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- 2026-05-03 10:14:46
- Policy
- MFDS preannounces temporary narcotics designation of 2 drugs
- by Lee, Hye-Kyung Jan 26, 2023 06:05am
- On January 20th, The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) preannounced the designation of two drugs including ‘Etazene’ that is being misused or abused as a narcotics substitute in Korea and abroad. Etazene is a synthetic opioid that has a similar structure and effect to Etonitazene, which has been designated as a narcotic drug, and is being controlled as a temporary-class narcotics drug in Japan. 6-Monoacetylmorphine, whose temporary narcotics designation expires on March 8th, will be redesignated as a Group 2 temporary narcotics drug. The temporary narcotics designation system is a system that manages and controls certain non-narcotics in the same manner as narcotics within a 3-year period due to concerns of such being misused or abused as an alternative to narcotics and posing risks to public health. Substances designated as temporary narcotics are handled and managed in the same manner as narcotic drugs from the date of the pre-announcement. Therefore, carrying, possessing, using, controlling, exporting, importing, manufacturing, trading, assisting in the trade of, giving, or receiving temporary narcotics will be completely banned, and relevant substances can be seized. Also, anyone who export, import, manufacture, trade, assist in the trade, give or receive Group 1 temporary narcotics after the pre-announcement on the list of temporary narcotics will be punished by imprisonment with labor for an indefinite term or not less than 5 years. Anyone who imports, exports, or manufactures Group 2 temporary narcotics shall be punished by imprisonment with labor for not more than 10 years or by a fine not exceeding KRW 100 million. Those who trade, assist in trade, give or receive Group 2 narcotics shall be punished by imprisonment with labor for not more than 5 years or by a fine not exceeding KRW 50 million. MFDS expressed hopes that the preannouncement will help block the distribution of new illicit drugs in advance and will cooperate with relevant prosecution, police, the Korea Customs Service, and other related agencies, and continue making efforts to protect public health from the harms inflicted by new and illicit narcotic drugs.
- Policy
- Penalties for rebate drugs can be replaced by fines
- by Lee, Jeong-Hwan Jan 20, 2023 06:07am
- Rep. Kim Min-seok A bill will be promoted to replace drug price cuts and suspension of salaries for illegal rebates on drugs with fines. It also includes a clause that further strengthens the penalty standard for effective illegal rebate disposal. The move aims to solve the problem of increasing drug costs for patients who have to continue taking drugs due to administrative measures such as suspension of salary. On the 19th, Rep. Kim Min-seok of the Democratic Party of Korea proposed a partial amendment to the National Health Insurance Act. Under the current law, if drug suppliers such as pharmaceutical companies are found to have provided economic benefits to medical personnel for the purpose of promoting sales, drug prices will be lowered and salaries will be suspended. Kim Min-seok agreed to punish illegal rebates strictly but pointed out the problem of patients being damaged by the suspension of drug benefits and drug price cuts. Kim points out that the burden of drug costs for patients who have to continue to take existing drugs will increase significantly, and the anxiety of eating other drugs will also be borne by the patient, which could infringe on the public's right to health. In particular, Rep. Kim was also concerned that prescribing and selling identical drugs that are more expensive than the insurance price of administrative disposition drugs for suspension of salary will increase drug expenditure, increasing the financial burden of health insurance. In addition, in 2018, the National Assembly revised the law to replace the suspension of salary for rebate drugs before the revision but criticized that the government is still applying the old law. In response, Rep. Kim proposed a bill that could replace the drug price reduction and benefit suspension system for rebate drugs with a penalty sound. Kim said, "We will set a strengthened level of penalty standards to enhance the predictability of administrative disposition and effective sanctions on rebates," adding, "We will also solve the problem of patient drug options and accessibility violations due to suspension of drug subsidies."
- Policy
- Rinvoq PR 30 mg & Fexuclu 10 mg listed
- by Lee, Jeong-Hwan Jan 20, 2023 06:07am
- The Ministry of Health and Welfare will overhaul Rinvoq, Procoralan, and Fexuclu (from left) standardsWith the new listing of high-content products of Rinvoq PR, a severe atopic drug, the salary standard changes. The angina drug Procoralan is a standard treatment drug and an angiotensin II receptor blocker is added. Fexuclu, a gastroesophageal reflux disease drug, will have four new benefits listed, including a low content of 10 mg oral medicine. On the 18th, the Ministry of Health and Welfare will collect opinions by the 27th after giving an administrative notice of "partial revision of the detailed (drug) on the application standards and methods of medical care benefits." The scheduled effective date is February 1. ◆ Rinvoq PR 30mg will be newly registered, adding '30mg' to the name of the notification. Considering that the permission matters for each drug are different, the phrase is changed to "dose within the scope of permission for each drug." Currently listed 15 mg has secured indications of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and ulcerative colitis. The newly listed 30 mg can only be used for atopic dermatitis and ulcerative colitis indications. ◆ Ivabradine= Ministry of Health and Welfare clarifies Procoralan as standard treatment drugs by referring to the Ministry of Food and Drug Safety's permits, guidelines, clinical papers, and expert opinions. Currently, the standard treatment drugs for oral drugs composed of Ivabradin are beta-blockers, ACE inhibitors, and aldosterone antagonists. The Ministry of Health and Welfare will add an angiotensin II receptor blocker to this. ◆Fexuclu=Procoralan, a treatment for improving gastric mucosal lesions of acute gastritis and chronic gastritis, will have a revised salary standard as 10mg is set to be newly registered. Specifically, the phrase "medical care benefits are recognized when administered within the scope of permits (treatment of erosive gastroesophageal reflux disease)" is changed to "medical benefits are recognized within the scope of each drug, and the patient pays the full price except for this recognition." The criterion refers to the treatment of erosive gastroesophageal reflux disease. In the case of "improvement of gastric mucosal lesions of acute gastritis and chronic gastritis", which is an additional permit from the Ministry of Food and Drug Safety, the entire amount is recognized at the expense of the person. As a result, the scope of benefit according to the content of Fexuprazan has become clear. Fexuprazan 40mg, which was listed in July last year, was approved to be used to treat erosive gastroesophageal reflux disease. Salary is recognized at the time of administration. The 10 mg product, which will be listed in February this year, has added indications of "improvement of gastric mucosal lesions of acute gastritis and chronic gastritis." When administered with the indication, the burden is recognized, not the benefit.
- Policy
- Grace period for foreign API mfg site registrations ends
- by Lee, Hye-Kyung Jan 19, 2023 05:58am
- Starting on the 21st, the foreign manufacturing site for all pharmaceuticals (including APIs) imported to Korea from abroad must be registered in advance. The Ministry of Food and Drug Safety announced that the grace period that had been granted in consideration of the industry’s state of preparations in registering foreign manufacturing sites for APIs imported to manufacture of finished products, will end as of January 20th. The mandatory registration of overseas manufacturing sites for all pharmaceuticals went into effect on July 21st last year after the amendment of the Pharmaceutical Affairs Act on July 20th, but a grace period on its immediate implementation was granted until January 20th. Therefore, from January 21st, companies not only would need to register the foreign manufacturing sites for their imported finished drugs and Drug Master File (DMF) drugs but would also need to register the foreign manufacturing sites for imported APIs that the companies use to manufacture their own finished products. The MFDS urged the companies to thoroughly make preparations in advance to prevent disruptions in domestic drug supply and production. The foreign manufacturing site registration system, which took effect in December 2019, was designed to promptly respond to relevant imported drugs in the event risk is identified overseas and mandates the registration of the workforce, facility, and GMP status of the overseas manufacturing site. Information on the overseas manufacturing site is systematically registered, updated, and managed for the latest information, and is used for risk assessment of overseas manufacturing sites and selection of sites subject to on-site inspection. The number of registered overseas manufacturing sites has been steadily increasing, from 1882 sites in 2020 to 2208 sites in 2021, then 2531 sites in 2022. The MFDS said, “We expect the overseas manufacturing site registration system to increase reliability in the quality of imported drugs and contribute to the more thorough and safe management of the drugs. We will continue our efforts to manage the safety of imported drugs to allow our people the safe use of high-quality drugs.”
- Policy
- Generic for Dukarb to be released next month
- by Lee, Tak-Sun Jan 18, 2023 06:04am
- DukarbGeneric for Dukarb, a compound combined with Amlodipine in the new hypertension drug Kanarb developed by Boryung pharmaceutical, is expected to release in time for the expiration of the patent next month. Eight items from four companies approved last month will go to the market first, and they will be calculated at 53.55% of the initial price of every single ingredient. Among the same ingredient products approved this month, consignment items will be 15% cheaper depending on the standard requirements, and salary registration is expected to be possible only in March. According to industries on the 17th, as generics for Dukarb, which was approved in December last month, applied for benefits, the salary is expected to be applied from February 2, the day after the patent expires. Items licensed in December last month are Dunarb 30/2.5mg, Dunarb 60/2.5mg, Fimadipine 30/2.5mg, Fimadipine 60/2.5mg, Hana Pharmaceutical Fimaone-S 30/2.5mg, Fimaone-S 60/2.5mg, Aliko Pharmaceutical Ardewka 30/2.5mg, and Ardewa. All of these products are produced on consignment by Alico Pharmaceutical, and since they applied for drug prices in the same month, they are all considered data-submitted drugs, and the upper limit is expected to be 53.55% of the first price of a single ingredient. The original Dunarb, which was added as an innovative pharmaceutical company, is also expected to go down at the same price. Dunarb's first generic is different from amlodipine. The original Dunarb is Amlodipine Besylate, whereas the late drugs are S-Amlodipine Besylate 2.5. Since it is not the same ingredient as Dunarb, the drug price is calculated at the highest price according to the drug price standard. However, the drug price of the product approved in January is different. Products licensed in January are also 2.5 mg of S-Amlodipine Besylate, which are considered generics of the four products listed first, and consigned items without direct BA will be 15% cheaper as the standard requirements are applied. Of course, entrusted items with direct BA and DMF requirements are expected to be equally calculated at 53.55%. There was a difference in drug prices depending on the time of approval. None of the items released this time have the same active ingredients and content as Dukarb 30/5mg. This is because Dukarb 30/5mg is registered separately as a patent, and the composition patent lasts until August 8, 2031. Late pharmaceutical companies filed a passive trial to confirm the scope of rights to avoid the patent, but it was rejected in March last year. As a result, an appeal is currently underway in the Patent Court. Due to the failure of patent avoidance, the license of the capacity item is being delayed. Since Dukarb 30/5mg is the flagship capacity of about half of the market along with Dukarb 60/5mg, generic pharmaceutical companies are expressing regret over the failure of the first trial to evade patents. In addition to the approved generics, Fimasartan salt change generics are also reportedly preparing for approval.
- Policy
- MOHW-NECA issues notice on colorimetric assay
- by Kim, Jung-Ju Jan 18, 2023 06:04am
- The National Evidence-based healthcare Collaborating Agency (President: Kwang Hyub Han) announced the amendments to the notice on the new health technology, ‘colorimetric assay’ for anti-Xa apixaban testing, that had been deliberated as a safe and effective health technology at the 10th MOHW New Health Technology Assessment Committee meeting in 2022. The New Health Technology Assessment system was introduced in 2007 to assess the safety and clinical efficacy of new health technologies (acts of medical practice including treatment method, and testing method), and is implemented to prevent indiscriminate use of unverified medical technology and to protect the people's right to health. The anti-Xa apixaban assay technology, the ‘colorimetric assay, ‘is a test that quantifies the concentration of apixaban in plasma samples through colorimetric assay for patients that were administered apixaban and require monitoring for apixaban concentration. As it is safe as an in vitro test that uses patient samples and is recommended as a test to monitor the concentration of apixaban in patients that are administered apixaban when clinically necessary in textbooks and guidelines, the technology was determined to be a valid technique with an acceptable level of correlation to the current standard test method, liquid chromatography-tandem mass spectrometry. Meanwhile, the results of the new Health Technology Assessment were notified under Article 53-3 of the Medical Service Act and Article 4 of the Rules on New Health Technology Assessment and may be found on the MOHW and NECA’s Center for New Health Technology Assessment website.
- Policy
- Dupxient deemed adequate for reimb in children with AD
- by Lee, Tak-Sun Jan 13, 2023 06:01am
- The atopic dermatitis treatment ‘Dupixent’ was deemed adequate for reimbursement in children and adolescents. Therefore, attention is now focused on whether Dupixent will become the first biological agent to be reimbursed for atopic dermatitis in children and adolescents. The Health Insurance Review and Assessment Service announced that it had passed the agenda at the first 2023 Drug Reimbursement Evaluation Committee (DREC) meeting that had been held on the 12th. At the meeting, DREC concluded that Sanofi-Aventis Korea’s ‘Dupixent Prefilled Inj. 200, 300mg (dupilumab, genetical recombination)’ was appropriate for reimbursement in treating 'atopic dermatitis in children and adolescents.' With the drug passing HIRA's stage, pediatric and adolescent atopic dermatitis patients will be able to receive reimbursement after the company completes drug pricing negotiations with the National Health Insurance Service. In Korea, Dupixent is reimbursed for adult patients with atopic dermatitis since January 2020.
- Policy
- Lee Jong-sung, who pointed out Moon Care
- by Lee, Jeong-Hwan Jan 13, 2023 06:01am
- Lee Jong-sung, a member of the National Assembly's Health and Welfare Committee, pointed out that Moon Jae In Care's health insurance coverage rate has fallen and said he will take the lead in making policies for normalization. Rep. Lee Jong-sung posted this message on his social media on the 11th. Representative Lee criticized the failure of Moon Care conducted by the Democratic Party of Korea based on the results of the 2021 survey on health insurance patient medical expenses. Lawmaker Lee pointed out that the guaranteed rate fell last year compared to the previous year, and that it did not show a significant increase compared to before the implementation of Moon Care. In particular, Rep. Lee pointed out that Moon Care has increased the coverage rate of general hospitals or higher and the coverage rate of primary medical institutions at the clinic level has fallen by 4.1%p, confirming the concentration of higher hospitals. Rep. Lee said he would make efforts to normalize health insurance as a health and welfare committee member to solve the problem. Hee said, "The guaranteed rate in 2021 was 64.5%, down 0.8 percentage point from the previous year, and it rose only 1.8 percentage points compared to 2017," adding, "It is a natural lesson that even if you use your finances, you should not spend them wisely where you need them." Hee said, "I have continuously raised Moon Care issues such as the collapse of the medical delivery system, non-reimbursed balloon effect, and financial waste, including the concentration of upper-level hospitals," adding, "However, the Moon administration and the Democratic Party have been busy promoting a performance by hiding the health insurance budget deficit." In particular, the health insurance coverage rate for the disabled also decreased compared to last year. It must be improved, he said. "In the place where 20 trillion won in taxpayers' money was invested, only a poor report card remains." The Welfare Committee will also make efforts to establish a health insurance system for the weak in line with the Yoon Suk Yeoln government's stance on normalizing health insurance, he added.
- Policy
- Sama Pharm’s formoterol to receive clinical reevaluations
- by Lee, Hye-Kyung Jan 12, 2023 04:29am
- After the authorities issued a notice on conducting clinical reevaluations for the active ingredient formoterol fumarate, Sama Pharm, the only company that maintained its authorization for the ingredient, was found to have submitted a clinical trial protocol for its acute bronchitis indication among its 3 approved indications (bronchial asthma, acute bronchitis, asthmatic bronchitis). The Ministry of Food and Drug Safety ordered clinical reevaluations to be conducted for 16 tablet and syrup products that contain formoterol fumarate on December 23, 2020 and requested companies to submit their clinical trial protocols by March 31, 2021. However, all companies that own items other than the 3 items that were the first to receive marketing authorization in 1986 – Sama Pharm’s Atock Tab. Sama, and Sama Atock Tab. 20μg – have voluntarily withdrawn their licenses after the notice. According to the minutes of the advisory meeting of the Central Pharmaceutical Affairs Council that was recently disclosed by the MFDS, the CPAC approved the adequacy of Sama Pharm’s clinical trial protocol (its scope of effect·efficacy, trial period) but requested the company to submit data that adequately describes the basis for calculating the number of trial subjects. The minutes also showed that Sama Pharm first submitted clinical trial protocols for bronchial asthma and acute/chronic bronchitis but received administrative disposition for non-submission of supplementary materials, and then resubmitted a clinical trial protocol only for its acute bronchitis indication. Also, the company set the efficacy endpoint for the reevaluation as the 'improvement of wheezing,’ and the MFDS determined the endpoint reasonable in consideration of the pharmacological action of the active ingredient, the age of the test subjects, and expert advice from the Korean Academy of Tuberculosis and Respiratory Diseases. However, to address concerns about bias due to subjective judgment on the improvement of wheezing in the evaluation index, the CPAC ordered trial objectivity to be secured through a clinical trial design (placebo-controlled, double-blind). Regarding the validity of the scope of efficacy and effect verification in the clinical trial, one committee member pointed out, "As the trial will only prove efficacy and effectiveness in pediatric patients with acute bronchitis, its actual scope of use in the field will be different” Another member said, “The drug has been long used in the field, therefore, the drug is expected to be used for indications other than acute bronchitis even though the clinical trial is conducted only for acute bronchitis.” Meanwhile, the MFDS had recommended against the use of long-acting beta-agonists (LABAs) such as formoterol as monotherapy in asthma patients based on the US FDA’s analysis. The FDA had also issued such a guideline based on a study that showed that using LABA alone may increase the risk of exacerbation of severe asthma symptoms.
- Policy
- Take the burden off the hospital bills
- by Lee, Tak-Sun Jan 12, 2023 04:29am
- The NHIS announced that it had expanded the scope of particular calculation for rare diseases and chronic kidney dialysis patients subject to particular calculation of health insurance from January 1 this year to ease the burden on the medically vulnerable. The expansion will significantly reduce the burden on patients by lowering the burden on them from 20% of hospitalization and 30% to 60% of outpatients to 10% of both hospitalization and outpatients. First of all, it is expected that about 4,000 people with the disease will benefit from medical expenses reduction as special calculation cases will be applied to 42 new rare diseases, including "polycystic kidney, common chromosome dominance." The NHIS has been working with the Korea Centers for Disease Control and Prevention, which manages rare diseases, to collect opinions from patient groups and experts, and has been reviewed and resolved by the Ministry of Health and Welfare and the Corporation. With this expansion, the number of rare diseases subject to the particular calculation will increase to 1,165. Accordingly, patients with new rare diseases will pay 10% of their own charges for treatment of diseases registered for particular calculation and complications with clear medical causality with the disease, and health insurance subscribers with a median income of less than 120% (less than 130% for children) can receive 10% of their own charges through the Korea Centers for Disease Control and Prevention. In addition, special cases for calculating patients with chronic renal failure apply to outpatient treatment on the day of dialysis and inpatient treatment related to the procedure. Previously, failure to receive dialysis on the same day due to unavoidable reasons such as blood vessel surgery or bleeding after hemodialysis may cause excessive dialysis or financial burden. Based on expert advice and medical evidence, the system has been improved to allow dialysis vascular procedures and surgery. The improvement of the system is expected to further benefit artificial kidney dialysis patients, who have not been subject to special cases due to failure to perform dialysis after vascular procedures and surgery for dialysis. Lee Sang-il, senior executive director of the corporation, said, "The NHIS will continue to work with related agencies such as the Ministry of Health and Welfare and the Korea Centers for Disease Control and Prevention to strengthen essential medical coverage for the vulnerable by continuing to find and calculate rare and severe incurable diseases that require long-term treatment."
