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- 2025-12-24 08:23:57
- Policy
- Promote legislation to include the shingles vaccine in NIP
- by Lee, Jeong-Hwan Aug 21, 2020 06:26am
- A bill is being promoted to include the shingles vaccine, which is classified as a premium vaccine, in the National Immunization Program,(NIP). On the 19th, Yoo Sang-beom, a member of the United Future Party announced that it had proposed a bill with the same content. He explained that the onset of shingles markedly lowers the quality of life of the patient due to complications along with acute and chronic pain. In addition, he pointed out that the number of patients in Korea is increasing from about 660,000 as of 2015 to about 740,000 in 2019, which induces the burden of disease socially and economically. Currently, the KCDC is recommending vaccination of the shingles vaccine for the elderly aged 60 and over, but the inoculation rate is only 10% for those in their 50s or older at a cost of about ₩150,000 to ₩200,000. He said, "The shingles vaccination has great disease prevention effect and a great reduction in cost compared to the cost of an outbreak, so it is subject to national vaccination in the UK, Germany, Canada, and Australia, and Korea should also be included to reduce the burden of national medical expenses."
- Policy
- Global companies expand business in expensive orphan drugs
- by Lee, Tak-Sun Aug 20, 2020 06:24am
- Vyndaql approved for the Korean market in 2015. Shares the same substance with Vyndmax but indicated for different disease. As global pharmaceutical companies are on to expanding businesses in drugs for rare diseases, the companies are now winning item approvals in South Korean markets. Rare diseases have limited patient size and insufficient treatment options, but the drugs are expensive enough for the companies to seek for profit. On Aug. 19, Ministry of Food and Drug Safety (MFDS) approved Pfizer Pharmaceutical Korea’s Vyndamax 61 mg capsule (tafamidis). The medicine is indicated to treat cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. Although the patient size is small, the disease is known to develop a heart failure and have a high risk of death. Prior to the drug, no other treatment option was approved. Previously, Pfizer has received approval on another drug with the same substance—Vyndaqel 20 mg capsule (tafamidis meglumine). However, its salt base, substance amount and indication are different. Vyndqel is also indicated to treat a rare disease, transthyretin familial amyloid polyneuropathy (TTR-FAP). In October 2018, Vyndqel was listed for healthcare reimbursement and priced at 141,900 won per capsule. A yearly drug expense would add up to 51.79 million won. According to IQVIA, Vyndaqel earned approximately 1 billion won last year. Considering the high upper limit pricing of Vyndaqel, Vyndamax would also be another ultra high-cost drug. When the U.S. Food and Drug Administration (FDA) approved of the drug in May last year, Pfizer put forth a yearly expense of USD 225,000, or approximately 266 million won, for the listed price. The company also announced they are in a negotiation with insurers. A growing number of global pharmaceutical companies launching ultra high-cost drugs for rare diseases is seemingly making the Korean health insurance authority anxious. Early this year, Novartis submitted an official approval application for a spinal muscular atrophy (SMA) treatment Zolgensma with yearly expense proposed at 2.5 billion won. Currently designated as an orphan drug, Zolgensma is in process of getting approved with expanded user age group in Korea.
- Policy
- Drug Approval system under direct control of the MFDS
- by Lee, Tak-Sun Aug 20, 2020 06:23am
- #Drug Approval System, which was in charge of the National Institute of Food and Drug Safety Evaluation, will be carried out at the headquarters of the MFDS. The 'Convergence Innovation Product Support Group', a temporary organization that has been in charge of licensing affairs since last year, is formally incorporated into a department under the direct control of the Deputy General Manager. The MFDS (Minister Eui-kyung Lee) and the Ministry of the Interior and Safety (Minister Chin Young) reinforce the expertise of medical product approval and review, and to ensure the right to life for the people and strengthen the international competitiveness of companies through rapid productization support. It was announced on the 18th that the system will be reorganized. With the reorganization of the medical product approval/examination system, the approval task that had been carried out by the National Institute of Food and Drug Safety Evaluation will be carried out by the vice-minister of the MFDS, and the review will continue to be carried out by the National Institute of Food and Drug Safety Evaluation. Specifically, for medical product licensing, two new divisions are established and operated, the 'licensing general manager' and the 'high-tech product licensing manager' under the deputy of the headquarters. The NIFDS continues to carry out the evaluation work, and two new divisions are established and operated under the director, the 'pre-counseling department' and the 'expedited examination department'. First of all, among the two divisions of the headquarters, the licensing general manager generalizes the approval of medicines (including herbal medicines) and the improvement of the approval/examination system for all medical products, while the high-tech product licensing manager is responsible for converging medical products and biologics and medical device approval. In addition, the pre-counseling department conducts preliminary consultation on the application for approval of clinical trial plans and product approval of pharmaceuticals, medical devices, and new drugs subject to rapid review, and the expedited examination department designates rapid review of drugs, medical devices and new drugs. Review data on the application. Targets for rapid review are products that contribute innovatively to responding to public health crises or treating diseases such as life-threatening diseases, new infectious diseases, and digital-based medical devices, and categorized into crisis response drugs, innovative new drugs, and innovative medical devices. Since last year, the MFDS has formed a temporary organization called the 'Convergence Innovation Product Support Group' within the NIFDS and has been carrying out the licensing work. Instead, the person in charge of the approval work of the NIFDS-related department was dispatched to the Convergence Innovation Product Support Team. This time, it has become a formal office through reorganization. In addition, in accordance with the recently enacted 'Advanced Renewable Bio Act' and 'Medical Device Act', advanced biopharmaceuticals and innovative medical devices (software) permits and reviews, advanced regenerative medicine high-risk clinical research plans, etc. expand technical experts and introduce and operate a customized screening system. With this reorganization, the government is expected to establish a dedicated review system for high-quality rapid review of new concept medical products in accordance with the 4th industrial revolution and biohealth trends by strengthening policy linkage under comprehensive review of permits and screenings in a rapidly changing era. Through the reorganization of the medical product approval/examination system, the Ministry of the Interior and Safety added rational policy judgment on the basis of scientific basis for approval, and consulted in advance from the R&D stage for the review, while conducting a rapid review for innovative treatments. By shortening the productization period, such as, the opportunity for patient treatment will expand, and it will greatly contribute to rapid response to public health crises. The MFDS has reinforced the policy functions of the headquarters of the license and maintained the evaluation expertise of the NIFDS through the reorganization of the approval/examination system. By shortening it, it has made efforts to strengthen the global market competitiveness of the pharmaceutical industry while putting the life and safety of the people first. The MFDS plans to complete the revision of the 'The MFDS and the Directive Enforcement Regulations of its affiliated organizations' with the goal of the 25th. However, the procedure for passing through the Ministry of Public Administration and Security, which is the main ministry related to the organization, remains. related personnel are expected to proceed in line with the revision.
- Policy
- Kwang Dong is continuing the business of Pomalyst
- by Lee, Tak-Sun Aug 20, 2020 06:23am
- Kwang DongKwang Dong is continuing the business of specializing anticancer drug first generics by challenging the patent for Celgene's multiple myeloma treatment 'Pomalyst' (Pomalidomide). Recently, Kwang Dong is showing a prominence in the anticancer drug business by introducing the first generic drug for multiple myeloma treatment, Revlimid and breast cancer treatment, Afinitor. According to the MFDS and the industry on the 13th, Kwang Dong requested a trial for a confirmation of passive rights scope to evade the formulation of Pomalyst (expired on July 21, 2030). Earlier, on the 31st of last month, Boryung also filed a trial to confirm the scope of passive rights to the same patent. Exclusivity generic drug, which grants market monopoly to drugs after successful patent challenge, applies to companies that have requested within 14 days of the initial request for trial. After Boryung's initial request for judgment, other companies must file it by the 14th of this month for the condition to be established. It is worth noting that Kwang Dong has succeeded in evading the patent of Celgene's other multiple myeloma treatment, Revlimid (Lenalidomide). Kwang Dong confirmed the patent evasion by receiving a citation trial in the 2016 trial to confirm the passive scope of rights filed against the crystal-form patent of Revlimid . Kwang Dong is the only pharmaceutical company that has succeeded in the patent challenge of Revlimid. Kwang Dong has launched and sold the first generic drug 'Lenaldo' since 2018. Last year, Lenaldo recorded sales of about ₩600 million based on IQVIA. Kwang Dong was the first Korean company to challenge the patent for Novartis' breast cancer treatment drug 'Afinitor' and received a license for the first generic drug in March. Through a long patent dispute with Novartis, Kwang Dong won the trial for invalidation of a patent for use earlier this month, and was granted a first generic drug. Afinitor’s first generic 'Elinito', which was approved in March, is a drug imported from Synthon Chile Ltda. in Chile. It has obtained generic exclusivity right to the market by December 31 of this year. In the case of generic for Afinito, only two companies of Kwang Dong and Samyang Biopharm were licensed, and generics for Revlimid were licensed only from Kwang Dong, Chong Kun Dang, Samyang Biopharm and Alvogen Korea were licensed. It is relatively free from competition as there are few generic companies. However, in the case of anticancer drugs, the original preference is high and the probability of using them in general hospitals is high. Pomalyst, which has been challenged by Kwang Dong this time, is a drug that can be used in patients with multiple myeloma that do not respond to Revlimid. The product lineup can be strengthened if Kwang Dong, which has the first generic for Revlimid, Lenaldo, succeeds in acquiring drugs that are generic for Pomalyst. Multiple myeloma is one of the three major hematologic cancers with a high incidence, along with lymphoma and leukemia, and the market size of the drug has been increasing since the introduction of the target treatment, Revlimid.
- Policy
- Chong Kun Dang recruits consignment companies for Atozet
- by Lee, Tak-Sun Aug 19, 2020 06:28am
- Atozet by MSDChong Kun Dang submitted an application for approval in April for Atorvastatin-Ezetimibe, generic for Atozet and recruiting consignment companies is also gaining popularity. Chong Kun Dang applied for item approval of Atorvastatin-Ezetimibe through its own clinical trial. Considering the maximum period of 6 months for the approval review period, it is expected around October. On the other hand, generic companies must apply for approval after the expiration of Atozet's PMS on January 22, next year, so it is possible to approve product permission as early as February of that year. However, if generic companies sign an entrusted production contract with Chong Kun Dang, which allows early approval, to obtain product permission, not only will the market entry be accelerated, but it will be advantageous in terms of drug price registration. Only 20 companies can receive benefits. According to the industry on the 18th, more pharmaceutical companies expressed their willingness to participate in the recruitment of 20 consignment manufacturers of generic for Atozet by Chong Kun Dang. Chong Kun Dang started recruiting consignment manufacturers, seeing that product approval was possible within this year. In particular, Chong Kun Dang's products are drugs for data-based re-evaluation that have undergone clinical trials, and are not generic drugs. Therefore, the consignment licensed items produced by Chong Kun Dang become authorized generics rather than generic drugs. Authorized generics can receive the highest price regardless of the conditions for DMF listing or direct bioequivalence test. However, prices for generics that are applied for permission after the end of the PMS of the original drug, drop at a certain rate if they do not directly go through the bioequivalence test. Currently, 29 cases have been approved for bioequivalence protocols to conduct bioequivalence tests directly with Atozet. However, they can apply for permission on January 22, when PMS ends, so there is a high possibility that the approval of the item will be delayed than that of Chong Kun Dang consigned products. Moreover, when the number of Chong Kun Dang commissioned production items reaches 20, the drug prices for generics that are applied for permission after the end of the PMS will drop again due to stepped pricing system. For this reason, many pharmaceutical companies are expressing their intention to participate in the recruitment of Chong Kun Dang's consignment companies. An industry official said, "Pharmaceutical companies that do not directly proceed or fail the bioequivalence test want a contract for consignment production with Chong Kun Dang. It is known that more companies than the 20 recruitment limit already expressed their intention to participate." On the other hand, companies that have already conducted bioequivalence tests and have been successful are complaining that they may be disadvantageous in drug prices due to Chong Kun Dang's consignment companies. Some say that companies of incrementally modified drugs should regulate the tricks of recruiting contractors using stepped pricing system.
- Policy
- No more approval on all appetite suppressants
- by Lee, Tak-Sun Aug 19, 2020 06:28am
- New approval on appetite suppressant amfepramone, also known as diethylpropion hydrochloride, and mazindol drugs would be restricted. These substances were added to the list of restricted approval substance due to the risk of abusing narcotics for medical purposes. Now, the list of restricted narcotic drugs includes amfepramone, mazindol, GHB, phentermine, phendimetrazine and propofol. On Aug. 14, South Korea’s Ministry of Food and Drug Safety (MFDS) announced appetite suppressant amfepramone and mazindol would be designated as narcotics for medical purpose (psychotropic drug) ad restricted from new approval. Currently, 14 amfepramone items and two mazindol items are approved and available in the market. The ministry explained the restriction has been ordered to protect the safety of the people as concerns of abusing these drugs have been raised, regardless of the effort made so far to promote the adequate use of appetite suppressants. The production volume of appetite suppressants have increased from 244,213 in 2017 to 283,042 in 2019. Also 128 users have been reported for using the products from July last year through last May. Other appetite suppressants like phentermine and phendimetrazine have been restricted from new approval since 2013. With the new action, MFDS stated all appetite suppressants would be restricted from new approval. However, a product in new formulation or for export purpose would be able to seek for approval, regardless of the new restriction. Prior to the action, MFDS noted the government has explained the need of tightened control over these drugs through industry meetings and opinion survey. MFDS official said, “For the safe use and appropriate prescription of narcotics for medical purposes, the government would draw up plans to raise awareness of safe use of narcotics among the public and medical professionals. And by cooperating with relevant institutes and companies, the ministry would do the best to prevent any harm caused by abusing narcotics for medical purpose.”
- Policy
- Vaccine by Novavax, produced by SK Bioscience
- by Kim, Jung-Ju Aug 19, 2020 06:27am
- The government has signed a letter of intent (LOI) for cooperation in domestic production and supply in order to smoothly supply the vaccine developed overseas for COVID-19. The domestic supply chain is SK Bioscience, which has joined the production of AstraZeneca products. The MOHW (Minister Park Neung Hoo) at SK Bioscience Research Institute (Pangyo, Seongnam) at 9 p.m. on the 13th, together with Novavax (CEO Stanley C. Erck) and SK Bioscience (CEO Ahn Jae-yong), COVID-19 being developed by US Novavax. A letter of intent (LOI) was signed for cooperation in global production and domestic supply of vaccines. Currently, about 160 COVID-19 vaccines are being developed worldwide, and these vaccine candidates are largely classified into ▲viral carriers ▲synthetic antigens ▲nucleic acids (DNA, mRNA) ▲inactivated types (platforms) according to the type of technology. The vaccine being developed by Novavax is a synthetic antigen method, which is different from the virus carrier vaccine being developed by AstraZeneca, UK, which signed a LOI for cooperation in securing domestic vaccine supply for the first time in July. As it aims to enter phase III clinical trials in October this year, it is evaluated that the development speed is the fastest among synthetic conjugated vaccines. The MOHW said, "This agreement signifies that a domestic company has been recognized for the production capacity and technology level of vaccine supply from other platforms, and participates in the global production and supply chain. It is of great significance in that it has prepared a channel for cooperation to secure vaccines from Novavax, which has a different vaccine platform following AstraZeneca in July.” At the signing ceremony, The MOHW (Minister Park Neung Hoo) said, "Following July, the signing of a LOI has been a very big achievement as it has been able to further increase the possibility of supplying vaccines to Korea by diversifying available vaccines in preparation for the uncertainty of the success of vaccine development. The government supports domestic companies' own vaccine development until the end, while making great efforts to quickly secure excellent overseas vaccines with a fast development speed based on a two-track strategy."
- Policy
- Development of generic for Pelubi is active
- by Lee, Tak-Sun Aug 18, 2020 06:03am
- Daewon Pharm’s anti-inflammatory generics for Pelubi, which recorded an outpatient prescription of ₩28.9 billion last year, is actively developing. In July, the first application for permission of generic for Pelubi was received, and nine bioequivalence test plans were approved this year. Generic companies are now developing not only Pelubi, but also Pelubi SR. However, additional indications acquired late through a clinical trial by Daewon Pharm are expected to be protected as long as the PMS expires. According to the industry and the MFDS on the 17th, Mothers Pharm received approval of two bioequivalence test protocols for the generics of Pelubi SR on July 29 and July 31. The first approved bioequivalence test is conducted on an empty stomach, and the second approved test is to determine the equivalence with Pelubi after meals. Earlier in May, generic by Huons was approved for the same bioequivalence test. Daewon Pharm's Pelubi SR is a drug approved in March 2015 and is administered orally after meals twice a day. Pelubi which was approved as a new drug made in Korea in April 2007, is a drug that is administered orally after meals three times a day. Generics for Pelubi by Mothers Pharm and Huons were also approved for bioequivalence tests in March, and are currently ended. In addition, Yungjin Pharm, Nexpharm, and Hutecs were also approved. However, in order for them to obtain and release generic for Pelubi, they must overcome the patent first. Formulation patent for Pelubi is scheduled to expire on November 12, 2028. Starting with Yungjin Pharm at the beginning of this year, Mothers Pharm, Hutecs, Huons, Nexpharm Korea, and Chong Kun Dang in turn requested a trial to confirm the scope of their rights for patent evasion, but a trial decision has not been made yet. In addition, the composition patent of Pelubi SR is listed on the patent list of the MFDS in the. The composition patent is scheduled to expire on October 17, 2033, but there is no patent challenge from generic companies. At the end of July, the first application for Pelubi’s generic was received, but if the patent cannot be overcome even after the product permission, it cannot enter the market for the duration. However, generic companies are confident in the success of the patent challenge and are highly likely to release early. Even so, it is difficult to secure and release all indications of Pelubi and Pelubi SR. In the case of Pelubi, there are antipyretic indications for acute upper respiratory tract infection along with osteoarthritis, rheumatoid arthritis, and low back pain (low back pain). Among them, PMS will expire on September 18, 2021 for antipyretic indications. Generic companies can apply for permission after the PMS expires. In addition, Pelubi SR has indications for osteoarthritis, rheumatoid arthritis, low back pain (low back pain) and post-traumatic pain. Pelubi's antipyretic effect and Pelubi SR's indication for pain were obtained through additional clinical trials after the marketing of Daewon Pharm. The indications for post-traumatic pain in Felubiceron will only expire on June 16, 2024. generic companies are developing generics, excluding additional indications. In the case of Pelubi’s generic, which applied for permission at the end of July, the antipyretic indication for acute upper respiratory tract infection was omitted. In addition, generic for Pelubi SR, which is currently being developed, is expected to exclude the indication for nervous tension post traumatic pain. The recent development of Pelubi's generics shows that its popularity in the market is rising rapidly. Pelubi, which recorded ₩28.9 billion in outpatient prescriptions last year, surpassed ₩10 billion for the first time in 2017. It was only eight years after launch. As PMS already ends in April 2013, it is an analysis that generic companies have confirmed marketability and started developing generics. Pelubi, which did not meet expectations at the beginning of its release, gradually expanded its market share. This also affected the part in which Daewon Pharm acquired the indications sequentially through subsequent clinical trials. When it was approved, Pelubi's only indication was osteoarthritis. Even if another generic is released through the success of the patent challenge, the indications for acute upper respiratory tract fever and post-traumatic pain can be valid.
- Policy
- Zolgensma was added to target diseases
- by Lee, Tak-Sun Aug 18, 2020 06:02am
- The minutes of the Central Pharmaceutical Affairs Review Committee were released in connection with the expansion of the target age of the expensive drug 'Zolgensma' of ₩2.5 billion, and it was revealed that the target disease was added on the 3rd. The committee presented a negative opinion on the expansion of the age group, but Orphan drug designation change announcement revealed that the age group has expanded. At the beginning of this year, Novartis Korea, a sales company of this drug, applied for a formal approval, and it is noteworthy how the indications will be determined when the product is approved. This is because, as this drug is an ultra-high-priced drug with a price of ₩2.5 billion by the manufacturer, the difference in the amount of benefits in the future increases depending on the difference in the number of patients. According to the industry on the 13th, the MFDS has further expanded the target disease of Zolgensma, currently designated as an orphan drug on the 3rd. Zolgensma was designated as an orphan drug in December 2018 in Korea. When designated as an orphan drug, approval screening is accelerated, and purchases are facilitated through the KOEDC. It was designated as the first orphan drug, the target disease was announced as 'spinal muscular dystrophy (Type 1)'. However, the target diseases announced this time have been changed to ▲if there is a clinical diagnosis of type 1, and ▲the number of copies of the Survival Motor Neuron 2 (SMN2) gene is 3 or less Survival Motor Neuron 1 (SMN1)' in patients with Spinal Muscular Atrophy (SMA) with a double allelic mutation in the gene. Spinal muscular dystrophy is all about patients with mutations in the SMN1 gene that act on the motor nerves. However, it is divided into 3 types according to symptoms. Type 1, which was previously a target disease, dies within 2 years of age from 2/3 or more, and type 2 can survive until elementary school entrance, but there are many cases of using a wheelchair due to muscle disorder, and type 3 appears normal in the neonatal period, but progresses slowly. In particular, type 1 is mostly diagnosed in infants under 6 months. Zolgensma can be administered to children under the age of 2 in the United States and Japan, and to children under 21 kg of body weight, regardless of age, approved earlier this year in Europe. On the other hand, since the use of TYPE 1 for orphan drugs designated in Korea is limited to infants under 6 months, Novartis tried to expand the patient group by adding diseases for orphan drugs before official approval. However, at the committee held in May, it was desirable to further restrict the target age, type, etc., and presented a negative opinion on the contents of Novartis' application. However, the 'survival motor neuron 2 (SMN2) gene's copy number of 3 or less' is also included in the target disease, resulting in an expanded age group. This is because many patients with type 2 and type 3 SMA diagnosed after 6 months have 3 to 4 SMN2 genes. Patients with type 1 have only one or two SMN2 genes. Currently, 60% of SMA patients are in type 1, 30% in type 2, and 10% in type 3. It means that Zolgensma can be used in types 2 and 3 regardless of age. However, it is difficult to predict the final indication as this drug has not yet been officially approved in Korea. However, there is a high possibility that the designation of orphan drugs will be reflected in the official approval. From a manufacturer's point of view, sales can be expected to increase due to the expansion of the age group. On the contrary, it seems that the insurance authorities' concerns will increase in the phase of applying for benefits after formal approval. This is because even if the number of patients used increases by just one or two, the size of the health insurance premium differs by several billion won(₩). Currently, about 17 SMA patients under the age of 2 in Korea are known to have been diagnosed annually. When the manufacturer's suggested amount is applied to the domestic patient group, the size of the treatment will reach ₩42.5 billion per year.
- Policy
- MFDS imposes fine on imported Nesina Met and Xeomin
- by Lee, Tak-Sun Aug 14, 2020 06:22am
- Takeda Pharmaceuticals Korea’s antidiabetic drug Nesina Met and other imported drugs have received administrative measure from Korea’s Ministry of Food and Drug Safety (MFDS). Specifically for Nesina Met, the importer would be responsible for the health authority’s 30.15 million won fine that substituted a three-month sales ban. On Aug. 13, MFDS disclosed a list of administrative measures imposed as of Aug. 7 with the said details. Besides Nesina Met, other imported botulinum toxin products were also found on the list. Takeda Pharmaceuticals Korea’s Nesina Met was fined with 30.15 million won, instead of a three-month ban, as the company neglected submission of required data for the post-marketing survey (PMS) reevaluation. The fine is due on Sept. 7. An alogliptin benzoate plus metformin hydrochloride combination antidiabetic drug, Nesina Met was approved for the Korean market in February 2015. Currently the drug is imported to Korea by Takeda Pharmaceuticals Korea. The PMS reevaluation on Nesina Me was completed as of May last year. For a new drug, the company had to submit usability investigation data like adverse reaction report to MFDS during the reevaluation period. Omitting a part of required data submission once gets a three-month sales ban, and twice gets a six-month sales ban. However, the penalty can be replaced with a fine. A dipeptidyl peptidase-4 inhibitor, Nesina Met has made 3.4 billion won in outpatient prescription from the first half of the year, according to UBIST. Administrative measures on some imported pharmaceuticals as of Aug. 7 (Source: MFDS) Two imported botulinum toxin products competing against Korean botulinum toxin products have also received administrative measure due to an omission of serial number. Merz Asia Pacific omitted serialization information when reporting supply history and shipping of ‘Xeomin injection’ and ‘Xeomin injection 50 unit’ from July through December 2019. As a result, the health authority imposed a fine of 14.85 million won due Sept. 7, substituting a month-long sales ban. Ipsen Korea has also gotten a sales ban on a botulinum toxin Dysport injection for to the same charges. From July through December 2019, the company also omitted to report Dysport serialization along with its supply record. The product sales would be banned for ten days from Aug. 21 to 30. Xeomin and Dysport have been imported to Korea for 4.6 billion won and 900 million won, respectively, in 2018. The two products together take up a small pie of 2.7 percent in the Korean botulinum toxin market. The serialization system has been enforced since January 2019. The government has mandated reporting of product serial number when a company ships out the products to improve transparency in distribution and user safety. Same administrative measures were given on Ipsen Korea with the same charges. The sales on Diphereline PR injection and Diphereline SR injection would be banned for ten days from Aug. 21 to 30.
