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- 2026-05-05 20:40:08
- Policy
- A clinical study on CAR-T tx at SNUH has been approved
- by Kim, Jung-Ju Dec 14, 2021 05:56am
- A clinical study at Seoul National University Hospital for CART-T (Chimeric Antigen Recepter-T cell) treatment for pediatric leukemia patients was first approved. This is the first approval since the enforcement of the "The Act on the “Safety and Support of Advanced Regenerative Medical and Advanced Biopharmaceuticals” (hereinafter Advanced Bio Act)" in September last year. The MOHW (Minister Kwon Deok-cheol) and the MFDS (Minister Kim Kang-rip) announced on the 8th that the clinical research plan applied by Seoul National University Hospital (Professor Kang Hyung-jin) was approved as the first high-risk high-tech regenerative medical clinical study since the implementation of the "Advanced Bio Act." CAR-T is the introduction of a gene that combines the receptor site of immune cells (T cells) and the characteristic antigen recognition site of the cancer cell surface into the patient's T cells, which has the function of specifically recognizing and attacking the surface antigen of cancer cells. The clinical study applied by Professor Kang Hyung-jin's team this time is a phase 1b clinical study of CD19 chimeric antigen receptor T cells (SNUH-CD19-CAR-T) produced by children and adolescents, which are recurrent or non-adaptive CD19-positive B cells acute lymphoid leukemia. This case is a "clinical study with uncertain or high risk of impact on human life and health (Article 2, Item 3 (a) of the Advanced Regenerative Bio Act), and high-risk clinical studies require detailed examination of safety and effectiveness as they can be treated in innovative ways different from previous treatments. In the case of high-risk clinical studies, clinical research plans can be conducted after being approved by the Minister of Food and Drug Safety after deliberation by the Advanced Regenerative Medicine and Advanced Biopharmaceutical Review Committee under the Advanced Regeneration Bio Act. Considering that this is the first high-risk clinical study, the deliberation committee and the MFDS thoroughly verified research capabilities, protection of research subjects, safety and effectiveness, and completed approval of the committee's results under the Advanced Regeneration Bio Act. The approved clinical study aims to treat patients with acute lymphocytic leukemia in children and adolescents using CAR-T. Patients with acute lymphocyte leukemia in children and adolescents have been treated with chemotherapy, but in the case of recurrent and non-adaptive patients, leukemia cells did not decrease with existing treatments, so there was a limit to leukemia treatment. It is the principle of attacking cells that proliferate at an excessively high rate, and it simultaneously attacks existing proliferating cells (bone marrow, mucous membrane, hair, etc.) as well as cancer cells that proliferate rapidly. Treatment using CAR-T is expected to minimize damage to normal cells in the body while accurately targeting only cancer cells, increasing the therapeutic effect, and minimizing the side effects of existing treatments. We will do our best to promote the regenerative medical field through related projects such as clinical research funding projects and pan-ministerial regenerative medical technology development projects, said Kim Young-hak, head of the regenerative medical policy department.
- Policy
- 241 items of the impurity detected Losartan were recovered
- by Lee, Tak-Sun Dec 14, 2021 05:56am
- Azido impurities are detected in Losartan, HTN treatment , and all 241 items are recovered, and only some manufacturing numbers of 54 items are recovered. However, 11 items are sold as they are because impurities are not detected excessively. The MFDS explained that the risk of harm to the human body is very low, but in the case of patients, it is possible to exchange products, be re-prescribed, and be re-dispensed. It has been decided that Hanmi Pharmaceutical products can be sold. The MFDS announced on the 7th that as a result of a safety survey on impurities in the middle of the drug containing Lozartan, which is a treatment for hypertension, the daily intake allowance (1.7~88.7㎍) was exceeded (1.5㎍/day), but concerns about human harm were very low. This impurity is an Azido impurity that occurs specifically in Losartan, and its mutagenicity (genetic mutation-causing property) has been confirmed and carcinogenicity has not been confirmed. It is explained that the impurities of the Losartan product are different from the impurities AZBT identified among Sartan products in September, and the safety survey was conducted according to the safety information of medicines such as overseas recovery. As a result of the safety survey, all or some lot number products of 295 items (98 companies) that are feared to exceed or exceed the daily intake allowance of Losartan impurities out of 306 items (99 companies) in circulation are voluntarily recovered by pharmaceutical companies. It is voluntarily being recovered from the pharmaceutical company. However, the MFDS confirmed that all or some of the 65 items (23 products) are within the daily intake allowance, and from December 1, only products with less than the allowable amount of Losartan impurities have been shipped. Patients taking Losartan should not stop taking it arbitrarily, but should decide whether to continue taking it after consulting with a doctor or pharmacist. It is explained that if necessary, it can be ▲exchanged for a different manufacturing number ▲ or re-prescribed and re-dispensed with another product. The MFDS consulted the Central Pharmaceutical Review Committee to set the daily intake of Azido impurities, and applied the International Guidelines (ICHM7) in the pharmaceutical sector to set it at 1.5//day. ICHM7 sets a "negligible level" as a daily intake allowance for mutagenic impurities that have not been confirmed to be carcinogenic when consumed daily for life (70 years). As a result of evaluating the health effects of most patients who took Losartan, which daily intake allowance of Losartan impurities was excessively detected, it was found that 0.54 out of 100,000 people had a very low possibility of developing additional cancer, which was negligible. It is explained that the human impact assessment of patients taking excess impurities detection products of Losartan was conducted according to ICHM7 by comprehensively considering ▲ the HIRA's prescription data for the past six years ▲ the maximum dose per day ▲ impurity test results. The MFDS stressed that patients prescribed the product should not arbitrarily stop taking drugs because taking Losartan, which exceeds the daily intake of impurities, has little impact on health. However, patients with health concerns visited the hospital where the drug was prescribed and asked the medical staff to consult whether they were taking the drug and the need to re-prescribe it. They can be exchanged for another lot number by visiting a pharmacy they previously prepared without visiting a medical institution, and patients wishing to re-prescribe can be re-prescribed and re-dispensed with other hypertension treatments. In the case of re-prescribing, re-dispensing, or exchanging medicines at hospitals, clinics, or pharmacies that have previously been prescribed or dispensed, patient compensation is exempted only once for the first time. It will support the use of the health insurance claim system for smooth cost settlement between nursing institutions and pharmaceutical companies. An official from the MFDS emphasized, "We will continue to strictly manage only Losartan, which is less than the daily intake allowance, to supply safe and effective high-quality medicines based on scientific knowledge and regulatory expertise."
- Policy
- Phase III for Amivantamab-Lazertinib was approved
- by Lee, Tak-Sun Dec 13, 2021 05:57am
- Leclaza (Lazertinib), a non-small cell lung cancer tx by YuhanLazertinib was exported to Janssen in 2018 worth 1.4 trillion won. Janssen is attempting to overcome existing treatments through the combination of its developed non-small cell lung cancer treatment "Amivantamab (Rybrevant)" and Lazertinib. The MFDS approved a phase 3 clinical trial plan for "JNJ-61186372" applied by Janssen Korea on the 10th. This clinical trial is the second phase 3 combination therapy of Amivantamab-Lazertinib in Korea. This test is a phase 3, label disclosure, and randomized clinical trial comparing platinum-based chemotherapy and combination therapy of Amivantamab and Lazertinib in clinical trial subjects with EGFR-mutagenic or metastatic non-small cell lung cancer that failed Tagrisso treatment. Tagrisso is a third-generation EGFR (Oral Epithelial Cell Growth Factor Acceptance)-TKI (Tyrrosine Inhibitor) such as Leclaza, and is the latest drug and widely used in the non-small cell lung cancer treatment market. Based on IQVIA, Tagrisso's 2020 sales alone amounted to 106.4 billion won. Janssen is developing combination therapy between Amivantamab and Lazertinib as a competitive drug for Tagrisso. In September last year, phase 3 comparative clinical trials with Osimertinib or Lazertinib were approved by the MFDS as the primary treatment for clinical trial subjects with EGFR mutant local progressive or metastatic non-small cell lung cancer. Leclaza, which was approved in Korea in January, was released by Yuhan in July. It recorded 1.5 billion won in sales in the third quarter of last year based on IQVIA. Janssen's Amivantamab is also known to be under review by the MFDS, and is expected to obtain domestic approval soon. This drug is attracting attention as a treatment for MET mutations in non-small cell carcinoma patients. In May, it was approved by the U.S. FDA as an indication to block EGFR and MET mutations at the same time. If the combination therapy of Amivantamab and Lazertinib is recognized for its efficacy and successfully commercialized, it is expected to lead to a rise in the global value of Lazertinib. Developer Yuhan Corporation can also expect royalties revenue.
- Policy
- MFDS is considering changing the permission of Remdesivir
- by Lee, Tak-Sun Dec 13, 2021 05:56am
- Attention is focusing on whether COVID-19 treatment Veklury (Remdesivir) will be officially approved. In July last year, Veklury of Gilead Science Korea was conditionally licensed based on non-clinical test literature and interim clinical trial analysis results. At that time, the MFDS quickly approved the final results of clinical trials, some GMP data, and additional risk mitigation measures on the market. According to the industry on the 9th, Veklury submitted data that satisfies the conditions granted at the time of approval to the MFDS and applied for permission to change. On the 7th, an advisory meeting of the Central Pharmaceutical Affairs Council was also held. For now, there is a high possibility of Veklury's permission to change. The U.S. FDA officially approved Remdesivir in October last year. In a clinical trial conducted on 1,062 COVID-19 patients in the United States, the Remdesivir-treated group showed 10 days to recover, and the placebo-treated group showed 15 days, indicating that it was effective in shortening treatment time. However, the WHO announced that Remdesivir was not effective, sparking controversy. In October last year, the WHO reported that in a large-scale clinical trial, Remdesivir was found to have little or no effect in overall mortality, hospitalization period, and need for ventilation. In a small clinical trial released in July this year, Remdesivir drew attention by saying that it had no antiviral effect. In Korea, researchers at 20 university hospitals led by Professor Baek Kyung-ran of Infectious Diseases at Samsung Medical Center earlier this year announced the results of clinical effects. As a result of the analysis of 110 patients, 22.9% of the Remdesivir dosing group deteriorated enough to apply mechanical respiration as of the 28th day of hospitalization, lower than that of other treatment groups (44.7%). Based on this, some argued that Remdesivir should be administered early to severely ill COVID-19 patients. In Korea, Remdesivir and Dexamethasone, which controls immune response inflammation, are used in combination for severely ill patients who are hospitalized and treated. According to Central Disease Control Headquaters, Veklury was administered to 172 hospitals and 22,571 patients by the 3rd. Currently, only Remdesivir and Celltrion's Regkirona are approved treatments for COVID-19. Regkirona is being used to treat mildly high-risk COVID-19 and all secondary adult patients with permission to change. Currently, the MFDS is reviewing the EUA, Merck's oral treatment, and Pfizer's products are also being reviewed in advance before the approval review. Remdesivir is needed until a treatment that shows a definite effect is released. Attention is focusing on whether the controversy over the efficacy will disappear through this review of the change permit.
- Policy
- Janssen Korea voluntarily withdrew Tylenol 500mg
- by Lee, Tak-Sun Dec 10, 2021 05:51am
- It is known that the item license for Janssen Korea's antipyretic analgesic "Tylenol 500mg" will be withdrawn soon. This was expected to some extent because the Hyangnam plant will be shut down at the end of this year. Janssen has already been approved for imported items with the same ingredients and the same dosage. According to the MFDS on the 9th, Janssen Korea expressed its intention to withdraw "Tylenol 500mg," which was approved in Korea in 2001. This product has been manufactured at Janssen Korea's domestic factory (Hyangnam). However, as Janssen announced that the Hyangnam plant will be shut down this year, related manufacturing items are also undergoing withdrawal procedures. Janssen's Hyangnam plant was acquired by Whanin Pharmaceutical for about 46 billion won in November last year, and it was decided to withdraw from Korea for the first time in 38 years. In preparation for the withdrawal of the item, Janssen has already been approved for imported items with the same ingredient (Acetaminophen) in August. The product name is Janssen Acetaminophen. This product is expected to replace 500 mg of Tylenol, which is suspended from manufacturing in Korea. Janssen is known to have put in a large number of inventory items this year as demand for "Tylenol 500mg" surged to ease the break from COVID-19 vaccination. Tylenol recorded cumulative sales of 50.1 billion won in the third quarter of this year based on IQVIA, showing a whopping 177% year-on-year growth. In particular, the demand for Tylenol is likely to increase as the number of COVID-19 confirmed cases has soared recently and new and additional vaccinations are expected to increase as vaccine passes are implemented. Janssen is expected to make the most of the inventory items manufactured at the Hyangnam plant, but to hurry to introduce imported items. Until now, it has been found that there is no shortage of Tylenol inventory on the market.
- Policy
- The method of writing for HBP combination is improved
- by Lee, Tak-Sun Dec 10, 2021 05:51am
- The method of writing permission for HBP and dyslipidemia combinations is improved more efficiently. Previously, information on individual ingredients was simply listed, but in the future, it will be prepared based on a comprehensive evaluation of combinations. According to the pharmaceutical industry on the 6th, the MFDS prepared a plan to improve the method of writing permission for high blood pressure and dyslipidemia combination drugs and guided them through pharmaceutical organizations. According to the improvement plan, the efficacy of the high blood pressure and dyslipidemia combination will be described in consideration of the purpose of administration, clinical trial results, and primary and secondary therapy. In particular, precautions related to the treatment of individual ingredients for dyslipidemia should not be described. However, in the case of a composite containing Ezetimibe, the matters related to diet, administered drugs, and lipid tests described in the "effect" can be stated in the "Precautions for Use." The precautions for use include prohibition of administration of each main ingredient, careful administration, and general caution related to administration as a complex agent. As for the adverse reaction, the contents of the clinical trial conducted as a composite agent may be first described, and then the adverse reaction may be additionally described as a single agent. However, adverse reactions of unlicensed ingredients can be omitted. For example, in the case of the fourth composite, the adverse reactions of the second to third composite agents should not be described. As the existing permission for high blood pressure and dyslipidemia complex drugs lists information on individual components, it is difficult for the general public to recognize the product characteristics of the combination drugs, and only the attached documents are prolonged. In this improvement plan, the MFDS said, "The permission for complex drugs should provide information so that experts and patients can use the drug safely and effectively." The MFDS explained, "It should be mainly prepared based on information obtained from combination or combined administration, and information obtained when individual ingredients are administered alone can be additionally presented if appropriate." An official from the MFDS said, "There was an opinion that it was difficult to read the existing description method because it lists individual ingredients." The MFDS distributed a revision to the "Guidelines for Clinical Trial of Combination Drugs" along with this improvement plan to guide efficacy, effectiveness, and approval of primary therapy. According to the guidelines, if an unlicensed single agent is developed as a combination agent, in principle, it is possible to obtain permission only for the efficacy of the combination drug through clinical trials (therapeutic confirmation clinical trials, etc.). In order to be approved as a primary therapy, the feasibility of development as a primary therapy must first be proven in consideration of the mechanism of action of individual main components of the complex and clinically recommended treatments. In particular, it is possible when a therapeutic confirmation clinical trial is conducted on patients who need to administer complex drugs from the beginning to reach the target treatment effect, and safety and effectiveness are proven.
- Policy
- The ruling party shouted to review the Judiciary Committee
- by Lee, Jeong-Hwan Dec 09, 2021 05:58am
- Democratic Party of KoreaThe ruling party members of the Health and Welfare Committee issued a statement and strongly protested when the revision to the National Health Insurance Act, which included strict regulations on doctor licenses, and the bill to return and refund drug prices, were put on hold at the stage of the Legislation and Judiciary Committee. Members of the Democratic Party of Korea and of the Welfare Committee, urged the bill to be immediately proposed, saying that the leak of national health insurance finances is intensifying due to the brakes of the agenda of the Legislation and Judiciary Committee. On the 7th, the ruling party's welfare committee members adopted and published a statement. The ruling party's welfare committee members asked the People Power Party to withdraw its opposition to the revision of the Health Insurance Act and immediately cooperate with the Legislation and Judiciary Committee on the agenda.This is the second time that ruling party members have issued a statement after the bill on health medicine has been canceled. Earlier on February 26 this year, the ruling party's welfare committee held a press conference and issued a statement after the revision to the medical law, including the cancellation of a serious crime doctor's license, failed to be reviewed during the extraordinary National Assembly in February. In addition, the Democratic Party of Korea's welfare committee criticized the People Power Party for blocking the review of the revision to the Health Insurance Act. Democratic welfare committee members say that despite the administrative litigation of pharmaceutical companies' suspension of execution over the past five years, the People Power Party has prevented the bill from being proposed only with opposition from some pharmaceutical companies. In addition, members of the Democratic Party of Korea pointed out that the Health Insurance Act also included a bill to recover all unfair profits from illegal health insurance recipients such as illegal secretariat hospitals, and that the process was delayed due to opposition from the People Power Party. In addition, the Democratic Party of Korea's welfare committee members said, "An alternative to the Health Insurance Act passed by the ruling and opposition parties at the plenary session of the Welfare Committee was not presented on the agenda of the Legislation and Judiciary Committee on December 8th." They pointed out, "People Power Party argues that the Moon Jae In government's strengthening of health insurance coverage is at stake, but opposes legislation that leaks health insurance finances due to indiscriminate overuse of lawsuits by pharmaceutical companies." He then said, "Alternatives to the Health Insurance Act also included provisions to block illegal supply and demand by collecting all unfair profits from illegal hospitals run by the office manager." They emphasized, "It is a betrayal of interest to leave the office manager's hospital, which gnaws away insurance finances, and insist on protecting health insurance premiums while leaving the health insurance leak intact due to indiscriminate administrative litigation by pharmaceutical companies."
- Policy
- 6 cases of Ultomiris & 1 case of Spinraza were pre-approved
- by Lee, Hye-Kyung Dec 09, 2021 05:58am
- Benefits for pre-approval of six new PNH patients for Ultomiris administration were approved and four cases were rejected. There were no applications for new salary administration for Soliris, but two applications for pre-approval for new aHUS patients were not accepted. In the case of Spinraza, a treatment for Spinal Muscular Atrophy (SMA), one application for new patient benefits and two data supplementations were decided. Of the 25 monitoring reports, 23 were approved and 2 were disapproved. The HIRA conducted deliberation on six items, including Soliris and Ultomiris, and whether hospitalization fees were recognized. According to the results of the deliberation on the 2nd, Soliris decided to approve 33 PNH monitoring applications, to disapprove 2 new aHUS cases, to disapprove 1 retrial, to approve 2 monitoring cases, and to disapprove 1 case. Ultomiris has approved 6 out of 10 new patient approval applications for PNH, 4 disapproval, 3 re-deliberation, and 1 monitoring approval. Soliris is 5,132,364 won per vial (30 ml), and if three vials are administered every other week, the drug price per year alone is 400 million won. Ultomiris was listed at 5,598,942 won per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered. Soliris and Ultomiris are ultra-high-priced new drugs, so they implement a pre-approval system to determine whether they are eligible for medical care benefits, and the agency must administer Soliris or Ultomiris within 60 days from the date of notification of the results of the deliberation. If it is intended to be administered after 60 days, it must be re-applied. In one case, data supplementation was requested, and in the other case, data supplementation was required as it was necessary to confirm whether the patient could receive spinal canal injection stably due to the long course of the disease. Spinraza is an ultra-high-priced new drug of 92.35 million won per bottle of 5ml, and medical institutions that want to take it must apply for pre-approval and submit a monitoring report every four months after approval of salary. Details of the deliberation can be found in the case of www.hira.or.kr or biz.hira.or.kr > Comprehensive Review Standards Service> Criteria> Review Standards> Public Deliberation.
- Policy
- Patients fume over non-deliberation of Kymriah·Keytruda
- by Lee, Jeong-Hwan Dec 09, 2021 05:58am
- Patients have set out to demand PBAC's prompt deliberation of the new reimbursement listing for Novartis Korea’s cancer immunotherapy Kymriah in acute lymphoblastic leukemia and diffuse large B-cell lymphoma and reimbursement expansion for MSD Korea’s non-small cell lung cancer treatment Keytruda to first-line in NSCLC. The patients expressed strong regrets after it was found that the agenda related to the reimbursement of Kymriah and Keytruda was not put up for deliberation by the Pharmaceutical Benefit Assessment Committee on the 2nd, the last meeting set for this year. On the 1st, the Korea Alliance of Patient Organizations (KAPO) said, “The non-deliberation of the agenda at the PBAC meeting reduces the will to fight the disease and threatens the lives of leukemia, lymphoma, and NSCLC patients in Korea." Novartis had applied for the reimbursement of its leukemia and lymphoma treatment, the CART-T therapy Kymriah, on March 3rd this year through the ‘approval-reimbursement review linkage system,’ and received a conditional nod from the Cancer Disease Deliberation Committee deliberation 7 months later on October 13th. Keytruda, which was listed for reimbursement as a second-line treatment, applied to extend its reimbursement to first-line monotherapy in NSCLC in September 2017 but failed 9 times. After 4 years and numerous attempts, the agenda had finally received a conditional nod at the CDDC meeting on July 14th, 2021. The life expectancy of recurrent·refractory leukemia and lymphoma patients that need treatment with Kymriah is only 3 to 6 months. In other words, patients who cannot bear the non-reimbursed 460 million won cost of the drug are dying waiting for the reimbursement listing. Also, Stage 4 NSCLC patients had borne the 70 million to 100 million won drug cost of Keytruda for the past 4 years to receive treatment or received partial support with their indemnity medical insurance or MSD's non-reimbursement drug cost support program. Others received treatments from hospitals that have been pilot operating the new DRG system or received treatment with another anticancer drug then used Keytruda as second-line with disease progression. KAPO said, “Deliberations on Kymriah and Keytruda have barely passed the CDDC on condition and are being delayed, but this is not due to the clinical efficacy of the drugs. Kymriah and Keytruda are representative drugs that are directly related to life, and there is little controversy about their therapeutic effect. It is just that the drugs’ prices are very expensive and patients so many. The concern over the increased burden on NHI finances, the drug price, and fiscal concerns are what has been delaying the listing of these drugs.” The patient organization stressed that the access to treatments that are directly related to life should not be obstructed due to administrative procedures for reimbursement listing. It said, “Patients who meet the MFDS indication can even now receive non-reimbursed treatment with Kymriah or Keytruda. The harsh reality is that the late-stage patient’s life or death, and extension of life depends on their economic ability, on whether they have the ability to pay for the high priced non-reimbursement cost for their treatments. For new drugs directly related to life such as Kymriah and Keytruda, the government should spend NHI finances to save the patients’ lives first, then decide on how to list and set their drug price through formal procedures as they are doing now.” Currently, no system in Korea allows for the priority use of NHI finances even if the new drugs are directly related to life. Therefore, KAPO demanded that the government and the National Assembly introduce a constitutionally guaranteed 'rapid NHI listing system for new drugs directly related to life'. The organization also plans to propose the introduction of this system as a presidential campaign to presidential candidates. It added, "Pharmaceutical companies develop and market new drugs to save the lives of patients. Also, the nation operates a NHI system to ensure that no citizen is left untreated due to reasons of cost if there are drugs available. To fulfill this objective, we need to quickly complete Kymriah’s reimbursement listing process that has been ongoing for 9 months and Keytruda’s first-line reimbursement that is being discussed for over 4 years.”
- Policy
- Impurity detected Cozaar is excluded from recovery
- by Lee, Tak-Sun Dec 08, 2021 06:01am
- In the case of a single drug in Losartan formulation where impurities were detected, it is interpreted that only the original drug was excluded from recovery, exposing the risk of domestic generics again. It is analyzed that the reason why the original drug was excluded from the collection list is because the raw material process is different. The MFDS announced on the 7th that it will recover 295 items (98 companies) of Losartan drugs that have been excessively detected with Azido-based impurities. The majority of the 306 (99 companies) items in circulation are included. As impurities were confirmed to be within the daily intake allowance, 11 items were excluded from the collection, 5 items from foreign pharmaceutical companies and 6 domestic pharmaceutical companies. In particular, in the case of Losartan potasium, only "Cozaar" and "Cozaar 100mg" of Organon, Korea were excluded from the recovery list. All of the remaining identical generic drugs were included in the recovery list. An official from the MFDS explained, "We estimate that this impurity was caused by unintended residue from the use of Azide during the raw material process," adding, "However, we know that the original did not use Azide." However, the official explained that there are products that are currently shipped below the standard by improving the raw material synthesis process for generic drugs. The original and generic materials are the same ingredients, but there was a difference in the synthesis process. Finished drugs were included in the collection list one after another due to consignment. There are 16 factories in Korea that produce Losartan single 5-mg finished products. These 16 places are connected by consignment and consignment structures supplied to 88 pharmaceutical companies. As a result, if a problem occurs in one finished product factory, products from various companies will also be recovered. This consignment structure has also been problematic in the Valsartan formulation, where the NDMA impurity crisis first occurred. Accordingly, the government has been implementing a policy since last year to discriminate against generic items entrusted with biological equivalence tests for consignment production when registering drug prices. In addition, from July this year, a revision to the Pharmaceutical Affairs Act was implemented to require one trustee to supply products to only three consignment companies to restrict consignment production through sharing of biological equivalence tests. As a result, it can be seen that the Losartan impurity incident also showed generic risks. However, experts say that it is dangerous to interpret that there is a difference in quality between the original and generic in that the generic raw material process was initially approved by the MFDS.
