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- 2025-12-24 23:31:10
- Policy
- Mandatory evaluation of MFDS when using all off label drugs
- by Lee, Jeong-Hwan Dec 19, 2019 06:35am
- A bill is piloted to require government assessments when using 'off-labeled drugs' in patients that go beyond the indications that have been proven in clinical trials, which are phases of drug marketing. Representative Sang-hee Kim of the National Assembly on Health and Welfare on the 18th proposed the partial revision of the Pharmaceutical laws and regulations. Off-labeled use of current drugs differs from individual use procedures, such as those subject to reimbursed benefits and non-reimbursed, over-the-counter and anticancer drugs. Representative Sang-hee Kim said that the pharmaceutical industry is passive in research and development of medicines that meet the medical needs such as rare and severe diseases, children, and pregnant women, and encourages the use of off-label. It is pointed out that the use of off-labeled drugs with different efficacy, effect, indications, and dosage is not frequently recognized by the Ministry of Food and Drug Safety, which is a drug approval authority. Representative Kim criticized that MFDS conducts off-label use evaluation only for non-reimbursed generic drugs according to the Ministry of Health and Welfare, so systematic safety management of over-licensed drugs is not possible. Representative Kim said, “To prevent this, we need to establish a legal basis for the safety and effectiveness evaluation of MFDS for all use of off-label drugs, we will promote public safety by establishing a systematic evaluation environment for non-permission use”.
- Policy
- First Samsca generic submits approval application
- by Lee, Tak-Sun Dec 19, 2019 06:34am
- 오츠카 The first generic to follow Korea Otsuka Pharmaceutical’s Samsca (tolvaptan), indicated for treating euvolemic hyponatremia, has submitted an approval application to Korean Ministry of Food and Drug Safety (MFDS). The industry believes Myung In Pharma would be the one to grab the approval as it has been challenging the patent and developing the follow-on drug. According to MFDS on Dec. 17, a tolvaptan-containing drug submitted an application for approval. The drug in 15 mg dose is administered once-daily to treat patients with hyponatremia. As stated by the Drug Approval-Patent Linkage system, MFDS notified Otsuka, the patentee, about the submitted application. Otsuka’s Samsca is protected by a patent on solid preparation and its manufacturing method of the medicine including bezoazepine, which is to be expired on June 20, 2028. In last May, Myung In Pharma evaded infringement of Samsca’s drug patent with Intellectual Property Trial and Appeal Board’s ruling. The company filed a defensive confirmation trial for the scope of a right, which then was affirmed. And in the same month, the company’s bioequivalence test protocol was cleared. Based on the clues, the industry is convinced Myung In Pharma has probably applied for the approval. The original Samsca is the first-and-only hyponatremia treatment approved by MFDS in September 2011. Hyponatremia is an electrolyte-associated adverse event commonly found in hospitalized patient, which can cause serious neurologic complications. Before Samsca was available, intravenous fluid with high concentration of sodium was given to the patients, but it did not treat the cause. Recently, Samsca was granted with reimbursement approval on indication for treating patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). If Myung In Pharma snatches the first generic title in the market, it is expected to earn a significant commercial success with minimum competitors.
- Policy
- The MFDS plans to collect & test Metformin
- by Lee, Tak-Sun Dec 18, 2019 06:24am
- The Ministry of Food and Drug Safety (the Minister, Eui-Kyung Lee) has decided to collect and inspect commercial distribution items to investigate impurities on Metformin. As a result, the MFDS is preparing a test method with a goal within the year and is conducting a raw material system investigation for the preliminary safety management. The MFDS said it is conducting an impurity investigation on Metformin on the 16th. Prior to this, the Singapore Health Sciences Agency (HSA) announced that it detected and recovered trace amounts of 'N-nitrosodimethylamine (NDMA)' in three out of 46 Metformin-containing products. NDMA is a Group 2A human carcinogen suspected by the World Health Organization (WHO) International Cancer Institute (IARC). The MFDS confirmed that the same products as those recovered in Singapore were not imported in Korea. However, raw materials from the same manufactory used in the medicine are said to have come from Korea. However, even if the raw material of the same manufactory lot may be different because there is not necessarily the risk of problems. First, the MFDS is conducting a systematic investigation of the source (import source) of the use of Metformin-containing medicines in advance of safety management. It also plans to establish a test method for NDMA in metformin within the year. After the test method is established, Metformin raw materials and drug products will be collected and tested as soon as possible. An official from the MFDS said, "We will start collecting products this month and carry out inspections from January next year". Investigations are expected to be conducted first with products that are the same manufacturer as the raw material for products recovered in Singapore. It will be considered whether to expand the survey. This is because the test subjects are so large that Metformin is allowed in 640 items in Korea. An official from the MFDS said, “We will carry out test tests promptly, and we are working closely with regulatory agencies such as the European EMA, the US FDA, and the Japanese PMDA to exchange related information such as the cause of occurrence”. In addition, the MFDS and the Korean Diabetes Association, Metformin is a diabetic drug, and continuous medication is very important for the treatment of diseases. Patients taking Metformin-containing medicines were advised not to stop taking it without consulting their doctor or pharmacist. In the future, if there is a test result exceeding the acceptance criteria, it will immediately notify the health professionals and the public, including medical and pharmacists.
- Policy
- Why did MFDS release its Metformin self-investigation plan?
- by Lee, Tak-Sun Dec 17, 2019 07:20am
- The Ministry of Food and Drug Safety said on the 16th that it is directly investigating the drug 'Metformin', a drug that has been recovered and detected by carcinogen NDMA (N-nitrosodimethylamine) in Singapore. It was the first time that the MFDS announced its own investigation since the Singapore Health and Science Agency announced the recovery of three Metformin items. The MFDS has said through media coverage that it is investigating the domestic inflow of raw materials used in Singapore's products in question, but the MFDS kept silent about collection and inspection plans for domestic distribution items. Let’s learn about the background of MFDS' silence and the release of Metformin's own investigation through a press release. Public opinion has changed, ordered from the Diabetes Association The MFDS released a press release on the 16th, is currently preparing a test method for Metformin formulations, and is conducting a systematic survey on domestic distribution items to identify the source of raw materials. In addition, as soon as the test method was prepared, the MFDS added that they plans to collect and inspect domestic distribution items. In fact, the MFDS has not said that they will not directly conduct an investigation into Metformin's impurities. Nor did they instruct the vendor to do the test autonomously. However, as part of the follow-up measures of Ranitidine and Nizatidine, the press release and public hearings revealed that companies should directly investigate raw materials and finished products that are likely to cause impurities. Some companies have conducted their own tests. Some expressed suspicion that the MFDS was not actively involved in collection and inspection, as opposed to when NDMA problems were raised in Valsartan or Ranitidine. Indeed, the Korean Diabetes Association, which consists of domestic diabetic doctors on the 13th, said, "There is no official announcement whether the raw materials of the company in question were imported to Korea". The Society stressed that the MFDS should address the public's concerns through direct investigations. The Diabetes Society's point was enough to raise suspicion that the MFDS remained a mere spectator. An official from the industry said, “If the MFDS conducted a survey of domestic distribution items based on Singapore collection only when the impurity risks of Metformin preparations were not verified, it would have increased public anxiety, however, on the contrary, it seems to have disclosed its own research plan immediately after pointing out that it should actively take the measures to resolve the public unrest”. Raw material check… increased need for recovery investigation Although it did not appear in the press release distributed on the 16th, it is confirmed that the drug substance imported from Singapore is met with the same drug substance as the Metformin preparation recovered in Singapore. Earlier, the MFDS said that there was no inflow of finished products in Korea, and that it was checking whether the drug substance was imported. The fact that the MFDS conducted a systematic investigation to identify drug substance manufacturers for Metformin ingredients and finished drugs in Korea was influenced by the inflow of ingredients from the same factories as those of Singapore. Therefore, the necessity of checking the raw materials through the systematic investigation, collecting them directly, and increasing the need for self-investigation was increased. However, an official of the MFDS said, “Even if the raw materials are the same, there is no risk because the production lot (process) may be different”. also added “there is no intention to select the raw materials in question because the systematic survey is to investigate the source of all distribution items”. However, it is highly likely that the target of the first collection, inspection planned by MFDS will be the same raw material manufacturer as the recalled product in Singapore. If the risk is identified, the collection and inspection can be extended, otherwise the case can be closed. The MFDS also recognizes the limitation of recovery and investigation of all items. Metformin is a multi-frequency prescription drug that is used as the first-line drug for type 2 diabetes treatment, and this is because 640 domestic licensed items are available. The MFDS expects to investigate domestic distribution items as early as January next year. As such, collection of some distribution items is highly likely to begin this month. The MFDS' full-fledged investigation does not increase the risk of Metformin. The MFDS said in a press release on the 16th. that, among other things, patients taking Metformin-containing medicines should not stop taking it without consulting their MDs or pharmacists.
- Policy
- Exclusivity for Galvus’ generics applied Aug 2021
- by Lee, Tak-Sun Dec 13, 2019 11:00pm
- Galvus by NovartisAs expected, Ahn-Gook Pharmaceutical obtained the approval for exclusivity for generic product as Galvus (Vildagliptin), a diabetes treatment of DPP-4. The MFDS designated the priority sale items for Ahn-Gook Vildagliptin Tablet 50mg of Ahn-Gook Pharmaceutical and Ahn-Gook Newpharrm Vilagliptin Tablet 50mg of its subsidiary Ahn-Gook Newpharm. As a result, it is not possible to sell any of the late-release drugs, except for Ahn-gook Pharm., From August 30 2021 to May 29 2022. Ahn-Gook Pharmaceuticals first filed a trial for extended period of invalidity on Galvus' patent for the first time as a domestic company on July 14 2017. This succeeded in invalidating the extended duration 187 of the material patent. The company received the affirmed decision. It is the first generic item to submit a permit application in last March. The company obtained a product license last month. Three conditions required for the right of exclusivity for generic product : the first patent challenge, the successful patent challenge, and the first application for permission and The company achieved all 3 conditions perfectly. The ban on late drug sales from August 30 2021. This is because Ahn-Gook advanced 187 during Galvus' patent expiration date, which is expected to expire on March 4, 2022 On the other hand, late-runners outside of Ahn-Gook are trying to circumvent the sale ban by Ahn-Gook’s right of exclusivity for generic product. Hanmi pharmaceticals has a strong chance of obtaining a separate right to sell salt-modified drugs and is currently applying for a permit. Korea United Pharm Inc , Kolmar Korea, and Alvogen Korea have also begun developing late-on drugs.
- Policy
- Galvus SR developed by Alvogen, 100mg once daily
- by Lee, Tak-Sun Dec 13, 2019 06:34am
- Galvus by NovartisAlvogen Korea is trying to differentiate itself from domestic competitors by developing Galvus SR tablets. The drug Alvogen develops is a sustained-release multi-layered tablet containing Vilagliptin, which is known to be taken once a day, unlike the original. The MFDS approved Alvogen Vildagliptin SR tablet’s clinical protocols on the 27th of last month. It proceeds to compare the pharmacokinetics and safety of the original drug, Galvus and to evaluate the pharmacokinetics after food intake. According to the latest detailed plan, clinical trials will be conducted from January to February next year for a total of 42 healthy adults. The control group is taking 50 mg of Galvus tablet twice a day, and the test group is taking 100 mg of Vildagliptin sustained-release tablet once a day. In the second test group, after taking a high-fat meal, take 100 mg of Vildagliptin sustained-release tablet and compare and analyze the pharmacokinetic characteristics. The original Galvus is 50mg. Alvogen Korea is trying to differentiate itself from domestic competitors by developing Galvus sustained-release tablets. The drug Alvogen develops is a sustained-release multi-layered tablet containing Vilagliptin, which is known to be taken once a day, unlike the original. The original Galvus is 50mg twice daily if needed. On the other hand, Alvogen's product is taken once a day, which seems to improve convenience. Vildaliptin is currently approved by Original Novartis and Generics Ahn-Gook Pharmaceutical. If Alvogen succeeds in commercializing Vildagliptin sustained-release tablets, it will be able to enter the market regardless of Ahn-Gook's right to exclusivity for generic product. This is because the main ingredient is the same, but This is not the case with exclusivity for generic product. However, as Galvus' material patents last until March 4, 2022, they will not be able to enter the market early unless they are neutralized. It is noteworthy which strategy Alvogen will enter the market.
- Policy
- 'WHO PQ' for 3 domestic vaccines, including Skycellflu
- by Lee, Jeong-Hwan Dec 12, 2019 10:52pm
- Three domestic vaccines have secured international procurement bidding rights, obtaining WHO Prequalification (PQ). SK Bioscience's Sky Cellflu Multi inj, Sky Cellflu inj, and Sky Varicella inj are the main characters. On the 11th, the Ministry of Food and Drug Safety (The Minister, Eui-Kyung Lee) said, "The domestic vaccines passed the WHO PQ, allowing participation in international procurement bidding". WHO PQ is a system for evaluating safety and efficacy for the supply of medicines, including vaccines, to developing countries through international procurement. MFDS has systematically supported WHO certification of domestic vaccines and biosimilar products by establishing a cooperative system with WHO as well as customized consultation services from companies and public-private experts. Specifically, ▲technical consultation on 1: 1 expert consultation team, ▲on-site technical advisory on certificated companies, ▲WHO PQ information sharing seminar, and ▲WHO PQ information book publication. Since 1996, 'Euvax B inj.' is a domestic product that has received WHO Prequalification. There are a total of 16 products by this year. The MFDS said, “We will actively support the activities of companies to enhance the export competitiveness of domestic biopharmaceuticals such as WHO Prequalification, in addition to running customized counseling services, we will continue to publish on-site technical consultations for WHO PQ survey experts and WHO PQ question and answer collections next year”.
- Policy
- Court controversy, the price of Synovian reduction postponed
- by Kim, Jung-Ju Dec 12, 2019 06:31am
- LG Chemicals dissatisfied with the drop in insurance prices, and the price of 3 ml of Synovian (BDDE cross-linked sodium hyaluronate gel), which is fighting a legal battle with the government, is being provisionally maintained. The trial is in progress, and the court has limited the time limit from the date of the sentence to 30 days. The 6th government of the Seoul Administrative Court decided to extend on the 10th of the trial against the company (2019KuHap88095) regarding the decision that the Ministry of Health and Welfare decided to lower the price of this drug in the 'List of Drug Benefits and reimbursed Limits' (Notice 2019-254). Earlier, the Ministry of Health and Welfare decided to lower the price of medicines through the November 28 notice. Afterwards, LG Chemicals filed a lawsuit for unfair drug price cuts, and the court suspended the Ministry of Welfare's action until the first interrogation date. As a result, the price, which was supposed to be lowered to ₩ 477,041, will remain at ₩67,200 as it was until the 30th day from the date of judgment. The Ministry of Health and Welfare explained that the case is currently underway and may change depending on the outcome of the trial in the future, and they will guide you further when it changes“. No.2 is effective as of July 1, 2020, due to the suspension date. As a suspension, ₩67,200 is applied instead of ₩47,041
- Policy
- 5 years after the drug patent linkage system
- by Lee, Tak-Sun Dec 12, 2019 06:30am
- At the Four Points Hotel Seoul Guro, the 2019 Drug Forum was held under the direction of Jae-Hyun Lee, School of Pharmacy, Sungkyunkwan University (fourth from left)."There are many cases where overseas pharmaceutical companies have succeeded in using the US-licensed patent linkage system. But Korean pharmaceutical companies haven't even tried it. It's time to think about why they are not using the system". More than five years have passed since the introduction of Korean licensed patent linkage system based on the US Hatch Waxman Act with the Korea-US FTA in March 2015. The licensed patent linkage system protects the original drug patents listed in the MFDS and grants generic monopoly rights to companies that have neutralized the patents. Although there was a lot of concern that generic drugs would enter the market in the early stages of implementation, the impact on the market is less than expected. Director General, Myung-jin Chung Myung-jin Chung , head of the Korea Health Industry Development Institute, who conducted an impact assessment during the 2018 year at the Policy Forum held at the Four Points Hotel Seoul Guro, said, “Contrary to concerns over the introduction of the system, domestic pharmaceutical companies sales increased YoY due to the lack of many original companies’ ban on sales and the activation of exclusivity for generic product. The KHID's impact assessment showed that sales of generics increased up to ₩6.5 billion in 2018, and the market entry period was also shortened from 1.3 months to 4.6 months. However, there are a lot of comment that the drug patent linkage system lacks effectiveness. In the policy forum discussions, Sung-min Park, lawyer at HnL Law Office, pointed out that there were no cases of entry into the United States using the drug patent linkage system. “Even if a generic market monopoly is given through exclusivity for generic product, lower profits will be lowered if the market entry rate or market share of the latter is low during that period. In the US, the market share of late-release drugs is high in the monopoly period of 180 days, but in Korea, this is not the case, so we need to discuss how to increase the speed and market share” emphasized the lawyer. Hye-eun Shin, professor of law at Chungbuk National University, made a similar point. Professor Shin said, "There are no successful cases of entry into foreign countries by using the law, we should identify the cause and give direction". The professor added, "We need benchmarking on success cases such as Teva and Ranbak". Yoon-ho Kim, the chairman of the Korea Pharmaceutical Patent Research Society (Hanmi, Patent Team) said, “Maybe the goal was to minimize the impact when it was introduced in Korea. Now, I think that we will be a better system if we become more substantial and develop it as an opportunity for R & D development and globalize it”. In addition, the company is likely to raise the profits of items sold in exclusivity for generic product., and the MFDS, which is a related ministry, is concerned about entering the global market. Hyo-jeong Kim, Director of the Drug Management and Patent Licensing Division, said, "The way to increase the market entry rate and market share of exclusivity for generic product is deeply related to the reliability of generic drugs." "Currently, the MFDS is the most important part, and there is a part to improve awareness Kim said, "I believe that a patent case and product development technology have been accumulated through the introduction of the drug patent linkage system, so a real case study position is necessary for entering the US market." Some also suggested that the market entry period was shorter than the impact assessment results with the drug patent linkage system. Kyung-Joon Lee, head of Boryeong Pharmaceuticals, said, “If we take into consideration the fact that patents are incapacitated due to the challenges of pharmaceutical companies, we will have a much more positive number than the results of impact assessments.” “We are still unable to lag behind our competitors. There are many cases of requesting unconditional judgment without consideration, and I hope that the related laws will be revised in such a way that the positive aspects of the introduction of the drug patent linkage system can be highlighted through the impact assessment”. It was pointed out that if the patent invalidation is confirmed, exclusivity for generic product efforts will be lost. Therefore, even if it is determined to be invalid, it is necessary to improve the system so that it can be used as a right target. However, Hyo-jeong Kim explained, "There are some parts that are difficult to consider as a result of the review so far, but if you get exclusivity for generic product, you can be protected even if the patent is invalid In addition, it also defeats exclusivity for generic product challenge by intentionally deleting the patent list. Kim said, "There is a reasonable part, and we will revise and revise it". Kim said, “We will go through the process of collecting opinions by the end of this year, and we will start the legislative process for improvement plan, and we made some practical improvements and gathered opinions”.
- Policy
- 10 new rare diseases applied with special case from 2020
- by Kim, Jung-Ju Dec 11, 2019 10:20pm
- Special case insurance benefit would be applied on ten new rare diseases including adult-onset Stills disease and Kienbock’s disease from next year. Korean Ministry of Health and Welfare (MOHW) issued a revised notice on Tuesday of ‘Standard on Special Case Insurance Benefit for Individual Copayment’ reflecting the changes. The special case benefit would be applied to patients, diagnosed with one of designated rare diseases, starting from the day of hospital visit or hospitalization the diagnosis is made. The newly designated ten rare diseases are; Cryoglobulinemia vasculitis; choroideremia; Long QT syndrome; hereditary hemorrhagic telangiectasia (HHT); adult-onset Still’s disease; Kienbock’s disease; adult-onset Kienbock’s disease; X-linked ichthyosis; steroid sulfatase deficiency and X-linked ichthyosis; and infant-onset Harlequin syndrome. The changes would come in effect from Jan. 1, 2020. The ministry is to accept public opinion on the notice until Dec. 20, and finalize the changes as it is, if no concerning issue arises.
