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- 2026-05-01 00:26:33
- Policy
- Gilead’s Yescarta approved in KOR...3rd CAR-T therapy
- by Lee, Hye-Kyung Aug 14, 2025 06:13am
- The third CAR-T therapy has been approved in Korea. The Ministry of Food and Drug Safety approved Gilead Sciences Korea's Yescarta (axicabtagene ciloleucel) today (13th). Yescarta is a CAR-T therapy that received approval from the U.S. FDA in 2017 and the European EMA in 2018. Last year, the EMA approved it as a second-line treatment for patients with adult diffuse large B-cell lymphoma and B-cell acute lymphoblastic leukemia. In June, the FDA expanded the indication for Yescarta to include patients with follicular lymphoma. In Korea, after the drug was designated as an orphan drug by the MFDS in September last year, it has been undergoing the formal approval process. According to a brief issued by the Korea Biotechnology Organization, Yescarta is currently the CAR-T therapy with the highest market share worldwide. Posting sales of USD 1.5 billion (approximately KRW 2 trillion) last year, Yescarta ranked first with a 40% share of the entire CAR-T market. It was followed by Novartis' Kymriah posting USD 500 million (approximately KRW 700 billion), Johnson & Johnson's ‘Carvykti’ at USD 500 million, BMS's ‘Abecma’ at USD 470 million (approximately KRW 650 billion), and Gilead Sciences' ‘Tecartus’ at USD 370 million (approximately KRW 500 billion). Kymriah and Carvykti have already been granted marketing authorization in Korea. Meanwhile, according to an analysis presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, at a median follow-up of 47.2 months, the overall survival (OS) in the Yescarta treatment group had not yet reached the median, while the placebo group had a median OS of 31.1 months, indicating a statistically significant 27% lower risk of death with Yescarta. The estimated 48-month overall survival rate was 54.6% for Yescarta and 46.0% for the control group, with Yescarta demonstrating consistent survival benefits across pre-specified subgroups, including age, primary resistance, early relapse, and high-grade B-cell lymphoma.
- Policy
- New drug approval fees ₩410mil in KOR
- by Lee, Hye-Kyung Aug 13, 2025 06:07am
- Since the new drug approval fee was significantly increased to KRW 410 million starting this year, a total of 14 new products containing 10 ingredients have been submitted for approval. Although the specific product names cannot be disclosed, dedicated teams have been formed for 6 chemical drug substances and four biopharmaceutical substances, and the review process is currently underway. On the 12th, Young-joo Kim, Director of the Drug Approval Division at the Ministry of Food and Drug Safety, So-hee Kim, Director of the Director of the Cardiovascular Drug Division of the Drug Review Department, and Jae-ok Kim, Director of the Biological Products Division of the Bio and Herbal Medicine Review Department, met with specialized media journalists to provide an interim briefing on the new drug approval and review innovation process that began this year. , Young-joo Kim, Director of the Drug Approval Division at the Ministry of Food and Drug Safety, So-hee Kim, Director of the Director of the Cardiovascular Drug Division of the Drug Review Department, and Jae-ok Kim, Director of the Biological Products Division of the Bio and Herbal Medicine Review Department On January 1, the MFDS raised the new drug approval fee to KRW 41 million, formed dedicated teams for each item, expanded face-to-face consultations and reviews between companies and approval reviewers for items submitted for approval to a maximum of 10 times, and shortened the manufacturing and quality control evaluation and actual condition survey of new drug manufacturing facilities (to within 90 days). The increased approval fees were to be used mostly to hire high competency reviewers, and the MFDS has established a policy to operate a professional, swift, transparent, and predictable approval review system so that the process from new drug approval application to license issuance can be completed within 295 days. The new drug approval and review process begins with a pre-submission consultation, followed by the submission of a product license application. A dedicated team of approximately 15 members is then formed for each product. Actual meetings begin within 2 weeks of the submission of the application. GMP inspections for new drugs are also completed within 90 days of the submission date. On January 31, multinational pharmaceutical company Eli Lilly applied for marketing authorization for its new breast cancer drug “Inluriyo Tab (imlunestrant),” and a total of 10 substances are currently under review. While actual marketing authorizations are not completed in the order of application submission, for Inluriyo, if the innovative approval scheme for new drugs is applied, approval could be granted as early as November or by December at the latest. Director Young-Joo Kim stated, “While I cannot comment on the approval process for specific products, we are striving to complete the approval process within 295 days from the date of submission of the marketing authorization application in accordance with the new drug approval and review procedures. Despite the increase in new drug approval fees, we anticipate that the number of marketing authorization applications submitted will be similar to previous years.” As of August, applications for new drug approvals for 10 ingredients have been submitted, and based on the usual number of applications, applications for 20 ingredients were submitted in 2023 and 19 ingredients in 2024. The MFDS believes that if this trend continues, the number of item approval applications will remain similar to those of previous years. Kim added, “Until last year, when requests for supplementary data were made, everything was handled via documents. However, now, there are over 10 face-to-face meetings from preliminary consultations to supplementary data submission requests, and all of this process is documented.” However, despite the significant increase in fees, only 15 to 17 dedicated staff members are being assigned to expedite approvals. This is why, when a meeting is held regarding supplementary materials, everyone has to gather for a meeting lasting over an hour and a half. Director Jae-ok Kim explained, “One hour and a half may seem short, but when supplementary materials are submitted, pharmaceutical companies also select the points they want to focus on and ask questions. The meeting lasts about an hour and a half, with the purpose of the supplementary data request being explained and any questions being answered.” In the case of new drug approval fees, most of the increased amount will be used to cover the pay of high competency reviewers. Currently, there are 31 high competency reviewers hired specifically for the new drug team, which is close to the total quota of 36. The new drug dedicated team is composed of a team leader who is the head of the approval department, a product manager from the approval department, and specialists in safety and efficacy, quality control, GMP (good manufacturing practice), and GCP (good clinical practice), rendering the need to reinforce the specialized review staff. Director Young-joo Kim said, “With the increase in new drug approval fees, the cost of review is borne by the beneficiaries. The MFDS has a total of 370 reviewers, including those for medical devices, and about 10% of them are high competency reviewers.” However, as high competency reviewers are hired as public employees rather than civil servants, it is difficult for them to provide stable service. As a result, they may only receive training on high competency review techniques and move to other organizations within a few years. Director Jae-ok Kim added, “The current review staff is going through a transitional period. High competency reviewers cannot be immediately deployed; they must first undergo training, work as assistant reviewers, and then transition to head reviewers." He also pointed out that “this process is causing an overload of work for existing review staff.” Director So Hee Kim also emphasized, “Since the system is still in its initial stages, mid-level managers are facing significant challenges. While hiring high-skilled reviewers is important, expanding the pool of personnel capable of fulfilling mid-level management roles is also necessary.” In this regard, Director Young-joo Kim said, “It is important to enable high competency reviewers hired as public officials to be appointed civil servants,” adding, “We plan to consult with other ministries and request that the number of civil servants be continuously increased.” Although the MFDS is applying the new drug approval fee hike only to new drugs, it plans to gradually expand it to other items. President Jae-myung Lee's remarks also support this stance. At a recent cabinet meeting, the president stated, “Insufficient review costs and a shortage of personnel are causing delays in new drug approvals, which is a loss for society as a whole. Increasing review costs is a way to expand the budget without increasing the financial burden.” Director Young Joo Kim said, “The MFDS understands that the intention is not to further raise the new drug approval fees, but to expand the fees to items other than new drugs to increase revenue. We are in ongoing discussions with government ministries and related industries on items for which fees can be raised based on principles such as the novelty and complexity of the substance.”
- Policy
- Smokers at 54.5 times higher risk of SCLC than non-smokers
- by Lee, Tak-Sun Aug 12, 2025 06:13am
- A study has found that 30-year smokers have a 54.5 times higher risk of developing small cell lung cancer than non-smokers. The National Health Insurance Service (NHIS) Health Insurance Policy Research Institute announced on the 11th the results of a comparative analysis of cancer incidence risk and attributable risk by cancer type among individuals with the same level of polygenic risk score (PRS) and similar living environments, focusing on major cancers with high incidence rates in Korea. The study found that the risk of developing small cell lung cancer among current smokers (30 years or more, 20 pack-years or more) was 54.5 times higher than that of non-smokers, significantly higher than colorectal cancer (1.5 times), liver cancer (2.3 times), and stomach cancer (2.4 times higher). T Cancer risk according to smoking history (hazard ratio) This study was jointly conducted by the Health Insurance Policy Research Institute (Director Seongin Jeong) and Yonsei University Graduate School of Public Health (Professor Seon-ha Ji's research team). The study analyzed data from 136,965 participants who underwent health screenings at 18 private screening centers nationwide from 2004 to 2013, linking health screening results, polygenic risk scores (PRS), central cancer registry data, and health insurance eligibility data, and followed the participants until 2020. The analysis of cancer incidence risk showed that even when general characteristics, living environments, and PRS were at the same level, the incidence risk of smoking-related cancers (small cell lung cancer, squamous cell lung cancer, and squamous cell laryngeal cancer) was higher in the smoker group than that of other cancers. Compared to non-smokers, current smokers with a smoking history of “30 years or more and 20 pack-years or more” had a significantly higher cancer incidence risk: 54.5 times higher for small cell lung cancer, 21.4 times higher for squamous cell lung cancer, and 8.3 times higher for squamous cell laryngeal cancer. However, the risks were 2.4 times higher for stomach cancer, 2.3 times higher for liver cancer, and 1.5 times higher for colorectal cancer. The extent to which smoking contributes to the development of small cell lung cancer was found to be 98.2%, followed by 88.0% for squamous cell laryngeal cancer, and 86.2% for squamous cell lung cancer, confirming that smoking is the primary cause of the cancers targeted in the tobacco litigation. In contrast, the extent to which smoking contributes to the development of colorectal cancer is 28.6%, stomach cancer 50.8%, and liver cancer 57.2%, indicating that smoking contributes significantly less to these types of cancer compared to the cancers subject to litigation, and that other factors play a major role. Genetic factors contribute only 0.4% to the development of squamous cell lung cancer, whereas they account for 7.3% of colorectal cancer and 5.1% of stomach cancer, indicating that genetic factors have a significantly greater influence on these cancers compared to squamous cell lung cancer, with respective differences of 18.3 times and 12.8 times. Sunmi Lee, Director of the Health Insurance Policy Research Division at the Health Insurance Policy Research Institute, emphasized, “The results of this study show that smoking contributes significantly more to the development of lung cancer and laryngeal cancer compared to other types of cancer, while genetic factors play an extremely minor role. This further clarifies the causal relationship between smoking and the development of lung cancer and laryngeal cancer.”
- Policy
- Will RSV vaccines be included in the NIP?
- by Whang, byung-woo Aug 08, 2025 06:03am
- With the RSV (respiratory syncytial virus) vaccine being released in Korea this year, interest in its inclusion in the National Immunization Program (NIP) has been gaining attention. According to the National Assembly's legislative information system, on the 6th, Rep. Yong-ki Jeon of the Democratic Party of Korea introduced a bill titled “Partial Revision of the Infectious Disease Control and Prevention Act,” which contained provisions on including RSV in the NIP. Rep. Jeon explained, “The current law stipulates diseases subject to mandatory vaccination for the prevention of infectious diseases with high prevalence rates and frequent outbreaks. For influenza, a representative disease subject to mandatory vaccination, the prevalence rate of respiratory viruses from 2015 to 2019 was 11.7% to 21.5%.” He went on to point out that “Even though the prevalence rate of respiratory syncytial virus (RSV) and acute respiratory infections caused by RSV during the same period was 11.7% to 20.1%, indicating a risk level similar to that of influenza, mandatory vaccinations are not currently being administered for RSV.” Accordingly, the legislative intent of the bill is to contribute to improving public health through infectious disease prevention by stipulating that mandatory vaccinations be administered for acute respiratory infections as well. If the bill is passed, it is expected to accelerate the inclusion of RSV vaccines into the National Immunization Program (NIP). Currently, Sanofi's Beyfortus, an RSV preventive antibody for infants and young children, and GSK's Arexvy, an RSV vaccine for adults aged 60 and older, have been approved and released in South Korea. Currently, the KDCA maintains that the inclusion of RSV vaccines in the NIP requires sufficient discussion and review. During last year's government audit, Rep. Myeong-ok Seo (People Power Party) of the National Assembly Health and Welfare Committee questioned the KDCA about the necessity of including RSV vaccines in the NIP, and the KDCA responded that it would “conduct a thorough review in the mid- to long-term through expert and vaccination committee deliberations.” In particular, the NA’s inquiry referred to Beyfortus, the only preventive antibody approved for RSV at the time. Still, the KDCA also mentioned that Beyfortus is not classified as a vaccine. The KDCA explained, “The NIP includes vaccines, so to introduce new formulations such as preventive antibodies into the program, there must be social consensus on the NIP itself.” RSV preventive antibodies work by injecting passive antibodies into the human body to trigger an immune response. Although the goal and mechanism are similar to those of vaccines, strictly speaking, they are not traditional vaccines. Under these circumstances, it appears that the KDCA is taking a cautious approach to determining whether a drug of a different class can be incorporated into such existing programs. In this case, if the bill is passed, it is likely that Arexvy, which has been approved as a vaccine, will be approved. According to the medical community, the Korean Society of Infectious Diseases is reportedly discussing guidelines for adult RSV vaccination. However, if the proposed amendment is passed, discussions will likely take place within the broader framework of contributing to the promotion of public health through the prevention of infectious diseases. With the support of the legislation, it could also have a positive impact on securing the budget necessary for NIP discussions. However, the proposed amendment includes provisions regarding the submission of a cost estimation report, which may require the submission of economic evaluation data for the vaccine in the future.
- Policy
- Gov’t sets criteria for drug shortage prevention
- by Lee, Hye-Kyung Aug 07, 2025 06:06am
- Prime Minister Min-seok Kim chaired the 7th Biohealth Innovation Committee at the Government Complex Seoul on the 5th The government will improve the criteria to raise the prices of drugs essential for patient treatment. Specifically, it will establish detailed evaluation criteria for price adjustment requests submitted by pharmaceutical companies that deem the current insurance price ceiling unreasonable. Prime Minister Min-seok Kim chaired the 7th Biohealth Innovation Committee at the Government Complex Seoul on the 5th and discussed measures to foster Korea into a biohealth powerhouse with government and private sector members. The meeting covered major issues such as improving drug price standards, revising the cost calculation method for exit prevention drugs, and expanding support for late-stage clinical bio venture funds. First, the criteria for designating drugs subject to drug shortage prevention measures will be revised upward to align with the changing pharmaceutical market environment in consideration of how their stable supply would affect the population as well as the fiscal expenditures required from the national health insurance. There have been calls from the field that the current criteria for designating drugs subject to drug shortage prevention measures, which have been in place since 2017, lack practicality, and there is a consensus that the minimum threshold amount needs to be revised to reflect factors such as inflation rates. In response, the government plans to publicly disclose by the end of the year a price adjustment criteria for such essential medicines, which will comprehensively consider factors such as the medical necessity, availability of alternatives, the number of suppliers of the same formulation (including whether the product is de facto the only drug supplied), and the supply situation of the drug, when evaluating price increases for drugs whose maximum prices have been announced and deemed significantly unreasonable by pharmaceutical companies. The government stated that through this, it expects to realistically adjust the minimum benchmark amount for selecting drugs to prevent withdrawal from the market by reflecting factors such as inflation rates, and to evaluate whether to adjust the maximum price based on drug price adjustment criteria that comprehensively consider actual supply conditions, thereby improving the profitability of essential drugs for patient care. Additionally, based on results of a recent study on improving the system for drug shortage prevention drugs, the government will revise part of the Standards for the Determination and Adjustment of Drug Prices (Appendix 5) to improve the cost calculation method for such medications, with the revised standards to be implemented in the first half of next year. The system improvements that will be made through revisions to the relevant regulations are expected to ensure preservation of appropriate production costs for drug shortage prevention drugs, leading to an increase in drug prices and enhanced supply stability for such drugs. Discussions on support for biotech companies were also held. The government is considering the establishment of a specialized fund for companies with ongoing or complete Phase III clinical trials that possess candidate substances or pipeline for innovative new drugs and biobetters. This is expected to enable domestic pharmaceutical and venture companies with excellent capabilities to secure sustained investment for Phase 3 clinical trials, which require significant time and costs, thereby increasing the likelihood of developing blockbuster new drugs. The government also plans to establish a basic-specialized-advanced step-by-step support system to help domestic companies enter the global market in response to the rapidly changing global pharmaceutical environment and provide customized consulting services. In addition, the government plans to provide specialized information through workshops on approval and licensing of advanced pharmaceutical and biotech products, produce online educational videos, and publish expert articles. Discussions were also held on expanding customized cost support in response to regulatory tightening in advanced countries such as the United States and the EU. To prepare for the tight regulations in advanced countries such as the FDA and MDR, the government plans to adjust the schedule for announcing customized cost support programs (from March 2024 to January 2025) to extend the support period for selected companies in the same year. Also, the government plans to change the project operation method to allow continuous cost support without additional project solicitations after monitoring the first-year performance when selecting this year's support recipients. Through these measures, domestic companies will be able to alleviate the financial burden and human resource shortages associated with certifications for the U.S. FDA and European MDR. In order to respond to the rapidly changing global pharmaceutical environment, the government plans to establish a step-by-step (basic-specialized-advanced) support system for domestic companies to advance into the global market and provide customized consulting services. Discussions were also held on a project being carried out by the Korea Disease Control and Prevention Agency (KDCA). The KDCA’s project supports the development of mRNA vaccines for pandemic preparedness in order to secure a vaccine platform that can be developed at a rapid pace in preparation for future pandemics. This project is a large-scale research project with a total budget of KRW 505.2 billion, which will support research and development tasks from preclinical to Phase III clinical trials over four years (2025-2028) with the goal of obtaining approval for a COVID-19 mRNA vaccine by 2028. The preliminary feasibility study was exempted in 2024, and the total budget and project period were finalized in March this year through a review of the appropriateness of the project plan. The KDCA confirmed the selection of four non-clinical trial project institutions in April and is currently supporting research and development to enter Phase I clinical trial in December of this year. To ensure the smooth implementation of the project, the KDCA's mRNA Vaccine Development Support Team and the Korea Health Industry Development Institute are planning the project and managing the performance targets. If the COVID-19 mRNA vaccine is developed through the project, it will not only ensure a stable supply of vaccines for high-risk groups but also enable the rapid development of vaccines within 100 to 200 days using Korea’s own mRNA vaccine technology in the event of a future pandemic.
- Policy
- H1 Pharma exports amounted to $5.38B
- by Lee, Hye-Kyung Aug 07, 2025 06:05am
- In the first half of this year, healthcare industry exports increased by 13.2% compared to the same period last year, reaching $13.79 billion, an all-time high for a half-year period. By sector, exports were led by cosmetics at $5.51 billion (+14.9%), pharmaceuticals at $5.38 billion (+20.5%), and medical devices at $2.91 billion (△0.6%). The Korea Health Industry Development Institute (KHIDI, President: Soon-do Cha) announced these export figures for pharmaceuticals, medical devices, and cosmetics for the first half of 2025 on August 6. Exports of pharmaceuticals increased by 20.5% year-over-year to $5.38 billion, driven by a surge in biopharmaceutical and vaccine exports. Biopharmaceutical exports (accounting for approximately 63.4% of total pharmaceutical exports) recorded $3.41 billion, a 27.4% increase year-over-year. Notably, exports saw a significant increase to the United States ($980 million, +41.4%), Hungary ($520 million, +26.8%), Germany ($470 million, +66.7%), Switzerland ($460 million, +76.9%), and the Netherlands ($250 million, +719.8%). H1 2025 Healthcare Industry Exports (unit: $1 million, %) Vaccine exports ($170 million, +53.3%) grew significantly in Sudan ($20 million, +397.3%), South Sudan (from $0 in H1 2024 to $10 million in H1 2025), and Congo (from $0 in H1 2024 to $10 million in H1 2025). According to Lee Byung-kwan, head of KHIDI's Biohealth Innovation Planning Division, "In the first half of 2025, healthcare industry exports were driven by all-time high half-year performances in the cosmetics and pharmaceutical sectors," and added, "In the second half, export growth is also expected to continue, driven by the expanding global demand for key products like biopharmaceuticals and basic cosmetics." Lee emphasized, "As external uncertainties such as changes in the U.S. tariff policy persist, it is crucial to monitor market trends and respond with caution and strategy carefully."
- Policy
- Faslodex’s price stays as is…supply instability concerns
- by Lee, Tak-Sun Aug 05, 2025 06:08am
- The breast cancer drug Faslodex (fulvestrant, AZ Korea), was facing a price cut due to the expiry of its premium pricing period, but this was prevented by the pharmaceutical company's request for a stay of execution. On the 31st of last month, the MOHW announced that the court had temporarily suspended the execution of the disposition to reduce the insurance price ceiling for Faslodex until August 31. The expiration of the premium pricing period for Faslodex was scheduled following the entry of generic drugs. Although the one-year price adjustment period expired in 2023, it was extended for an additional 2 years because three or fewer companies were producing the same drug. The price of AstraZeneca's Faslodex Inj was scheduled to be reduced from KRW 376,724 to KRW 288,194, while Boryung’s Fulvet Inj’s price was set to decrease from KRW 357,888 to KRW 288,194 as a Korean innovative pharmaceutical company’s product. At the time, AstraZeneca and Boryung requested an extension of the premium pricing period, citing supply issues prior to its expiration. However, with the emergence of Hankook Korus Pharm’s “Elbracan inj,” a domestically produced generic version of the drug, the insurance authorities decided in February to end the premium pricing as planned. Boryung Fulvet's price was reduced as planned, while AZ Faslodex's price remained unchanged due to the suspension of the administrative disposition. The Faslodex issue unexpectedly came up during Minister of Health and Welfare Eun-kyung Jeong’s confirmation hearing last month. In a written Q&A, the then-candidate exchanged with the NA before the confirmation hearing, multiple members of the National Assembly raised concerns about potential supply disruptions due to the termination of the premium pricing. At the time, Jeong, “Two identical drugs (substitutes) from other companies are currently listed, so the Drug Reimbursement Evaluation Committee (DREC) decided to terminate the preimium pricing for Faslodex,” adding, “We will manage generic drug prices at an appropriate level and strengthen domestic production and supply bases to ensure a stable supply of essential drugs.” The original manufacturer and patient groups argue that Faslodex, which was designated as a national essential medicine in November last year, requires price protection measures. The multinational pharmaceutical company AZ is reportedly considering withdrawing from the Korean market if Faslodex’s prices are reduced due to the end of the premium pricing period. However, domestic insurance authorities maintain that they decided to end the price adjustment period in accordance with principles, as domestic generic drugs are now available and there are no supply issues with the generic versions. AZ appears to have planned to continue domestic supply while maintaining its drug’s price through the lawsuit. However, if the court ultimately rejects the request for a stay of execution or if AZ loses the lawsuit, there is a possibility that the company’s global headquarters could decide to withdraw the drug from the domestic market. If the supply of the original anticancer drug is discontinued, its impact on the market could be significant, even if generic drugs are available. Given the nature of anticancer drugs, there is a strong preference for the original product, and with the original drug already holding a 90% market share, it would be difficult to immediately switch to generics. Accordingly, while the insurance authorities have upheld the principle of ending the premium pricing for Faslodex, the analysis is that special management would be necessary to prevent future supply issues. An industry insider explained, “Compared to AstraZeneca's withdrawal of the diabetes treatment drug Forxiga from the domestic market last year, the situation with Faslodex is not as straightforward. While Forxiga is a chronic disease treatment that can be replaced by generics, Faslodex is a life-saving drug for cancer patients, and cannot be immediately substituted with its generic versions.”
- Policy
- MFDS clarifies support for advanced biopharmaceuticals
- by Lee, Hye-Kyung Aug 04, 2025 05:53am
- With the Ministry of Food and Drug Safety raising the approval and review fees for advanced biopharmaceuticals by up to KRW 410 million from January 1 this year, it has clarified the criteria for those eligible for fee reductions. In addition, detailed administrative disposition standards have been set for cases where human cell managers and cell processing facilities commit two or more violations. According to industry sources on the 1st, the MFDS recently re-announced its partial amendment to the Regulations on the Safety and Support of Regenerative Medicine and Advanced Biological Products and is collecting opinions. The revision includes the following provisions: ▲Integration of forms related to new drug fees (Appendix 4); ▲Clarification of fees for new drugs eligible for expedited processing; ▲Addition of supplementary provisions (application examples and transitional measures) to clarify the application of fee regulations; ▲Clarification of the wording of administrative disposition standards (Appendix 2). Specifically, the provision that previously stated that small and medium-sized enterprises would receive a 50% reduction in approval and review fees has been revised to require that the reduction be granted only if certain conditions are met. For fee reductions on new drug approvals, among advanced biopharmaceuticals designated for expedited review, the applicant must meet at least one of following conditions: ▲Manufacturers or entities that have filed a commissioned manufacturing and sales report in accordance with Article 23(3) of the Act, who have applied for product approval under Article 23(2) and (3) of the Act, customized review under Article 37(1), or conditional product approval under Article 38(1) of the Act. ▲Importer who has applied for an import license under Article 27(1) of the Act, customized review under Article 37(1), or conditional product approval under Article 38(1) of the Act For advanced biopharmaceuticals not designated for expedited review, fee reductions apply only when an applicant applies for marketing authorization under Article 23(2) and (3) of the Act. If the conditions for reduction are met, the fees for the approval and review of advanced biopharmaceuticals are set as follows: KRW 205 million for advanced biopharmaceuticals classified as new drugs requiring safety and efficacy reviews, KRW 123 million for those requiring reviews of manufacturing and quality control standards and test methods, and KRW 41 million for those requiring an evaluation of the implementation status of manufacturing and quality control standards. Additionally, the administrative disposition standards for cases involving two or more violations have been clarified as follows: “In cases where two or more violations have occurred, the most severe administrative penalty standard shall apply. However, if the administrative penalty standards correspond to the same business suspension, the most severe administrative penalty standard shall be applied, with half of each remaining administrative penalty standard added, provided that the maximum period does not exceed one year.” Meanwhile, in January, the MFDS raised the fees for new drug approval and preliminary review by about 50 times to KRW 410 million to strengthen the speed and expertise of new drug approval reviews. The revised fees apply to new drugs (including advanced biopharmaceuticals) and drugs that have been granted marketing authorization as orphan drugs and subsequently apply for conversion to new drug status (change approval). The review period is expected to be reduced from an average of 420 days to 295 days.
- Policy
- ENT and pediatric departments prescribe the most drugs
- by Lee, Hye-Kyung Aug 01, 2025 06:16am
- Last year, medical institutions prescribed an average of 3.85 drugs per prescription. Outpatient clinics prescribed the most at 3.94, followed by hospitals at 3.88, general hospitals at 3.48, and tertiary hospitals at 3.10. The percentage of medical institutions prescribing 6 or more drugs increased by 0.79% from 18.34% in the previous year to 19.13%. These figures were released on the 31st by the Health Insurance Review and Assessment Service in its “2024 Drug Reimbursement Adequacy Assessment Results.” In the case of tertiary hospitals, the standard deviation in the number of drugs per prescription between institutions ranged from 2.60 at the lowest to 3.98 at the highest, indicating no significant difference. In contrast, clinics showed a range of 1.00 at the lowest to 8.89 at the highest, revealing a substantial difference. By age group, the number of drugs per prescription was highest for infants at 4.65, followed by children and adolescents at 4.25, adults at 3.75, and the elderly at 3.62. Among tertiary hospitals, the number of drugs prescribed for the elderly was the highest at 3.34, while general hospitals, hospitals, and clinics had higher rates for infants at 4.39, 4.90, and 4.62, respectively. The most common condition for medication prescriptions was acute lower respiratory tract infection, with 5.12 drugs prescribed per prescription. This was followed by acute upper respiratory tract infection at 4.77 and other upper respiratory tract disorders at 4.66. The number of drug items per prescription at clinics was 3.94, an increase of 0.03 from 3.91 in the previous year. By subject, the highest numbers were in otolaryngology (4.80), pediatrics (4.62), and general medicine/family medicine (3.97). By region, the ratio of the number of drug items per prescription was highest in Sejong (4.14%), then Incheon (4.04%), then Jeonbuk (4.03%), and lowest in Daegu (3.82%), then Seoul and Daejeon (3.85%). The prescription rate for 6 or more items was 18.143%, with tertiary general hospitals at 13.08%, general hospitals at 15.25%, hospitals at 19.02%, and clinics at 19.19%. Among clinics, 18,317 institutions (54.53%) had a prescription rate of 10% or less for six or more items, which was the highest number, and the ratio decreased by 0.99% compared to the previous year. Institutions with a rate of 40% or higher for prescribing six or more items accounted for 2,063 institutions (6.14%), with the highest rates observed in otolaryngology (29.22%) and pediatrics (20.76%) departments. The antibiotic prescription rate for acute upper respiratory tract infections was 45.20%, with tertiary general hospitals at 7.15%, general hospitals at 34.67%, hospitals at 53.60%, and clinics at 44.87%. Compared to the previous year, the rate increased the most in clinics (increased 3.97 percentage points). The number of institutions with an antibiotic prescription rate for acute upper respiratory tract infections below 10% was the highest at 3,320 (22.26%), a decrease of 3.23 percentage points compared to the previous year. The number of institutions with an antibiotic prescription rate for acute upper respiratory tract infections of 70% or higher was 2,338 (15.67%). The antibiotic prescription rate for acute upper respiratory infections at clinics was 44.87%, with the highest rates in otolaryngology (51.76%), pediatrics (46.07%), and general medicine (42.72%). By region, the rates were highest in Gwangju (50.23%), Chungnam (49.05%), and Chungbuk (47.97%), and lowest in Ulsan (42.06%), Daejeon (42.20%), and Seoul (42.50%). The antibiotic prescription rate for acute lower respiratory tract infections was 61.86%, with 21.73% at advanced general hospitals, 48.84% at general hospitals, 59.55% at hospitals, and 62.29% at clinics. The antibiotic usage per patient was 1,837.9 DDD for acute upper respiratory tract infections, 2,672.5 DDD for acute lower respiratory tract infections, and 2,463.0 DDD for respiratory diseases.
- Policy
- PPP also proposes free HPV vaccination for ppl under 26
- by Lee, Jeong-Hwan Aug 01, 2025 06:16am
- Following the ruling party, the main opposition party, the People Power Party, also submitted a bill to the National Assembly to provide free HPV vaccines to all citizens aged 26 and under, regardless of gender. The People Power Party’s bill also included provisions to expand the scope of free influenza vaccinations beyond the current coverage. This would involve increasing the age eligibility for influenza vaccines under the National Immunization Program (NIP), which was previously only applied to children, adolescents, and the elderly. Currently, three types of HPV vaccines are approved in South Korea: Cervarix (bivalent), Gardasil (Quadrivalent), and Gardasil 9 (9-valent). If the legislation is passed, the expansion of the scope of NIP is expected to bring positive outcomes. Currently, only Cervarix and quadrivalent Gardasil are included in the NIP, but the demand for Gardasil 9’s inclusion in the NIP will likely grow if the legislation is enacted. On the 31st, People Power Party member Mi-ae Kim introduced a bill to amend the Infectious Disease Control and Prevention Act to include these provisions. Expanding eligibility for free HPV vaccinations to both men and women was a common campaign promise of both the ruling and opposition parties in the last presidential election. Until now, only the ruling party had submitted related bills to the National Assembly (by Reps. Hee-seung Park and Sujin Lee), but with Rep. Mi-ae Kim introducing a bill with the same intent, the legislation is gaining momentum. Rep. Kim pointed out that HPV is a virus that can cause various diseases, including cervical cancer, anal cancer, and oral cancer, and can affect both men and women. However, she said that the issue is that the current NIP is limited to “women aged 12 to 26.”. To address this, Rep. Kim introduced a bill to include anyone under the age of 26, regardless of gender, in the free HPV vaccination program. In addition, Rep. Kim’s bill includes a provision to expand the scope of free influenza virus vaccinations. Currently, the NIP (free vaccination) for influenza vaccines is limited to “pregnant women, children aged 13 and under, and seniors aged 65 and over.” In the bill, Representative Kim expanded the scope of free influenza vaccinations to “those aged 18 and under and those aged 62 and over.” Rep. Kim explained, “Considering that most children engage in group activities at school until around the age of 18, it is necessary to extend the age range for vaccination to 18 to more thoroughly prevent the spread of the influenza virus. In addition, vaccination support for the elderly, who are vulnerable to influenza, must be strengthened further.” Meanwhile, the Democratic Party of Korea has proposed swift passage of bills related to the common campaign pledges of both parties during the presidential election to PPP and other opposition parties, which include free HPV vaccinations for both men and women.
