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- 2025-12-24 13:20:48
- Policy
- Remdesivir's special import was decided
- by Lee, Tak-Sun Jun 05, 2020 06:10am
- RemdesivirThe special import of Gilead’s Remdesivir was decided. It will be used in severely hospitalized patients infected with the COVID-19. The MFDS (Minister Lee Eui-kyung) decided to import special cases for Remdesivir, which is being developed as a treatment for COVID-19, and accordingly, the KCDC (Director Eun-Kyung Jung), announced on the 3rd that it is planning to negotiate with the MFDS and Gilead science Korea as soon as possible In the special drug import system, the MFDS imports unlicensed drugs from the country through importers at the request of the relevant ministries in order to deal with the public health crisis, such as pandemic of infectious diseases. The KCDC requested the special import from the MFDS, as the 'Clinical Committee for Infectious Diseases' proposed the introduction of 'Remdesivir' as a treatment for COVID-19 in Korea. As a result, the MFDS announced that it had decided to import special cases after deliberation by the National Stabilization and Supply Council for Essential Drugs (Disease Management Subcommittee). The MFDS judged that the shortening of the treatment period in severe patients due to the use of Remdesivir was clinically meaningful and that it was necessary to secure additional therapeutic agents. In addition, the US, Japan, and the United Kingdom are also considering the fact that the use of Remdesivir in the COVID-19 Pandemic situation was also considered. The government announced that it will support as much as possible to ensure that the medicines are imported as soon as possible, along with domestic importer Gilead Sciences Korea. Remdesivir is used for COVID-19 confirmed patients through PCR tests, in case of ▲Patients who have 94% or less of oxygen saturation (SpO2) in room air ▲Patients who need supplemental oxygen treatment ▲Non-invasive or invasive machines. It is used for severely hospitalized patients, such as those requiring ventilation or extracorporeal membrane oxygen therapy (ECMO). The total administration period is within 10 days.
- Policy
- COVID-19 vaccine by Inovio was first approved in Korea
- by Lee, Tak-Sun Jun 05, 2020 06:09am
- COVID-19 vaccine is the first clinical trial approved in Korea. It is a vaccine candidate developed by Inovio of the United States and is conducted by theInternational Vaccine Institute (IVI). On the 2nd, the MFDS approved phase I/IIa of IN0-4800, a candidate for COVID-19 vaccine, applied by the IVI. In clinical trials, the safety, tolerability and immunogenicity of COVID-19 preventive vaccine INO-4800 using electroporation after intradermal inoculation in healthy adults will be evaluated. It will be administered to 160 healthy adults in Korea and will be administered at Seoul National University Hospital. Inovio began clinical trials of INO-4800, a candidate for COVID-19 vaccine, in 40 healthy adults since last April. It is expected that the results of Phase I clinical trial will be released soon, and antibodies have been successfully generated in animal studies. INO-4800 is a DNA vaccine that activates immune T cells in the body by inserting a part of COVID-19 gene into the plasmid and a 'transcription factor' to express it as an antigen. It is different from the existing fertilized egg or cell culture vaccine. Currently, the fastest clinical candidate for COVID-19 vaccine in Moderna, the United States, is also a DNA vaccine. The vaccine candidate developed by Genexine in Korea is also a DNA vaccine.
- Policy
- Permission is increasing prior to the end of PMS
- by Lee, Tak-Sun Jun 04, 2020 10:41pm
- Hanmi's RosuzetEven before the end of PMS (Post marketing surveillance), a lot of new items have been approved through a contract production contract with the original company. Since PMS system in Korea is also provided with the data protection function of the original drug, it is possible to apply for a license for the same ingredient after PMS expires. However, as more and more original companies share item data in order to expand commissioned production, market competition is intensifying even before PMS. According to the industry on the 3rd, 18 new drugs (6 companies) were approved for the hyperlipidemic complex (Rosuvastatin and Ezetimibe) on the 29th of last month. New products have been released in about 3 years since December 2017. The first licensed item for this formulation is Hanmi's Rosuzet. Rosuzet was approved in June 2015. Subsequently, by December 2017, 84 additional drugs with the same ingredients were approved. All of these items, including Rosuzet, are drug for data-based re-evaluation, and were granted PMS until June 7, 2021, in recognition of the new combination of the two ingredients. During this period, the vendor of the item should conduct a post-marketing investigation on a certain patient. If post-marketing investigation is mandatory, data protection rights are also granted to prevent the generic drug of the same ingredient from applying for permission during the PMS period. As expected, until June 7, 2021, the same ingredient generic cannot apply for permission. However, 18 items that received this new license were commissioned and produced by the original PMS-granted original company and shared data, making it possible to enter the market. In 2016, it was approved through Ajou Pharm, which has been approved for Cretrol. Imported original companies do not increase their competitors. However, these days, domestic companies often share it with competitors even though it is a drug that has been granted exclusive rights. As for the sustained-release tablet of the indigestive drug, Mosapride citrate, PMS expires on June 29th, but 50 items of the same ingredient have already been approved. The original company, Daewoong Pharmaceutical, was granted permission to share data and produce it in consignment. Telmisartan, Amlodipine besylate The hypertensive complex Telmisartan-Amlodipine besylate complex also ends PMS on October 30th, but only 30 items have been approved this year. This is because Ildong Pharmaceutical, one of the original companies, is a consigned product. This trend is accelerating in recent years as the calculation of consignments aimed at rapidly entering the market and pharmaceutical companies seeking to increase profits by expanding commissioned production. However, pharmaceutical companies that maintain the No. 1 market share are not happy with the addition of competitors. These are Hanmi Pharm, which owns Rosuzet, and Yuhan, which has a dominant share of Duowell (Telmisartan-Amlodipine besylate) and Gastin CR (Mosapride citrate sustained release tablet). Industry officials said, "This is a result of a combination of Korean development situations driven by lucrative items."
- Policy
- Labeling will be promoted on product packaging
- by Lee, Tak-Sun Jun 04, 2020 06:14am
- In the future, it is expected that pharmaceutical companies carrying out bioequivalence tests will be separately labeled on generic drug packaging. In addition, policy initiatives are being undertaken to strengthen the global competitiveness of generic drugs, such as finding ways to disclose generic companies on a manufactory basis. The MFDS announced on the 1st that it is planning to draw the final plan through the public-private consultative body to strengthen the international competitiveness of generic drugs by this month. The public-private consultative body, which strengthens the international competitiveness of generic drugs, has been in operation since April, consisting of about 50 people from the pharmaceutical industry, academia, medical experts, patients, and consumer groups. The tasks for which the public-private consultative body came up with the final plan are: ▲ Conduct bioequivalence test, strengthen drug labeling and information disclosure ▲ Develop bioequivalence test evaluation indicators and disclose evaluation results ▲ Establish a generic drug database for each ingredient. First, among generic drugs, the number of bundled products that are entrusted and manufactured by companies that have not already conducted a bioequivalence test directly is increasing. Therefore, it is necessary to promote a method of labeling the product, such as the name of the pharmaceutical company that actually conducted the bioequivalence test. In particular, the MFDS explained that it is also considering ways to bundle generic drugs with the same bioequivalence test as a factory standard, and to disclose the information through the MFDS website and prescription preparation system. It means that bioequivalence tests are conducted on generic drugs, and products that are manufactured directly and products that have been granted product approval through consignment manufacturing are released together. The MFDS will also develop bioequivalence quality assessment indicators and disclose the evaluation results. It is a plan to increase the quality level and reliability of generic drugs by preparing quality evaluation indicators and transparently disclosing the evaluation results so that they can evaluate the quality level of generic drugs. The MFDS said that the analysis of the effect of the actual use stage after marketing, the MFDS in the bioequivalence test results indicates the ratio (The closer to 1 means the same) of the generic drug (test drug) to the original drug (control drug), the frequency of side effects after the generic drug is marketed may be an example for the quality evaluation index. In addition, the generic drug, which is manufactured by entrusting the entire process, will also clarify the responsible relationship between trustees, such as entrusting quality control obligations to consigned companies and strictly managing quality management of consigned companies. In addition, the establishment of a generic drug database for each ingredient will be promoted. In response, the MFDS will explain the current status of generics by ingredient in English so that overseas buyers and distributors can identify them to support the global advancement of generic drugs, and will also provide them to international organizations such as the World Health Organization (WHO). An official from the MFDS said, "We plan to prepare a plan to improve the specific system so that the contents under the agreement can be carried out normally in the public-private consultative body, and to prepare and announce a detailed action plan for the improvement method by the end of June."
- Policy
- The MFDS designated Mobocertinib as an orphan drug
- by Lee, Tak-Sun Jun 03, 2020 06:25am
- The MFDS (Minister Eui-kyung Lee) announced that Mobocertinib was newly designated as an orphan drug, and it announced on June 1 that target diseases were added for three types, such as Ipilimumab, designated as an orphan drug. An orphan drug is a drug that is used for the purpose of diagnosing or treating a rare disease, a drug that has no or no substitute drug, or is significantly improved in safety or effectiveness than a substitute drug, and has been designated by the MFDS. In order to support the development of treatments for rare and incurable diseases, the MFDS firstly authorizes orphan drugs and operates 'Orphan drug designation system' so that it can separately set data, standards, and conditions for approval according to the nature of the disease. The main announcement of this orphan drug designation was that Mobocertinib was designated for the treatment of patients with non-small cell lung cancer with epidermal growth factor receptor mutation, and Ipilimumab has been further designated for use in recurrent metastatic colorectal cancer in adult patients with DNA mismatch repair defects, etc. Also, Ixazomib was added to maintenance therapy of patients with multiple myeloma who received autologous hematopoietic stem cell transplantation, and Ravulizumab was added as a treatment for patients with atypical hemolytic uremic syndrome. Atypical Hemolytic Uremic Syndrome (aHUS) is a disease that occurs in blood clots in blood vessels, interferes with blood flow, destroys red blood cells, and causes hemolytic anemia. An official from the MFDS said, "The orphan drug designation is expected to help in the development of treatments for people with rare and intractable diseases., and will continue to develop policies to ensure patient care opportunities in the future."
- Policy
- Handok takes over Eisai’s Aricept license from Daewoong
- by Lee, Tak-Sun Jun 03, 2020 06:25am
- The Korean market license for the dementia treatment market leader Aricept (donepezil) has been transferred from Daewoong Pharmaceutical to Handok. Except for a few items, Handok is to manufacture the treatment in Korea. Daewoong Pharmaceutical has been importing active ingredient from a Japanese-based pharmaceutical company Eisai that developed Aricept and manufactured and supplied the finished product. Eisai Korea is in charge of the sales. On May 29, a pharmaceutical industry source reported Handok recently took over the Aricept license from Daewoong Pharmaceutical. The rights over five items including Aricept Evess 10 mg tablet, Aricept Evess 5 mg tablet, Aricept 10 mg tablet, Aricept 23 mg tablet and Aricept 5 mg tablet have been handed over. Daewoong Pharmaceutical would be the cosigned manufacturer of Aricept 5 mg tablet and Aricept 10 mg tablet, while Handok manufactures the rest. Meanwhile, Eisai Korea would maintain the license over Aricept 5 mg ODF and Aricept 10 mg ODF. Since the first approval won in 2000, Aricept’s license in Korea has remained with Daewoong Pharmaceutical. The partnership deal assigned the manufacturing to Daewoong Pharmaceutical and the sales to Eisai Korea. However, a slight change occurred in the deal as Eisai has decided to ink a joint sales deal with Chong Kun Dang. And now the license has been transferred from Daewoong Pharmaceutical to Handok. Technically, the shift in license ownership means Deawoong Pharmaceutical has ended the close relationship it had with the original Aricept. Regardless, the Korean company already owns a donepezil generic Dimenpezil tablet, which five items under the brand name so far have received approval since 2018. On the contrary, Handok with the new deal would expand its revenue source. According to pharmaceutical market research firm IQVIA, Aricept has generated 65.6 billion won last year. Eisai Korea’s official statement informed the pharmaceutical distribution industry of Aricept labeled with the new Handok product code valid from June 1, due to the change in manufacturer. Eisai also explained the healthcare reimbursement on Daewoong Pharmaceutical-manufactured Aricept products can be claimed until Nov. 30, 2020.
- Policy
- MFDS & FDA have different NDMA’s follow-up measures
- by Lee, Jeong-Hwan Jun 02, 2020 09:13pm
- The domestic pharmaceutical industry has pointed out that the MFDS and the US Food and Drug Administration (FDA) have made unusually different follow-up measures over NDMA detection Metformin. The MFDS caused an immediate and irreversible damage to pharmaceutical companies by disposing of manufacturing and sales prohibition along with the full recovery of items before the detection of impurities exceeding the standards, but FDA did not enforce the prohibition of sales other than the recovery of the existing distribution volumes. Some pharmaceuticals explain that there are aspects that minimize damage to the pharmaceutical industry through delicate regulation. In particular, about the cause of NDMA detection, the MFDS ordered the pharmaceutical companies to submit a compulsory order within three months, but the FDA also cooperated with the pharmaceutical company to find the cause of detection. .According to the pharmaceutical industry on the 1st, 22 pharmaceutical companies that detected NDMA above the reference level in Metformin are in the voluntary recovery process according to the recommendation of the MFDS .Nonetheless, the pharmaceutical industry is focusing on the differences between the MFDS and the FDA in responding to the NDMA crisis .22 companies holding 31 items that have been confirmed to have exceeded the standard have been affected by the withdrawal of their drugs from the pharmaceutical prescription market since The items detected by the MFDS were recovered and production·sale suspensions were announced on the 25th of last month .Compared to Valsartan or Ranitidine in the past, the number of items was small, so the damage to the entire pharmaceutical industry was minimal, but pharmaceutical companies such as JW Pharma and Hanall, which sold about ₩10 billion a year as a single item, were barred from selling for a day .So how did the MFDS and the FDA take other follow-up measures ?The MFDS, instructed the pharmaceutical company to verify the NDMA detection drug manufacturing process The MFDS went through the review of the Central Pharmaceutical Affairs Review Committee and announced further restrictions on the manufacture, sale and prescription of Metformin exceeding its own standards .It is mandatory to submit manufacturing process verification data that NDMA is no longer detected in the company's Metformin within 3 months until August 31 .Specifically, ▲ Process variables that can affect NDMA production ▲ NDMA generation possibility review data due to the effect between Metformin and other ingredients (main ingredients and other additives) ▲ Storage conditions tests such as acceleration and harshness and packaging and container review ▲ Preventive and corrective measures to prevent NDMA from occurring in the manufacturing process in the future or to be adjusted within the maximum allowable capacity per day ▲ Variability of NDMA detection between manufacturing numbers is the scope of verification data .As a result, 22 pharmaceutical companies were forced to focus on making NDMA process data along with recovering the total amount of their medicines scattered at the prescription sites such as medical institutions and pharmacies .It has long since been removed from physician's prescribed list .This is because the patient's sensitivity to NDMA is greatly increased, and sales are immediately banned .FDA has taken the lead in identifying the cause .Inspection by batch prior to manufacturing and sales ban. The pharmaceutical industry claims that unlike the MFDS, the FDA began to work with pharmaceutical companies to determine the cause, when and where NDMA was detected .In particular, even for items that detect impurities above the reference level, the pharmaceutical system view that FDA decides to recover the total amount of the existing distribution volume, while allowing subsequent distributions to be distributed immediately after the NDMA inspection before shipment rather than immediately stopping manufacturing and sales .In fact, according to a press release issued by the FDA on Metformin’s NDMA, the FDA ordered all Metformin to be tested for NDMA exceedingly, and each batch was individually inspected before shipment to the market, so that it would not be regulated for manufacturing and sales below the reference value .FDA has instructed not to market and report the detection of excess detection only for batches that exceeded the acceptance threshold .There is no immediate sale ban except voluntary recovery, even if NDMA is excessively detected in the collected items .Experts argue that these regulatory differences affect the pharmaceutical industry .It is explained that NDMA detection will result in market exit because the drug will be removed from the market immediately if the sale is prohibited due to excessive detection .In response to this, there is an opinion that the MFDS, like the FDA, requires a delicate regulation to prohibit the sale of detection batches by mandating NDMA inspection for each batch of Metformin for excess detection items .An official from the pharmaceutical industry said, "Unlike the MFDS, the FDA allows NDMA-detected items to be shipped consistently after inspection by batch .The items announced by the MFDSy have already been withdrawn from the prescription market .As a pharmaceutical company, the damage is severe .The official said, "If the MFDS applied batch-by-batch regulations like the FDA, 22 pharmaceutical companies would not have been accused of damaging prescription sales or immoral pharmaceuticals from the public." "The regulatory gap created by the FDA's recognition of the possibility that NDMA could be over-detected at any time and in any drug."
- Policy
- Janssen to import Ultracet as Hyangnam factory closes
- by Lee, Tak-Sun Jun 02, 2020 06:09am
- As Janssen Korea is closing down its Hyangnam factory next year, the locally manufactured pain reliever Ultracet fast-acting tablet (acetaminophen plus tramadol hydrochloride) would be imported, instead. However, the extended release tablet form of the drug, developed in Korea, would be manufactured by Handok. A pharmaceutical industry source reported that the Ministry of Food and Drug Safety (MFDS) has approved the imported Ultracet tablet on May 21. The imported tablet is manufactured in Janssen’s factory in Italy. It shares the same substance and dose as ‘Ultracet Tablet Janssen Korea’ approved in Korea in 2001 for export. The company explained, “The fast-acting tablet would be imported as the Hyangnam factory would be shut down.” However, Handok is apparently taking over the manufacturing license over Ultracet extended release (ER) tablet and Ultracet semi-ER tablet, which were developed by Janssen Korea in 2010 and 2012, respectively. The two drugs release the effect slower than the fast-acting tablet, which reduce the dosage regimen. The company official commented about the extended release tablet and said, “It is unclear when the manufacturing transfer would be completed.” So far in the year, Janssen Korea has announced Invega ER tablet, Topamax springkle capsule and Jurnista slow release tablet would be imported, instead of locally manufacturing them in Hyangnam factory. In 2018, Janssen Korea has announced the Hyangnam factory would stop operating in 2021. The factory was opened in 1983.
- Policy
- The emergency introduction of Remdesivir was confirmed
- by Lee, Tak-Sun Jun 02, 2020 06:09am
- 정은경 중앙방역대책본부장The government urgently introduced Gilead's 'Remdesivir' as a cure for COVID-19. Accordingly, the MFDS is planning to go through a special import procedure. Eun-kyung Jung, Head of the Central Disease Control Headquarters, said at the regular briefing on the 29th that the Central Clinical Committee on 28th suggested the need for the introduction of Remdesivir. Accordingly, the Central Disease Control Headquarters plans to apply for the special import (emergency introduction) of Remdesivir from the MFDS in response to the opinion of the Central Clinical Committee. The Committee evaluated that Remdesivir is safe and effective in the treatment of COVID-19 pneumonia, and that it is necessary to medically introduce Remdesivir in the absence of an alternative antiviral agent. In addition, it is said that the need for Remdesivir is given to patients with severe pneumonia from COVID-19 infection and who require oxygen treatment. The dosing period is about 5 days, and it is extended for 5 days depending on the patient's condition. However, the need for monitoring for effects or side effects is mentioned. Remdesivir is a drug that is currently undergoing clinical trials in Korea. The MFDS can import special drugs under the pharmaceutical affairs law at the request of the KCDC for drugs not approved for domestic use. If special import is recognized, it is possible to enter and use the imported items in Korea without the approval procedure. Pediatric Kaletra syrup, currently used to treat COVID-19, has also undergone this procedure. "Currently, there is not so much supply or production of drugs, so we plan to cooperate with related ministries as much as possible to secure drugs," said Jung. "It seems difficult to tell about the time now."
- Policy
- Pfizer's non-steroidal eczema, under phase III in Korea
- by Lee, Tak-Sun Jun 01, 2020 06:20am
- A non-steroidal ointment that can be used for eczema in children is under clinical trial for domestic introduction. Pfizer's Crisaborole is a drug sold in the United States under the name of 'Eucrisa' after it was approved by the US in 2016. The MFDS approved a multinational clinical trial phase III for Pfizer’s Crisaborole on the 29th of last month. This clinical trial is aimed at verifying the efficacy and safety of 2% of Crisaborole ointment in Asian children and adult subjects (over 2 years of age) with mild to moderate eczema. Of the 510 subjects, the total number of domestic patients is 120. If safety and effectiveness are proved through this clinical trial, it is expected that the drug approval process will be conducted in Asia, including Korea. Eczema is a symptom of itching and dry skin, which usually starts in early childhood. the cause of the disease is still unknown, but it is said to be affected by genetic factors and environmental factors. Topical steroid ointments are used to moisturize the skin and suppress itching. However, the side effects of steroids are thinning the skin and there is a risk of infection, so long-term use should be avoided. Crisaborole is a non-steroid, and is a new ointment that can be used for eczema in the PDE-4 (phosphodiesteras). PDE-4 drugs that maintain immune homeostasis by increasing the release of inflammatory mediators include CDPD treatment, Daxas and psoriasis treatment, Otezlar, the first ointment to treat pediatric eczema. Accordingly, it is expected that the release of Crisaborole will act as an alternative to steroid ointments. Crisaborole was approved by the United States FDA in December 2016 for children over 2 years of age and adults with eczema. Recently, clinical trials have been conducted to lower the age group so that it can be used by children over 3 months of age. It is reported that there are about 950 thousand eczema patients in Korea, which is increasing every year. Treatment for non-steroidal eczema exists in Korea, but it is likely that attention will be focused on the introduction of Crisaborole in that it is rare for ointments that can be used in children.
