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- 2025-12-19 22:00:09
- Policy
- Legislation of restricted INN Prescriptions gain momentum
- by Lee, Jeong-Hwan Sep 26, 2025 06:11am
- With the ruling party accelerating legislation of “restricted international nonproprietary name (INN) prescriptions,” which was one of President Jae-myung Lee’s campaign pledges, the medical community is showing visible unease. Democratic Party of Korea lawmakers In-soon Nam, Young-seok Seo, Yoon Kim, and Jong-tae Jang, along with Rebuilding Korea Party lawmaker Sun-min Kim, announced that they will host a policy forum on September 30 at the National Assembly under the theme “Introducing a Korean Model for INN Prescriptions.” In response, doctors’ associations have directly talked with Rep. Joo-min Park, chair of the NA Health and Welfare Committee, and are planning a protest rally. On the 24th, the Seoul Medical Association said it would hold a “Seoul Medical Association Representatives’ Rally Against INN Prescriptions” on September 26 at 7:30 a.m. at its headquarters. Participants will include the members of its executive board, auditors, the council’s steering committee, and presidents and executives of local medical associations. The day before, the Seoul Medical Association President Kyu-Seok Hwang visited NA Health and Welfare Committee Chair Joo-min Park's office on the 23rd for a meeting and conveyed their position on how the INN-based prescription policy threatens the sustainability of primary care. Doctors argue that since generic substitution is already legally guaranteed, further mandating INN prescriptions would jeopardize patient safety and undermine the foundation of Korea’s doctor-pharmacist separation system. They also contended that trying to address drug supply shortages through INN prescriptions is not a fundamental solution, and that the clause stipulating penalties of up to 1 year imprisonment or fines up to KRW 10 million is excessive. Nonetheless, the ruling party maintains the position that legislation is inevitable to resolve the harm to patients caused by shortages of essential and unstable supply of medicines. The lawmakers co-hosting the INN prescription forum with the Korean Pharmaceutical Association and the Korea Institute for Pharmaceutical Policy Affairs include not only pharmacist-turned-lawmaker Young-Seok Seo but also physician-turned-lawmakers Yoon Kim and Sun-min Kim, indicating broad support on the need for its institutionalization. The ruling party lawmakers recognize that the bill on restricted INN prescribing (led by Representative Jong-tae Jang), which is currently pending in the National Assembly, is far removed from undermining the intent of the separation of medical and pharmaceutical practices or threatening patient safety. This is because the bill proposes establishing a ‘Supply Management Committee for Medicines with Unstable Supply’ under the Ministry of Health and Welfare, involving both pharmacists and doctors, to designate out-of-stock drugs and permit generic prescribing only for those designated drugs. Lawmakers argue that legislation on restricted INN prescriptions must focus on easing patient inconvenience and improving access to medicines, rather than fueling conflicts over professional boundaries between doctors and pharmacists. A ruling party official said, “The restricted INN prescription bill should prioritize the public over doctors and pharmacists. The bill establishes a new committee to designate medicines with supply shortages subject to INN prescribing, and institutionalizes a management system requiring pharmaceutical companies, wholesalers, pharmacies, and physicians to submit information on such shortages. The goal is to resolve the long-standing inconvenience faced by the public.”
- Policy
- PVA monitoring for high-priced drugs conducted in Q4
- by Jung, Heung-Jun Sep 25, 2025 06:12am
- High-priced anticancer drugs, including Keytruda and Opdivo, have been placed under monitoring for price-volume agreements (PVA, Type A·B) in the 4th quarter. On the 23rd, the National Health Insurance Service (NHIS) released ‘prior information on the Q4 monitoring list for drugs subject to PVA (Type A·B).’ A total of 111 items were listed, including many blockbuster products from multinational pharma companies such as ▲ Novartis Korea’s Zolgensma (onasemnogene abeparvovec), ▲ MSD Korea’s Keytruda (pembrolizumab), ▲ Ono Pharmaceutical Korea’s Opdivo (nivolumab) 20mg, 100mg, 240mg, ▲ Roche Korea’s Alecensa (alectinib HCl) 150mg, ▲ Sanofi-Aventis Korea’s Dupixent (dupilumab) 200mg, 300mg. Also, products from Korean pharmaceutical companies on the list include: ▲ Celltrion’s Donerion Patch (donepezil) 87.5mg, 175mg, ▲ GC Biopharma’s Denol (bismuth subcitrate potassium), ▲ Bukwang Pharma’s Agio Granule, ▲ Dongindang Pharma’s LecClean Solution (sodium phosphate) 133ml, 1000ml, ▲ Ildong Pharmaceutical’s Pirespa Tab (pirfenidone) 200mg, and ▲ Boryung Corp’s Kanarb (fimasartan potassium trihydrate) 30mg, 60mg, 120mg. The NHIS said, “Claims filed for the monitored drugs will be analyzed, and if they meet the negotiation criteria, they will be designated as subjects for price-volume agreement negotiations.”
- Company
- Twice-yearly 'lenacapavir' for HIV expected to land in KOR
- by Eo, Yun-Ho Sep 25, 2025 06:12am
- Product photo of lenacapavir 'Lenacapavir,' a HIV prevention drug taken twice a year, is expected to be marketed in Korea. According to industry sources, the Ministry of Food and Drug Safety (MFDS) is currently reviewing the approval of lenacapavir from Gilead Sciences Korea. The drug was designated as an orphan drug in January. Its specific indication is "a combination therapy with other antiretroviral agents for the treatment of multidrug-resistant HIV-1 infection in adults who are not being treated with their current antiretroviral therapy." This drug, marketed overseas under the brand name Sunlenca, is the first long-acting HIV-1 capsid inhibitor and is administered as a subcutaneous injection every six months. It was approved in countries like the United States and Europe in 2022 and is currently being prescribed. Current HIV treatment is maintained through daily oral administration of antiretroviral drugs. However, with the development of long-acting formulations, the administration frequency is advancing to once every two months or once every six months. Lenacapavir is also garnering more attention for its potential in HIV 'prevention,' not just treatment. In June, this drug received approval in the U.S., and more recently in Europe, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg. The product name for lenacapavir used in prevention is 'Yeytuo.' The efficacy of lenacapavir for prevention was proven through the Phase 3 PURPOSE 1 and PURPOSE 2 studies. The PURPOSE 2 study results showed that lenacapavir reduced HIV infection by 96% compared to the background HIV incidence (bHIV). In the study, 2 cases occurred among 2,180 participants, meaning that 99.9% of the lenacapavir arm did not contract HIV. Last year, Gilead also prematurely unblinded its PURPOSE 1 trial, which evaluated lenacapavir as PrEP in cisgender women in Sub-Saharan Africa, after it met its primary efficacy endpoint. Meanwhile, the international science journal and news Science selected lenacapavir as its 'Science Innovation of the Year' last year based on these research results.
- Company
- 'Drug pricing reform is overdue in Korea'
- by Son, Hyung Min Sep 25, 2025 06:11am
- KRPIA held a commemorative meeting marking its 25th anniversary on the 24th at Some Chavit in Banpo, Seoul. During the panel discussion held that day, experts raised the opinion that the industry and government must work together to improve patient-centered access to new drugs Concerns persist that domestic patients still face slow progress in accessing global new drugs. Although the government has introduced system reforms such as expansion of the risk-sharing scheme and pilot projects linking regulatory approval and reimbursement evaluation, experts argue that the current incentive system for innovative drugs is still insufficient, hindering both industry growth and patient treatment opportunities. On the 24th, the Korean Research-based Pharmaceutical Industry Association (KRPIA) held a roundtable to mark its 25th anniversary at Some Chavit in Banpo, Seoul. During the panel discussion, domestic and international pharmaceutical experts emphasized the need to improve patient-focused access to innovative drugs, pricing systems, and value recognition structures. Dong-ho Yeo from LG Chem, who has experience in both multinational and Korean pharmaceutical companies, stressed the importance of properly recognizing the value of innovative new drugs. Yeo said, “Although Korean companies don’t yet have many achievements that can truly be called innovation, they are continuing development. How the global innovative new drugs are evaluated will serve as an important signal for Korean companies as well.” “For Korean companies to move from being fast followers to first movers, innovative drugs must be appropriately valued. It would be difficult for a domestic drug to prove competitiveness in overseas markets if its innovativeness is not even recognized in its home country.” Panelists noted that despite systems being in place, it still takes a long time before actual patients gain treatment opportunities. They added that price negotiations and the financial savings logic often delay companies’ local launch strategies. Jae-min Cho, Senior Director at Eli Lilly Korea, said: “It’s encouraging that the government has designated biotechnology as a strategic national industry. However, the conservative value assessment practices of innovation hinder access for patients.” Cho pointed to ▲ Conservative evaluations that focus on price cuts rather than value recognition; ▲ Short evaluation periods (5–10 years) that fail to reflect long-term drug value; and ▲ even groundbreaking drugs developed after decades are often compared against the cost of outdated, low-priced drugs, as main challenges that hinder “Social consensus is needed on setting appropriate weighting factors and premiums that meet the Korean context. Only through continuous institutional improvements by the government, academia, and industry can we simultaneously achieve patient accessibility and industrial innovation.” Panels at the KRPIA 25th Anniversary Commemorative Panel Discussion “New drugs pushed out of priority lists... industry bears responsibility too” Responsibility within the industry itself was mentioned, alongside systemic limitations. Calls continued for the pharmaceutical industry to prioritize patient access as its foremost value. Dailypharm journalist Yoon-ho Eo remarked, “While the government and industry engage in reimbursement battles, many drugs are being pushed out of the priority list and disappearing. As a result, patients are losing timely access to essential medicines.” He added, “Companies tend to concentrate reimbursement strategies only on flagship products. Alongside government efforts, the industry must itself prioritize expanding patient access.” Specific improvement tasks were also proposed. Tae-Kyung Kim, a specialist at Yoon&Yang criticized the practice of cost-effectiveness-centric evaluations and stressed the need for new approaches. Kim noted, “It's a positive change that various values beyond cost-effectiveness are now reflected in evaluations, leading to higher reimbursement rates for new drugs that would have struggled to gain listing in the past. However, in practice, rather than recognizing the value of new drugs, the structure has solidified into one where the government reduces uncertainty through risk-sharing agreements (RSAs).” “The transfer of uncertainty via risk-sharing agreements is effectively resulting in ‘self-pay by pharmaceutical companies. Health technology assessments must become more flexible to reflect realistic real-world treatment patterns.” Moderator Eui-Kyung Lee, Professor at Sungkyunkwan University’s College of Pharmacy, said, “Post-COVID-19, two values—patient safety and speed—have simultaneously come to the fore. It is essential to find a balance between health insurance finances, timeliness, and safety, while adopting a more multi-dimensional and flexible approach for evaluating the value of innovative medicines.”
- Company
- Xeomin marks 20 years since launch…'pure toxin'
- by Hwang, byoung woo Sep 25, 2025 06:10am
- Celebrating the 20th anniversary of Xeomin's global launch, Merz Aesthetics is emphasizing the importance of 'pure toxin' for managing botulinum toxin resistance. The company explains that in an era of repeated procedures, a highly purified toxin can inhibit antibody formation and become as a sustainable treatment option. Merz Aesthetics Korea held a press conference on September 24 to commemorate the 20th global anniversary of its botulinum toxin type A product, Xeomin, highlighting its scientific value and global leadership. Professor Michael Martin (Retired from Justus Liebig University, Germany)Firstly, Professor Michael Martin (Retired from Justus Liebig University, Germany), an immunology expert from Germany, said that in the global botulinum toxin market, the issue of resistance is no longer optional but a necessary management task. Professor Martin explained, "Only a highly purified toxin free of complexing proteins, inactive neurotoxins, and other impurities can be defined as a true pure toxin. While there are many products on the market, it is challenging to meet all these criteria." He emphasized the importance of pure toxins, citing the consensus of the ASCEND (Aesthetic Council for Ethical use of Neurotoxin Delivery) panel, which includes experts from around the world. The ASCEND panel was formed to systematically review literature and share clinical cases to establish a better standard for botulinum toxin use, as resistance has become an issue with its widespread use in aesthetics beyond therapeutic purposes. Professor Martin said, "To ensure the safe use of botulinum toxin, the key criteria for preventing resistance are to select a highly purified product with a low risk of resistance and to use the minimum effective dose at appropriate intervals." Dr. Juergen Frevert (Merz Pharmaceuticals Consultant)Dr. Juergen Frevert (Merz Pharmaceuticals Consultant), the developer of Xeomin, mentioned that the product is manufactured using Merz's stringent purification technology and a biotechnological production process that is approved by the U.S. Food and Drug Administration (FDA). Dr. Frevert said, "Merz's proprietary purification technology removes complexing proteins that can trigger antibody formation. By using only the active neurotoxin (150kDa) with approved excipients like human serum albumin (HSA) and sucrose, it minimizes the risk of resistance." He added, "In the global botulinum toxin market, pure toxin and resistance prevention are emerging as key keywords. Patients are significantly considering safety, long-term efficacy, and the ease of repeated procedures," and concluded, "Based on scientific evidence, Xeomin provides differentiated value that meets these patient expectations." Xeomin, Strengthening market leadership and ESG commitment In the subsequent presentation, Managing Director So Young Kim of Merz Aesthetics Korea's Brand Marketing Department shared Xeomin's 20-year journey and achievements under the theme of "Xeomin Global Heritage and Leadership." Kim said, "Since its approval by the European Medicines Agency (EMA) in 2005, Xeomin has been approved in 81 countries worldwide, with over 35 million vials supplied cumulatively. In Korea, since its launch in 2009, it has ranked first in import performance for six consecutive years, starting in 2018." Kim added, "Xeomin is a pure toxin that leads the botulinum toxin market and has built a strong trust with medical professionals and patients for a long time since its launch in 2009," and highlighted, "With its room-temperature storage approval in 2023, it contributes to long-term environmental protection by reducing the need for coolants and energy used for refrigeration. We also plan to introduce a new eco-friendly product package." Su Yeon Yu, CEO of Merz Aesthetics Korea, added, "Xeomin has been able to achieve significant results in the global and Korean market over the past 20 years, thanks to the trust of medical professionals and consumers," and concluded, "Merz will continue to meet the expectations of patients and medical professionals through innovative, science-based solutions, while leading the right future of medical aesthetics through ESG management and social responsibility.
- Company
- 'Drug access still stagnant despite improved survival'
- by Son, Hyung Min Sep 25, 2025 06:10am
- While innovative new drugs have raised survival rates for patients with cancer, rare diseases, and other difficult-to-treat conditions and are transforming the treatment paradigms, industry voices argue that domestic patients' access to such drugs remains limited. Both the introduction rate and approval rate of global new drugs fall short of the OECD average, highlighting the urgent need for fundamental institutional reforms. On the 24th, the Korean Research-based Pharmaceutical Industry Association (KRPIA) held a commemorative event at Some Chavit in Banpo, Seoul, to celebrate its 25th anniversary. At this event, KRPIA held a roundtable event to share the current status of patient access to global new drugs in Korea. Just 20 years ago, cancer was considered untreatable. However, with the rise of innovative drugs from multinational pharmaceutical companies—including immuno-oncology therapies, targeted therapies, antibody-drug conjugates (ADCs), and bispecific antibodies—the landscape has changed dramatically. In some cancer types, survival rates have now improved to 70–80%, rendering the new drugs a prime example of extending patient life. In-hwa Choi, Executive Director of KRPIA 20 million people are newly diagnosed with cancer globally each year, and this number is projected to nearly double by 2050. The number of deaths is also expected to reach 18 million. Consequently, sustained and equitable access to innovative cancer drugs is more critical than ever. In-hwa Choi, Executive Director of KRPIA, stated, “Fundamental system improvements that prioritize patient access are necessary. While Korea’s health insurance system is exemplary, its single-payer structure creates inherent complexity and delays in reimbursement decisions for new drugs.” Choi acknowledged recent policy efforts—including expanded risk-sharing arrangements, exemption of pharmacoeconomic evaluations, and pilot programs linking drug approval with reimbursement—as positive developments. Choi noted, “Patients are still left with a long await.” KRPIA member companies supply around 1,450 innovative medicines in Korea, accounting for 83% of all new drugs in the domestic market. They also provide 92 treatments for rare and intractable diseases, expanding access for vulnerable populations such as the elderly, women, and children. KRPIA analyzed that new drugs extend patients' life expectancy by over 35%, reduce cancer mortality rates, and facilitate social reintegration, yielding annual socio-economic cost savings of KRW 126 trillion. Young-Shin Lee, Vice Chairman of KRPIA Nevertheless, patient access to new drugs in Korea remains stagnant. Only 5% of global innovative drugs are introduced in Korea within a year of launch, just one-fourth of the OECD average. Korea’s drug approval rate (30%) also falls below the OECD average (49%) and the G20 average (46%). Young-Shin Lee, Vice Chairman of KRPIA, stressed, “Innovation cannot be achieved by merely altering existing garments. The link connecting innovation to patients is the system; without systemic improvements, new drugs cannot meaningfully reach patients.“ The government, National Assembly, academia, media, and patients must jointly seek institutional solutions to ensure the social value of innovative drugs is properly conveyed to patients. KRPIA will also continue communication and cooperation as a responsible policy partner."
- Company
- Celltrion acquires Eli Lilly's U.S. plant for $460M
- by Sep 25, 2025 06:09am
- Celltrion has signed an agreement with Eli Lilly and Company (United States) for the acquisition of a biopharmaceutical manufacturing plant in Branchburg, New Jersey, for approximately $460 million. According to the Financial Supervisory Service, on September 23, Celltrion plans to make a total investment of KRW 700 billion, covering costs such as the factory acquisition price and initial operational expenses. The company plans to pursue facility expansion on the plant's idle land, which would require at least an additional investment of over KRW 700 billion. The total investment for the acquisition and expansion will be at least KRW 1.4 trillion. The company explained that the acquiring entity is the U.S. subsidiary, considering its local operations and strategic geographic location. Both companies will cooperate to finalize the factory acquisition procedures by the end of the year. The plant to be acquired is a large-scale campus spanning approximately 150,000 square meters, comprising four buildings: a manufacturing facility, a warehouse, and technical and operational support buildings. The facility is a fully operational, cGMP-compliant drug substance (DS) production plant that can be operated immediately upon acquisition. This will significantly shorten the time to production and reduce costs compared to building a new plant, which would take more than five years and cost over a trillion KRW. The plant also has approximately 36,000 square meters of idle land for capacity expansion, allowing the company to respond to future market demand. Celltrion plans to quickly begin expanding its facilities for the production of key products on the secured, idle land. Once the expansion is complete, the company anticipates having a production capacity that is 1.5 times that of its Plant 2 in Songdo, Incheon. Celltrion stated that this acquisition agreement completes its comprehensive plan to address U.S. tariff risks. "We have already taken short- to medium-term measures to counter tariffs, such as relocating two years' worth of inventory to the U.S. and expanding contracts with local Contract Manufacturing Organizations (CMOs)," a Celltrion official said. "With the addition of a fundamental solution, securing a local production plant, Celltrion is now poised to be free from all potential tariff risks in the future." The company explained that once the facility changes and expansions are realized, its flagship products supplied in the U.S., as well as future products, will be exempt from tariff impacts early on. Notably, the agreement also includes the complete employment transfer of local personnel with expertise and experience in plant operations. This agreement will enable the company to maintain seamless plant operation, ensuring the continuation of operational stability and productivity. A company official said, "Constructing a new plant requires a massive investment and several years just to prepare for initial operations and secure and train personnel. In contrast, by acquiring an existing cGMP-compliant plant with a skilled local workforce, Celltrion can significantly reduce this burden," and added, "During future expansion, we will also be able to actively utilize the talent infrastructure of New Jersey, which has a large pool of pharmaceutical and biotech professionals." The official continued, "By signing a CMO contract with Lilly at the same time, we have not only secured a local production base in the U.S. but also a powerful growth engine," and added, "Under the agreement, Celltrion will steadily supply drug substance produced at the plant to Lilly, which will enable us to expand our revenue and recover our investment early."
- Company
- Concurrent reimb review likely for Mounjaro and Ozempic
- by Eo, Yun-Ho Sep 24, 2025 06:25am
- Two anti-obesity drugs that have drawn intense attention may soon undergo reimbursement evaluations for their diabetes indications at the same time. With Novo Nordisk Korea’s Ozempic (semaglutide) already scheduled for review at the upcoming October meeting of the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee, there is growing speculation that Eli Lilly Korea’s Mounjaro (tirzepatide), which submitted its reimbursement application more recently, may also appear on the agenda. In fact, HIRA recently requested Lilly to promptly submit additional supplementary data for Mounjaro’s reimbursement evaluation. Novo Nordisk had already submitted its supplementary data earlier this month. As in all other markets, when supply increases while demand remains constant, prices fall. The pharmaceutical market is no exception. In the era of high-priced medicines, the government has shown a tendency to review two or even three new drugs simultaneously if multiple drugs in the same class are expected to seek reimbursement around the same time. Because of the high cost of these drugs, price competition between manufacturers allows the government to leverage the market’s natural mechanism. Under the national health insurance system, any savings can create opportunities to expand coverage elsewhere. Thus, given Mounjaro’s reimbursement application was filed in July, the government may likely wish to conduct reimbursement evaluations for the diabetes indication simultaneously for the two drugs. It remains to be seen how the fierce competition between the two drugs in the obesity market will extend into the diabetes market. A Novo Nordisk representative said, “We decided to initiate supply of Ozempic in Korea prior to reimbursement to address the unmet needs in type 2 diabetes treatment. We are working closely with the authorities to secure prompt reimbursement approval and further improve patient access.” A Lilly representative said, “We applied for reimbursement listing in order to provide Mounjaro to patients in a fast and sustainable way. We are currently doing our utmost to secure reimbursement for Mounjaro and are continuously collaborating with health authorities.”
- Policy
- Parties disagree with non-face-to-face medical service bill
- by Lee, Jeong-Hwan Sep 24, 2025 06:25am
- Lee Su-jin, the chief secretary of the Democratic Party of Korea (left), requested that Kim Mi-ae, the Chief Secretary of the People Power Party, hold a review committee for the "one-point" bill on non-face-to-face medical services.The government's effort to pass a "one-point" bill on non-face-to-face medical services through the National Assembly's Health and Welfare Committee, Judiciary Committee, and plenary session this month has failed. The chief secretary of the Democratic Party of Korea, Lee Su-jin, on behalf of Vice Minister of Health and Welfare Lee Hyung-hoon, requested that Kim Mi-ae, the Chief Secretary of the People Power Party and chair of the First Legislative Subcommittee, hold an additional subcommittee meeting today (September 24). However, they failed to reach an agreement. An official from the Democratic Party of Korea's office on the Health and Welfare Committee explained, "We continued to negotiate with Chief Secretary Kim Mi-ae's office to hold an additional one-point subcommittee on the non-face-to-face medical service bill, but they ultimately did not agree so that it won't be held." Consequently, this means that the amendment to the Medical Services Act, which includes: ▲The formal institutionalization of the non-face-to-face medical service pilot program ▲The legalization of a public electronic prescription delivery system for medical services ▲Allowing first-time medical consultations within a broader metropolitan area ▲Limiting drugs and prescription days for first-time non-face-to-face medical consultations ▲Allowing drug delivery for a limited group of patients within their residential area ▲Mandating doctors to confirm the DUR (Drug Utilization Review) during non-face-to-face medical services. It is now expected to get another chance for review in November, after the National Assembly's annual audit concludes next month. During the legislative subcommittee meeting on the afternoon of September 22, the non-face-to-face medical service bill was reportedly nearing passage, as most contentious points had been resolved. Kim Mi-ae, the chair of the legislative subcommittee, even hinted at bill passage, saying immediately after the meeting, "We've reached over 80% agreement. It will be possible to pass it within the regular session." The Ministry of Health and Welfare's request for an additional subcommittee meeting to expedite the bill's passage was not realized due to the legislative subcommittee chair's disagreement. An official from the Democratic Party's office said, "We tried to negotiate with the People Power Party's office, but we ultimately received a no," and added, "We were told that there was an internal party directive to halt all bill discussions due to the planned filibuster at the plenary session this month." Meanwhile, the People Power Party has announced its plan to filibuster all bills scheduled to be introduced at the plenary session on September 25, which is a legal method of obstructing legislative proceedings under the National Assembly Act. This is the People Power Party's response to the Democratic Party proposed amendments to the Government Organization Act along with key bills.
- Policy
- MFDS to review Tylenol safety following Trump’s remarks
- by Lee, Tak-Sun Sep 24, 2025 06:24am
- The Ministry of Food and Drug Safety (MFDS) announced that it will carefully review safety concerns regarding Tylenol, following remarks made by US President Donald Trump. On the 22nd (local time), President Trump held a press conference at the White House, stating, “Acetaminophen, widely known as Tylenol, may increase the risk of autism in children when taken during pregnancy. The US Food and Drug Administration will inform physicians about this and, if necessary, recommend restricting Tylenol use during pregnancy.” According to reports, the FDA is currently considering relabeling acetaminophen. Trump’s announcement has fueled debate about Tylenol’s safety, especially since the drug has long been considered a safer option for pregnant women and fetuses compared to other pain relievers. The MFDS also plans to conduct its own review. In an official statement released in the afternoon, MFDS said: “Regarding the US government’s announcement on Tylenol, we will request the company to submit its opinions and data on this matter and carefully review the relevant evidence and materials.”
