Latest news with #MinistryofFoodandDrugSafety
Hans India
25-05-2025
- Business
- Hans India
South Korea: Compensation for drug side effects falls for 1st time in 6 yrs
The amount of compensation paid to victims of drug side effects in South Korea declined in 2024 for the first time in six years, government data showed on Sunday. The government collected 4.75 billion won (US$3.5 million) last year from 760 pharmaceutical companies for the national drug side effects relief fund, according to the Ministry of Food and Drug Safety and the Korea Institute of Drug Safety & Risk Management. The relief program provides financial support to individuals or bereaved families of those who suffer death, disability or illness caused by adverse drug reactions, reports Yonhap news agency. Financial assistance includes lump-sum payments for death or disability, medical expenses and funeral costs. In 2024, compensation was paid out for 161 cases, reaching 1.84 billion won, down 18.3 percent from 2.25 billion won a year earlier, the data showed. The decline is mainly due to a decrease in compensation for deaths linked to side effects and lack of public awareness of the program. "As payouts accounted for only 38.7 percent of the funds collected last year, the government should more actively promote the program through hospitals, medical professionals and pharmacies," an industry official said. Meanwhile, South Korea will work to triple the size of the animal medicine market to 4 trillion won (US$2.7 billion) by 2035 as part of efforts to foster new growth engines for the economy, the agriculture ministry said last month. The government also aims to increase the country's exports of veterinary medicine products fivefold to 1.5 trillion won and create 15 animal pharmaceutical companies with an annual revenue of at least 50 billion won each over the next 10 years, according to the Ministry of Agriculture, Food and Rural Affairs. The ministry said the plan comes amid growing demand for animal pharmaceutical products around the globe, sparked by an increase in pet ownership, livestock product consumption and infectious diseases in animals.
Korea Herald
01-05-2025
- Business
- Korea Herald
S&E bio Receives Korea's First Approval for Exosome-Based Therapy Clinical Trial
SEOUL, South Korea, May 1, 2025 /PRNewswire/ -- S&E bio Co., Ltd., a biotechnology company specializing in exosomal microRNA-based therapies, has received approval from Korea's Ministry of Food and Drug Safety (MFDS) to initiate a Phase 1b clinical trial of its investigational stroke therapy, SNE-101. This is the first exosome-based therapy in Korea to enter clinical trials, marking a major milestone in the country's biopharmaceutical landscape. S&E bio developed SNE-101 using a proprietary 3D culture system to optimize exosome production from umbilical cord-derived mesenchymal stem cells. The exosomes carry therapeutic microRNAs designed to enhance neuroregeneration. The approval followed successful resolution of Chemistry, Manufacturing, and Controls (CMC) issues, as well as demonstration of therapeutic efficacy not only in rodent models but also in non-human primates, which better reflect human stroke pathology. Long-term safety was also confirmed. The Phase 1b trial will evaluate the safety, dose-limiting toxicity, and preliminary efficacy of SNE-101 via intravenous administration. As no approved pharmacological therapies currently exist beyond reperfusion treatments for stroke, SNE-101's potential neuroregenerative, neuroprotective, and anti-inflammatory effects offer new hope for improving recovery in stroke patients. Media Contact:
Korea Herald
26-04-2025
- Health
- Korea Herald
Adolescent use of weight-loss drug Wegovy sought in S. Korea
Novo Nordisk Korea applies for anti-obesity drug to be used among children 12 and older The South Korean office of the Danish pharmaceutical company Novo Nordisk recently requested the local authorities to permit the use of its anti-obesity medication Wegovy for children aged 12 and above. Novo Nordisk Korea purportedly requested the permit from the Ministry of Food and Drug Safety, which currently allows the medication to be used only for those aged 18 and above. The drug was released here in October of 2024, prescribed to obese patients with a body mass index of 30 kilograms per square meter or those with a BMI of 27 who have weight-related diseases. South Korea defines obesity as a BMI of 25 or above, different from the global standard of 30 or above. The ministry's stance on the underage use of Wegovy is that its safety and effectiveness on children and teenagers have not been proven. Wegovy is the brand name of the diabetes and weight-loss medication sold by Novo Nordisk, also under the names Ozempic and Rybelsus. Wegovy use in children aged at least 12 has been approved by authorities in other countries such as the European Medicines Agency and the US Food and Drug Administration, with the latter approving once-weekly injection of the medication for treatment of teens in 2022. It was reported by the Associated Press last year that nearly 31,00 children aged 12 to 17 used the medication in 2023, with over 162,000 aged 18 to 25 using it in the same period. A local branch of the Danish company submitted the clinical data on the adult patients when receiving the permit for domestic use, as the firm had not previously requested a permit for juvenile use. The government said in December that it will review the use for children if Novo Nordisk submits the clinical data for children. Concerns over abuse and side effects The drug is designed to reduce patient appetite by mimicking the actions of the hormone called GLP-1 (glucagon-like peptide-1), released after meal ingestion. It is among the class of anorectic drugs that reduce blood sugar and energy intake by activating the GLP-1 receptor. Research indicated significant weight loss effects among the injected patients in the US. Some 45 percent of teenagers who took the medication managed to lose enough weight to drop below the clinical cutoff for obesity, according to a 2023 study conducted by researchers at the University of Minnesota and published in the International Journal of Obesity. Possible adverse effects, including nausea, vomiting, constipation, abdominal pain, headache and fatigue, were reported. Particularly among people with type 2 diabetes, flatulence, gastroenteritis and gastroesophageal reflux disease were reported side effects. Wegovy use has seen a significant rise in use in Korea, with public figures such as YouTuber Pani Bottle publicly saying he lost 10 kilograms with the medication. He posted on his Instagram on April 14 that his acquaintances experienced side effects such as nausea, depression and fatigue, with him personally experiencing a prolonged nausea. With the rising popularity of Wegovy and concerns over abuse, the South Korean government in December restricted prescribing the medication via telemedicine, or remote diagnosis.
Korea Herald
16-04-2025
- Health
- Korea Herald
Brain boost backlash: ADHD patients caught in pill shortage
Study aid myth fuels pill shortage among teens on race to prestigious colleges Twenty-six-year-old Lee Jung-woo — not his real name — has been living with Attention Deficit Hyperactivity Disorder at least since he was diagnosed at 10 years old. For over a decade, he relied on a steady prescription of methylphenidate, the core ingredient in the most widely used ADHD medications in South Korea. But when his regular hospital unexpectedly shut down, a new challenge emerged: finding a place that still had his medicine. 'It's like a treasure hunt,' Lee said. 'I've called more than 20 hospitals trying to find one that prescribes the same medicine I've taken since childhood.' Lee is not alone. A nationwide shortage of ADHD medications, particularly Concerta — a long-acting methylphenidate product manufactured by Johnson & Johnson's Janssen — is sending patients and families scrambling. The shortage, ongoing since last year, has persisted alongside a rising number of people diagnosed and treated for ADHD. According to the Ministry of Food and Drug Safety, 337,595 patients were prescribed methylphenidate-based ADHD drugs last year, nearly three times the number from 2019. But supply has failed to keep pace. Janssen Korea has reported supply disruptions to the government three times since April 2023. While experts attribute the rise to clearer diagnostic criteria, increased mental health awareness and sustained care needs into adulthood for half of childhood cases, some note the shortage is being worsened by widespread misuse and misinformation. Methylphenidate is often misunderstood as a 'study aid,' falsely believed to enhance academic performance for otherwise healthy students. Its reputation as a concentration booster has fueled demand in education-driven districts such as Seoul's Gangnam-gu, Songpa-gu and Seocho-gu, where prescription rates are among the nation's highest. According to data from the National Health Insurance Service, prescriptions for ADHD medications in 2021 were most concentrated in Seoul's Gangnam-gu, with 2,004 patients receiving treatment. This was followed by Songpa-gu (1,971), Seocho-gu (1,333) and Nowon-gu (1,108) — areas all known for intense academic competition and pressure. One doctor The Korea Herald talked with over the phone in one of these neighborhoods said the number of patients has "definitely increased." "It's very noticeable. The number of students coming to get prescriptions has increased. However, it's very hard to differentiate the ones who really need the drugs and the ones who think they do, as prescribing is based on what the patients say." As supply thins, patients are being prescribed alternatives like Medikinet, which shares the same active ingredient, methylphenidate. But some patients say the substitutes are not as effective. In online forums, parents are sharing pharmacy locations with available stock and venting frustrations. A parent-led petition on the National Assembly's electronic petition site calling for a government-led solution has garnered over 13,500 signatures as of mid-April. 'These are not just pills,' wrote the petition's author. 'They are essential for children to manage their emotions, build friendships and get through a school day safely. When these medications are unavailable, our children face emotional swings, anxiety and academic setbacks.' Amid growing public concern, calls for stronger governmental intervention are increasing. Some experts and lawmakers argue that ensuring stable access to essential psychiatric medication is a matter of public health that must be addressed through expanded production, import diversification and emergency stockpiles. The surge in distribution has also raised concerns about misuse. Methylphenidate, the primary ingredient in most ADHD medications, is a controlled psychotropic substance. Improper or extended use can lead to dependency, mood instability, anxiety and even aggression. Critics point to the loosely applied prescription standards, noting that some clinics may exaggerate symptoms or offer short-term prescriptions without comprehensive evaluation. In response to growing concerns, the Drug Safety Ministry issued public guidance stating that 'ADHD medication is not a drug to improve academic performance.' While it acknowledged that some children may experience better grades after treatment, the ministry clarified that such outcomes are due to improved concentration and symptom relief, not cognitive enhancement. The ministry also warned of risks of dependency associated with misuse. Despite these efforts, the government has yet to introduce effective measures to resolve the ongoing shortage. In September last year, the ministry added methylphenidate to its list of substances subject to abuse prevention protocols and began monitoring medical institutions more closely. However, these steps have failed to address the fundamental supply crisis. As the situation persists, patients and caregivers continue to call for more practical, long-term solutions.
Forbes
14-04-2025
- Business
- Forbes
K-Beauty Boom Lands Former Dermatologist On Korea's 50 Richest List
A woman receiving facial treatment at a beauty clinic. This story is part of Forbes' coverage of Korea's Richest 2025. See the full list here. The growing K-beauty craze catapulted Jung Sung-jae, founder of beauty device maker Classys, into the ranks of Korea's 50 Richest list for the first time with an estimated fortune of $760 million. The company's shares shot up more than 50% in the past year on the back of increasing popularity of Korean cosmetics and beauty devices. Cosmetics exports out of South Korea grew 21% year-over-year in 2024 to a record $10.2 billion, according to the country's Ministry of Food and Drug Safety. Classys' revenue rose over a third from a year ago to 243 billion won ($170 million) in 2024, with 67% of sales coming from overseas markets, while net income increased 32% to 98 billion won over the same period. ss Based in Seoul's upscale Gangnam neighborhood, Classys was founded by Jung, a former dermatologist, in 2007. The company sells to hospitals and beauty clinics, as well as directly to consumers through its own online shopping mall, in more than 80 countries such as Australia, Brazil, Thailand and the U.S. Its flagship product is Ultraformer MPT (which stands for 'Micro-Pulsed Technology'), a high-intensity focused ultrasound (HIFU) device that provides a non-invasive way to tighten and lift skin by regenerating new collagen. In 2022, Bain Capital Private Equity bought a 60% stake in Classys from Jung and his wife, Lee Yeon-joo, and their two children for 670 billion won (about $560 million at the time). Shortly after the deal, Jung handed over the reins of the company to Baek Seung-han, the company's chairman and CEO, to position it better for overseas growth leveraging Bain Capital's global network. The cash from the stake sale accounts for the bulk of Jung's fortune, while the family retain a minority stake in the business.
