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- 2026-04-27 17:57:17
- Opinion
- [Reporter’s View]Reimbursement of antidiabetic combos
- by Eo, Yun-Ho Aug 27, 2021 05:59am
- After 3 long years, discussions on extending reimbursement of SGLT-2 inhibitor combos are expected to begin. In September, the Health Insurance Review and Assessment Service will hold an expert meeting to discuss approving reimbursement for combination use of the two classes of oral antidiabetics: DPP-4 inhibitors and SGLT-2inhibitors. ‘Recognizing the expected efficacy of two drugs with the same MOA.’ Acknowledging this class effect has been a long-discussed dilemma in the industry. The opinion has been divided among the HCPs, and the interest of individual pharmaceutical companies also differ. The conclusion was to take on the agenda ‘case by case.’ It is not necessarily a question that requires a fixed answer. The decision made by the prescribing doctor based on his or her experience and medical knowledge is, of course, most important. However, for the SGLT-2 inhibitor issue, the problem lay in the consistency of the decisions. For some classes, the class effect was recognized regardless of the drug’s indications and applied the same reimbursement standards, while reimbursement for other classes was approved for different scopes by each product. In 2013, the Korean Diabetes Association had played a leading role in extending reimbursement to cover the combined use of DPP-4 inhibitors and Thiazolidinedione (TZD) class drugs, insisting on the justification and necessity of its reimbursement. Clinical experience and expert judgment were emphasized rather than the fiscal impact, and the government accepted the reimbursement extension based on the disease characteristics and drug use experience. What has changed since then? In 2018, the academic community had mixed opinions regarding SGLT-2 inhibitors, which put discussions on reimbursing the combined use of the drug on hold. Many drugs were at stake, as this not only affected SGLT-2 inhibitors like ‘Jardiance(empagliflozin),’ ‘Forxiga(empagliflozin),’ ‘Suglat (ipragliflozin), ‘Steglatro (ertugliflozin),’ but also the many DPP-4 inhibitors including ‘Januvia (sitagliptin), ‘Galvus (vildagliptin),’ ‘Tradjenta (linagliptin),’ ‘Gemiglo(gemigliptin),’ etc. However, the changes that followed were encouraging. In April last year, the academic society saw consensus and submitted the opinion that expanding reimbursement is necessary. In August last year, the Ministry of Health and Welfare announced that it will simplify the indication listing method of antidiabetic drugs from by substance to ▲monotherapy or ▲combination therapy. Now the baton is in the hands of the insurance authorities. Time has already passed, and dissatisfaction still does exist around primary medical institutions. As it is a prescription drug, it is also true that the issue should be considered carefully, and a cautious approach is needed. However, if the class effect is to be finally acknowledged, this could be the perfect opportunity for the stakeholders to reach a consensus on ‘the time or amount of prescription required to accumulate sufficient prescription experience.’
- Opinion
- [Reporter's view] Controversy over α-GPC
- by Lee, Hye-Kyung Aug 25, 2021 05:57am
- Negotiations on the return of benefits of the 'Choline alfoscerate' legislation, which was the subject of the revaluation project of the listed drugs, have been concluded. However, the controversy over the return rate has not ended. The NHIS negotiated with 58 pharmaceutical companies that owned 123 Choline alfoscerate on August 10. It announced that it has agreed with 44 pharmaceutical companies on a 20% return rate. Chong Kun Dang, which had been conducting PVA in the third quarter of this year, also finished negotiations. There are about 10 pharmaceutical companies that have not agreed. Negotiations on the repatriation of Choline alfoscerate lasted about eight months from December 14 to August 10. In the process, the timing of recovery was changed from "the day of submission of a clinical trial to the MFDS" to "the day when the MFDS approved the clinical trial," and the amount of recovery also fell from "full 100%" to "20%." The controversy erupted when three pharmaceutical companies that had already signed a 100% return rate in PVA negotiations before the benefit revaluation Choline alfoscerate filed complaints with the Anti-Corruption and Civil Rights Commission for equity reasons. Negotiation about Choline alfoscerate is the first conditional recovery negotiation in conjunction with the MFDS' clinical reassessment. However, all the NHIS negotiations in accordance with the safety and validity verification and quality control requirements have a redemption clause related to revaluation. This is a revised guideline after the 2019 Lipiodol crisis. In the second quarter of last year's PVA negotiations, Arlico, Hana and Kyongbo agreed that if the authorization for revaluation is dropped, the pharmaceutical company should return the full claim from the date of clinical testing to the NHIS. Anti‑Corruption and Civil Rights Commission has conveyed to health authorities that the NHIS and the three pharmaceutical companies should maintain a contract following a clinical trial revaluation, but set a 100% return rate equal to 20%. Anti‑Corruption and Civil Rights Commission's recommendations are not compulsory. However, it is unlikely to raise the rate again, as the rate of return of Choline alfoscerate, which is undergoing simultaneous re-evaluation and clinical re-evaluation, has been agreed to 20% with an eight-month negotiation process. The NHIS should set out what guidelines to maintain in future drug price negotiations in accordance with AAnti‑Corruption and Civil Rights Commission's recommendations. Through revaluation, it is necessary to clarify whether there is a possibility of maintaining the existing "health insurance claim in full" or changing it to 20% agreed with pharmaceutical companies.
- Opinion
- [Reporter's view] Unstable supply of imported vaccines
- by Lee, Tak-Sun Aug 13, 2021 05:58am
- Moderna's unstable supply and demand disrupted the vaccination. Moderna's vaccine was originally scheduled to come in 8.5 million doz in August, but Moderna informed that it would supply less than half of the vaccine due to laboratory problems related to production. As a result, not only Moderna but also the first and second vaccinations of the same mRNA vaccine, Pfizer vaccine, will temporarily increase inoculation interval from four weeks to six weeks. The quarantine authorities, which are preparing for the final vaccination in their 40s or younger due to the sudden supply disruption notice by Moderna, are also in trouble. However, since Pfizer vaccine is being supplied properly, it is expected that there will be no change in the primary vaccination plan for 70% of the nation until September. However, it is not known when the second vaccination will proceed normally because the supply and demand of modalities or vaccines will be resolved.. AstraZeneca vaccine is produced at SK Bioscience' Andong plant by several million doz at a time. It is much more stable in terms of supply and demand than Pfizer and Moderna vaccine, which are imported by airplanes below 1 million doz per week. The quarantine authorities used the amount of AZ vaccine contracted because the number of people aged 60 to 75 exceeded 10 million. However, since all of them are imported vaccines except for AZ, we should have prepared for possible supply accidents. It is the quarantine authorities that have not used the AZ vaccine well. In February, when AZ vaccine was first approved, the MFDS allowed the elderly to be vaccinated despite a lack of clinical data, but quarantine authorities failed to ensure administration of the age of 65. Since then, data has been accumulated abroad such as the UK, allowing vaccinations for older people aged 65 or older, but the government has decided to vaccinate the elderly aged 75 or older. In April, people under the age of 30 were excluded from the inoculation list due to rare thrombosis, and in July, people under the age of 50 were not allowed to be inoculated. As a result, those under the age of 50 who took the first AZ vaccine before July will be cross-inoculated with Pfizer vaccine during the second round. Such inoculation policies are largely responsible for the unstable public opinion and quarantine authorities created by the media. Of course, there are some reflections that reflect cases from other countries such as advanced countries, but it is questionable whether the conclusion was made based on public opinion rather than science. Although AZ vaccine played a role in preventing infectious diseases among the elderly, the quarantine authorities should reflect on the fact that it is recognized as the next-order mRNA vaccine due to negative public opinion. Also, for those aged 50 and 75 and older who can use AZ vaccine, it was changed to Moderna and Pfizer respectively, which prevented the use of AZ vaccine produced in Korea. If AZ had been used for these age groups according to the inoculation criteria, it would have dealt with both modalities and supply and demand instability. Quarantine authorities should think about the utilization of AZ vaccine. Although there are no vaccines developed in Korea yet, it is fortunate that there are vaccines produced in Korea. If the supply of imported vaccines such as Moderna is uncertain, it should take advantage of the fact that AZ domestic vaccine is being secured.
- Opinion
- [FOCUS] Why retrieve the insurance paid for CA?
- by Chon, Seung-Hyun Aug 09, 2021 06:04am
- The tug-of-war between the health authorities and pharmaceutical companies over the negotiation on the restitution of insurance claims paid for the brain function enhancer choline alfoscerate (cholinergic agents) has been now ongoing for 8 months. In December of last year, the Ministry of Health and Welfare (MOHW) ordered the National Health Insurance Service (NHIS) to negotiate with choline alfoscerate companies by February 10th of this year to agree on 'returning the full amount of insurance that was claimed for the drug, from the date the clinical trial protocol was submitted to the Ministry of Food and Drug Safety to the date the indication is removed if the clinical trial fails' to retrieve the claims paid for the drug. 8 months had passed since the order was issued, and 6 months had passed from the first deadline that was set for negotiations. However, the only change made to the terms of the negotiation was that the period of insurance retrieval had been pushed back from the 'date the clinical trial protocol was submitted to the 'date the protocol was approved,' and the breakdown of negotiations and deadline extensions have repeated continuously. Some companies have agreed to the 20% retrieval rate proposed by the NHIS. In other words, these companies will be paying back to the NHIS 20% of the amount that was prescribed from the date the clinical trial protocol was approved by MFDS to the date the indication is deleted if their clinical reevaluations for their choline alfoscerate products fail. However, many other pharmaceutical companies, including those that are earning much from choline alfoscerate products, have not been able to reach an agreement with the NHIS even in the several additional negotiation periods that were provided. Even the 20% rate was considered to be too great a risk for these companies. The clinical reevaluations will be completed in 6.5 years at the latest. If companies agree on the 20% rate, and the trial fails after 6.5 years, each company may have to pay out more than 100 billion won each. Due to this burden, many companies are trying to reach an agreement by proposing a lower recollection rate. Some companies are also considering discounting their drug prices in advance while requesting a recollection rate that is lower than 20%. Their opinion is that it may be more efficient to share the risk early on rather than paying out a large sum at once if the clinical trial fails. However, the biggest reason why the negotiations are being indefinitely extended is that there is no justification for the negotiation itself. There had never been a case where the companies had to agree to a restitution rate of the prescribed amount, presuming that the clinical trial would fail even before the trial has begun. There also has been no social consensus made on whether it is reasonable to demand restitution for the failure of a clinical trial that was conducted for reevaluation purposes, for a product that had already been approved and was distributed according to due processes. Clinical reevaluations are conducted to reexamine the safety and efficacy of drugs that are on the market. Selling the drugs that are under clinical reevaluations during the trial period is not illegal because the approval granted by the MFDS stays valid. The MFDS approved the renewal of the product license for choline alfoscerate drugs in 2018. In other words, the authorities in charge of approving drugs acknowledged the safety and efficacy of choline alfoscerate drugs just 3 years ago. Therefore, the legal dispute over whether the attempt to retrieve the claimed insurance benefits is reasonable if the clinical reevaluations fail is deemed inevitable. The health authorities had never once asked the companies to pay back the prescribed amount of a drug that failed reevaluations. The health authorities are also now at a dead-end in this never-ending tug-of-war. With some companies already reaching an agreement with the authorities, the authorities have no choice but to impose sanctions on the pharmaceutical companies that refuses to negotiate and take measures such as removing the company's drugs from the reimbursement list. However, pharmaceutical companies will naturally take legal action if their drug is removed from the reimbursement list. The negotiations on choline alfoscerate products have deepened the confusion across the pharmaceutical industry. One question that lingers is: did the health authorities not expect such fierce resistance when they began negotiations? Did they really not expect the pharmaceutical companies to take legal actions in every direction, filing suits to nullify the negotiation, suspend execution, as well as file constitutional and administrative appeals? Even the period of retrieval that had been modified recently was changed inevitably due to unexpected variables. Choline alfoscerate is approved under 3 indications: to treat ▲ secondary symptoms and degeneration due to cerebrovascular defect or degenerative organic brain syndrome ▲ emotional and behavioral changes ▲ senile pseudo-depression. Of these, only ‘secondary symptoms and degeneration due to cerebrovascular defect or degenerative organic brain syndrome’ is subject to reevaluation, and the remaining two indications will be removed regardless of the clinical trials' success or failure. If the time of retrieval is set to 'the date the clinical trial protocol was approved', pharmaceutical companies will have to pay back insurance for the two indications that had been removed before the clinical reevaluations had begun. This indicates that the retrieval period has not been through from the start. If pharmaceutical companies have to pay back several years' worth of prescriptions due to the failure of their clinical trials, patients could also demand repayment for the drugs that they have taken during those years. The government may also be criticized for allowing the sale of such a problematic drug. A clear explanation seems to be necessary as to why the government is causing more harm than good by pushing ahead with the negotiations for recollection of insurance benefits.
- Opinion
- [Reporter's view] The MFDS shouldn't selectively explain
- by Lee, Tak-Sun Jul 26, 2021 05:50am
- In a recent series of incidents, the MFDS did not properly explain, causing confusion. It wasn't a big issue, but it's not something to skip. The issue of whether the RNA-based QTP104, which was approved for phase 1 clinical trial on the 20th, was initially marked as "domestic development" on a site where approval status can be checked, but it was changed to "foreign development." A reporter raised a question through an article, and this time it was changed to "domestic development." As a result, there was confusion among reporters. The vaccine could not be clearly processed because it was not distinguished whether it was the first RNA-based or overseas vaccine. As of 4 p.m. on the 22nd, it is marked as "domestic development," so it seems to be a domestic development vaccine, but there is no clear answer from the MFDS. It is the government's long-cherished project to localize the RNA vaccine that Pfizer and Moderna monopolized. As there is also a great interest in the public, it was important to understand the reality of phase 1 clinical approval of QTP104. However, the MFDS has changed its mark from "domestic development" to "foreign development" again, making it difficult to identify the reality. I also asked the MFDS. Even now, the MFDS should quickly answer whether QTP104 is a vaccine developed in Korea. It seems necessary to explain the use and capacity change of the 31st new drug "Leclaza" developed by Yuhan. The MFDS said it was legally changed at the request of the company, but the usage and capacity were changed a day before the benefit confirmation this month. .Moreover, it is necessary to clarify why the dosage and indications have been changed because the diagnosis method is different compared to Leclaza's competitive drug Tagrisso .The MFDS should not just announce on its website the cancellation of the item license of Daewoong's Albis D, but explain it more actively .Previously, the Fair Trade Commission and the Korea Intellectual Property Office detected data manipulation during the patent registration process of this product .The cancellation of item permits is the strongest disposition that the MFDS can make .It should be explained whether the disposition is an extension of the disposition of the Fair Trade Commission and the Korean Intellectual Property Office, or is part of the GMP investigation .Watching this series of events, I suspect that the MFDS is deciding what to explain .It also seems that there is no problem with procedural justification or neglects explanation if it does not become an issue .Even though the method of storing the Pfizer vaccine was changed last time, journalists of daily and economic newspapers raised questions because they did not notify it .Since the MFDS has not explained each and every change in permission, the reporter thought it would not be a big issue .However, As the MFDS' lack of objectiveness continues, it may not have been recognized as a public communication problem.
- Opinion
- The patient's life comes first
- by Lee, Jeong-Hwan Jul 15, 2021 07:06pm
- On March 5, the MFDS approved Kymriah(Tisagenlecleucel), the world's first treatment for CAR-T, as the first advanced bio-medicine under the Advanced Regenerative Bio Act. Targets are patients with B-cell acute lymphocytic leukemia and submicrobial giant B-cell lymphoma under the age of 25 who are recurrent and nonresponsive. Kymriah was already licensed in August 2017 by the U.S. FDA and in March 2019 by the Ministry of Health, Labor and Welfare of Japan, where there was no further treatment due to recurrence or non-compliance, resulting in treatment for late-stage blood cancer patients. Emily Whitehead, who was diagnosed with acute lymphocytic leukemia at the age of five and failed to treat it, has been living in good health since joining the first clinical trial of the CAR-T drug Kymriah in 2012. However, in Korea, there was news of Eun-chan who recently died while preparing for Kymriah treatment. Emily Whitehead's experience is touching around the world, but we are facing sad news that we are not being treated in time. Eun-chan's mother left a wish on her blog, saying, "It will be a lifelong regret that Eun-chan was not able to receive CAR-T treatment, but I hope that other patients in similar cases will not lose their lives like Eun-chan." Kymriah has been given only once in a lifetime, or "one shot," to allow for near-cure treatment and long-term survival. Therefore, if the existing treatment does not work, or if patients with multiple recurrences of blood cancer can rely on it for the last time.In acute lymphocytic leukemia, 82% and lymphoma 39.1% show Complete Response Rate. The effectiveness of treatment above a certain level can be verified. When Kymriah was licensed in Korea, not only were it already licensed in more than 30 countries, but there are also many countries that have health insurance registered, including Japan. What if Kymriah's domestic approval had progressed a little faster? In Korea, it would have been a medical environment where CAR-T treatment could be done as quickly as in Japan, and health insurance coverage would have been carried out as quickly as in Japan. If that were the case, Eun-chan might have been able to receive Kymriah treatment by now. A sad situation like Eun-chan should not be allowed to happen again. Korea also needs a system that can quickly register new drugs directly related to life without alternatives and has more than a certain level of therapeutic effect like Kymriah. The scope of the "new drug directly related to life" should be set through social discussions, and the MFDS should set a "temporary drug price" at the same time as the approval and apply health insurance to save the patient's life first The HIRA's Cancer Drugs Benefit Advisory Committee and Pharmacological Benefit Advice Committee, the NHIS negotiations, will be carried out quickly to ensure that the "final drug price" is finalized. Afterwards, the government shall actively engage in the introduction of a new drug health insurance rapid registration system directly related to life by post-settlement. The reason why pharmaceutical companies developed new drugs is to save people's lives, and the reason why the government creates and operates a health insurance system is to prevent patients from losing their lives because they have no treatment costs. Pharmaceutical companies and governments should put priority on patients' lives over profits and health insurance finances. Novartis Korea should actively cooperate with the government to quickly provide health insurance benefits by preparing a socially acceptable rational CAR-T treatment Kymriah financial sharing plan.
- Opinion
- [Reporter’s view] Request for suspension of execution
- by Kim, Jin-Gu Jul 05, 2021 05:54am
- The MOHW has announced that it will improve the system so that drug costs paid during the suspension of the enforcement of the drug reduction can be recovered. The plan calls for improvements to numerous revocation litigation and request for suspension of execution. request for suspension of execution in drug prices includes a lawsuit filed by pharmaceutical companies to cancel the reduction after the MOHW announced a reduction in the upper limit of insurance benefits. Pharmaceutical companies request for suspension of execution in the reduction of the drug price until the results of the lawsuit are released. The court accepts the request for suspension of execution. It follows the outcome of Lawsuit on the Merits. Each time the request for suspension of execution is repeated. The court accepts as well. This process takes up to five years. The court cites most of the request for suspension of execution because the outcome of lawsuit on the merits is unclear. So far, the only case in which the application for suspension of execution has been rejected is the case of a reduction in eyedrops. For pharmaceutical companies, the suspension of investment citation is as important as drug price reduction. The drug price maintained during the proceedings is much higher than the cost of the lawsuit. If pharmaceutical products with annual performance of ₩50 billion are subject to a reduction due to the launch of generics, they can keep more than ₩70 billion for five years during the lawsuit. Even if a pharmaceutical company loses at lawsuit on the merits, it already benefits enough. The pharmaceutical industry opposes the government's announcement of system improvement. It is argued that it is unconstitutional for the administration to effectively restrict the rights guaranteed by the judicial system. It is argued that the MOHW should not arbitrarily judge whether pharmaceutical companies abuse the disposition of the reduction of drugs. In April, the Supreme Court sided with the original company in patent suit of Eliquis. Generics were released based on the verdict of the first trial, and the reduction of drug price was taken accordingly. The MOHW is aware of this situation. "We are considering compensation for damages and recovery at the same time. "If it is not systemized, we will consider more ways to respond to the lawsuit results." The pharmaceutical industry should look at why the MOHW is worried. The MOHW believes that there are too many applications for suspension of execution. It is judged that pharmaceutical companies are abusing their rights guaranteed by the judicial system. The pharmaceutical and distribution industries believe that there is a lot of confusion in this process. The MOHW stresses, "So far, the government has never lost in a drug-price lawsuit." The pharmaceutical industry should think about why the MOHW is even reforming the system by limiting its jurisdiction.
- Opinion
- [Reporter’s view] Confusion by 1+3 bill must be minimized
- by Lee, Tak-Sun Jun 30, 2021 05:56am
- Sharing the results of the biological equivalence test with other companies and obtaining permission is restricted by the revision of the law. The National Assembly passed the pharmaceutical affairs law amendment on the 29th, which included 1+3 bill. Accordingly, a trustee who manufactures medical supplies may share permitted data and supply medical supplies only within three consignment companies. Therefore, it is expected that this will greatly reduce generic items that are easily licensed only by data sharing. Trustees are expected to suffer a setback in their projects due to a decrease in consignment production. Overall spending costs are also expected to increase as the number of medicines manufactured by pharmaceutical companies increases. The 1+3 bill was revised by the MFDS in 2019 by reflecting it in the screening regulations due to numerous generic drugs. However, the office for government policy coordination's Regulatory Reform Committee decided to withdraw the system, and the regulations were not amended. The National Assembly said that the number of generics should be limited when impurities were detected in preparations such as Ranitidine following Valsartan. As a result, it was re-promoted with the Pharmaceutical Affairs law, and despite opposition from small and medium-sized pharmaceutical companies, the MFDS, the KPBMA, and lawmakers from the ruling and opposition parties were generally in favor. Now, when the law is promulgated in July, it will be restricted from new medicines received from the future. Since the law takes effect immediately, pharmaceutical companies may suffer unfair damage due to the application of products prepared before that. Regulations can be avoided by proving joint development within one month of the enforcement date of the law. However, there may be complaints over the targets of exceptions, evidence, and procedures. Consequently, failure to make the exception correctly can be confusing. The MFDS should establish detailed rules after passing the law to minimize complaints from pharmaceutical companies and to ensure that the law is settled quickly. The 1+3 bill was effective and any debate became meaningless. The MFDS, which is in charge of ensuring that the law is applied fairly and quickly. It is up to the MFDS now.
- Opinion
- [Reporter's view] Tylenol is out of stock
- by Jun 02, 2021 06:10am
- As vaccinations began in earnest, the Tylenol crisis broke out in pharmacies. The Tylenol crisis has become inevitable as vaccinations for people aged 75 or older and those aged 65-74 have been implemented following preferential vaccinations for essential social workers. The government and the media are instructing people to take Tylenol if they have a fever after the inoculation. If pharmacists order Tylenol through wholesale, only the quota amount is supplied, so there are always times when the stock is tight or out. "Do you have Tylenol in stock?" "No, but we have the same active ingredient as Tylenol." "Oh, never mind." "Do you have any masks in stock?" "There are no more masks any more" This situation is similar to the mask crisis of the past. Pharmacies with relatively stable supply and demand through Jansen direct transactions do not mean that the situation is better. It is exhausting to guide dozens of consumers to take "after vaccination." Pharmacies are innocent, but it's as if they've become sinners. The pharmacy said this. "The moment I took out Tacenol, the patients looked different. That's exactly where I am going to do business. I don't know why I have to be a merchant, not a pharmacist, with a same pill." The Korean Pharmaceutical Association also urged the government to take Tylenol. The reason why patients only look for Tylenol at a time when many APAP are in sufficient stock is that health authorities have mentioned Tylenol directly since the beginning of the vaccine, causing confusion in their choice of fever reducer. Through the KCDA, the Korean Pharmaceutical Association asked each district health center to guide them to take APAP such as Suspen, Bukwang's Tacenol, and Penzal when fever symptoms occur after inoculation. The government, which authorizes the people to "Tylenol," should correct this issue. The situation has already deteriorated to persuade patients that pharmacies have the same ingredients and that other pharmacies do not have Tylenol. The MFDS has unveiled 70 items that have the same efficacy and effect as acetaminophen preparations, but pharmacists question their effectiveness. Since Tylenol has already been so deeply established in the public's perception, it is necessary to come up with effective measures, saying that the release of 70 products will not be much help unless campaigns and advertisements are combined. The target will also be expanded sequentially. Pharmacies say there will be a bigger problem in the future than it is now. It seems necessary to come up with measures quickly before vaccinations for the entire country are implemented in earnest.
- Opinion
- [Reporter's View] It's up to pharmaceutical companies
- by An, Kyung-Jin May 17, 2021 05:53am
- Drug quality management is at stake. Over the past two months, four companies, including Binex, Vivozon, Chong Kun Dang and Hanall Biopharma, have been caught violating drug quality control. A total of 62 products are under administrative disposition due to violations of quality control by four companies. Including pharmaceutical companies in consignment contracts, the impact is even greater. Thirty-four pharmaceutical companies that have entrusted production to four companies are also focusing to whether the MFDS will dispose of them further. A total of 38 companies are on the verge of being kicked out of the market because of the trustee's deviant behavior. The pharmaceutical industry fears it will spread to distrust of consignment generics. It is only a matter for some companies, and the consignment act itself should not be a problem. In July 2018, the Valsartan crisis, which shook the global pharmaceutical market, was unprecedented in overseas countries as carcinogenic substance N-Nitrosodimethylamine (NDMA) was detected in Valsartan manufactured by China's Zhejiang Huahai. NDMA was not originally subject to standard checks on Valsartan. Until Zhejiang Huahai reported that more NDMA was detected than the standard, no pharmaceutical company in the world cared about NDMA detection. The FDA and the EMA were not aware of the need for inspections, but rushed to investigate and come up with measures to determine the cause. It was just an unexpected accident. Chinese raw medicine and generic are starting to be blamed as if they were the causes of "low quality." It is also from this time that regulations on consignment generic have been tightened in Korea. Health authorities set up a "Generic Drug System Improvement Council" and began to come up with measures to curb generic disorder. The MFDS has removed all deregulation granted to Entrusted generic. From next year, mandatory production of licensed products, which had been exempted from consignment generics, will be implemented again. It is also pushing to exclude consignment generics from generic exclusivity. Following the reorganization of the drug price system, which took effect in July last year, the standard for calculating the drug price of consigned generic has also been lowered. The 53.55% upper limit price can be maintained compared to the original drug before the patent expires only when all requirements are met to conduct biological equivalence tests directly and use registered raw material drugs. The regulation on joint development of drugs under discussion at the National Assembly is also key to restricting the permission of consignment generic. Some amendments to the Pharmaceutical Affairs Law, which limits the number of drugs licensed in one clinical trial, passed the Health and Welfare Committee, leaving procedures for future plenary sessions, the Legislation and Judiciary Committee, and the plenary session. The government's justification for tightening regulations on generic seems to be somewhat out of standard. The MFDS defines "generic" as a officially licensed drug based on the same quality as the original developed drug. It is not appropriate that the large number of generic drugs authorised by the Government is of low quality. Nevertheless, pharmaceutical companies are largely to blame. If unreasonable regulations and misunderstandings are unfair, they should prevent repeated violations and come up with self-rescue measures to improve competitiveness in drug quality. The drug quality control agenda has already been controversial, although it was not originally due to generic. It is up to pharmaceutical companies to restore generic drug reputation.
