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- 2026-03-11 17:57:20
- Policy
- Korean gov. to introduce preferential drug pricing criteria
- by Lee, Jeong-Hwan Feb 08, 2024 05:49am
- Director Chang-Hyun Oh explained the pharmaceutical policy directions in the 2nd comprehensive National Health Insurance plan. By the first half of this year, the government plans to establish a detailed criteria for ‘National Economic Growth,’ including the research and development (R&D) of new drugs and incrementally modified drugs, essential drugs supply, and new job creations, which will be the basis for preferential drug pricing intended for pharmaceutical companies in Korea. The criteria will be used to implement a new policy aimed at enhancing preferential drug pricing benefits for pharmaceutical companies that have contributed to Korea’s economic growth. The government has promised to strengthen drug pricing support using the National Health Insurance finance if a pharmaceutical company shows achievements, such as enhancing R&D efforts, alleviating essential drug shortages, and increasing hires, regardless of its status as an innovative pharmaceutical company. Notably, the government has announced a plan to establish a new direction for generic drug pricing system. The current stepwise pricing system for generic drugs was analyzed in research service report, upon which this revision is based. On the 5th, Lee Joongkyu, Director of the National Health Policy at the Ministry of Health and Welfare (MOHW), held the meeting for the 2nd comprehensive National Health Insurance plan with the KSPA NEWS and announced the plan. Chang-Hyun Oh, Director of Pharmaceutical Benefits, attended the meeting and answered the questions regarding the 2nd National Health Insurance plan in detail, including the drug pricing system and issues related to drug prices. Pharmaceutical companies contributing to healthcare security and Korea economic growth will receive preferential drug pricing The 2nd NHI plan announced on the 4th by the MOHW contains policy objectives of assessing preferential drug pricing differentially based on companies’ contribution to improvement in citizens’ healthcare, considering the sustainability of NHI and national economic growth The plan outlines a vision to provide preferential drug pricing to pharmaceutical companies that advance healthcare and establish a stable supply chain. This includes investing in R&D of innovative pharmaceuticals, such as new drugs and incremental new drugs, contributing to the supply of essential drugs, and creating new jobs opportunities. Director Oh emphasized that the 2nd NHI plan is focused on contributing to economic growth and healthcare security. Particularly, the plan includes various measures within the health insurance policy to encourage pharmaceutical companies to engage in the development of new drugs, incrementally modified drugs, and generics. “The current health insurance plan includes discussions on assessing ICER value flexibility and implementing measures to reduce drug pricing if a company positively contrivutes to Korean medical healthcare through substantial investment in R&D, as well as job creation,” said Oh. “Compared to the current incentive system, the revision may yield more improvements because the development of new drugs, incrementally modified drugs, and combination drugs can help healthcare finances.” Oh also mentioned that regardless of a company’s status as an innovative pharmaceutical company, the policy of higher drug pricing will apply to pharmaceutical companies that contribute to Korean economic growth. A reference criteria for preferential drug pricing will be set in the first half of this year after working with a public-private consultative body comprised of the MOHW and pharmaceutical companies, Oh answered. Oh stated that they plan to revise the qualification criteria for innovative pharmaceutical companies to make them less stringent. “Additionally, we will consider creating an administrative system that provides drug pricing benefits to companies that do not qualify as innovative pharmaceutical companies but have made significant contributions to the healthcare industry and health insurance finances through their R&D investments,” Oh said. “We will put our efforts into formulating the criteria of preferential drug pricing by the first half of this year.” “In the 2nd NHI plan, we have suggested a course of direction. We will hear from industry experts in a public-private consultative body to discuss drug pricing index, systemization, and ratios. We have not yet decided on the execution date, but we will implement the system soon,” Oh commented. The MOHW will look into the revision of the generic drug pricing system and the post-management system of drug pricing The MOHW will assess whether the post-management drug pricing system should be revised as well, in addition to enhancing administrative measures for better patient access and considering revision to the drug pricing system of generic drugs. Since July of last year, the MOHW has initiated research with a team led by Professor Dong-Sook Kim at Kongju National University under the government contract to work on evaluating the necessity of restructuring Korea’s drug pricing of generic drugs and to devise revision. The MOHW is currently finalizing the research. Comparing Korea’s drug pricing system for generics to the overseas drug pricing system, the research aims to evaluate whether the current step-wise drug pricing system is valid. Specifically, the research team will analyze whether it is appropriate to set the number of items, differentially priced at 53.55~38.69%, that receive differential drug pricing to 20, should drug prices of generics be maintained at 53.55% of the originals before the patent expires, and whether it is necessary to differentially set the drug prices of generics to 53.55% once the patent of the originals expires. The research includes the post-management methods, including the price-volume agreement. Oh has announced that they will begin working on amending the drug pricing system and the post-management of generic drugs this year after completing the research and a comprehensive review of the post-management system,. However, the execution date will be determined later “after gathering opinions from patients, pharmaceutical companies, and experts.”
- Policy
- Production and supply of Cifex Eye Drops is discontinued
- by Lee, Hye-Kyung Feb 08, 2024 05:49am
- Samil Pharm will suspend production and supply of its 2nd generation fluoroquinolone antibiotic eye drop, Cifex Eye Drops (ciprofloxacin hydrochloride hydrate). According to the Ministry of Food and Drug Safety's status report on the discontinued or supply shortage drugs, Samil Pharm had reported the discontinuation of its Cifex Eye Drops on the 6th. Samil Pharm said, "We are suspending production and supply due to low sales and increased amount of disposed products. There is a possibility of resuming production if there is a large demand in the future." Cifex Eye Drops was approved in 1995 and have been used to treat corneal ulcers and conjunctivitis. According to the Ministry of Food and Drug Safety's production performance report, sales of the drug have steadily increased from KRW 36.75 million in 2020, KRW 36.77 million in 2021, to KRW 40.94 million in 2022, but Samil Pharm believes that inventory is increasing due to low sales. The company added, "There are many quinolones such as ‘ofloxacin,' 'levofloxacin,' and 'moxifloxacin' available to substitute Cifex Eye Drops, so we do not expect any inconvenience to occur for the patients due to the discontinuation of Cifex Eye Drops. Currently, the only remaining second-generation quinolone antibiotics that contain ciprofloxacin like Cipex Eye Drops is Daewoong Pharmaceutical's Ciplus, and other ofloxacin products available include ‘Effexin,’ ‘Ocuflox,’ ‘Ofbella,’ ‘Quinovit,’ and ‘Tarivid.’ Other alternative antibiotic eye drops available include 3rd generation quinolone antibiotics like ‘Cravit,’ ‘Levofexin,’ which contains levofloxacin, and ‘Ozex,’ which contain tosufloxacin. Among 4th generation quinolone biotics, ‘Gatiflo,’ which contains gatifloxacin, and ‘Vigamox’ and ‘Vigaflo’ that contain moxifloxacin are available in the market.
- Policy
- Preferential pricing possible for non-innovative new drugs
- by Lee, Tak-Sun Feb 08, 2024 05:48am
- The government has announced a plan allowing new drugs developed by pharmaceutical companies not designated as Korea’s innovative pharmaceutical companies to be eligible for preferential drug pricing. This has turned attention to whether Jeil Pharmaceutical’s new drugs will benefit from this plan. On the 4th, the Ministry of Health and Welfare (MOHW) announced the 2nd comprehensive National Health Insurance plan (2024~2028), stating that the ministry will establish a measure to provide preferential drug pricing to pharmaceutical companies, regardless of their innovative new drugs designation status, that advance healthcare and establish a stable supply chain. The current plan offers expanded support compared to the ‘the drug pricing system to ensure fair-value compensation for innovative new drugs’ announced by the Biohealth Innovation Committee, which is chaired by the Prime Minister. In ‘the drug pricing system to ensure fair-value compensation for innovative new drugs’, domestically developed new drugs, which were produced by innovative pharmaceutical companies and underwent confirmatory clinical trials targeting Koreans and received expedited approval by the Ministry of Food and Drug Safety (MFDS), were eligible for receiving the drug pricing measures. Previously, if a drug's clinical usefulness was assessed to be the same or less than that of its substitute, it was priced lower than the weighted average price of the substitute. However, from now on, it will be allowed to be priced between the weighted average price and the maximum price of the substitute. Following the announcement, the pharmaceutical industry welcomed the news, but expressed disappointment at the limited benefits for only innovative pharmaceutical companies. During last month’s public-private consultative body meeting, the pharmaceutical industry proposed that non-innovative pharmaceutical companies should also be considered for preferential drug pricing. It seems that such measures have been incorporated into the 2nd NHI plan. Particularly this year, there is anticipation surrounding the emergence of domestically produced new drugs developed by non-innovative pharmaceutical companies, raising interest in whether they will also receive drug pricing benefits. ‘Zastaprazan,’ developed by Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical, is one of those drugs. Zastaprazan has applied for product approval form the MFDS. Zastaprazan, like Kcab, is a P-CAB class treatment for gastroesophageal reflux disease. Compared to PPI-class medications, it has a rapid onset of action and can be taken regardless of meals. Onconic Therapeutics conducted a Phase 3 trial enrolling 289 patients with gastroesophageal reflux disease at 28 medical institutions, demonstrating non-inferiority compared to Esomeprazole. The product approval is expected to be confirmed this year, followed by the reimbursement listing process. Based on current criteria, since it is considered a non-innovative new drug, it is expected to receive a price below the average weighted price of substitute drugs. Although the government announced ‘the drug pricing system to ensure fair-value compensation for innovative new drugs’ measure end of last year, Jeil Pharmaceutical and Onconic Therapeutics have been excluded from potential beneficiary because they are not designated as innovative pharmaceutical companies. With the 2nd NHI plan, these new drugs can receive higher prices if subjected to preferential drug pricing. DA-8010, which is a new drug being developed by Dong-A ST for treating overactive bladder (OAB), has been identified as a potential beneficiary. If the phase 3 trials of this drug are completed within the first half of this year, there is a high possibility that the company will apply for product approval by the end of the year. Previously, Dong-A ST has been excluded from drug pricing incentives as it is not designated as an innovative pharmaceutical company, despite the new drug development. The industry expects the government to formulate preferential drug pricing criteria for non-innovative new drugs in the first half of the year. During a meeting with the KSPA NEWS On the 5th, Chang-Hyun Oh, Director of Pharmaceutical Benefits, stated that “We will consider creating an administrative system that provides drug pricing benefits to companies that do not qualify as innovative pharmaceutical companies but have made significant contributions to the healthcare industry and health insurance finances through their R&D investments.” Oh explained, “We will put our efforts into formulating the criteria of preferential drug pricing by the first half of this year.” After the New Year holiday, the government is expected to begin discussing measures of preferential drug pricing with the pharmaceutical industry through a public-private consultative body.
- Policy
- HIRA 'Ease entry of new drugs and strengthen post-evals'
- by Lee, Tak-Sun Feb 07, 2024 05:59am
- HIRA President Jung-Gu Kang is answering questions from the press corp on June 6 Jung-Gu Kang, President of the Health Insurance Review and Assessment Service, said that he will lower the barriers to entry for new drugs while strengthening post-listing evaluations. For this, Kang explained that HIRA had established the ‘Pharmaceutical Performance Assessment Department’ to improve the management system of high-priced drugs. Regarding the external reference pricing reevaluations, Kang said that the reevaluations will be conducted this year, but that the specific date of its implementation is unclear. He added that it will take time for their review. President Kang said so at a meeting with its press corp at HIRA headquarters in Wonju on June 6. Kang said, “Drugs that have waived pharmacoeconomic evaluations, immunotherapy drugs that have been studied for a short period of time, or drugs for rare and incurable diseases should be evaluated after being listed. We need to conduct long-term follow-up on the effect of these drugs to continue reimbursing effective drugs and removing or switching ineffective drugs.” Regarding the external reference pricing reevaluations that will be conducted using foreign drug prices,Gook-Hee Kim, Director of the Pharmaceutical Benefits Department at HIRA, said, "We are in discussions with the industry to come up with a reasonable and transparent plan. We plan to conduct the reevaluations within the year, but may only be able to release the specific implementation plan at a later time.” The following is a full transcript of Dailypharm’s interview with President Kang. Q. You have been working on a number of projects since your first year in office. What significant achievements and regrets have you had since your appointment? I would like to start by saying that my focus in my first year in office was on the ‘people.’ We sought to help more people benefit through adequate compensation for essential healthcare, which was also a key national agenda. In the lowest low fertility rate crisis, we focused on providing compensation for critically ill and emergency pediatric patients and strengthening the pediatric care system and delivery infrastructure while expanding reimbursement to the public by listing serious diseases such as cancer and brain diseases. While expediting the reimbursement listing of ultra-high-priced drugs, we also contributed to protecting health insurance finances through patient-level performance management. Q. Your organization had completed reorganization in the past year and began full-scale implementation on January 1 of this year. What was the main point and direction of this reorganization? HIRA’s new mission is to ‘Contribute to the Health and well-being of the people by establishing safe and advanced medical environments.’ The reorganization was conducted as a key part of our efforts to achieve this mission. To this end, we have established the Health Insurance Innovation Center, a dedicated organization to review and carry out national tasks such as preventing gaps in essential healthcare and improving the irrationalities in the medical service fee system. We will improve the existing insurance system by remedying the imbalances in the fee-for-service fees and developing various payment systems to create a sustainable compensation system. Also, to improve the management of high-priced drugs that weigh heavily on health insurance finances, we established the Pharmaceutical Performance Assessment Department. We defined high-priced drugs and prepared a performance management system for those drugs to ensure that the system stays effective in protecting public health as well as in managing health insurance expenditures. The 2nd Comprehensive National Health Insurance Plan contains a plan to re-evaluate drug prices by comparing them to overseas prices. I understand that the HIRA prepared its proposal at the end of last year and is in discussions with the pharmaceutical industry. Could you brief us on the time of its implementation, approximate method of reevaluation, and target drugs? (Gook-Hee Kim, Director of the Pharmaceutical Benefits Department) Regarding the external reference pricing reevaluations, we are holding discussions with the industry to come up with a reasonable and transparent method. I believe it will be carried out within the year, but will be able to share the specific timeframe later. When looking at the drug pre-approval review system, quite a few drugs with a very low number of new approvals stand out. I think it can be quite frustrating on the patients’ part to be rejected in the pre-approval process. There needs to be a way to fundamentally remedy this, and I would like to ask for your opinion. Also, could you tell us when the fair compensation on the value of new drugs that were also mentioned in the 2nd Comprehensive National Health Insurance Plan will be implemented? Pre-approval is possible only for the right indications. Therefore, the doctors would first need to accurately file for the right indication. There are also discontinuation criteria, so we need consent on that. Regarding the recent issues in drug reimbursement review, I would like to mention that the pharmaceutical companies first need to submit the required data accurately. A part of the misunderstanding comes from that. The pharmaceutical companies also need to cooperate. We have been working to shorten the review process to within 150 days. So what we want to do is lower the barriers to entry and strengthen the post-approval evaluation process for high-priced intractable diseases and anticancer drugs. The drugs that have waived pharmacoeconomic evaluations should be followed up to see how these drugs are working and if they are effective. Immunotherapies, targeted therapies, and treatment for rare intractable diseases have not been studied on a large scale, so we need to collect a lot of data and evaluate them after the drugs are on the market. Due to opinions on facilitating smoother entry of drugs that have verified their effect through post-evaluations, we are conducting research on that. Through long-term follow-up of listed drugs, we need to continue reimbursing effective drugs and removing or switching ineffective drugs.
- Policy
- Bill for consigned manufacture of advanced biologics
- by Lee, Jeong-Hwan Feb 06, 2024 06:10am
- A bill is being promoted to allow advanced biological products such as cell and gene therapies Kymriah and Zolgensma to be manufactured by government-authorized consignment organizations and facilities. The goal of the bill is to expand the domestic production infrastructure for advanced biological products to reduce the time and cost of manufacture while increasing patient access to treatments. Rep. Hye-sook Jun of the Democratic Party of Korea submitted a bill for the partial amendment to the ‘Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biological Products’ as representative. Cell and gene therapies are highly complicated and expensive to produce as they require the harvesting of patient cells, but if developed successfully, it is highly effective in treating serious and incurable diseases and are therefore attracting attention in the global pharmaceutical market. Currently, most of the cell and gene therapies used in Korea are developed by foreign pharmaceutical companies, and it takes a lot of time and money to send the patients’ cells overseas, manufacture them into therapeutic products, and then bring them back to Korea to be administered to patients. If the therapies can be manufactured in Korea, it will be possible to reduce this time and cost, thereby increasing patient convenience. Rep. Jun explained that she saw the need for this bill in this aspect. In particular, Jun pointed out that even if Korean companies succeed in developing and receiving approval for homegrown cell and gene therapies in the future, it is not realistically possible for all domestic cell and gene therapy developers to build and operate large cell processing facilities for manufacture. Therefore, to encourage the development and use of cell and gene therapies in Korea, Jun explained that it is necessary to reorganize the system and allow proactive consigned manufacture of cell and gene therapies. For this, Jun introduced a bill to allow advanced biological products to be manufactured on consignment by institutions and facilities authorized by the Ministry of Food and Drug Safety. Jun said, "The bill aims to increase patient access to treatment by reducing the time and cost of developing cell and gene therapies as well as time to administering it to patients. It also aims to expand the domestic infrastructure for the manufacture of advanced biopharmaceutical drugs."
- Policy
- Reimb of Enhertu, Ilaris pass DREC review…deemed adequate
- by Lee, Tak-Sun Feb 05, 2024 05:53am
- High-priced drugs such as Enhertu and Ilaris have passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review. This means that they have crossed the 80% mark to reimbursement, as the drugs can now be covered by health insurance after negotiating drug prices with the National Health Insurance Service. The Health Insurance Review and Assessment Service (HIRA) announced that it recognized the adequacy of reimbursement for Enhertu Inj and Ilaris at the 2nd DREC meeting that was held on the 1st. Enhertu Inj is indicated for HER2-positive breast cancer and HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Although it has a high cost, of over KRW 5 million per single administration, it has demonstrated higher survival rates than existing breast cancer treatments. The company had difficulties passing the reimbursement evaluation process for Enhertu due to differences in views with insurance authorities, as the authorities were concerned about financial losses due to the high cost of treatment. This was why the committee failed to conclude the first DREC meeting that was held in January. However, it seems that DREC was unable to delay the decision-making process any longer due to the patient’s continued call for its coverage and the favoring public opinion. Ilaris, which was also deemed adequate for reimbursement with Enhertu at the 2nd DREC meeting, is a treatment for a hereditary recurrent fever syndrome, which affects only 13 patients in Korea. During the NA audit in October, HIRA president Jung-Gu Kang announced that he would make efforts to reimburse the drug as soon as possible. Ilaris is also a high-priced drug that costs KRW 8 million to KRW 100 million per year with once every 8-week dose. However, Ilaris was recognized as appropriate for reimbursement on the condition that the pharmaceutical company submit further evidence in the future. Meanwhile, reimbursement of 7 morning sickness treatments for pregnant women, including Diclectin Enteric Coated Tab, was also deliberated at the meeting. The result was a conditional approval of reimbursement adequacy, deeming the drugs reimbursable if the companies accept a price below the assessed amount.
- Policy
- Price of drugs listed in 2002-2006 may be adjusted next year
- by Lee, Tak-Sun Feb 02, 2024 12:28pm
- The Health Insurance Review and Assessment Service will be selecting drugs subject to reimbursement adequacy reevaluations in 2025. The drugs to be reevaluated next year are expected to be those listed from 2002 to December 2006, before Korea implemented the Positive List System. According to industry sources, the Drug Reimbursement Evaluation Committee met on February 1st to discuss the targets for the 2025 drug reimbursement adequacy reevaluations. After the committee selects the targets, the decision is expected to be finalized through the Health Insurance Policy Deliberation Committee the same month. The target ingredients are expected to be disclosed after the DREC or HIPDC’s decision. However, drugs listed from 2002 to December 2006 will likely be subject to reevaluation in 2025. This is because the 2024 reevaluations are being conducted for 6 ingredients listed from 1998 to 2001. The reevaluations are being conducted sequentially in order of the year of reimbursement. Since the Positive List System was implemented in December 2006 as part of the drug cost rationalization plan, it is expected that drugs listed under the Negative List System will first be subject to reassessments. Subsequently, drugs subject to reevaluation among those listed after the implementation of the PLS are expected to be decided upon through separate discussions. Meanwhile, thioctic acid, pranlukast hydrate, itopride hydrochloride, sarpogrelate hydrochloride, levodropropiaine, mosapride, and formoterol fumarate hydrate are subject to reevaluations in 2024. Of these, mosapride has the largest insurance claims amount, which amounts to KRW 130 billion a year. Sarpogrelate hydrochloride has the second largest amount of KRW 110 billion a year.
- Policy
- Referencing lowest A8 price will result in a supply crisis
- by Nho, Byung Chul Jan 29, 2024 06:05am
- Health authorities and the pharma-bio industry are at an impasse over the implementation of 'A8 external reference pricing reassessments.’ Engaged in a tug-of-war, the two parties have difficulty finding common grounds. The Ministry of Health and Welfare, the Health Insurance Review and Assessment Service, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, and the Korea Research-based Pharmaceutical Industry Association, have been meeting since the end of 2022 and have completed the 5th round of negotiations as of this month, but they have been unable to reach a consensus, with each being busy making mutual claims. The ‘reassessment for the A8 external reference pricing system’ was proposed to add Canada to the existing list of A7 countries (U.S., U.K., Germany, Switzerland, Italy, France, and Japan) as a detailed reference point for drug price reevaluations. During initial discussions, there was talk of expanding the number of countries to A9, to include Australia and Canada, but Australia was removed due to strong public opinion that the 2 countries with the lowest drug prices were selected to cut prices. The issue that remains in the restructured external reference pricing system is that health authorities are sticking to using the lowest listed prices among A8 countries, while the industry believes using the average of the highest listed price is best. The average and median values, excluding the upper and lower extremes and U.S. drug price, are also considered options but are not on the table. Following a comprehensive discussion process scheduled for the end of next month, health authorities are now looking to implement the program as soon as 2025 after an appeal process in the middle of this year. Initially, the A8 external reference pricing system was planned to be applied only to diabetes, hypertension, and hyperlipidemia drugs, but there always remains a possibility that it could be extended to virtually all drugs, including anticancer drugs. If the health authorities adhere to their original proposal, the ramifications of its megatonne drug price cut are self-evident. Moreover, it is likely to add fuel to the fire of essential drug supply disruptions that arose due to the unstable price of drug substances due to the aftermath of the COVID-19 pandemic and the Ukraine-Russia war. In addition, the A8 drug price reference countries do not have a large number of data submission drugs or salt-modified drugs compared to Korea, therefore major price cuts for these drugs are also expected. An industry insider said, "Following the bulk drug price reduction in 2012 and the linkage of drug prices upon fulfillment of the ‘self-bioequivalence tests-DMF registration' requirement in 2019, there is a lack of objective basis for conducting drug price cuts using reference countries overseas that is currently being planned by the health authorities. Imposing such a policy is nothing short of an invasive act against domestic medicines and could lead to a serious industry contraction." As it is common for drug prices to be determined by taking into account all the specificities of the country's economy, society, and culture, therefore, it is not common sense to use the low drug prices set in one or two countries as a reference or standard. In addition, according to some research service data, Korea's generic price is 53.55% of the original price, ranking fourth among OECD countries, so it is difficult to say that Korea has a high drug price structure. The drug price reevaluation using the A8 external reference pricing system had been sparked by a booklet that had been published by Canada’s Patented Medicine Price Review Board, which was released at the 2022 National Assembly Audit, but the booklet seems to be an intuitive interpretation that is far from a precise report, as it lacks the correction values of domestic new drug and generic drug prices at that time and now. In other words, concluding that domestic generic drug prices are higher than those of external reference countries is highly likely to cause distortions in the drug pricing system, as it does not consider how the generic drug prices were set to the high insurance drug prices the multinational pharmaceutical companies received at the time of initial listing. Another industry insider said, "There is a strong sentiment that we should expand the drug price referencing to Canada and use it as a reference point for reevaluation. If the application of the system is expanded to include new drugs introduced from abroad and homegrown new drugs, this may not only discourage R&D efforts but also deprive patients of the right to treatment."
- Policy
- Remote GMP inspections not recognized from April
- by Lee, Hye-Kyung Jan 29, 2024 06:05am
- The GMP inspections, which were temporarily allowed non-face-to-face due to the difficulty of on-site evaluations during the COVID-19 outbreak, are gradually returning to ordinary procedures. After switching the pre-approval GMP item inspections back to full on-site inspections in December last year, the Ministry of Food and Drug Safety (MFDS) now decided to recognize only on-site reports rather than the written reports, which had been recognized for a limited time due to difficulties in conducting on-site inspections. From April 25, the only written reports the MFDS will accept are vendor audit results from on-site inspections. In order to import active pharmaceutical ingredients (API), the company must submit a GMP certificate of API issued by the government or public institution of the country of manufacture. However, when the company seeks to receive a supply of the APIs for the manufacture of finished pharmaceutical products, vendor audit results based on an on-site inspection of the finished pharmaceutical product manufacturer are also recognized as a GMP certificate. Due to the COVID-19 pandemic, It had been difficult to conduct on-site inspections, which was why the MFDS had recognized written inspection result reports. The MFDS stated, "During the COVID-19 pandemic, it was difficult to conduct on-site inspections, which was why we temporarily recognized written inspection reports. However, with the end of the COVID-19 pandemic, we will give a 3-month grace period and then recognize only on-site GMP inspection reports from April." Previously, the MFDS had replaced GMP on-site inspections with remote inspections such as by reviewing PIC/S report data during the COVID-19 outbreak, but since September last year, it has been phasing out the flexibilities that were put in place and started on-site inspections for some items, new drugs, or aseptic preparations, conducting a phased transition back to on-site inspections. As regulatory agencies such as the U.S. and PIC/S have announced that non-face-to-face inspections cannot replace on-site inspections, the MFDS is also converting some parts of the non-face-to-face inspections back to on-site inspections.
- Policy
- Lilly’s UC drug Omvoh is soon to be approved in KOR
- by Lee, Hye-Kyung Jan 26, 2024 05:51am
- Lilly's ulcerative colitis treatment Omvoh (mirikizumab-mrkz) is nearing approval in Korea. Omvoh received U.S. FDA approval in October last year and settled as the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. According to industry sources, the Ministry of Food and Drug Safety recently completed a safety and efficacy review for Omvoh’s marketing authorization in Korea. MFDS’ completion of the safety and efficacy review means that marketing authorization for the drug is imminent. Omvoh is the only ulcerative colitis treatment that selectively binds to the p19 subunit of IL-we and inhibits interaction with the receptor. Ulcerative colitis is a chronic inflammatory disease of unknown cause characterized by inflammation localized in the mucosal or submucosal layers of the large intestine, and the p19 subunit plays an important role in the development of inflammation associated with ulcerative colitis. The FDA’s approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of LUCENT-1 - a 12-week induction study (UC-1) - and LUCENT-2 - a 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. All patients in the LUCENT program had past treatments, including biological treatments, that did not work, stopped working, or that they could not tolerate. After 12 weeks of treatment with Omvoh, 65% of patients achieved clinical response and 24% achieved clinical remission compared to placebo (43% and 15%, for clinical response and clinical remission, respectively). Among those who achieved clinical response at 12 weeks, one-half (50%) achieved steroid-free clinical remission at one year, compared to placebo (27%). Per a post-hoc analysis, 99% of patients who achieved clinical remission at 1 year were steroid-free. Patients in steroid-free clinical remission were steroid-free for at least 3 months prior to the end of the 52-week assessment. In 2018, a Phase III trial for Omvoh was approved by the Ministry of Food and Drug Safety under the same details as the LUCENT program, and completed in Korea. Omvoh was approved in Japan in March and in Europe in June last year.
