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- 2025-12-19 10:17:00
- Policy
- MFDS grants EUA to COVID-19 variant vaccine for infants
- by Lee, Hye-Kyung Oct 22, 2024 05:51am
- The Ministry of Food and Drug Safety (MFDS) announces. The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on October 21st that it has granted Emergency Use Authorization for 'Comirnaty JN.1 Inj 0.033 mg/mL (bretovameran),' a SARS-coV variant (JN.1) vaccine for infants aged 6 months-4 years. Emergency Use Authorization is a system designed to respond appropriately to a public health crisis, including infectious disease pandemics. In this system, the MFDS minister enables the supply of medical products that do not have domestic approval by ordering manufacturers and importers to manufacture or import upon requests from the central administrative agency. The Korea Disease Control and Prevention Agency (KDCA) requested the Emergency Use Authorization to provide immunization for infants (6 months-4 years old), and the MFDS quickly reviewed it and granted approval. For Emergency Use Authorization, MFDS gathers expert opinions by reviewing company's submitted clinical and quality documents through the official posting of the emergency use authorization upon request from the central administrative agency. Then, after review and voting from the committee for the 'Public Health Emergency Preparedness and Responses for a Medicinal Product,' the MFDS makes a final decision. "We will continue to put efforts in enhancing public health by quickly supplying medical products that are effective in overcoming COVID-19, based on our scientific knowledge and regulatory expertise," the MFDS stated.
- Policy
- 2nd GIFT drug Nefecon’s approval imminent in Korea
- by Lee, Hye-Kyung Oct 21, 2024 05:48am
- Meditip's Nefecon (budesonide), which was designated as the 2nd Global Innovative Products on Fast Track (GIFT) drug last year, is close to receiving approval in Korea. According to industry sources on the 21st, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Nefecon. The completion of the safety and efficacy review in general leads to approval in Korea. Nefecon has been designated as a GIFT item as a drug that developed a new efficacy and effectiveness using the already marketed budesonide ingredient. A GIFT designation can also be given to a previously approved ingredient that has no treatment for a disease but can be used to treat a new patient population. Nefecon is a drug used to treat primary IgA nephropathy in adults with a urinary protein-to-creatinine ratio of 1.5 or greater who are at risk of rapid progression. In a presentation made at Kidney International, Nefecon was associated with a 27% lower urinary protein-to-creatinine ratio at 9 months of treatment compared to placebo. Glomerular filtration rate remained stable, with a difference of 3.87 ml/min/1.73 m2 compared to placebo. The drug was approved by the US FDA last year under the brand name Tarpeyo and by the European EMA under the trade name Kinpeygo. In China, the National Medical Products Administration (NMPA) designated Nefecon as a Breakthrough Therapy Designation (BTD) in 2020, and the Taiwan Food and Drug Administration granted it an Accelerated Drug Designation (ADD). IgA nephropathy is a disease caused by the deposition of immune complexes, including IgA, in the glomeruli of the kidneys, causing an inflammatory response. About 9,000 patients are known to be affected by IgA nephropathy in Korea. In clinical practice, antihypertensive drugs such as ARBs and ACEIs, immunosuppressants, and diuretics are used to treat IgA nephropathy. However, these drugs are symptomatic treatments that prevent the worsening of symptoms, and no drug fundamentally treats the condition. Meanwhile, drugs are given the GIFT designation if it is a ▲ drug aimed at treating serious diseases such as life-threatening cancer or rare diseases ▲ drug aimed at preventing or treating infectious diseases that may cause serious harm to public health, such as bioterrorism infectious diseases or pandemics of infectious diseases ▲ new drug developed by a Korea Innovative Pharmaceutical Company as designated by the Ministry of Health and Welfare ▲ a combination of a drug and medical device subject to fast-track review ▲ a case where there is no existing treatment or a drug showed clinically significant improvement in efficacy over existing treatments. The MFDS reviews the eligibility for the GIFT designation when a pharmaceutical company applies for expedited review and, if necessary, designates a drug as a GIFT item after consulting with the Medical Product Expedited Review Expert Council. Once designated, the review period is reduced by at least 25% (e.g. from 120 working days to 90 working days). Applicants will receive a variety of support for rapid commercialization, including rolling review, where the application data is reviewed on a rolling basis, close communication between the reviewer and the developer, such as item briefings and supplementary briefings, and expert consulting on regulatory matters.
- Policy
- How to stabilize supply of national essential medicines
- by Lee, Hye-Kyung Oct 18, 2024 05:49am
- While prescribing drugs by ingredient name and introducing international nonproprietary names (INNs) are being discussed as measures to stabilize the supply of drugs, voices have emerged calling for a system that allows the use of the same ingredient drugs as nationally essential medicines. The issue of stabilizing the supply of not only national essential medicine but also drugs that are constantly experiencing supply and demand instability is one of the most frequent questions asked by the National Assembly's Health and Welfare Committee's national audit this year. According to the written inquiries submitted by the MFDS to the National Assembly on the 17th, 7 lawmakers - Yoon Kim, Hee-Seung Park, Jong-Heon Baek, Mi-Hwa Seo, Young-Seok Seo, Byung-Hoon So, and In-soon Nam - inquired about stabilizing the supply of medicines. Representative Yoon Kim pointed out the unstable supply of national essential medicines and asked how the MFDS plans to promote the use of drugs with the same ingredient name. “Changing the method of prescriptions is the responsibility of the Ministry of Health and Welfare,” said the MFDS, adding, ’The MFDS will cooperate with the competent ministry, which is MOHW, if requested.” For national essential drugs, the Stable Supply Consultative Group is discussing comprehensive measures, improving the criteria for designating pediatric drugs as national essential medicines and the designation and removal national essential medicines. In particular, in the case of pediatric drugs, products that are essential for pediatric patients but have unstable supply are designated as national essential medicines. The MFDS said, “In the case of medicines whose supply is expected to be interrupted (shortage) due to insufficient production, we will jointly respond with the Ministry of Health and Welfare through the Public-Private Consultative body for Unstable Supply and Demand of Medicines, reviewing measures including raising drug prices.’ Representative Hee-Seung Park inquired about the reasons for the supply chain instability of national essential drugs, to which the MFDS responded, “We understand that the supply chain instability of national essential drugs is intensifying due to a combination of factors such as increased demand due to infectious diseases such as COVID-19 and deterioration of solvency due to rising production costs.” There was also an inquiry about the supply interruption report, which is required to be reported to the MFDS 60 days before the supply interruption. On this, the MFDS announced on the 4th of this month that the ‘Rules on the Safety of Drugs, Etc.’ will be amended to change the supply interruption reporting criteria from 60 days to 180 days in advance from April 5th next year. Until now, reporting drug shortages had been a recommended measure, but from next year, it will become mandatory. “In order to promptly receive drug supply interruption reports, the deadline for reporting supply interruptions has been moved up from 60 days to 180 days in advance,” said the ministry, adding, “If a pharmaceutical company has a plan to reduce production and imports below a certain standard, it must file a report within 1 month.” Representative Jong-Heon Baek called for a stable supply plan through the expansion of domestically produced drugs. “We support domestic pharmaceutical companies to develop manufacturing process technologies for national essential medicines that are highly dependent on imports and require stable supply and demand, and will continue to strive for the stable supply and self-sufficiency of raw materials and finished products for national essential medicines that are essential for healthcare,” the MFDS explained. Through the self-sufficiency of national essential medicines project, which has been underway since 2022 with the Korea Orphan & Essential Drug Center and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the associations completed the development of 3 raw materials (amiodarone, ketoconazole, and benserazide) and 2 finished drugs (amiodarone injection and tablets) in the first phase (2022-2023). As the second phase (2024~2026) of the project, the company is developing 3 raw materials (acetaminophen, ipratropium, and furosemide) and 2 finished products (acetaminophen and furosemide). The MFDS also responded to Representative Young-Seok Seo’s inquiry about the need to monitor the process of distributing medicines that are difficult to supply to pharmacies and medical institutions. The MFDS said, “The MOHW is in charge of reporting on the supply of medicines, and the two ministries are responding to timely identification of supply and demand issues through smooth information exchange. We will continue such information exchange in the future so that the relevant ministries can jointly respond to drug supply insecurity.” It was also pointed out that compared to direct response measures such as emergency import or made-to-order production, the measures made by the ministries end at indirect measures such as monitoring and encouraging production. “There are many reasons for drug supply interruptions, such as production issues and raw material supply problems, and we are responding to each cause by reviewing the existence of substitute drugs and consulting with experts,” the MFDS said, adding, “We will prepare a response manual for drug supply interruptions in the future.”
- Policy
- 'Can the Yoon administration develop blockbuster drugs?'
- by Lee, Jeong-Hwan Oct 18, 2024 05:49am
- Criticism has been raised that the government's policy to create global blockbuster drugs is not working and has a dark future. It has been pointed out that the difficulty in raising funds to support the R&D costs for pharmaceutical and biotech companies and ventures is causing financial difficulties for bioventures, and that expert human resource training is not being done properly, either. On the 17th, lawmaker In-soon Nam of the Democratic Party of Korea questioned Soon-do Cha, President of the Korea Health Industry Development Institute, about the policy direction of the pharmaceutical bio-industry during the National Assembly audit of the agency. Rep Nam said, “At the beginning, there was some talk that Cha is closely communicating with President Suk-Yeol Yoon. I'm not pointing any fingers, but I was expecting the business of the KHIDI to progress better.” ‘The Yoon administration is saying that we should support the development of the pharmaceutical bio industry as a future growth engine, but not much speed nor progress is being made in the field. The administration said that it will support the creation of 2 blockbuster drugs by 2027, but can it really achieve this?” “We have set an implementation plan and are checking the implementation of the comprehensive plan every year,” Cha replied, “I know it is difficult, and there are no guarantees, but we are proceeding surely and cautiously.” Nam criticized Cha's tendency to give generalized answers and requested more specific result reports. “What I'm hearing is that biotech companies are facing financial difficulties,” Nam said, adding, “New investments should be flowing in, but they're decreasing. I wonder if the Yoon administration is really setting a policy direction for the pharma-bio industry as Korea’s future food.” “I heard that the pharma-bio fund has not been created yet. Are they fostering human resources? Please submit your progress in detail before the comprehensive audit,” said Nam.
- Policy
- Gov't opposes to suspending reimb·ingredient prescribing
- by Lee, Jeong-Hwan Oct 17, 2024 05:52am
- The government has opposed the proposed measure, which aims to minimize the chaos in prescription·dispensing by suspending insurance reimbursement or blocking prescription code of drugs when substitute drugs are available. Suspending reimbursement of drugs covered by insurance is a temporary measure implemented in the case of administrative meaures from the Ministry of Food and Drug Safety (MFDS), such as canceling marketing authorization. The government rationale is that suspending reimbursement due to drug shortages would only confuse patients and pharmacies. At the time of the separation of prescribing and dispensing of drugs, the government also opposed to the measure to allow active ingredient prescribing of drugs in shortages. The rationale for the opposition was that it violated the agreement between the government and the medical community. On October 15th, the Ministry of Health and Welfare (MOHW) announced this in response to written parliamentary questions submitted by Rep Seo Youngseok and Rep. Nam In-soon of the Democratic Party of Korea. Rep. Seo asked MOHW's opinion about suspending insurance reimbursement or blocking the prescription code of drugs when substitute drugs are available. To resolve the issue of drug shortages, Rep. Nam proposed the need to legalize the DUR notification, limit the number of days of prescription, temporarily suspend issuing reimbursement, and implement active ingredient prescription. The MOHW explained that they are reviewing drug pricing adjustments after receiving applications from pharmaceutical companies when the drug shortages consultative body requests that it is necessary to increase the supply by adjusting the ceiling price. The MOHW also answered that suspending reimbursement of drugs in shortages and implementing active ingredient prescription requires careful consideration. "Suspension of reimbursement is a limited measure when the MFDS' approval of the product is revoked," the MOHW stated. "Suspension of reimbursement for drugs in shortages may cause confusion in the field, such as patients and pharmacies, so careful consideration is required." "Currently, the drugs that have been reported to be out of supply are being directed to DUR. In addition, the DUR notification on additional drugs in shortages should be prioritized by establishing standards for drugs in shortages," the MOHW stated, adding, "We believe that limiting the number of prescription days for drugs in shortage is necessary in exceptional cases where it is difficult to increase production, such as a shortage of raw materials. It is necessary to prepare a relevant legal basis." Regarding the active ingredient prescribing for drugs that are in shortage, the MOHW stated, "It is necessary to be cautious by changing the agreement at the time of the separation." Regarding the MOHW's measures against the shortage of Imotun supply at clinical sites such as pharmacies, the MOHW staged that they would consider utilizing substitute drugs. In response to Rep. Suh's point that special measures such as restricting Imotun's salary are necessary, the MOHW expressed their position on careful consideration. The MOHW explained, "Imotun Cap is produced by receiving the supply of Avocado-Soya Unsaponifiables raw materials from France," adding, "As it is a herbal ingredient, the production of raw materials is constant. Therefore, there will be a small increase in supply in 2023 compared to 2022, but there will be a limit to sufficient supply." "The drug in question was discussed at a meeting between the public-private consultative body for drug shortages and the medical community," the MOHW added. "It was discussed as an adjunctive treatment for osteoarthritis, and it was discussed as a drug that is difficult to respond to first considering the possibility of using other drugs with similar effects. We will consider the use of alternative drugs in the future." "Imotun Cap was recognized for its clinical usefulness in the 2022 re-evaluation after the conditional reimbursement was maintained in the 2021 reimbursement appropriateness re-evaluation," the MOHW added. "The reimbursement restriction should be reviewed carefully considering the overall social needs. The supply of the drug has been maintained by 160,000 capsules annually, and it does not fall under the reason for the reimbursement restriction due to the recognition of usefulness."
- Policy
- HIRA President, "Copayment ratio needs to be adjusted
- by Lee, Tak-Sun Oct 17, 2024 05:51am
- HIRA President Jung-Gu Kang HIRA President Jung-Gu Kang said that the copayment ratio should be adjusted for anticancer drugs that lack verification of effectiveness. Kang said during the parliamentary audit by the Health and Welfare Committee, "We must lower the patient access hurdle and increase monitoring." Adding, "Especially because we evaluate high-cost drugs that have not completed phase 3 studies, copayment ratio needs to be adjusted to lower patient access hurdle for drugs that lack verification of effectiveness." It means that the current 5% ratio needs to be increased for anticancer drugs lacking verification of effectiveness. Rep. Juyoung Lee of the National Reform Party said, "I agree with differential ratio," adding, "But, the rationale to supply cheap does not meet the global standard." Rep. Lee has requested expanding reimbursement through fast track, investing in clinical trials, and specifying a monitoring plan for the alternative measure to the Korean passing of anticancer drugs.
- Policy
- Alvogen receives approval for its Humira biosimilar in KOR
- by Lee, Hye-Kyung Oct 17, 2024 05:51am
- AbbVie A fifth Humira biosimilar has been approved in Korea. On the 15th, the Ministry of Food and Drug Safety approved Alvogen Korea's Simlandi pen40mg/0.4mL (adalimumab, recombinant), Simandi Prefilled Syringe Inj 40mg/0.4mL and 80mg/0.8mL.. Simlandi is imported and manufactured on consignment by Alvotech, a subsidiary of Alvogen Korea. It is the fourth biosimilar to be approved in Korea after Samsung Bioepis, Celltrion, and LG Chem, with more than 10 biosimilars approved globally following the patent expiry of the original, AbbVie's Humira. Simlandi is indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondyloarthritis, adult Crohn's disease, psoriasis, ulcerative colitis, Behçet's enteritis, hidradenitis suppurativa, and uveitis in adults. In pediatrics, it is also approved for the treatment of Crohn's disease in children (6 to 17 years of age). In February, Simlandi was approved by the U.S. FDA as the 10th Humira biosimilar. At the time of FDA approval, it was recognized for its high-concentration, citrate-free biosimilar formulation and for being the first biosimilar that pharmacies can substitute for the original drug without consulting a physician (prescriber) in the U.S. In the case of Humira, 88% of the prescriptions in the US are for high-concentration formulations. High-concentration products have the advantage of requiring fewer injections and less frequent dosing. They are usually subcutaneous (SC) rather than intravenous (IV), allowing for self-injection at lower doses. In the U.S., Humira biosimilars include Amgen's ‘Amgevita,’ Boehringer Ingelheim's ‘Cyltezo,’ Sandoz's ‘Hyrimoz,’ Samsung and Organon's ‘Hadlima,’ Pfizer's ‘Abrilada,’ Biocon’s ‘Hulio,’ Coherus‘ ‘Yusimry,’ Fresenius Kabi’s ‘Idacio,’ and Celltrion's ‘Yuflyma.’ Humira is a blockbuster drug that posted global sales of approximately USD 21.27 billion (approximately KRW 27.926 trillion) in 2022, with the adalimumab market valued at approximately KRW 100 billion.
- Policy
- ‘Will raise ICER threshold for innovative new drugs’
- by Lee, Jeong-Hwan Oct 16, 2024 05:50am
- The government has reaffirmed its policy to flexibly evaluate the ICER (incremental cost-effectiveness ratio) threshold for drugs that demonstrate innovativeness in order to strengthen patient access to new drugs. The intent is to increase the ICER threshold of new drugs based on previously announced criteria such as substitutability, prolonged survival outcomes, and whether the drug is a fast-track drug. The government maintained its position that it should be cautious about the need to extend the pharmacoeconomic exemption system to pediatric rare disease drugs and anti-cancer drugs. The Ministry of Health and Welfare's Pharmaceutical Benefits Division explained so in response to a written inquiry made during the NA Audit by Representative Myung-ok Seo of the People Power Party. Rep Seo pointed out the limitations and problems with the economic and non-economic indicators used to evaluate life. Rep. Seo asked whether the MOHW plans to raise the ICER threshold to improve access to new drugs based on analyses of recently listed drugs that have undergone pharmacoeconomic evaluations in comparison to those set in major overseas countries. The MOHW judges the cost-effectiveness of a new drug by comparing its clinical utility, such as the length of patient survival, to the additional cost. The MOHW replied that it revised the relevant regulations in August this year by specifying the ‘innovativeness’ condition among the ICER threshold evaluation factors based on the ‘Measure to Improve the Drug Pricing System Reflecting Innovation Value of New Drugs’ announced in December last year. Based on this, new drugs that satisfy the conditions of innovativeness will have their ICER value adjusted upward. The conditions for innovativeness are: ▲ there is no equivalent product or treatment that is substitutable or therapeutically equivalent; ▲ is recognized for a significant clinical improvement in the final outcome indicator, such as prolongation of survival; or ▲ the drug is a new drug approved under Article 35(4)(2) of the Pharmaceutical Affairs Act as a GIFT or equivalent. The MOHW said, “New drugs that meet the conditions of innovativeness will be flexibly evaluated with ICER thresholds that reflect their fair value. The government will strive to improve public health and ease economic burdens by strengthening patient access to new drugs for serious diseases such as cancer and rare diseases." In addition, the MOHW also plans to support the improvement of patient access to rare disease drugs through policy operations. Specifically, the ministry explained that it has reviewed measures to improve insurance listing of rare disease drugs in accordance with the ‘Specific tasks for improving access to rare disease drug reimbursement benefits’ in the Comprehensive Plan for Rare Diseases to support the prompt registration of treatments. It added that it secured flexibility in the ICER value, a criterion for pharmacoeconomic evaluation by adding 'innovation' to the evaluation factor, and has been implementing a parallel negotiation-evaluation system since January last year and a pilot project for the approval-evaluation-negotiation system since the second half of last year. The MOHW also pointed out that overseas cases such as Canada and the United Kingdom are applying measures such as flexible application of ICER values and expansion of the risk-sharing agreement systems to strengthen access to rare disease treatments, and the MOHW is also promoting policies modeled after them. To expedite the reimbursement of rare disease drugs, the MOHW replied that it will operate a pharmacoeconomic evaluation exemption system and a risk-sharing agreement system, and actively identify improvements to the system by collecting opinions on-site. However, the ministry expressed caution about expanding the pharmacoeconomic evaluation exemption criteria to include rare disease drugs and anti-cancer drugs for children. “In January last year, the MOHW revised the relevant regulations to add new drugs that treat non-life-threatening pediatric diseases but have a small number of patients and are clinically proven to improve quality of life,’ the MOHW said, explaining that “Crysvita Inj, a new drug for treating X-linked hypophosphatemia, which was approved in May last year, is a typical example.” “The pharmacoeconomic evaluation exemption system is operated as an exception that substitutes the cost-effectiveness evaluation by referencing a drug’s listed price in other countries,” the MFDS said, adding, “The proposal to expand the pharmacoeconomic evaluation exemptions to adult patients needs to be carefully promoted through public discussion.”
- Policy
- Govt ‘is considering measures to overcome Korea Passing’
- by Lee, Jeong-Hwan Oct 16, 2024 05:50am
- The government has responded that it will come up with measures to ensure a stable supply of new drugs, including a dual pricing system, to overcome the so-called ‘Korea passing’ phenomenon, in which domestic and foreign pharmaceutical companies avoid launching their drugs in the domestic market and target overseas markets first, citing excessively low drug prices set by the government. The government also said it would consider measures that could boost the development of new drugs targeting chronic diseases. On the 14th, the MOHW responded so to a written inquiry submitted during the NA Audit by Representative Myung-ok Seo of the People Power Party. The lawmaker asked for the MOHW’s opinion on the introduction of a dual pricing system, pointing out that Korean patients' access to new drugs is deteriorating due to the Korea Passing phenomenon. The MOHW said it would take reasonable measures to stabilize the supply of new drugs, including dual pricing, to overcome Korea Passing. The MOHW said it negotiates drug prices in consideration of the impact on insurance finances, but acknowledged that there are cases of pharmaceutical companies abandoning domestic insurance reimbursement listing as it may hinder overseas drug price negotiations when the prices are set low in Korea. “For this reason, we will take reasonable support measures, such as a dual pricing system, to ensure that domestic patients‘ access to new drugs is not compromised,” said the MOHW. The ministry also promised to support policies to encourage the development of new drugs for chronic diseases. First, the MOHW explained that previously, the risk-sharing agreement system was applied to serious diseases that threaten survival with anti-cancer drugs and rare disease treatments that have no substitutes, but from August this year, the system was improved to apply RSA to new drugs for chronic severe diseases that have no substitutes and irreversibly worsen the quality of life and have a large disease burden. This means that severe asthma and atopic dermatitis drugs are also eligible for RSA. The MOHW agreed on the need to develop support measures for the development of new drugs for chronic diseases but said that national health insurance finances should be considered. “Chronic diseases have a large number of patients and varying degrees of severity, so it is necessary to review rational support measures that take into account health insurance finances,” said the MOHW. “We will review the targets of support in consideration of chronic diseases with a large disease burden and come up with rational support measures for the development of new drugs for chronic diseases.”
- Policy
- Stopping illegal online sales·advertisements of 'Wegovy'
- by Lee, Hye-Kyung Oct 16, 2024 05:50am
- Product photo of Wegovy. As 'Wegovy,' a dream treatment for obesity, is set to launch in South Korea, the health authority plans to focus on monitoring online illegal sales and fraudulent advertising. It will also implement post-marketing safety management related to side effects and drug abuse. The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on October 15th of plans to implement intense monitoring of cases of sales·advertising online and SNS for a month aligninig with the launching of the obesity drug, a type of glucagon-like peptide-1 (GLP-1) agonist. A GLP-1 type obesity drug is effective in increasing glucose-dependent insulin secretion, inhibiting glucagon secretion, and delaying hunger and weight loss. The drug is Novo Nordisk Korea's Wegovy. Wegovy is a non-reimbursable drug that is not covered by the health insurance, and the domestic supply price is KRW 372,025 (4-week dose). However, as it is non-reimbursable, the sales price, including prescription fee and distribution, is expected to be about KRW 800,000 to KRW 1 million. Wegovy can be used in obese patients who have a Body Mass Index (BMI) of 30kg/m2 or higher or those who are overweight with early BMI of 27kg/m2 or higher and below 30kg/m2 and have one or more weight-related accompanying diseases, with doctor's prescription and pharmacist's filling·medication counseling. "It is illegal for people who do not have pharmacy license to sell the obesity drug," MFDS stated. "To prevent the potential risk of consumers buying obesity drugs through online·SNS, the MFDS will implement an intense monitoring of individuals selling or advertising the obesity drug online·SNS for a month aligning to the launching date." The MFDS, in collaboration with the Korea Institute of Drug Safety & Risk Management, will also monitor cases of side effects·adverse reactions related to the use of the obesity drugs and organize a monitoring task force to implement necessary safety measures. The MFDS will collaborate with the Health Insurance Review and Assessment Service (HIRA) and review· analyze the supply volume and increasing·decreasing trends in each clinic. It will also conduct on-site monitoring for fraudulent advertisements. "We will ensure people use medicines safely by monitoring domestic and overseas safety information and adverse reaction cases for obesity drugs, and we will also check online sales advertisements and conduct on-site monitoring," the MFDS stated.
