung-Jun Mar 04, 2026 05:41pm
- Launched in 2018 as the “Proper Medication Use Support Program,” the National Health Insurance Service’s polypharmacy management project has now entered its ninth year.Although it remains designated as a pilot program, the time has come for the government to make the decision and transition it into a full-scale program.With the Integrated Care Support Act taking effect this year, the government must expand community-based medical and care services. This is a critical window to formally incorporate the polypharmacy management program, which has long remained outside the institutional mainstream.Elderly individuals who require integrated care services often take multiple medications due to frequent hospitalizations or outpatient visits. To achieve a truly home-centered, integrated care model, proper management must begin at an earlier stage.In other words, minimizing medication-related issues that arise (or may arise) as elderly patients move between medical institutions and home is essential to improving the overall quality of home-based services.For this reason, the hospital-based polypharmacy management model should be prioritized for transition to a full-scale program. Since 2020, participation and patient coverage have steadily expanded, while multidisciplinary collaboration among physicians, pharmacists, and nurses has become well established.Because the program operates through inpatient/discharge and outpatient models, it can significantly contribute to managing patients returning to their residences after receiving medical services.If the support is integrated care for elderly patients who have already received primary management, local governments can provide the service relatively easily. It also enables a smoother link between hospital-based and community-based models.The effectiveness of the polypharmacy management program has been sufficiently demonstrated over the past 9 years. Research results show not only a reduction in the risk of adverse drug reactions but also cost savings.Considering the financial benefits from reduced patient readmissions and additional outpatient visits, the budget required for full-scale implementation would not be substantial.At a time when the sustainability of the national health insurance system is becoming increasingly important, strengthening polypharmacy management can serve as a safeguard against unnecessary spending. While expanding participating institutions remains important, the program should now be scaled into a nationwide service through full implementation.A pilot program is meant to test effectiveness and reduce trial and error. After 9 years of validation, it is now time to transition to full-scale implementation, starting with the hospital model and gradually incorporating insurance funding.
- Policy
- Pharma exports surpassed $10 billion threshold
- by Lee, Jeong-Hwan Mar 04, 2026 05:41pm
- Lee Hyung-hoon, Second Vice Minister of MOHWIn 2025, South Korea's bio-health industry export sales reached a record high of KRW 27.9 billion. The Ministry of Health and Welfare (MOHW) met with exporting companies to listen to industry voices and gather opinions on support measures.Notably, pharmaceutical exports surpassed the $10 billion threshold for the first-time last year, recording $10.4 billion.This figure represents an approximately ten-fold increase over the past ten years as biopharmaceuticals, which account for 62.6% of pharmaceutical exports, expanded their export markets, focusing on the United States and Europe.Lee Hyung-hoon, Second Vice Minister of MOHW, held a corporate briefing on the activation of bio-health industry exports at City Tower in Seoul at 2:00 PM on the 3rd. Lee encouraged the efforts of export company officials and promised to strengthen support.After sharing industry trends, Vice Minister Lee sought government support measures by listening to difficulties in the field.Among pharmaceutical companies, Samsung Biologics, GC Biopharma, HK inno.N, and Alteogen attended. In the medical device field, CGBio, Vuno, Meerecompany, and Wontech attended.The briefing began with presentations on the 2026 outlook and export activation support plans, followed by officials from each exporting company presenting the difficulties they face and proposed policy improvement measures. It concluded with a free discussion for all attendees.◆2025 export performance=Last year, the export value of the bio-health industry, including pharmaceuticals, biotech, medical devices, and cosmetics, reached $27.9 billion, an increase of 10.3% compared to the previous year, despite uncertain conditions such as tariffs. This recorded an all-time high and ranked 8th among South Korea's major industries.Specifically, in terms of last year's performance by major industry, semiconductors ranked first with $173.4 billion, followed by automobiles at $72.0 billion, general machinery at $46.9 billion, petroleum products at $45.5 billion, petrochemicals at $42.5 billion, ships at $31.8 billion, steel at $30.3 billion, and bio-health at $27.9 billion.Notably, pharmaceuticals surpassed $10 billion for the first time, recording $10.4 billion in exports and achieving their highest-ever performance.This is the result of biopharmaceuticals, which account for 62.6% of pharmaceutical exports, expanding their markets in the United States and Europe and increasing approximately tenfold over the past decade.By country, the United States, Switzerland, and Hungary were the major countries for exports, accounting for 39.5% of total exports and showing steady increases centered on advanced markets.The export value of biopharmaceuticals grew from $670 million in 2015 to $3.49 billion in 2020, and further increased approximately tenfold to $6.52 billion last year.Medical devices, including in-vitro diagnostic devices, shifted back into a recovery trend, and general medical devices also made progress with steady growth. By country, the United States, China, and Japan accounted for 33.1% of total exports, maintaining the top three positions.◆2026 export outlook=The MOHW announced an export target for the bio-health industry of $30.4 billion, a 9.1% increase compared to last year.This year's goals are $11.7 billion for pharmaceuticals (+12.4%), $6.2 billion for medical devices (+2.7%), and $12.5 billion for cosmetics (+9.5%).In pharmaceuticals, domestic biopharmaceuticals are expected to lead export growth, driven by the global expansion of the biopharmaceutical market and South Korea's position as the world's number one in Contract Development and Manufacturing Organization (CDMO) capacity.This is the outcome of the current status for biosimilar development following the patent expirations of 58 original biopharmaceuticals through 2032, and the encouragement of biosimilar prescriptions in the United States and the EU.In medical devices, export expansion is expected in advanced and emerging markets for ultrasound imaging diagnostic devices and X-ray equipment incorporating AI technology, as they increase diagnostic accuracy and efficiency, in line with trends in aging populations and the AI transition.To support export activation, the MOHW will invest KRW 233.8 billion, a 3.5-fold increase from last year, to overcome export uncertainties and actively foster the bio-health industry through investment promotion, supply chain strengthening, overseas regulatory response, consulting, marketing, and the establishment of local bases. ◆Pharmaceutical and bio field=The MOHW will strengthen competitiveness by creating an investment environment. Based on industry suggestions and analysis of past performance, the ministry will promote improvements to the innovative pharmaceutical company certification system for companies with excellent R&D investment and continue to form a KRW 1 trillion mega-fund to ensure that domestic drug pipeline-based new drugs reach global commercialization.Specifically, a new specialized fund of KRW 150 billion will be established this year to support Phase 3 clinical trials, which require the most capital during new drug development, and more than KRW 1 trillion in national health and medical R&D will catalyze expanding private R&D investment.The MOHW will also revitalize the industrial ecosystem by strengthening the pharmaceutical supply chain. To prepare for supply chain crises, the ministry will prepare an integrated stabilization response system, including securing raw materials and parts, supporting production facilities for drugs with unstable supply, and supporting the stockpiling of core medicines.First, it will support the stabilization of new biomaterials) and expand support for diversifying new raw material purchases (10 companies, KRW 1.5 billion). It will also support the production of drugs with unstable supply (4 companies, KRW 3.8 billion), the stockpiling of new core medicines (5 companies, KRW 500 million), and the advancement of manufacturing for new promising export medicines (15 companies, KRW 8.1 billion).To strengthen support for global entry and export diversification, the goal is to move beyond the generic and biosimilar stages that have been the center of the pharmaceutical industry and enter the global market, with a focus on innovative new drugs.The ministry plans to strengthen full-cycle support, including 'open innovation' based on cooperation, 'consulting,' the operation of domestic accelerator programs (inbound), and key global market entry (outbound).The "K-Biopharma Next Bridge" project will be introduced to facilitate collaboration between domestic companies with promising technologies and global leading companies with high interest in the Korean market. Open innovation growth programs will be operated one-by-one, and the provision of information on regulatory changes by country and consulting for patent, legal, tax, customs, and distribution channel diversification will be strengthened.Domestically, an accelerator program will be operated to increase the commercialization success rate of technology-based startups, support for companies occupying the Boston CIC to establish a bridgehead for US market entry will be expanded from 30 to 40 companies, and various networking activities to secure global sales channels will be strengthened through export consultations, the dispatch of market pioneer groups, and support for participating in global medical societies.◆Medical device =An innovation ecosystem will be created to strengthen competitiveness, centered on the Medical Device Comprehensive Support Center, which covers the entire cycle from R&D to commercialization and overseas entry. Utilizing the Medical Device Comprehensive Information System and MDCC, the MOHW will strengthen customized consulting support for companies and provide more professional information.The Medical Device Consulting Council (MDCC) consists of 202 external experts in eight fields, including licensing and systems, R&D and clinical trials, overseas entry, commercialization, and legal and accounting.Furthermore, the ministry will strengthen technology verification and market linkage for domestic companies through the global open innovation program "New Impact Korea," which promotes cooperation with global companies, hospitals, and investment institutions.By holding "MedTech Insight," which systematically provides industry trends, regulations, and market information, the ministry will support the development of strategies aligned with field demand and lay the foundation for sustainable growth in the domestic medical device industry.To increase the export potential of the domestic medical device industry, new projects to strengthen competitiveness will be expanded.Support will be provided for the commercialization of innovative technologies and the strengthening of the competitiveness of the next-generation surgical robot industry, including support for the rapid commercialization of AI-applied products and the construction of an AI-based surgical robot innovation lab from 2026 to 2030.Additionally, the MOHW will support clinical trials and real-world evaluations through professional consulting and medical staff matching by operating six hospital-based demonstration support centers this year, thereby facilitating the acquisition of clinical evidence and market entry in domestic and overseas markets.To strengthen market-tailored export support, specialized support for major overseas markets will be increased. To facilitate local-based global entry cooperation, the ministry will support 10 companies in the US bio cluster in Houston with company occupancy and provide up to KRW 200 million per company annually to cover regulatory response costs essential for overseas market entry.The MOHW will also help secure stable sales channels by supporting marketing and auxiliary export costs amid uncertainties in the international supply chain.Furthermore, from this year, the "Medical Device Global Education and Training Support" project for overseas medical staff will be promoted to expand experience with key Korean products through linked education with overseas medical institutions, training facilities, and international medical societies, thereby strengthening product reliability and the foundation for market expansion.
- Policy
- GMP “one-strike” rule to be eased… suspension introduced
- by Lee, Jeong-Hwan Mar 03, 2026 09:21am
- The National Assembly and the government are launching a comprehensive overhaul of the “one-strike out” (immediate revocation) system for pharmaceutical GMP (Good Manufacturing Practice) compliance violations.This approach introduces an intermediate regulatory step: adding a ‘GMP suspension’ penalty before immediate revocation, depending on the severity of violations related to the manufacturing record. The suspension period can be set for up to 6 months.At the same time, a new provision will mandate immediate revocation of GMP certification for companies that fail to prepare, properly retain, or intentionally discard GMP records, equating such conduct with obtaining certification through false or fraudulent means.The reform aims to address concerns that the current system, which focuses heavily on the ‘repeated nature’ of GMP manufacturing record violations by pharmaceutical companies, has led to some unreasonable penalties.On the 27th, Rep. Jongheon Baek of the People Power Party and Rep. Mi-hwa Seo of the Democratic Party of Korea jointly introduced amendments to the Pharmaceutical Affairs Act to rationalize GMP regulations.The bipartisan push for legislation to improve the GMP one-strike-out system was influenced by the Ministry of Food and Drug Safety (MFDS) commissioning and completing a research project based on industry complaints.Previously, amid incidents involving unauthorized manufacturing and falsified GMP records, the MFDS and the National Assembly strengthened GMP sanctions to prevent recurrence.As a result, the one-strike-out system for GMP compliance violations of pharmaceutical companies was implemented in December 2022 following National Assembly legislation.However, since the law's enactment, pharmaceutical companies whose GMP certifications were revoked by the MFDS have repeatedly filed administrative lawsuits challenging the decisions. As shortcomings in the system became apparent, calls for improvement emerged from both the pharmaceutical industry and the National Assembly.Complaints frequently arose that immediate revocation of GMP certification not only halts a pharmaceutical company's drug production lines but also causes significant operational damage to contract manufacturers tied to the penalized company, necessitating pre-revocation regulatory measures.Specifically, pharmaceutical companies criticized the current GMP one-strike-out system as excessive punishment. They argued it applies the criterion of ‘repeated false or erroneous record-keeping’ without considering the severity of the violation (such as falsifying manufacturing records), its impact on human health, or the presence of intent.Pharmaceutical companies pointed out that focusing solely on repetition for GMP certification revocation can result in lighter penalties for serious violations compared to minor infractions and does not adequately account for intent.Consequently, some companies reportedly resorted to intentionally not preparing or discarding GMP records to avoid revocation triggered by repeated documentation errors.In response, the MFDS initiated a research project on the GMP compliance certification system and advanced supplementary legislation in collaboration with the National Assembly.The core revision introduces ‘GMP certification suspension’ as an intermediate sanction between corrective orders and full revocation. This penalty will be applied based on the severity of the GMP violation and its impact on drug quality.Notably, companies that fail to prepare or retain GMP records will face immediate revocation, targeting attempts to evade penalties through deliberate non-documentation or record destruction.Additionally, a new intermediate regulatory measure was established, allowing for a 6-month suspension of GMP certification for relatively minor GMP violations.The MFDS and lawmakers Jong-heon Baek and Mi-hwa Seo, who proposed the bill, plan to collaborate on advancing GMP certification revocation regulations through swift legislation.
- Policy
- Will pharma be able to request 'records of administrative sanctions' during acquisition?
- by Lee, Jeong-Hwan Mar 03, 2026 09:21am
- A bill is being developed to grant pharmaceutical manufacturers that intend to acquire an existing pharmaceutical company the authority to request and receive records of administrative sanctions imposed on the previous owner (the former operator) by administrative authorities.This legislation aims to address the issue that the current law lacks a legal basis for an assignee to verify the assignor's history of administrative sanctions.Once the bill is passed, cases in which an assignee suffers unfair losses, such as managerial damage, by acquiring a pharmaceutical company without knowledge of existing administrative sanctions are expected to disappear.On February 27, 2026, Representative Park Hyeong-soo of the People Power Party proposed a partial amendment to the Pharmaceutical Affairs Act containing these details.Under the current law, when a new operator succeeds to the status of a former operator through business transfer, inheritance, or merger between corporations, the effects of administrative sanctions on the former operator are transferred to the assignee, except for cases of good faith acquisition.In other words, if a pharmaceutical company with finalized administrative sanctions is purchased, the responsibility and effects of those sanctions are transferred to the assignee rather than the assignor.Rep. Park raised concerns that if a pharmaceutical company is acquired without knowledge of any administrative sanction history, the assignee is forced to fulfill the existing sanctions, which can sometimes lead to a situation worse than not having acquired the company at all.Accordingly, Rep. Park introduced a bill that allows a person seeking to succeed to a pharmaceutical manufacturing business (a person intending to acquire a pharmaceutical company) to request the history of past administrative sanctions and details of administrative sanctions currently in progress from the Minister of Health and Welfare (MOHW), the Minister of Food and Drug Safety (MFDS), provincial governors, or heads of local governments (mayors, governors, or district heads).Rep. Park explained, "This bill allows assignees to check the records of administrative sanctions against the previous operator in advance, enabling them to make more rational decisions regarding the acquisition," adding, "The Anti-Corruption and Civil Rights Commission has also recommended establishing procedures to verify administrative sanctions, as cases of attempting to transfer businesses to evade administrative sanctions have become frequent."
