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- Policy
- 13 drugs containing Nizatidine were banned for sale
- by Lee, Hye-Kyung Nov 26, 2019 07:15am
- 13 gastrointestinal drugs containing 'Nizatidine' which had been covered by health insurance, now are not available on the 22nd. The MFDS and the HIRA said that on the 22nd, they took action that Nizatidine medicines are not prescribed or dispensed by hospitals, clinics or pharmacies, from the midnight, prescriptions and dispensing were blocked through the DUR (Medical Insurance Information System) of the HIRA to prevent prescriptions from hospitals, clinics and pharmacies. The banned items are 13 items for discontinued benefits and 53 billing codes. When re-prescribing Nizatidine drugs in a hospital or clinic, the new prescription should be given only for the remaining days instead of changing the existing prescription. When re-prescribing, the specific description code 'MT059' should be entered. As the existing prescription is not changed, the date of re-prescription and re-dispensing at the time of patient visit comes to be the prescription (prescription) date. Although the patient's copayment is generated when preparing the bill for re-prescription and re-dispensing, there is no copayment for the re-prescription and re-prescription. Therefore, clinics, hospitals and pharmacies must claim the dispensing fee and prescription fee by writing the type code 'B / 01' for each medical service in 'MT059'. HS Codes and standard codes for 13 banned drugs containing Nizatidine
- InterView
- “Number one in Asia is what we are shooting for”
- by Kim, Jin-Gu Nov 26, 2019 07:15am
- “As far as dermatological treatment business goes, I think we have a shot at becoming the number one in Asian market”, Cho Yong-joon, CEO at Dongkoo Bio & Pharma (“Dongkoo”) commented. The CEO said ‘entering global market’ is the next long-term goal for the company while it gets closer to its 50th anniversary next year. CEO Cho was confident that Dongkoo’s two most prominent business sectors, dermatological treatment and contract manufacturing, would both be competitive in the global market. He explained the recent aggressive investment and company expansion have been executed with the global market in mind. Visiting his office on Nov. 18 for an interview, it has not even been 24 hours since came back from his business trip to the U.S. Apparently, Cho was already making moves for the global market. -What business took you to the U.S.? “It was to dip our toes in the water of global contract manufacturing organization (CMO) market. I shared some positive talks with a U.S. company especially on our strength, the soft capsule manufacturing. When we ink the deal, we would fully disclose the story. Next year would be Dongkoo’s 50th anniversary. Accordingly we would put forth our global market vision”. - Would it be safe to assume the latest Hwaseong plant expansion was a part of the vision? “We have invested ten billion won. The plant started running from this month. Our production capacity would go up half as much again as before or even double. The company’s CMO sector made 21 percent more last year with 33.1 billion won, compared to 15.3 billion won in 2014. We are expecting to make about 40 billion won this year. To date, the manufacturing factory could not catch up with orders pouring in. “When the manufacturing facility stabilizes from next year, the overall sales and profit would rise. Not only did we enhance production capacity, but also we are focusing on developing new technology on soft capsule. We gained expertise in dermatological treatment through our experience”. -After the valsartan incident, many are concerned of CMO industry “Korean CMO industry is faced with crisis and opportunity all at the same time. As the regulator decided to abolish the joint bioequivalence test system, and revived the gradual drug pricing system, I expect the industry would get the blow soon or later. That is what Dongkoo is preparing for. Specialization and differentiation is the key. The government is also encouraging companies to focus on specialized manufacturing. So far, Dongkoo has been doing well with soft capsule and ointment items. “But the opportunity lies in the global market. Korean CMO industry would be competent enough in the global market. I confirmed that at the CPhI Worldwide 2019. From now on production cost would heat up the already competitive generic market. Now it’s a matter of who sources drug the best. Korean companies could also easily source drug from other countries. We all need to target the global market competition”. -What are your visions on Dongkoo’s specialized sector, dermatological and urological treatments? “Not too different from others, we’re aiming for the global market expansion. First, we would tackle the Asian market. The company is carefully preparing for the leap. To be specific, we are considering opening an office in China. In Korea, our dermatological treatment prescription is ranked at the top with, and urological treatment prescription is at eighth place. Why not then go for the top rank in Asia? This is our goal. We have constantly introduced dermatological treatment. Some are ready to be released next year. For the long-run, we are in process of developing new drug and incrementally modified new drug”. -You’ve shown some notable moves not only on facilities but also on venture investment. “We have signed deals with Novacell Technology, D&D Pharmatech and BioNote. D&D Pharmatech is a bio venture led by a group of professors from the Johns Hopkins University School of Medicine. They are developing treatments for Parkinson’s disease, Alzheimer’s disease and rare fibrosis conditions. Dr. Lee Seulki from Johns Hopkins University School of Medicine is leading the R&D and clinical trials. “We have invested 3.1 billion won on D&D Pharmatech. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for the venture company’s rare fibrosis treatment. Recently, the company successfully attracted 140 billion won worth of series B funding. We expect the company to go public next year. “Novacell Technology obtained its U.S. patent on atopic dermatitis peptide this year. And BioNote was the first Korean company to develop African Swine Flu diagnosis kit”. -Investment expansion comes with business profit drop. Seems like Dongkoo’s revenue has been falling for last two years. “It was given that operating profit would go down. We have spent much of capital on facility expansion investment, recruitment, clinical investment and marketing. But the actual sales revenue has constantly gone up. It verifies that the business is growing steadily. The last two years of decreased revenue was about preparing for the future ‘quantum jump’. The return on the investment is expected to show even from next year and on". -Some other business expansion on other sectors like cosmetics and medical device has been noticeable as well. “We’ve jumped into cosmetic market. ‘Cell Bloom’ is a brand based on 3D stem cell media skin care products. We are expecting the brand to generate synergy effect with our expertise in dermatological treatment. And we are taking this for a long run. A few home shopping TV channels have offered us a slot, but we turned them down. We could’ve gotten some instant sales hike, but we are planning to build the brand image centering hospitals and duty free shops first. “Besides Cell Bloom, we also have an ongoing development of bio medical device called ‘Smart X’. We are challenging the chronic disease sector with bio technology. There are unmet needs that cannot be resolved with drugs. An example would be diabetic foot (chronic foot condition derived from diabetic mellitus). Not many drugs treat diabetic foot. “Smart X is a convenient stem cell extraction kit. We have observed meaningful effect from extracting stem cell and injecting back into the ulcer on a foot. Clinical trial is in process to receive approval on the new medical technology. It would get approval in first half of next year at earliest, and generate expected sales from the latter half of the year. The approval application reviews are well on their ways in the U.S., China and Russia as well. And it’s already on sale in Spain”. -Celebrating the last 50 years of the business, what’s next for Dongkoo? “Bio sector is where Dongkoo would be investing on for the next 50 years. Cell Bloom and Smart X are on the same track as well. We would not superficially imitate bio technology, but strive for sustainable business with genuine bio technology, as I would reiterate at the company foundation ceremony. "For the goal, Dongkoo aims to transform from pharmaceutical and bio company into a total healthcare company. Dongkoo would generate great synergy effect with dermatological and urological treatments, as well as stem cell-applied healthcare technology, and reborn as a total healthcare company to cover from head to toe with diagnostic, preventive, treatment and maintenance products”.
- Policy
- MOHW lukewarm about Epilepsy Patient Support Bill
- by Lee, Jeong-Hwan Nov 26, 2019 07:12am
- ‘Epilepsy Patient Support Bill’ is at stake due to a dispute over feasibility of a bill specifically accommodating a certain disease. The National Assembly lawmakers and the government are contemplating on passing an individual bill for a disease as it could trigger other patients to demand bills for their disease, and cause confusion in administrative regulation and fairness among diseases. Whereas, patients and neurology healthcare providers are urging for the epilepsy bill to be passed as soon as possible, because the disease significantly shortens patient’s life span and poor social awareness and unfair social stigma are discriminating against patients with epilepsy. The National Assembly Health and Welfare Committee convened a public hearing session on Nov. 22 about the ‘Epilepsy Management and Support Bill’ introduced by Lawmaker Kim Kim Se-Yeon. The point of dispute was on fairness of establishing an independent law solely dedicated a single disease. Epilepsy is a central nervous system disorder that causes abnormal events in brain cells, which leads to sudden and intense spasm and seizure lasting few minutes. Experts say the estimated number of patients with epilepsy in Korea is around 360,000, and the disorder notably lowers not only the patients, but also the patients’ families’ quality of life, along with the huge impact of financial and social burden. The submitted bill mainly aims to stipulate legal grounds of planning and executing epilepsy preventive measures, diagnosis, related research, as well as a patient support program to help the patients recover and become independent. A couple of key objectives of the bill are to establish a policy raising public awareness and discrimination prevention of epilepsy and patients with epilepsy. And also it would form National Epilepsy Patient Management Committee affiliated under Ministry of Health and Welfare (MOHW). Another objective is to set up and operate Central Epilepsy Support Center and regional centers, and to allocate budget for contracted agency and Epilepsy Specializing Clinic Center assigned to manage patients by regional government body. Lawmaker Kim Se-yeon suggested MOHW to lay the bill and urged Korea to stop neglecting patients with epilepsy any more. “Usually, I keep a reserved stance on legislation, but this bill is different. When a healthcare institute with a scale of Samsung Seoul Medical Center struggles with surgery on the disorder, it means the problem is quite serious”, Lawmaker Kim stated. “If the weight of an individual bill accommodating a single disorder is too much, then consider a vision of a comprehensive bill covering three major brain disorders in few decades. As I am not in the place to come back to the 21st National Assembly, I am desperately requesting the ministry to establish the bill”, Lawmaker Kim urged as he would be leaving the next election. On the other hand, Lawmaker Ki Dong-Min pointed out an individual law for epilepsy could bring administrative and legal confusion, like the Deaf-blind Bill or so-called Helen Keller Bill, and also that it could unintentionally promote other patients to demand individual laws for their conditions fairly. “Although we agree with the objective of the bill, the ministry seems to be shy of passing the bill. Please elaborate further on the reality of patients with the disorder and why the bill should be process right now”, commented Lawmaker Ki. Professor Kim Heung-dong of Severance Pediatric Hospital (left) and Professor Hong Seung Bong of Samsung Seoul Medical Center testifying at the public hearing session. Professor Hong Seung Bong of Neurology Department at Samsung Seoul Medical Center and Professor Kim Heung-dong at Severance Pediatric Hospital testified that epilepsy is not only about ‘life or death issue’, but also about its critical impact on patient’s day-to-day life. In particular, the two professors claimed Koreans have little understanding of epilepsy, which induces patient discrimination and hinders the patients to get proper treatment timing, often leaving them in hospital emergency rooms. Apparently, people run away or give an unnecessary CPR to patients having a seizure, and eventually end up with unfortunate accidents like collapsed rib cage, all due to the public’s lack of awareness. Moreover, the testifiers also explained there are only five healthcare institutes in Korea to conduct a proper epilepsy surgery in Korea. Professor Hong Seung Bong explained “As far as individual laws for single disease go, there are ‘Dementia Management Act’, ‘Cancer Disease Support Law’, and ‘Act on Guarantee of Rights of and Support for Persons with Developmental Disabilities’. Epilepsy has been designated as a most common but serious brain disorder by the World Health Organization (WHO). The patient size of epilepsy is about a half of the dementia patients’, but the severity is much graver and the patients’ families often go through posttraumatic stress disorder after experiencing social discrimination”. Professor Hong added, “Epilepsy is the second most severe disorder shortening a patient’s life span. The severity of the disease should be taken more seriously. In Korea, only five hospitals are capable of the disorder surgery. Hospital’s training on doctors and policies are also problematic. Korean people in general are quite ignorant about the disorder. For instance, Australia spends about AUD 20 million to raise public awareness of the disorder”. Professor Kim Heung-dong stated “At the moment, patients with epilepsy are mostly neglected from the existing law, and it is the classic case of “hidden disabilities”, where the patient would not speak up of the disorder. Many people tend to run away from a patient experiencing a seizure, because first, they do not know how to react, and second, the fear of possible death. These factors create intentional ignorance of the disorder”. “Out of goodwill, some people try to give a CRP on a patient having a seizure, but the patient breaks a rib or two and visits emergency room. By educating the people about epilepsy and common knowledge, the patients can finally have their place in the society. If the individual law is not the main issue, then the bill should be processed immediately”, Professor Kim strongly emphasized. MOHW official answered it understands the hardship that the patients go through, but as a government body, processing an individual law for all disease is a stretch, realistically speaking. The ministry also elaborated that epilepsy treatment technology and drugs are mostly covered by National Health Insurance, and other neglected parts are supplemented by existing laws on persons with disabilities and rare disease. The ministry insisted that existing laws are already reasonably managing the epilepsy and patients with the disorder. “Setting a standard for testing feasibility of individual bill on a single disease should be approached carefully. Every case of what patients undergo is extremely unfortunate. But having a loose standard would only create unfairness in treating respective disease as a government body. Soon, other patients would complain why there aren’t laws solely dedicated to chronic respiratory disorder or hepatic cirrhosis and so on”, MOHW official stated. The government official added, “If the patients and their family feel the government support is insufficient now, then they can apply to have the disease designated as an individual disease under the grounds of Public Health and Medical Services Act. The government believes that the epilepsy and patients’ issues should be handled not with an individual law, but with existing law”. Some of Health and Welfare Committee members urged an individual law is needed. Lawmaker Choi Do-ja argued “Excessive legislation of bills is problematic, but law should be amended and bills should be passed when the people are in need of help. That is the purpose of National Assembly. When the patients and their families get the news of what MOHW has said about not needing an individual law for epilepsy, they would be in a deep despair. Law should be made, if need be”. “Korea should change. An individual law dedicated for 360,000 patients with epilepsy should be established for their improved treatment opportunity. If hospitals are not equipped with neurologic diagnosis exam tools, then it should be purchased to treat the patients. Running a daycare center for 31 years and taking care of a child with epilepsy myself, I personally experienced the traumatizing event. This is where the government should step in”, Lawmaker Choi added.
- Policy
- A transition of power? Xofluza landed in Korea
- by Lee, Tak-Sun Nov 26, 2019 07:12am
- Flu medicines, which have been greatly improved in convenience, have landed in Korea. It is Roche's Xofluza (Baloxavir marboxil). It is expected to see the effects of flu treatment with only a single dose. The oseltamivir formulations, represented by conventional Tamiflu, had to be taken for 5 days. With Tamiflu's patent expiration in 2017, the flu drug market has been restructured into a multi-competitive system. It is noteworthy whether Xofluza will regain Roche's glory. The Ministry of Food and Drug Safety approved the 20mg and 40mg of flu medicine, Xofluza by Roche, Korea. Xofluza is a single oral drug administered within 48 hours of symptom onset regardless of food intake. Conventional Roche's Tamiflu should be administered orally for 5 days regardless of adult or child. However, Xofluza can be taken only once after the onset of symptoms. Compared with Tamiflu, the time to symptom improvement was not significantly different, with 73 hours for Xofluza and 81 hours for Tamiflu. Currently, there is a single dose of flu treatment called Peramiflu by GC green cross, but it is intravenous injection type, different from oral preparations such as Tamiflu and Xofluza. However, it is unlikely to replace Tamiflu completely because it is not approved by children. Xofluza is used to treat influenza type A or B virus infections in adults and adolescents 12 years of age and older. The FDA approved the drug in last October and obtained a domestic license in one year.
- Policy
- How much does new drug's R&D Investment cost?
- by Lee, Hye-Kyung Nov 26, 2019 07:11am
- The Organization for Economic Cooperation and Development (OECD) has presented monitoring of project activities to countries as part of future projects. Recent data suggests that a successful R & D cost estimate ranges from at least $ millions to $ 2.6 billion. Dahee Lee, a senior researcher at the Health Insurance Review and Assessment Service, suggested improvement plan about calculating OECD’s drug and medical expenditure information through 'HIRA policy trends'. In Korea, employees of the HIRA are attending the OECD Drug and Medical Device Experts' Group meeting. Dahee Lee, a senior researcher has made an opinion on behalf of Korea at the second meeting held in May. At this meeting, the OECD has published a number of reports that provide estimates of the size of the pharmaceutical market and corporate profits, but it is difficult to assess reliability because the data sources and methodologies are not clear. In particular, as the controversy arises due to the lack of reliable data for the profitability of the pharmaceutical industry, the OECD Secretariat suggests that it is necessary to determine the source of data for a simple index list and to develop an analysis framework and select indicators. For the Performance-Based Managed Entry Agreements, which were discussed at the first group meeting of experts in March 2018, the OECD has carried out the survey of 11 countries including the United Kingdom, Australia, Belgium, Czech Republic, Estonia, Japan, Lithuania, the Netherlands, Norway, Sweden, and the United States. Comprehensive examples of MEAs in six countries responded and found that they are implementing MEA contracts for 24 drugs The OECD has discussed the related management and access to anticancer drugs with some member countries, and 6 key tasks were introduced: key issues including ▲up-front costs, ▲economics and financial sustainability, ▲uncertainties in clinical benefits, cost effectiveness and budgetary impacts, ▲ treatment location, ▲imbalance in access, and ▲patient expectations. At the meeting, the representative of WHO Geneva gave a presentation on the pricing of anticancer drugs, insisting that "drug selection should be directed towards increasing efficiency in drug expenditure and opening and adjusting mutual drug prices to promote transparency". The OECD will finalize its report on anticancer drug management and access by the end of this year. The senior researcher Lee said, "The OECD Secretariat introduced an overview of the challenges raised in access to anticancer drugs and shared procedures and future schedules for solving them" and the senior researcher added, “Anticancer drugs may cause inequality in access because coverage and accessibility vary depending on the level of country, region and institution”. Therefore, Korea needs to cooperate in the process of analyzing how the OECD's health system responds to the challenging task. Lee said, “OECD will carry out the investigation necessary to establish a policy regarding rational use of medicines this year.” The Ministry of Health and Welfare, the Health Insurance Review and Assessment Service, and the Ministry of Food and Drug Safety are expected to actively participate in the policy to encourage the use of medicines and to investigate ways to reduce the prescription of multi-items for the elderly.
- Policy
- HIRA, "price transparency of RSA was reduced"
- by Lee, Hye-Kyung Nov 25, 2019 06:23pm
- The National Health Insurance Service (NHIS) plans to make reasonable efforts to implement the risk sharing agreement (RSA) in consideration of patient treatment access and insurance finance. The NHIS responded to Insoon Nam, a member of the National Assembly at a national audit about the plan to rationalize pharmaceutical expenditures, including high-priced drugs. According to a written response on the 23rd, the National Health Insurance Service said, “It is true that there is concern RSA will reduce price transparency and increase administrative burden”. Although it has helped to increase access to treatments such as expensive anticancer drugs and reduce the burden on patients, there are also concerns. The NHIS said, "The government continues to make improvements to the RSA, but there is a demand for improvement in the scope of application or operation method." Regarding the introduction of a Fixed Budgeting Policy for Pharmaceuticals , which is raised only when the pharmaceutical expenditure-efficiency story comes out, the NHIS said, "we haven't specifically reviewed it.“ In the past, during the Park Geun-hye administration, the NHIS was suspected of introducing a Fixed Budgeting Policy for Pharmaceuticals to reduce the share of drug costs to the OECD level. The NHIS conducted the research service, but did not examine the introduction of the system in detail. When the system is introduced, we will fully share the results of the research service with stakeholders such as the pharmaceutical industry and collect opinions and consult with MOHW. For the management of ultra-high-priced drugs such as immunocancer treatments, only the drugs that have proven effective treatment and cost-effectiveness are covered by careful consideration of the expansion of reimbursement and financial management. The NHIS in consultation with related agencies such as the MOHW, is preparing a follow-up management plan to verify the treatment effect and cost-effectiveness after registration. The NHIS said, “We are preparing a cost-effectiveness evaluation plan, and will review post evaluation targets, methodologies, and institutional roles”. In order to improve price-volume agreement(PVA) negotiation system, some respondents said that they would consult with experts and the Ministry of Welfare to expand the targets in the future by improving the selection and exclusion criteria maintenance. The NHIS said, "The target of PVA negotiation is lower than the usage monitoring, so the selection rate of the negotiation target is only 0.2%, and the improvement of the system by selecting targets and improving exclusion criteria is needed". On the other hand, regarding 'Korea Passing', which has been an issue since last year, they said they would consider both insurance finance and patient access when negotiating drug prices so that the treatment access of medicines needed for future medical care is not reduced. The NHIS said, "Our country is showing a high proportion of drug costs for various reasons, such as the rapid increase in the elderly population, changes in disease structure, the emergence of high-priced drugs such as immunocancer drugs and biological drugs, the frequency of use of medical services, and cultural characteristics related to prescriptions. “by designing the reasonable expense structure, we will lower the share of pharmaceitical expenditure to the OECD level”.
- Opinion
- [FOCUS]Government sophistication to generic regulations
- by Chon, Seung-Hyun Nov 25, 2019 06:21am
- A few years ago, a multinational pharmaceuticals announced “high quality” by launching generics in the domestic market. It is the aspiration to show good quality generics based on strict production management, product monitoring and quality assurance system that have long been recognized in the global market. At the time, the head of the licensing review department of the Ministry of Food and Drug Safety, who got the news, rejected that "the quality of generic products is meaningless." Generics must pass strict standards from drug substances to finished product manufacturing facilities. In addition, a conformity test should be made in a bioequivalence study demonstrating that the generics are equivalent to the rate and concentration of original drug absorption. "Generic products that have passed all government-set standards and have been approved for sale should be regarded as equal in quality.“ The MFDS is trying to tighten restrictions on generics after last year's issue of Valsartan impurity. The MFDS announced the legislative draft of the “Revision of Partial Rules on the Safety of Pharmaceuticals,” etc. on the 18th. It contains a significant tightening of the licensing requirements for all fair commissioned manufacturing generics. It means that the GMP evaluation data, standards and test method data, which have been exempted from the consigned generic permit screening data, must be submitted. It is noteworthy that MFDS referred to “high quality generics” as the background for strengthening generic regulations. According to the Regulatory Impact Analysis Report of the revised regulations, the MFDS said that they will secure the trust of the people providing 'high quality' medicines and improving the soundness of drug distribution through the quality improvement of generics for each clause that strengthens the regulation of generics. The intention is to supply high-quality generics by strengthening generic regulations. It also means that there is differences in quality between generic products. This is contrary to the conventional view that "quality is equal if it passes the strict licensing process." It seems possible that even with the MFDS, there may be some low quality generics. It is also ambiguous to see how the strengthening of permit standards is related to quality improvement. Submission of GMP assessment data by authorized generic means re-release of data that has already been verified by the MFDS. GMP assessment data need not be submitted when consigning a product that is identical to a previously approved generic. However, one year after the proclamation of amendment, the authorized generics will also be required to produce three manufacturing units (batch) and submit relevant GMP data for approval. The submission of GMP evaluation data by authorized generics disappeared just five years ago. The MFDS implemented ‘the GMP Compliance Certification System’ in 2014, which permits Pharmaceutical production that all factories producing pharmaceuticals requires passing the standards set by the MFDS every three years. At this time, regulations for mandatory production of licensed drugs were relaxed. It was made possible for the establishment within the validity period of the conformity assessment to replace the data on the evaluation of the GMP implementation with the conformity assessment. They have already laid the foundation for strengthening quality management by introducing the ‘Certificate of GMP Compliance of a Manufacturer', and in the situation where the approved facility has determined the suitability of licensed drugs, it is decided that it is redundant regulation to receive the GMP evaluation data of the authorized generics again. The same applies to co-bioequivalence regulations currently underway. On April 15, the MFDS announced a partial revision of the “Regulations on the Authorization, Declaration, and Review of Pharmaceuticals,” which includes tightening regulations on co-bioequivalence regulations. According to the amendment, regulations will be tightened so that up to three authorized generic manufacturers are allowed to one original manufacturer one year after the notification. This means that up to four generics will be granted for each bioequivalence test. After three years, consiged bioequivalence is completely banned. Four years after the notification, only one generic may be approved in one bioequivalence study. As a result, after four years, the same product from the same manufacturing facility must be tested for bioequivalence separately. I don't know what it is related to run separate bioequivalence tests on the same product with ‘high quality generics’. Goal of the MFDS is clear that it tightens regulations of generics. Because of the serious difficulty of generics, the intention is to reduce the number of generics in the market by raising licensing barriers. It is clear that the overflow of generic manufacturing contractors is the cause of generic upheaval. It is also clear that generic upheavals were triggered by changes in government permit regulations. Wouldn't it be better to admit that the government's policies encouraged generic upheaval and try to persuade the reasons for changing the policy stance? Rather, the cause of “quality improvement,” which is not related to the regulations, can lead to confusion in the industrial field. This leads to distrust in government policy. Of course, the government may adjust the regulatory intensity in response to changing market conditions. However, companies need to be able to believe and follow only by providing a clear justification and justification for the new policy. If the government produces a policy without justification and changes the policy stance, in the turn of a hand, credibility falls.
- Policy
- Surprise order by MFDS for all substance impurity risk test
- by Lee, Tak-Sun Nov 25, 2019 06:21am
- The Korean pharmaceutical industry is shook up as Ministry of Food and Drug Safety ordered companies to conduct tests on impurity contamination in all synthetic active pharmaceutical agents. Other foreign health authorities like European Medicines Agency (EMA) has released a new templates of carcinogen risk evaluation and confirmatory testing for pharmaceutical manufacturers fill in. But the Korean regulator caught Korean pharmaceutical companies by surprise. At the moment, unprepared companies are in a hurry to find a testing lab. After the decision has been made to ban sales on 13 nizatidine products found with cancer-causing compound N-Nitrosodimethylamine (NDMA), MFDS ordered Korean pharmaceutical company on Nov. 22 to conduct an impurity risk test on all of their active ingredients to reinforce drug substance safety control. Accordingly, active pharmaceutical ingredient manufacturing and importing companies, and complete product manufacturing and importing companies are to evaluate and test for impurity risk in active ingredients. The risk evaluation result should be reported to MFDS by May 2020, and complete test result by May 2021. Impurity risk evaluation comprehensively analyzes and evaluates possible risk of impurity contamination in active agents based on effect of substance manufacturing procedure, self-decomposition and complete product storage conditions. The tests should follow test procedure verified by a Korean Good Manufacturing Practice (GMP) certified manufacturer, MFDS designated quality test institute, or city and provincial-managed environment research lab, according to test methodology officially disclosed by either Korean or international regulators. And also companies with at least three product serial numbers in the market are required to take the tests. MFDS stated Korean whole drug manufacturer may substitute required test result with data from active agent manufacturing and importing companies, but the ministry pressured that the ultimate liability would be on the companies. The pharmaceutical industry clearly seemed perplexed with the news. A mid-sized pharmaceutical company frustrated with the government order and complained, “The ministry unilaterally released the news on the media without a proper notice. So we are at a loss. They say there is an impurity risk evaluation program, but we are not sure if it could actually test all active ingredients.” Many also complain about overall cost and required time for the test are unknown. A top pharmaceutical company insider commented, “If the required materials can be substitute with active ingredient manufacturer’s data, then more than a half of products are off the hook. But for smaller-scale substance manufacturing companies may not have evaluation material, so probably complete product manufacturing companies would have to take the bullet”. But testing for agents with risk of impurity contamination definitely puts a strain on the industry. MFDS has reportedly disseminated an official notice demanding companies to hand in nizatidine product test results by next year. “Apparently, there are only a handful of laboratories able to test drug substances. As many pharmaceutical companies would rush to get the test done, our company is also promptly looking for a testing facility”, an executive from a mid-sized company explained. Companies are concerned that testing price skyrocket from a normal rate of one million won per a case to few millions per a case. “Regulators in EU and Switzerland have recently decided to reinforce safety management by requiring companies to submit impurity risk evaluation and test results of synthetic drug agents. MFDS plans to continue tightening regulation for active pharmaceutical ingredient safety control”, said MFDS official.
- Company
- The third JAK1 inhibitor,↑competition in Korea
- by Eo, Yun-Ho Nov 24, 2019 09:58pm
- It is the third rheumatoid arthritis drugs that is expectecd to enter domestic market. According to the industry, Abbie recently filed an application for permission to use 'Upadacitinib' for JAK inhibitors. Given the approval from the FDA in US on the 16th of last month, it is rapidly knocking on the Korean market. Abbie demonstrated the efficacy and safety of 'Upadacitinib' in various patient groups through a SELECT clinical program comprising approximately 4,400 patients with rheumatoid arthritis and a total of five phase III clinical studies. In the SELECT-EARLY study of patients with no experience with MTX, 52% of the Ufadacytinib-treated group achieved ACR50 at 121th week and showed a significant improvement over 28% of the MTX-treated control group. In the SELECT-MONOTHERAPY study, which compared the administration of 'Upadacitinib' alone with MTX treatment in patients with insufficient MTX treatment, such as the approved indication, 68% of the Upadacitinib-treated group achieved ACR20 at 141th week . 41% of the improvement was proved. On the other hand, Xeljanz (Tofacitinib) and Olumiant (Baricitinib)) are approved in Korea. Olumiant, once daily, has a mechanism to block JAK1 and JAK2, and drugs such as Xeljanz, Upadacitinib, and Filgotinib, which block twice daily, block JAK1.
- Policy
- NHIS, HIRA and NECA on joint reevaluation for listed drugs
- by Lee, Hye-Kyung Nov 24, 2019 09:58pm
- Drug Reimbursement Evaluation Committee (DREC) affiliated under Health Insurance Review and Assessment Service (HIRA) is to conduct reevaluation on already-listed high-cost drug items. When forming the seventh DREC, HIRA also established a ‘Post-marketing Drug Evaluation Subcommittee’ to be in charge of selecting insurance listed drug items or classes that need reevaluation. Initially, the subcommittee was to consist of four DREC members, two government officials and two experts, but HIRA finalized on three government officials, one clinical expert, two consumer and patient group representatives, and one external expert from DREC human resource pool. As a result, a chief of Pharmaceutical Management Department at HIRA Park Young-mi, a chief of Health Benefit Strategy Office at National Health Insurance Service (NHIS) Park Jong Heon, and a chief of Economic Evaluation Research Office at National Evidence-based Healthcare Collaborating Agency (NECA) Shin Sang Jin are to represent government bodies. The three government agencies have been running various researches related to post-management of already-listed drug items since last year. Professor Lee Dae-ho at Seoul Asan Medical Center, as recommended by Korean Academy of Medical Sciences, president of Korea Health Personnel Licensing Examination Institute Lee Yoon-seong and an executive director of Korea Alliance of Patients Organization Lee Eun-young, as recommended by consumer and patient groups, are selected to serve as members of the subcommittee. At the latest annual audit by National Assembly Health and Welfare Committee, HIRA answered Lawmaker Kim Myung-yeon’s question on ‘monitoring reimbursement feasibility of drugs with significant financial impact on National Health Insurance’, and stated “HIRA plans to have DREC to deliberate and compile a list of reevaluation subject items, and conduct reimbursement feasibility reevaluation on them”. After the Ministry of Health and Welfare (MOHW) unveiled the first National Health Insurance Comprehensive Plan, HIRA has been compiling reimbursement feasibility monitoring plan for drugs granted with the insurance reimbursement. “The subcommittee would consider clinical efficacy, financial impact, and external reimbursement listing reference of the reimbursed items. HIRA would consult with other government agencies and report reevaluation plan for more efficient management of National Health Insurance expenditure in the future”, HIRA official commented.
