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- 2025-12-23 20:01:58
- Policy
- The Vice Minister of Health and Welfare received AZ vaccine
- by Kim, Jung-Ju May 06, 2021 06:06am
- Second Vice Minister of Health and Welfare Kang Do-tae visited a public health center in Yongsan-gu, Seoul on the 3rd and received the AZ vaccineThe health and quarantine authorities and the head of the KMA met together to get the AstraZeneca (AZ) COVID-19 vaccine and agreed to overcome COVID-19. Kang Do-tae, the second vice minister of the MOHW, visited COVID-19 Vaccination Center in Yongsan-gu, Seoul on the 3rd to check the vaccination progress and encouraged the officials. Vice Minister Kang checked the vaccination progress and vaccination movements at the vaccination center, and listened to the difficulties and suggestions of the vaccination subjects and those involved in the field. In particular, Vice Minister Kang said, "We will do our best to manage the vaccine for the safe and rapid vaccination of the people, and cooperate with local fire departments and emergency medical institutions to ensure that there is no lack of a response system for adverse reactions that may occur after vaccination." After visiting the vaccination center, Vice Minister Kang visited the Yongsan-gu public health center and received AstraZeneca vaccine with Minister of the MFDS Kim Kang-rip and Lee Pil-soo, chairman of the KMA. The 2nd Vice Minister Gang-tae (right) and Lee Pil-soo, the new president of the medical association, are shaking hands Lee Pil-soo, the new chairman of the KMA, said, "As a representative of the medical field, we volunteered to alleviate public concerns and anxiety about vaccines and show our will to end COVID-19 as soon as possible." He said, "The KMA and 130,000 members are doing their best to vaccination against COVID-19 to protect the health and lives of the people, and the government, the public, and medical personnel will work together to overcome COVID-19 together." Minister of the MFDS Kim Kang-rip asked special attention, such as observing storage temperature, so that the quality could be maintained continuously during the process of receiving and storing the vaccine, examining the storage status of the vaccine. He also said, "The domestically approved COVID-19 vaccine is thoroughly verified for safety and effectiveness through triple expert consultation at the MFDS. The benefits far outweigh the risks caused by the vaccine, and as it is a vaccine approved by the MFDS, we hope that the people will be vaccinated with peace of mind." Vice Minister Kang expressed his gratitude for the cooperation and hard work of local governments and the medical community in the process of responding to COVID-19. He said, "Vaccination is a safe and effective preventive method, and I hope that the public believe in the government and experts and inoculate them in order for the health of themselves, their families and neighbors."
- Policy
- Samyang Holdings is expanding generics for anticancer drug
- by Lee, Tak-Sun May 04, 2021 05:55am
- Last month, Samyang Holdings, which merged with Samyang Biopharm, a subsidiary specializing in pharmaceutical bio, is expanding generics for anticancer drug business. In January, following generic for Votrient (Pazopanib HCl), a kidney cancer treatment, it is also developing generic for Sutene (Sunitinib Malate). Votrient and Sutene currently do not have generics in Korea. The MFDS approved the protocol of bioequivalence study for SYO-1767 applied by Samyang Holdings on the 30th of last month. SYO-1767 is presumed to be generic for Sutene in that the target disease name of this drug is the same as Pfizer's Sutene. Sutene, which was approved in Korea in 2006, is used for various carcinomas such as gastrointestinal stromal tumor, renal cell carcinoma, and pancreatic endocrine tumors. As of last year's IQVIA, Sutene's sales amounted to ₩13.9 billion, more than its rival Novartis Votrient's ₩12.6 billion. In particular, Sutene's patent expired on February 15th. Samyang Holdings is the first to develop generics in Korea. Generic for Votrient by Samyang Holdings was approved in January for a bioequivalence test, and Votrient's patent expires in 2022. It is analyzed that if Samyang preoccupies generics for Sutene and Votrient , it will be in high demand, especially in the kidney cancer treatment market due to its rarity and low price. Samyang has confirmed its competitiveness in the domestic market through anticancer drugs such as Genexol (Paclitaxel), which has been successfully localized. It has successfully commercialized the hemoamac treatment Bendalid (Bendamustine) and breast cancer treatment Everose (Everolimus), targeting the original market. Recently, it started the pharmaceutical business after the merger, such as developing mCureX and mRNA COVID-19 vaccine. Samyang Holdings held a board meeting in January and decided on the agenda for the merger and acquisition of Samyang Biopharm. At the time, Samyang Biopharm was a wholly owned subsidiary of Samyang Holdings. The merger and acquisition was completed on the 2nd of last month, which is expected to strengthen the competitiveness of the pharmaceutical bio business and increase management efficiency. In particular, it is evaluated that stable procurement and investment of drug development resources has become possible.
- Policy
- MFDS designates 3 new orphan drugs including asciminib
- by Lee, Tak-Sun May 04, 2021 05:55am
- On May 3rd, the Ministry of Food and Drug Safety (MFDS) newly designated 3 drugs including ‘asciminib,' which is used for the treatment of rare leukemia and breast cancer, as orphan drugs. Also, MFDS announced that it will extend the indication for ‘ibrutinib,’ and designate drugs used for neonatal hypoxic-ischemic encephalopathy as development-stage orphan drugs. The orphan drug designation is given by the Minister of Food and Drug Safety, to drugs that are used to diagnose or treat rare diseases with no alternatives or with a significantly improved safety and efficacy compared to existing alternatives. The MFDS operates the ‘orphan drug designation system’ to promptly facilitate the approval process of orphan drugs by setting the data, criteria, and conditions for approval for each disease separately according to its characteristic, to support the development of rare and incurable diseases. "We hope the new and expanded designation of orphan drugs set out today will contribute to the development of treatments for patients with rare and incurable diseases,” said an official from MFDS. “We will continue to prepare policies to guarantee treatment opportunities for our patients in Korea.”
- Policy
- Combination of Forxiga + Januvia was applied for permission
- by Lee, Tak-Sun May 04, 2021 05:55am
- MSD It was found that two companies applied for a combination drug license that combines Forxiga (Dapagliflozin Propanediol Hydrate, AZ), a SGLT-2 inhibitory family, leading the diabetes treatment market, and Januvia (Sitagliptin Phosphate Hydrate, MSD), a DPP-4 inhibitory class. Combination of Forxiga+Januvia has not yet been approved in Korea. It is expected that market success is expected if commercialized. According to the MFDS on the 30th, a combination of Dapagliflozin Propanediol Hydrate (10mg)-Sitagliptin Phosphate Hydrate (100mg) was applied for approval on the 30th of last month and the 1st of this month. Dongkoo recently applied for the same ingredient to the MFDS. As Donggu Bio has signed consignment contracts with about 20 pharmaceutical companies, it may be a consigned pharmaceutical company, or it may be a pharmaceutical company that has been pursuing development alone. The applied indications are ▲When Sitagliptin alone cannot control blood sugar sufficiently, ▲When Dapagliflozin alone cannot control blood sugar sufficiently, ▲If Metformin alone cannot control enough blood sugar and it is difficult to control enough blood sugar with two-drug therapy, ▲If sufficient blood sugar control cannot be achieved with Metformin and sitagliptin combination therapy, Metformin and this drug are administered concurrently,▲ if Metformin and Dapagliflozin cannot sufficiently control blood sugar due to combination therapy, Metformin and this drug are administered together, and ▲ it is administered when replacing Dapagliflozin and Sitagliptin combination therapy. Currently, the SGLT-2+DPP-4 combination drug has been approved mainly for imported drugs, but there are no items that are still covered, so it is difficult to estimate the size of the market. The market is expected to achieve expected sales if the benefit is applied because the ratio of prescriptions for both drugs is already high. Even after obtaining permission due to the patent registration of the original drug, it is impossible to sell it on the market right away. This is because Januvia's product patent ends on September 1, 2023, and Forxiga's product patent is scheduled to expire on April 7, 2023. Moreover, since Forxiga is also valid for subsequent patents, generics must succeed in the challenge of subsequent patents in order to be released after the product patent expires. Forxiga and Januvia are leading items that are gaining popularity in the diabetes treatment market. As domestic generic companies have not yet participated in the DPP-4 and SGLT-2 markets, dozens of pharmaceutical companies are expected to participate in product development.
- Policy
- Afstyla will be reimbursed from June
- by Kim, Jung-Ju May 04, 2021 05:55am
- SK Chemicals' self-developed hemophilia treatment Afstyla (Lonoctocog Alfa (blood coagulation factor VIII, genetic recombination) ) finally passed the Health Insurance Policy Committee. It took 15 months after obtaining a domestic permit and one year after applying for insurance registration. The start of benefits was set on June 1, when supply was available, and the price was set at ₩625 per IU. The MOHW announced that the amendment (draft) of the Pharmaceutical Benefit List and benefit upper limit price table', which provides benefits for Afstyla, was submitted to the agenda of the Health Insurance Policy Committee during the day (30th), and that both deliberation and resolution were passed. .This drug is a hemophilia A treatment developed by SK Chemicals, and it was exported to CSL in Australia in 2009 .This drug applied for insurance registration to the HIRA on April 29, about three months after obtaining approval from the MFDS on January 20 last year .The HIRA held the Pharmaceutical Benefits Advisory Committee on December 3 of the same year for deliberation .This drug was introduced as a gene recombination product among factor VIII replacement therapy in textbooks such as Hemostasis and Thrombosis Advisory and recommended for use in clinical guidelines .In terms of cost-effectiveness, the weighted average price of the alternative drugs Blood Coagulation Factor VIII, Recombinant (ADVATE), Moroctocog Alfa (Xyntha Solofuse Prefilled Inj.), Beroctocog Alfa (Greengene F), Efmoroctocog alfa, and Rurioctocog alpha is less than ₩625 per IU .It was judged to be cost effective .In the case of biopharmaceuticals, if they accept the weighted average price or less, they are classified as drugs that omit drug price negotiations, so negotiations are exempted .Related conferences such as The Korean Society on Thrombosis and Hemostasis and The Korean Society of Hematology also commented that the effect was comparable to that of conventional drugs and improved convenience by reducing the number of administrations .When looking at the listing status of excluded countries, it was listed in the United States, Italy, Japan, Switzerland, and Germany in five of the A7 .The adjusted average prices in these countries range from ₩1274.72 to ₩1350.89 per IU . Accordingly, the Pharmaceutical Benefits Advisory Committee decided that if the alternative drug was accepted below the weighted average price, the company would accept it and skip the negotiation, and only negotiate the estimated billing amount with the NHIS from January 19th to 19th of this year .As a result of the negotiations, the two sides agreed to an estimated billing amount of ₩5.6 billion, taking into account the market share reflecting clinical usefulness .The NHIS predicted that there would be no additional fiscal requirements as alternative drugs exist .The items are 250, 500, 1000, 2000, 3000 IU, and the price is ₩625 per IU .The MOHW decided to apply insurance benefits as of June 1, taking into account the availability of supply from the company .CSL Behring Korea Ltd will sell this product, and SK Chemicals is receiving royalties and sales milestones from global sales .
- Policy
- MFDS, "will make all efforts to pass and land the 1+3 bill"
- by Lee, Jeong-Hwan May 03, 2021 05:54am
- The Ministry of Food and Drug Safety announced its plan to pass the revised Pharmaceutical Affairs Act at the National Assembly's plenary session and soft-land the system afterward. The revised Act contains a clause that limits the number of consignees to three for each company that conducts the bioequivalence test for generics and drugs requiring data submission (incrementally modified drugs, iMD). The Ministry also reaffirmed its position regarding the 1+3 bill for generics and IMDs, on how the bill will partially resolve the rampant drug production issue in Korea, and have a positive influence on preventing recurrence of GMP violations of domestic pharmaceutical manufacturers like Binex and Vivozon. In addition, MFDS said it will actively increase its manpower to systemize and operate the 'GMP Special Planning Inspection Team' at all times through discussions with the Ministry of Public Administration and Security. The answers above were provided on May 1st as a response to the written questions sent by the members of the National Assembly's Health and Welfare committee, In-soon Nam, Yeong Suk Seo, and Hye-young Choi of the Democratic Party of Korea. The three lawmakers questioned the MFDS on the countermeasures against GMP violations of domestic pharmaceutical companies, its position on the 1+3 regulation bill, and the direction the domestic pharmaceutical industry should pursue. On the reason why domestic pharmaceutical manufacturers intentionally violate GMP when producing drugs, MFDS pointed to ▲ financial reasons, such as the time and cost of receiving approval for changes ▲ the internal perception that violations are okay as long as the company avoids drug surveillance and ▲ the small scale of punishment. As for countermeasures to prevent recurrences, the MFDS will continue to conduct random spot inspections with the GMP Special Planning Inspection Team while improving the system, with measures such as increasing the punitive fines and implementing one strike-out system for the GMP acceptance test. In particular, the MFDS responded that it was “necessary” to operate the GMP Special Planning Inspection Team at all times. Also, the Ministry added that it will actively implement policies to increase MFDS personnel to allow the Special Planning Inspection Team to operate at all times. “We are grimly aware of the illegal activities conducted by pharmaceutical companies that should have been tending to public health. This is not a universal problem in the industry, but still, we are operating random spot inspections at all times in case similar cases arise,” wrote MFDS. “We believe a year-round operation of the Planning and Inspection Team is necessary to prevent illegal activities in advance.” Also, it wrote, "We will actively discuss measures to increase personnel in local governments with relevant ministries including the Ministry of Public Administration and Security," adding that the Ministry "asks for active support from the National Assembly.” Regarding the bill that restricts sharing bioequivalence and clinical data between companies to prevent rampant production of generics and IMDs, the MFDS strongly agreed on the need for its legislation and promised to make every effort to implement the post-revised system. On the question of how to strengthen the competitiveness of the domestic pharmaceutical industry, the MFDS responded that it intends to make efforts to build a development-oriented pharmaceutical industry by reducing the development period and cost of drugs through measures such as providing advice on clinical trials, technical support after authorization, and training professional manpower. “The domestic pharmaceutical industry has been continuing its efforts to invest in R&D to produce new products, however, the current circumstances are not enough to reorganize the current sales structure that is focused around generic sales competition,” wrote MFDS. “We will foster a development-focused industry environment. The 1+3 bill is one of the measures that may improve the quality of drugs while preventing rampant drug production, so we will do our best to pass the bill at the plenary session.”
- Policy
- The number of COVID-19 vaccinations exceeded 3 million
- by Kim, Jung-Ju May 03, 2021 05:53am
- The cumulative value of the first vaccination patients who received COVID-19 vaccine exceeded 3 million. The quarantine authorities achieved the cumulative amount of vaccinations one day earlier than the initial target set by the quarantine authorities, and the authorities predict that 12 million vaccinations in the first half can be carried out without any problems. COVID-19 Vaccination Response Promotion Team (KCDA Commissioner Jeong Eun-kyeong) said that as of 3:30 pm today (29th), 3,012,654 people (provisional count) who received the vaccine (based on the first vaccination), It has been revealed that it has exceeded 3 million. In response to this, the promotion team explained, "reinforced vaccination capabilities, such as opening additional vaccination centers and early operation of consigned medical institutions, and expanding vaccination targets according to the vaccination sequence, and trusting experts and the government to actively participate in vaccination. Thanks to the medical staff who safely administered the vaccination." The promotion team said that the originally established vaccination plan was proceeding smoothly, about 80% of vaccinations in nursing hospitals and facilities, where there were many seriously ill patients and fatalities, were also achieved, and that the vaccination of essential social personnel is also accelerating. The promotion team explained that it plans to strengthen the surveillance of adverse reactions with the medical community and continue compensation for damage so that the public can receive vaccinations more safely. The promotion team said, "We will inoculate 12 million people (based on the first vaccination) for the elderly, high-risk groups, quarantine and medical personnel, etc. by the end of June, and use it as a starting point for recovery to daily life." The promotion team requested that the people actively participate in vaccination on a healthy day, when the vaccination order came.
- Policy
- There is no problem with AZ vaccine safety
- by Kim, Jung-Ju Apr 30, 2021 06:09am
- The government announced that it is concerned about the avoidance of the AstraZenega (AZ) COVID-19 vaccine due to the thrombosis side effect issue. It is said that there are no safety issues with side effects and solutions that appear around the world. Son Young-rae, Team Leader of Countermeasure Headquarters COVID-19 Social Strategy, answered this way through Q&A for regular briefings in the morning of today (28th). He said, "Recently, the amount of COVID-19 vaccine secured by purchasing additional Pfizer vaccines has increased to a total of 99 million this year. As the supply of vaccines from other companies is increasing, we are concerned about the phenomenon of avoiding AZ vaccination." He said, "In the case of the UK, half of the vaccination targets are AZ products. tens of millions of people are inoculated, so our government continues to monitor it." He said, "There is no problem with safety and rare thrombosis, which appears as a side effect, is also extremely rare, and because it is possible to treat it, the practical benefit of vaccination is high, so the Korean government also recommends vaccination." “Experts are also recommending AZ vaccination in common, and the Central Disaster Management Headquarters and the Central Disease Control Headquarters (employees) are also vaccinating AZ products. I hope that the people do not worry more than necessary, and that the AZ product candidates receive the vaccine as much as possible." The authorities forecast the completion of domestic vaccine development in the first half of next year. Five pharmaceutical companies have entered clinical trials through vaccine development, and it is expected to enter phase 3 as soon as possible in the second half of this year. He said, "It is the principle that domestic vaccines are supported until they are successful, and the government is actively supporting them with the aim of developing them in the first half of next year. It is difficult to recruit subjects due to the small number of domestic patients, but we will also review and apply for comparative clinical trials."
- Policy
- MFDS added blood clots to the precautions for AZ vaccine
- by Lee, Tak-Sun Apr 29, 2021 07:21am
- A specific thrombosis with thrombocytopenia was added to the precautions for using the AstraZeneca COVID-19 vaccine. For this adverse reaction, the MFDS also recognized the causality with the vaccine. The MFDS announced on the 27th that it changed the precautions for use after consulting experts on the case of blood clots that occurred after vaccination with AstraZeneca COVID-19 vaccine. On the 8th, the MFDS issued a safety letter regarding a specific thrombosis with thrombocytopenia of the AstraZeneca COVID-19 vaccine. It is explained that additional necessary measures have been reviewed. Through the Central Pharmaceutical Affairs Review Committee meeting on the 20th, the MFDS received advice on the safety and action of the AstraZeneca COVID-19 vaccine against the occurrence of blood clots. As a result, vaccination did not increase the overall risk of thrombosis, and the unique thrombosis with thrombocytopenia, which has not yet occurred in Korea, is very rare outside the country. As in the evaluation, we received an opinion that it was judged that there was a possibility of a causal relationship with the vaccine. Accordingly, the Central Pharmaceutical Affairs Review Committee concluded that it is reasonable to change the information on unique thrombosis with thrombocytopenia in addition to the precautions for use. As a precaution for use, ▲people who have experienced major venous or arterial thrombosis with thrombocytopenia after vaccination of COVID-19 should not receive this vaccine.▲ It should be carefully administered to patients with a history of thrombosis in uncommon areas such as cerebral sinus thrombosis and visceral venous thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome, and risk factors for thromboembolism and thrombocytopenia. ▲ After vaccination, serious cases of thrombosis with thrombocytopenia were observed very rarely, and ▲ people pay attention to the signs and symptoms of thromboembolism, thrombocytopenia and coagulation Accordingly, health care professionals should pay attention to the signs and symptoms of thrombosis and thrombocytopenia after vaccination so that patients can be treated promptly; and, after vaccination, severe or persistent headaches, blurred vision, confusion, and If symptoms such as seizures, shortness of breath, chest pain, leg swelling, leg pain, persistent abdominal pain, skin bruising or spotting bleeding other than the injection site appear, seek medical attention immediately. An official from the MFDS said, "We will continue to monitor abnormal cases after vaccination against COVID-19 in the future. In addition, we will promptly inform safety and whether or not measures are necessary through expert advice."
- Policy
- NDMA was detected again in Nizatidine
- by Lee, Tak-Sun Apr 29, 2021 06:10am
- NDMA (N-nitrosodimethylamine), a carcinogenic substance, was detected again. There is a possibility that the number of NDMA detection items will increase in self-test. The MFDS announced on the 27th that a business operator will recover some of the manufacturing numbers of four items, including Korea Pharma's Nizatide, Nexpharm Korea's Nitadin, Nex by Binex, and Ari's Artidine, which are used as GI drugs . All are products of Nizatidine. Nizatidine was temporarily banned from selling the item because NDMA was detected in 13 products in November 2019. The items to be recalled at this time are different from those found at the time. The MFDS explained that as NDMA is detected in the company's own product stability test, it is proceeding with recovery as a precautionary measure. All four items are consigned by Binex. Binex is consigning production of a total of 9 items, including its own. Therefore, NDMA was detected again in the product. It is known that this product recovery was triggered by an accelerated test conducted by the pharmaceutical company itself. The accelerated test is a test to find out the stability of a drug under conditions beyond the standard of storage for distribution. Nizatidine can be stored at room temperature between 1°C and 30°C, but NDMA was detected as a result of testing at higher temperatures and humidity. Dr. Reddy's Laboratories reported that NDMA was detected in the accelerated Nizatidine test and reported to the drug product company it trades. It is observed as a follow-up action by a drug product company starting from Dr. Reddy's Laboratories. The problem is Dr. Pharmaceutical companies that use Reddy's Laboratories' ingredients are not the only four pharmaceutical companies that are collecting items this time. All 13 items that were temporarily banned from sale and recalled in November 2019, when the MFDS discovered the NDMA problem in Nizatidine, all used raw materials from Solara Active Pharma Sciences. Dr. Reddy's Laboratories and Nizatidine products using domestic ingredients were able to sustain sales. Dr. It is known that among the items using Reddy's Laboratories raw materials, there are also items with relatively high sales. The pharmaceutical industry analyzes that Dr. Reddy's Laboratories raw materials can also cause problems, affecting other finished products using the same raw materials. An official in the pharmaceutical industry said, "There are a lot of domestic distribution items that use the ingredients of Dr. Reddy's Laboratories. However, it remains to be seen how many items NDMA is detected in the accelerated tests of finished products of these companies." The MFDS said, "The items in which NDMA was detected in this accelerated test are not commercially distributed items. As a precautionary measure, it recommended the drug company to recall." The MFDS added, "This issue is the company's action in accordance with the instructions for evaluating the likelihood of occurrence such as NDMA for all drugs. However, he added that there is a possibility that there may be more items to be recalled according to the results of the company's own test. "
