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- 2025-12-25 17:28:51
- Policy
- Generic for Teribone was approved & the competition began
- by Lee, Tak-Sun Dec 30, 2020 06:02am
- Dong-A ST As a treatment for osteoporosis, generics have begun to be released in the latest bone formation promoting agents. Following Lilly's Forsteo, Dong-A ST's Teribone was also a generic version. The MFDS approved Terrosa 56.5μg (Teriparatide acetate) from BMIKOREA on the 28th. Terrosa is a generic of Teribone subcutaneous injection 56.5 μg and the same ingredient (Teriparatide acetate), which was approved by Dong-A ST in November 2015. This is the first time Generic for Teribone has been licensed. Teribone is a partially synthesized formulation of parathyroid hormone involved in bone formation, and is a product introduced in Korea by Dong-A ST from Asahi Kasei Pharma in Japan. In a clinical trial in Japan, it showed a fracture inhibitory effect that reduced the incidence of vertebral fractures to 78.6% compared to the placebo group. In particular, in Korea, it is treated like IMD because of improved ease of administration than Lilly's Forsteo (Teriparatide), which was licensed in 2002. Forsteo should be injected subcutaneously once a day, whereas Teribone can be injected once a month. In December 2016 by Forsteo and January 2017 by Teribone, benefits were recognized for patients who were ineffective or unable to use existing bone resorption inhibitors. Therefore, it has been in the domestic market in less than four years. Generic for Forsteo was released for the first time and was in competition. In October of last year, Forsteo's biosimilar'Terrosa cartridge' by Daewon was approved. This product was developed by Richter-Helm, a Hungarian-German pharmaceutical joint venture, and was given a re-examination for four years (until October 28, 2023) in recognition of its equivalence with the original. With BMIKOREA's approval of generic for Teribone this time, the number of promoting bone formation drugs of Teriparatide increased to four. Forsteo and Teribone's IQVIA sales last year were 21.7 billion won and 2.9 billion won, respectively. The gap between Forsteo and Teribone is widening. If generics such as BMIKOREA's Teria are sold in earnest following Daewon's Terrosa, it is believed that it will affect the market structure. Terrosa was released last May.
- Policy
- Vaccination will be given for medical staff and the elderly
- by Lee, Jeong-Hwan Dec 29, 2020 06:09am
- The Democratic Party of Korea, the government, and Cheongwadae have decided to start vaccinating COVID-19 from February of next year. On the 27th, the Party, the government, and Cheongwadae held a party government council at the National Assembly to discuss support measures for COVID-19 damage, measures to secure treatment and isolation facilities, and vaccine contracts. The Chief Presidential Secretary Noh Young-min said, "We have already secured enough COVID-19 vaccines to protect our people." He said, "Vaccinations for medical staff and the elderly will begin by February next year. " He said, "Countries around the world will start vaccinating the general public in the second quarter of next year. We will begin vaccinating the general public at a similar time." He explained, "The timing of the formation of group immunity will be similar to that of foreign countries, or it will be faster. The government is making all-out efforts to accelerate this period and is making progress." Lee Nak-yon, Leader of Democratic Party of Korea said, "We will mobilize all available means for the disaster damage subsidy to be executed from January in order to further help COVID-19 victims. We will focus on overcoming COVID-19 outbreak, stabilizing people's livelihood, and recovering the economy.” Kim Tae-nyeon, floor leader, asked, "Financial authorities have an extraordinary awareness of the war situation and drastic financial execution. I request that the government's customized emergency damage subsidies be expanded from '₩3 trillion + α." Prime Minister Chung Sye-kyun said, "We will promote rental support and income preservation measures for small business owners and the underprivileged. We will prepare necessary beds in advance with the possibility of worsening COVID-19."
- Policy
- What are the major systems of the MOHW, the MFDS, & the KCDA
- by Kim, Jung-Ju Dec 29, 2020 06:08am
- From next year, medical expenses for rare diseases and diseases subject to the exempted calculation will be expanded. In addition, the national infrastructure necessary for rapid introduction and verification of the safety and effectiveness of COVID-19 vaccines and treatments using high-tech new technologies will be expanded. The Ministry of Economy and Finance announced on the morning of the 28th a summary of the government's business plan for 2021, which will have a great impact on the public among all government ministry projects next year. In the health care and pharmaceutical industry sectors, reinforcement of coverage for rare and essential targets and reduction of entry into essential medical care and advanced and precision technologies are typical. ◆Ministry of Health and Welfare = Diseases subject to the exempted calculation of health insurance will be expanded from January. The exempted calculation is a type of guarantee that reduces the estimated copayment rate to 10%. The targets for promotion are patients with severe incurable diseases, rare diseases such as keratoconus patients, or 68 rare diseases such as hydranencephaly and severe atopic dermatitis. Newly designated as a disease subject to exempted calculation. For these diseases, the current hospitalization co-pay rate is 20% and the outpatient co-pay rate is 30-60%, and from next month, the inpatient and outpatient co-pay rates will be 10%. In August 2017, health insurance coverage for chest (breast) and echocardiography will be expanded according to measures to strengthen health insurance coverage. The MOHW will expand and apply echocardiography in order from the first half of next year to the chest (breast) and from the second half of next year. Until now, the government has completed health insurance coverage. Beginning with the upper abdomen in April 2018, ultrasound examinations in the lower abdomen and the urinary system in February 2019, the emergency and critically ill patients in July of the same year, the male genitalia in September of the same year, the female genitalia in February this year, and the ophthalmology sector in September will be expanded. In the meantime, despite the high cost-effectiveness of ultrasound, insurance has been applied mainly to patients with four major serious diseases (cancer, heart, cerebrovascular, rare intractable teeth) due to financial burden, but from now on, the disease is affected by the medical judgment of the doctor. Health insurance benefit will be expanded if there is a need for examination due to a disease or suspected disease. The government announced that it plans to discuss specific insurance coverage and medical cost reduction effects, and to prepare related legal procedures later with the medical community. The government has been expanding responsible medical institutions in each region in order to close the gap in essential medical care between regions since last November. This is a project to strengthen cooperation in essential medical services centered on public hospitals, focusing on 15 regionally responsible medical institutions such as national university hospitals, and 35 regionally responsible medical institutions such as local medical centers. The main goal is to establish a system of direct and essential medical cooperation. In addition, the business area in the essential medical field is expanded step by step to develop a cooperation model and carry out the project. It also promotes referrals and transfers between partner organizations. The MOHW is carrying out a project to revitalize medical referrals with the main focus of improving the reimbursement rate system so that exchange of medical information can be activated through an electronic method such as electronic record. This is a method in which a medical institution in a non-capital region increases the fee when it is requested above the general hospital level (including specialized hospitals) in the same city. As a result, the government is expecting to establish the function of each type of medical institution and to ease the focus of patients in large hospitals. In addition, patient treatment and image information will be exchanged through an electronic method so that patient’s referrals can be made. The government explained that this will increase patient safety by ensuring continuity of treatment at the time of referral and return, and increase patient convenience as patients do not have to submit treatment information directly. In addition, it added that it is possible to expect efficient use of medical resources and savings in health insurance finances by reducing duplicate examinations and imaging. In addition, the reimbursement rate system will be improved so that medical institutions in non-metropolitan areas can induce referrals to general hospitals, general hospitals, and specialized hospitals within the same city (17 administrative districts) to strengthen the connection of medical institutions within the local community. A plan is also underway to shorten the period of entry into the medical field with new medical technologies through regulatory innovation of medical devices. The MOHW expanded the targets for the evaluation of innovative medical technologies from last November so that cutting-edge medical technologies such as digital therapeutics and precision medicine can enter the medical field early. Specifically, the number of innovative Health Technology evaluation targets has been expanded from 6 to 9, and the disease group, which was limited to 4 fields, has been abolished, enabling the use of advanced medical technology for various diseases with a large impact on society. ◆The KCDA = The KCDA will expand supportable diseases such as medical expenses for rare diseases from January next year. The KCDA announced a list of additionally designated rare diseases in October this year, and plans to increase support for rare diseases such as medical expenses support and expansion of target diseases for diagnosis next year. From January, the number of diseases subject to the medical expense support project for rare diseases has expanded from 1,014 to 1,078, supporting health insurance copayment. In accordance with the designation of new rare diseases, the number of diseases subject to “genetic diagnosis support for rare diseases” will also be expanded from 126 to 175. Online applications for medical expenses support for people with rare diseases will also be expanded. The scope of the online application for the “medical expense support project for people with rare diseases,” which started in March this year, will be expanded from next September. Specifically, it will expand from low-income health insurance subscribers who do not currently have a support obligation to all low-income household health insurance subscribers, medical benefit patients, and the next higher-ranking out-of-pocket patients who are eligible for deductible deductions regardless of whether they are obligated to support or not. In addition, from next month, free vaccinations for the elderly pneumococcal (PPSV23) will be expanded from the current public health center to a consigned medical institution. The government is temporarily expanding operation of vaccination institutions to consigned medical institutions from June 22 to the end of this year in response to COVID-19 by public health centers this year. If it is expanded to entrusted medical institutions, about 14,000 sites will be added from 256 existing ones. In addition, the KCDA strengthens the protection of personal information exposure of patients with infectious diseases. In the event of an infectious disease crisis, personal information such as the name and detailed address of residence that are not related to the prevention of infectious disease should be excluded when disclosing the route of movement of the patient with an infectious disease. This project will be applied from the 30th of this month. ◆The MFDS = The MFDS will support education and training to nurture experts in regulatory science to strengthen the safety supply of biohealth products and domestic industrial competitiveness from next year. The government explained that it is essential to develop safety technologies that can evaluate product safety, effectiveness, quality and performance in order for biohealth products to which future technologies (AI, application of big data, etc.) are applied to the market quickly. Accordingly, the MFDS will select five excellent universities in Korea and provide more than ₩500 million per year to each university for five years in order to cultivate professional researchers who research safety technology while learning legal knowledge about the licensing of biohealth products In addition, universities that have received applications are planning to cultivate more than 600 new researchers and field experts by establishing master's and doctoral degrees in regulatory science in the field of food and medicine at graduate schools. Product development and safety management for COVID-19 will also be strengthened. The MFDS is planning to reinforce infrastructure, such as verification of the safety and effectiveness of COVID-19 vaccines and treatments using state-of-the-art new technologies, and national testing equipment necessary for rapid domestic supply. All vaccines, including the COVID-19 vaccine, must undergo a lot release from the MFDS after reviewing data on manufacturing and quality control and verification tests for domestic supply. Accordingly, for the rapid and safe national lot release of COVID-19 vaccine, advanced analysis equipment will be added and newly introduced, and a special laboratory will be built. In addition, in order to accelerate the development of a vaccine and treatment for COVID-19, the country plans to designate an “IRB” for rapid review. It shortens the entry period for clinical trials by conducting an integrated review (one time) by IRB for approval of clinical trials conducted by various medical institutions. To this end, the MFDS will regularly review major new information such as side effects of clinical trial drugs to prevent harm to patient safety in advance. In addition, it will provide a platform that can be used for new drug development by transparently disclosing information from clinical trial approval to results, and release a lot of vaccines quickly and safely to successfully overcome COVID-19. In addition, a design for the expansion of patient treatment opportunities and the rights, safety and welfare of clinical trial participants will be established. Mandates education to prevent recidivism in people who commits a crime related to narcotics. Since the 4th of this month, the MFDS has been convicted by a court or notified of a summary order as a mandatory education to prevent recidivism of people who commits a crime related to narcotics has been implemented. The crime related to narcotics is a policy that compulsory completion of an order to attend education or rehabilitation programs necessary to prevent recidivism within 200 hours. In addition, safety inspections for overseas direct purchases will be further expanded. Even though the rate of nonconformity such as overseas fast-purchased food is very high, there are only about 1600 purchase inspections as of this year, and there is a possibility of domestic inflow of hazardous food, and the government inspects it at twice the level of the previous year (3,000 cases) from next year. It plans to expand the number of cases. In particular, the MFDS plans to reinforce the safety management of foods purchased directly from overseas by diversifying inspection targets such as foods of vulnerable groups and foods that are domestic issues from the existing tests focused on improving sexual function, strengthening muscles, and diet food. The MFDS also implements an innovative medical device software manufacturing company certification system to promote rapid commercialization of innovative medical device software. Innovative medical device software refers to a software-only product among medical devices with significantly improved safety and effectiveness compared to existing medical devices by applying advanced technologies such as artificial intelligence (AI) and virtual reality (VR). When manufacturing licenses for innovative medical device software of certified companies, some of the submitted data will be exempted so that innovative products can be quickly released to the market. The special exceptions for certification and permitting of manufacturing enterprises will be implemented within the first half of next year when the relevant regulations are revised.
- Policy
- The MFDS announces it will shorten the lot release period
- by Lee, Tak-Sun Dec 29, 2020 06:08am
- The MFDS announced on the 27th that a preliminary review is currently underway for three items of COVID-19 vaccines developed by overseas pharmaceutical companies, and that a domestic antibody treatment development company is planning to apply for use approval within this month. The MFDS said that it would approve the COVID-19 vaccine with a target within 40 days after application for approval and within 20 days of national lot release. According to The MFDS, the drug approval process begins when a manufacturer or importer applies for product approval, and the company submits the data stipulated in Articles 31 and 42 of the Pharmaceutical Affairs Act to the MFDS' Integrated Drug Information System. The main data to be submitted are non-clinical, clinical and quality data. Non-clinical data is to verify the safety and effectiveness through animal testing before administering a drug to humans, and clinical data can be viewed as data that test the safety and effectiveness of administering drugs to humans (patients). Quality data relates to the manufacturing process control, standards and test methods for quality control of the drug. The MFDS operates a dedicated COVID-19 vaccine/treatment approval review team, and final approval is given by combining the review results of experts in each field and the opinions of external experts such as the Central Pharmaceutical Affairs Review Committee if necessary. The MFDS aims to shorten the existing processing period (180 days or more) through rapid approval review and process it within 40 days. In addition, vaccines, which are biological products, can be distributed and sold only after the national lot release, where the country checks the quality once more. This is a procedure to go through the safety and effectiveness of the vaccine once more. National lot release must be applied by all domestic distributors and approved by the MFDS by conducting a quality inspection for each serial number. In the case of the COVID-19 vaccine, it plan to shorten the existing treatment period (usually 2 to 3 months or more) to treat it within 20 days. Pharmaceuticals can be manufactured or imported only after obtaining item approval, but Article 85-2 of the Pharmaceutical Affairs Law provides for special manufacturing and import procedures. The heads of relevant ministries may request special manufacturing or special import from the head of the Ministry of Food and Drug Safety in order to adequately cope with the pandemic of infectious diseases, and may manufacture or import pharmaceuticals that have not been approved for special manufacturing or import. .Meanwhile, the MFDS reported that a number of companies such as AstraZeneca, Pfizer, Modena, and Janssen (Johnson & Johnson) are conducting phase III clinical trials for COVID-19 vaccine .As of the 25th, Pfizer's vaccine has been approved for emergency use in eight countries (UK, Bahrain, Canada, Saudi Arabia, the United States, Mexico, Kuwait and Singapore) including the United States and the United Kingdom, and conditionally licensed in the European Union and Switzerland .And the Moderna vaccine was approved for emergency use in the United States .In Korea, five products are currently undergoing clinical trials, and most of them are undergoing initial clinical trials (Phase I or Phase I/II) .As for the treatment, Lilly and Regeneron are conducting phase III clinical trials for antibody treatments, and they have been approved for emergency use in the United States .In addition, a clinical trial is in progress to add the efficacy and effect of COVID-19 treatment to existing drugs such as Baricitinib (arthritis treatment) .In Korea, it is said that a total of 15 products (13 components), including antibody treatments being developed as COVID-19 treatment, are undergoing clinical trials.
- Policy
- Stop the politicization of COVID-19!
- by Lee, Jeong-Hwan Dec 28, 2020 07:25pm
- Cheongwadae directly refuted criticism from some media and opposition parties that President Moon Jae-in and the government coping with the lack of efforts to secure COVID-19 vaccine supplies. Since last April, President Moon's instructions regarding securing the corona vaccine have been disclosed, and a strong appeal to stop the political issue of quarantine and vaccines was also included. On the 22nd, Cheong-Wadae spokesman Kang Min-seok said, "The opposition party and the media are exaggerating and distorting as if President Moon didn't care about securing the vaccine, increasing public distrust. We hope this will stop the politicization of vaccines,” he said. This is a direct refutation of the situation that some media recently reported with the title of ``reproaching the staff belatedly'' over securing the quantity of corona vaccine, and criticizing opposition parties. Spokesman Kang said, "President Moon instructed at the staff meeting on the 30th of last month to'secure excess supplies and do not think roughly.'" "On this day, President Moon Jae-in twice said to secure enough, and this was not the first time in November," he said. "Some media said that President Moon did not accept the expert's direct vaccination on February 2, but it was January 20 that the first coronavirus confirmed in Korea." He pointed out, "It is said that he refused to speak directly in June, but it is not true as a result of confirming the minutes of the meeting." According to spokesman Kang, President Moon visited Institut Pasteur Korea in Seongnam City on April 9 and presided over the'Joint Meeting for Corona Treatment and Vaccine Development Industry-Academic Cooperation. At the meeting that day, President Moon pledged, "We will definitely help in the development of treatments and vaccines." On that day, President Moon promised to invest 210 billion won in vaccine development and will stockpile the developed treatment and vaccine (even when the corona is over).” On April 10, President Moon made a phone call with Chairman Bill Gates (Bill & Melinda Gates Foundation) and agreed to expand cooperation in the development of a COVID-19 vaccine and treatment. In May, after the call, the Gates Foundation supported SK Biosciences with $3.6 million in vaccine development. This month, it will select a target of 10 million dollars. On April 12, under the direction of President Moon, a pan-governmental support group for the development of a vaccine for corona treatment was formed and is still in operation. Two days later, at the State Council meeting (April 14), President Moon stressed to the State Council members that "we should use it as an opportunity to increase the level of biopharmaceuticals within the speed of vaccine and treatment development." At the meeting of the chief and advisors on July 20, he said, "The launch of the Smart Korea Fund will play a role in supporting vaccines and treatments." The next day, at an internal meeting, it was reported that SK Bioscience had decided to commission AstraZeneca vaccine. And he urged "supply enough supplies." At a Cabinet meeting on September 8th, President Moon encouraged the development of vaccines and treatments in line with the promotion of the KCDA and ordered "to increase the response to infectious diseases through the establishment of the National Institute of Infectious Diseases under the National Institute of Health and support for vaccine development." At the internal staff meeting on the 15th of the same month, after checking the corona vaccine situation, he instructed "to secure a sufficient amount of vaccine through Kovax and global pharmaceutical companies." The COVAX Facility is a multinational organization for the supply of Corona 19 vaccines. On October 15, President Moon visited SK Bioscience, a corona vaccine development company, to check the development status and encouraged it. President Moon said, “I will not spare support until the end, until it is definitely successful. SK Bioscience is in consultation with global vaccine companies such as AstraZeneca and Novavax. It will be a great force in securing.” He also encouraged, "Even if another country develops first, even if the corona passes, develop until the end for vaccine sovereignty. Be sure to end it." President Moon attended a bio industry event held at Yonsei University International Campus on the 18th of last month and said, "We will show progress in the development of vaccines and treatments, and will introduce antibody treatments and plasma treatments to the market as soon as possible from the end of this year." On the 24th of the same month, at an internal staff meeting, President Moon ordered, "The question of vaccine safety should be based on science and medicine, unless we are careless in the delivery process. Do our best to secure it." On the 8th, President Moon instructed Hong Nam-ki to provide support for securing additional vaccine supplies even if there is a financial burden at a meeting with the deputy prime minister for economic affairs and Minister of Economy and Finance. Spokesman Kang said, "It is a brief summary of the president's vaccination-related actions." He explained, "Because of the presidential order, the government has provided a budget of 218.6 billion won (including the third additional KRW 1936 billion) to secure vaccines. In addition, it has secured 4 million overseas vaccines." He said, "As the President mentioned at the invitational meeting of the fifth part, it is inevitable for the producing country that provided financial and administrative support to the vaccine to inoculate its country first. The vaccination time is also planned to be accelerated with the best efforts." He said, "Because children and adolescents were not subject to vaccine clinical trials, please pay attention to the opinions of experts that 4,400 is a vaccine for the entire population." He said, "The government is making every effort to secure additional quantities and shorten the vaccination period."
- Policy
- RSA-renewed Blincyto and PVA Xalkori pricing reduced
- by Kim, Jung-Ju Dec 28, 2020 06:13am
- Amgen Korea’s Blincyto 35 μg (blinatumomab) renewed the risk sharing agreement (RSA) with the National Health Insurance Service (NHIS) prior to its termination. As a result, the pricing was lowered by 11.4 percent, effective from next month. With surging sales, Pfizer Pharmaceutical Korea’s Xalkori (crizotinib) is now categorized as a subject for price-volume agreement (PVA) negotiation and has agreed to bring down the pricing of each dose by 2.3 percent. The pharmaceutical industry sources reported, the South Korean Ministry of Health and Welfare (MOHW) is working on the said revisions for the ‘List of Reimbursed Drugs and Upper Limit Pricing.’ The finalized revision would be enforced from Jan. 1. Apparently, Amgen Korea has negotiated with NHIS on the RSA renewal and settled on lowering the pricing by 11.4 percent. From next year, the existing price of 2,223,503 won per vial would be reduced to 1.97 million from next year. Newly categorized as a PVA Type Ga (가), Pfizer Pharmaceutical Korea’s Xalkori capsule has undergone pricing negotiation. A new drug listed through a pricing negotiation would be would be categorized as a Type Ga drug, if its total claim of the same product lineups exceeds over 30 percent of the projected claim decided during the pricing negotiation. And then, NHIS and the pharmaceutical company would negotiate and settle on a reduced pricing. The same product lineups mentioned above means a series of pharmaceutical items with identical supplier’s name, administration route, substance and form. The pricing of respective doses of the product would be lessened by 2.3 percent—previously 47,225 won to be 46,139 won for 200 mg, and previously 53,364 won to be 52,137 won for 250 mg. On the contrary, a company voluntarily chose to decrease the pricing as the drug has expanded its reimbursement scope, or the indication. Drug pricing reduction for expanded indication system preemptively reduces the pricing of a drug with new reimbursed indication by taking account of the projected increase or additional claim. Applying the change, Amgen Korea’s Xgeva injection’s (denosumab) existing price of 249,800 won would be brought down to 245,054 won by 1.9 percent.
- Policy
- The MFDS begins preliminary review of Janssen's vaccine
- by Lee, Tak-Sun Dec 28, 2020 06:12am
- Following AstraZeneca and Pfizer, Janssen also applied for a preliminary review to the MFDS for approval. The MFDS announced on the 22nd that Janssen (Johnson & Johnson) has applied for a preliminary review before applying for approval of COVID-19 Vaccine. This vaccine is one of the vaccines that the government has announced plans to introduce, and this time, it has requested a preliminary review of non-clinical and quality data. Accordingly, the MFDS said that virus-vector vaccine team will thoroughly review the toxicity, pharmacological and quality data of the vaccine in advance. The MFDS has formed and is operating two licensing teams for rapid evaluation in preparation for domestic applications for COVID-19 vaccines. The virus-vector vaccine team reviews vaccines developed by AstraZeneca and Janssen, and the nucleic acid vaccine team reviews vaccines by Pfizer and Moderna Vaccine developers can submit data such as quality, non-clinical, and clinical data to the MFDS as soon as they are prepared for preliminary review before applying for approval. The MFDS said it expects to secure time to sufficiently review the safety and effectiveness of the vaccine and shorten the period of review after application for approval. It plans to approve the product permission within 40 days after the application for permission. An official from the MFDS explained, "We will do our best to quickly supply safe and effective vaccines to our people."
- Policy
- Government TF to counteract pricing reduction litigations
- by Lee, Hye-Kyung Dec 24, 2020 06:10am
- The South Korean health authority is seeking for measure to keep their drug pricing reduction decision effective. Until recently, the Ministry of Health and Welfare (MOHW), the National Health Insurance Service (NHIS) and the Health Insurance Review and Assessment Service (HIRA) have been operating a taskforce for pricing reduction litigation and also completed a number of consigned researches. Based on the findings and knowledge gained so far, the authority plans to introduce relevant bills or revise regulations to counteract the pharmaceutical companies’ recklessly filing litigations to halt the drug pricing reduction. An ‘Analysis on Drug Pricing Reduction Litigation Related Administrative Order Suspension and Counteraction Strategies’ the NHIS entrusted Korea University’s industry-academy collaborative team with, and an ‘Analysis on Drug Pricing Reduction Litigation Cases and Seeking Response Plan’ the agency entrusted the Korean Government Legal Service (KGLS) with have been completed recently. On Dec. 17 and 21, NHIS posted the above mentioned details on the public agency management information disclosure system, ‘Alio.’ However, the in-depth information was decided to be kept confidential permanently as it could affect the ongoing litigation cases. The study was carried out while MOHW, NHIS and HIRA were operating the joint TF for months about the pricing reduction litigation. Since MOHW notified the new revision in drug pricing regulation, the court was swarming with large pharmaceutical companies trying to extend the reimbursement period by requesting the administrative notice suspension. Seeing the collective movement growing bigger, the health authority decided to take an action. The start of the government’s action was forming a taskforce for choline alfoscerate drugs currently in process of litigation after the authority announced its plan to reduce the reimbursement after it already enforced the order on single-use eye drops in 2018. The taskforce called for external consigned research and presented government legislation bills to seek measures to prevent pharmaceutical companies excessively requesting for administrative order suspension via pricing litigation. The confidential research report’s table of contents indicated the Korea University industry-academic collaborative team compared and analyzed foreign administrative order suspension system, addressed current status and issues in the existing administrative order suspension related to pricing reduction litigation and recommended prospective improvement. NHIS official explained the reason behind the confidentiality in the research and said, “The research report contains cases of administrative order suspension related to an ongoing litigation and short and long-term counteraction plan. Based on the research outcome, the government would consult with relevant organization to make decisions on the policy.” Highly likely the research report talks of the prospective plan on choline alfoscerate products. And the KGLS research recently turned confidential has compiled review on pricing reduction litigation status, analysis on the court decision regarding the first-in-class drug upper limit pricing adjustment, and pricing reduction notice on drug found providing rebate. NHIS official explained, “If the research result were to be disclosed now, the execution of the policy would be interfered greatly. It could harm the justification and objectivity of the pricing policy.”
- Policy
- TOC prevents the first approval of COVID-19 vaccine in Korea
- by Lee, Tak-Sun Dec 24, 2020 06:10am
- This is a response from the health authorities to concerns that the COVID-19 vaccine developed by AstraZeneca will be introduced in Korea in February-March next year, although approval by the US FDA is delayed. The MFDS is independently screened regardless of overseas institutions. However, Korea's licensing regulations require approval from other manufacturing and marketing countries, if FDA fails. The reason why the domestic authorities believe that the AstraZeneca vaccine can be introduced in February-March is that it is highly likely to be quickly approved by the UK MHRA or European EMA, not the FDA. According to Article 4 (1) 4 of the Regulation on Safety of Pharmaceuticals, etc., in the case of imported products, a manufacturing certificate certifying that they are properly manufactured according to laws and regulations by the government of the producing country or public institution, and the government or public institution of the country where the license is registered. A CPP must be submitted demonstrating that it is being marketed properly. In the pharmaceutical industry, this is called CPP (Certificate of Manufacturing Sales in Importing Country). It must already be used in another country to meet the CPP submission requirements. Therefore, the Ministry of Food and Drug Safety cannot approve the world's first overseas drug development. As AstraZeneca's COVID-19 vaccine is also the world's first overseas drug, the Ministry of Food and Drug Safety cannot approve it first. However, as it is a vaccine made in an urgent situation called Corona 19, there is a possibility of applying an exception. The MFDS has applied the CPP submission obligation only to imported new drugs. And at a briefing session on the 17th, the MFDS announced that it would completely abolish the submission of new drug CPP data. The MFDS said in a press release at the time, "Considering that The MFDS is conducting an independent review on safety, efficacy and quality, we will abolish the obligation to submit manufacturing and sales certificates, which are procedural regulations applied to imported new drugs." With the abolition of CPP, the MFDS was also able to license the world's first overseas drug development. The pharmaceutical industry also welcomes the complete abolition of CPP submissions. Although CPP has been abolished, documents proving data such as non-clinical trials or clinical trials submitted to the previous licensing countries must be submitted. An official in the industry explained, "It is called a TOC (Table of contents) certificate, and it is a document that proves that the same data was produced in the country where it was previously licensed. The country receiving this data should refer to the reference of the country prior to the license." Although the obligation to submit the CPP is abolished, the TOC certificate must be submitted as it is, so the first foreign drug can still be approved by the MFDS only after obtaining permission from another country. An official in the pharmaceutical industry said, "Korea has been classified as a CPP-dependent licensed country so far. It was backwards considering its status as a member of the ICH (International Drug Regulation and Harmonization Committee) or PIC/s (Pharmaceutical Initiative Mutual Cooperation Organization)." Explained. He said, "We expected the abolition of the CPP to lead to increased confidence in the domestic drug approval system. However, it is still difficult to approve the first overseas drug development because of the TOC certificate." He stressed, "To get out of the stigma of an underdeveloped country for permit screening as soon as possible, we must abolish the TOC certificate rather than request it." The MFDS aims to make an administrative notice within this year and complete the revision in the first half of next year on the regulations containing the abolition of the submission of imported CPP data. However, it is said that the content of the revocation of the TOC certificate has not been published.
- Policy
- References related to COVID-19 will not be present
- by Lee, Jeong-Hwan Dec 24, 2020 06:09am
- As the personnel hearing of candidate Kwon Deok-cheol of the MOHW took place in the morning of today (22), the adoption of references such as CEOs of Pfizer and AstraZeneca for inquiries related to COVID-19 vaccine was finally broken due to disagreement between the ruling party and the opposition party of the National Assembly Health and Welfare Committee. The opposition party requested the attendance of the CEO of the Korean subsidiary, a vaccine developer, for questions related to domestic supply and demand plans, vaccination timing, safety and effectiveness from the COVID-19 vaccine purchase contract, but the ruling party was reportedly rejected because it had no direct connection with the candidate personnel verification. According to the National Assembly's Health and Welfare Committee, Chairman Kim Min-seok, Sung-ju Kim, secretary of Democratic Party of Korea, and Ki-yoon Kang, secretary of People Power Party did not reach a mutual agreement on the adoption of witnesses and reference for candidate Kwon Deok-cheol's personnel hearing. As the agreement between the two parties has broken down, as a result, the hearing will be held without witnesses or reference members present. The hearing of the candidate for the MOHW is actually COVID-19 vaccine hearing. The People Power Party applied for CEO of Pfizer Korea/AZ Korea as reference at the personnel hearing. The intention is to inquire about the current issues such as the purchase contract process, domestic supply plan, supply and demand quantity, and actual vaccination timing to the CEO of the Korean subsidiary of COVID-19 vaccine developer with the candidate of the MOHW. The Democratic Party of Korea refused to adopt a reference by the opposition because it was not directly related to the candidate's hearing. Since the introduction of COVID-19 vaccine has already been confirmed and the government is facing additional contracts in addition to products that have completed a purchase contract, such as AstraZeneca, if unnecessary controversy arises at the personnel hearing hall, it may negatively affect additional purchase contracts and negotiations with global pharmaceutical companies. The People Power Party has consistently raised criticism that domestic supply and demand for COVID-19 vaccines is too late. Accordingly, the Democratic Party of Korea has announced its position that COVID-19 quarantine should not be contested. An official from the opposition party's office of the Welfare Committee said, "COVID-19 vaccine-related inquiries are a key issue for candidate Kwon Deok-cheol's personnel hearing. Many members of the opposition party applied for the CEO of Pfizer/AstraZeneca as a reference." "The Democratic Party of Korea unilaterally refused to adopt the reference, and it failed," he explained. An official from the ruling party's office of the Welfare Committee pointed out that "application for a reference person related to COVID-19 vaccine is not related to the personnel hearing of the Minister of Welfare or Candidate Deok-cheol Kwon. Since there are no witnesses or reference persons agreed between the ruling party and the opposition party, this hearing will proceed without interrogation."
