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- 2025-12-23 02:31:39
- Policy
- MFDS beings rolling review of Pfizer’s multivalent vaccine
- by Lee, Hye-Kyung Aug 08, 2022 06:09am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) announced that it had started a rolling review on the clinical trial data that Pfizer Korea submitted on the 5th for its COVID-19 vaccine ‘Comirnaty2 Inj. 0.1mg/mL.' Comirnaty2 Inj. 0.1mg/mL. is a multivalent mRNA vaccine that presents antigens for both the original COVID-19 virus (Wuhan strain) and its variant virus (Omicron strain, BA.1) that was developed as a booster vaccine to be received after primary vaccination. The MFDS plans to promptly and closely review the submitted clinical data. When the company applies for marketing authorization and additionally submits non-clinical data and quality data, the MFDS will promptly and closely review the data, and seek experts' advice on the safety and efficacy of the vaccine under review, including infectious disease specialists. The vaccine is also under rolling review in Europe and other countries. The MFDS said, “We will continue to make our best efforts to supply safe and effective vaccines to our people.”
- Policy
- 500 billion won in K-Bio and Vaccine Fund was created
- by Kim, Jung-Ju Aug 08, 2022 06:09am
- The government has finalized a plan to create a K-Bio and Vaccine Fund" worth a total of 500 billion won this year and has started selecting operators. In the future, the government plans to expand the scale to around 1 trillion won. The MOHW (first vice minister Cho Kyu-hong) announced on the 4th that it will report and confirm the plan to create a K-bio and vaccine fund at the emergency economic welfare meeting on July 27 and launch a public offering for the fund formation as a follow-up measure. To form the fund, the MOHW will announce the selection of operators to operate the fund through Korea Venture Investment from the 4th to 2 p.m. on the 26th, and hold a briefing session for fund managers online and offline on the 9th to guide them in detail. Looking at the purpose and plan of fund creation, the K-Bio and Vaccine Fund is designed to develop new global innovation drugs for domestic pharmaceutical companies, enhance competitiveness in the vaccine industry, and enter the global pharmaceutical and bio markets. The MOHW explained that the market size of domestic pharmaceutical and bio companies, new drug development pipelines and technology exports have been increasing significantly recently, and that there is a growing appeal that there is a lack of funds needed. The government predicted that the demand for funding will increase as domestic vaccine and therapeutic agent companies have investment plans such as production facilities worth about 13 trillion won by 2026. In fact, Samsung BioLogics is planned to have 8.74 trillion won, Lotte Biologics 1 trillion won, SK Bioscience 500 billion won, EuBiologics 101.5 billion won, and Amicogen 876 billion won. The K-Bio Vaccine Fund will be created with a total of 500 billion won, including 100 billion won in government investment, 100 billion won in government-run banks (Korea Development Bank, Export-Import Bank, and Industrial Bank) and 300 billion won in private investment. Among them, 50 billion won in government budgets and 50 billion won in existing fund profits, 45 billion won in KDB Development Bank, 30 billion won in Export-Import Bank of Korea and 25 billion won in IBK Industrial Bank of Korea will be invested. The fund's main investment targets are domestic pharmaceutical and bio companies (more than 60% of the total investment) and domestic vaccine companies (vaccine and vaccine raw materials and equipment-related companies, 15%), which can invest in late clinical trials that require large amounts of funds to create successful global innovative new drugs in Korea. Two funds worth 250 billion won will be created to quickly achieve the fund's target and investment will be initiated, and two operators will be selected. The selected operator operates the fund for eight years from the date of establishment of the fund, sets the base return (IRR) at 7%, and allows Fast-Closing to promote rapid investment execution after forming the fund. The K-Bio and Vaccine Fund management companies selected through the management company contest and the selection process in September will raise private investment funds to complete the formation of the fund within the year and conduct full-scale investment from the end of the year. Lee Ki-il, the second vice minister, said, "We plan to expand to 1 trillion won in the future starting with 500 billion won this year." He said, "I hope this fund will serve as an opportunity to revitalize the bio-health industry, and I hope to create cases of developing innovative new drugs in Korea and leap into a world-centered country in the pharmaceutical and bio sectors."
- Policy
- Supply of Children's Tylenol suspension will be normalized
- by Lee, Tak-Sun Aug 07, 2022 11:30pm
- The product license was withdrawn due to the suspension of the operation of the Jansen Hyangnam plant in Korea, but the new product re-licensed due to technology transfer will be listed as starting in August. This includes child Tylenol suspension, and attention is being paid to whether supply and demand will be normalized with new benefits, given that the product has recently been struggling to supply. According to the industry, Ultracet ER, Ultracet Semi, Ultracet Semi ER, and Children's Tylenol suspension will be newly reimbursed as of August 1. The upper limit is the same as before. Following the withdrawal of the Hyangnam plant, the permission for these products was withdrawn in the first half of last year, and the salary was scheduled to be deleted. In response, Janssen was re-approved as a new product by transferring technology to Handok in the case of three types, including Ultracet ER. Children's Tylenol suspension was also newly licensed as an imported item. Three types, including Ultracet ER, were scheduled to be removed in November and Children's Tylenol suspension in September. However, as new products are listed, prescription gaps are not expected to occur at all. Ultracet ER is a product developed directly by Janssen Korea in 2010, not by global Janssen. Since there were no imported items, Janssen Korea decided to transfer its technology to Handok, and has been taking steps. In March, a new product produced by Handok was approved, and this time, it was even paid. Children's Tylenol suspension was approved in early February as an imported item manufactured in Indonesia. However, due to difficulties in supply, products distributed in Australia were urgently introduced in May during the COVID-19 epidemic. Johnson & Johnson Korea, which distributes and sells Children's Tylenol suspension, announced that supply will be normalized in August. Attention is focusing on whether the supply will begin in earnest with this new product.
- Policy
- Security elaboration/ ultra-high-priced new drug coverage
- by Kim, Jung-Ju Aug 05, 2022 06:04am
- In order to strengthen accessibility to new drug patients, the government has steadily increased coverage by opening a benefit gateway. However, due to the development of innovative new drugs, limited funding of health insurance is a problem to catch up with the ultra-high price trend of anticancer drugs and rare disease treatments. The challenge of overcoming the sustainability issue remains a challenge. As Zolgensma, a treatment for Spinal Muscle Atrophy (SMA), called "ultra-high-priced one-shot treatment," was listed on the benefit starting this month, the government considered ways to improve accessibility from the basic definition of expensive new drugs. The procedure for registering new drug benefits in Korea is carried out sequentially by applying for benefits from pharmaceutical companies, deliberating and evaluating the HIRA, negotiating drug prices between the NHIS and companies, and deliberating and voting by the Health Insurance Policy Review Committee. However, it has been pointed out that the accessibility of drugs requiring urgent benefits is disrupted as HIRA deliberation and evaluation usually takes 120 days, 150 days for RSA targets, 60 days for drug price negotiations, and 30 days for review by the Health Insurance Policy Review Committee. The biggest problem is by far the price. The problem of price has been a constant obstacle even in the 2010s, when social needs were not heavily reflected. Since the government and the insurance authorities judged whether or not the salary was paid and the price was the top priority, there were many problems with the appearance of high-priced new drugs. Starting with the introduction of RSA in 2014, the government introduced a permit-evaluation linkage system in the same year and introduced a new economic evaluation data submission system and a drug price negotiation system in 2015 to improve accessibility to high-priced new drugs. With the listing of Zolgensma, the government announced plans to create a definition of expensive drugs that it has been preparing and expand the mechanism for shortening negotiations, while strengthening follow-up management and monitoring. The government will actively adopt a patient-level performance-based model by improving RSA, which used to be a financial base, but strengthen follow-up monitoring to utilize a payment method suitable for treatment effects and improve PVA in operation. In addition, it was decided to prepare a pre-approved standard operating procedure (SOP) before taking ultra-high-priced drugs. In addition, the National Assembly's legislative investigation office says it is desirable to discuss the introduction of a "pre-entry and post-evaluation" method as a new benefit pharmaceutical companies by paying the cost or evaluating the effectiveness of treatment after administration when claiming treatment expenses exceeding the set total benefit. This is the way that related academia and patient organizations have suggested so far, and it can be said that it belongs to the same context in the large framework as RSA's performance-based model. In order to make it common, the authorities and insurers should consider weakening the insurer's bargaining power and devices for effective operation in the process of negotiating drug prices. In addition, the National Assembly also suggested the need to set up a separate fund to solve financial problems that will be affected by strengthening the guarantee of expensive new drugs. This can be referenced in that advanced insurance countries such as the United Kingdom operate various types of drug funding systems as a mechanism for salary exceptions in consideration of uncertainties that arise when there is not enough data to evaluate the value of drugs. The government plans to subdivide the management method and registration process by lowering the speed and evaluation barrier of the benefit entry stage, increasing follow-up monitoring and evaluation, and improving the reference criteria for foreign drug price adjustment in the future. It is important to pay attention to how much more sophisticated the new drug guarantee policy will become in the future, so it is also important to pay attention to the parliamentary audit in the second half.
- Policy
- MOHW reluctant to CVS's request to expand SRADs
- by kang, hae-kyung Aug 05, 2022 06:04am
- The Ministry of Health and Welfare expressed disapproval over the convenience store industry's request that the scope of Safe and Readily Available Drugs (SRADs) should be expanded to antacids and burn ointments for sale at convenience stores. The MOHW explained that the SRAD system is a unique exception made from the healthcare system’s perspective, and that the policy environment is now changing so that drugs may be purchased from pharmacists at public late-night pharmacies or pharmacy vending machines. At the 'Policy Improvement Seminar for the Sustainable Development of Close-to-Life Retail Industry' that was organized by the Korea Franchisee Union and hosted by Seung-Jae Choi's Office of the People Power Party, Tae-Gil Ha, Director of Pharmaceutical Policy at MOHW, reiterated that the SRAD system is a special exception made from the perspective of Korea’s healthcare system. Director Ha said, “Pharmaceuticals are biologically active, and contrary to the claim that ‘no side effects have been reported from the use of SRADs sold at convenience stores, around 200-400 adverse events are being reported annually through the Ministry of Food and Drug Safety and Korea Institute of Drug Safety & Risk Management. Although in principle, pharmacists need to dispense pharmaceuticals, the SRAD system was allowed as an exception for the convenience of the patients for their use at times that pharmacists cannot cover. We are not aware how much SRADs' sales contribute to sales at convenience stores, but we have to put consumer convenience and health first." Director Ha added, “Although there is a claim that the operation of late-night pharmacies is poor, policy changes such as the expansion of public late-night pharmacies and pharmacy vending machines are currently being made. Still, there is much conflict over SRADs in reaching a social consensus.” In other words, in addition to the occupational conflicts that arise among pharmacists, experts have concluded that it is difficult to designate antacid and antidiarrheal drugs as SRADs. Director Ha also noted that contrary to the claims of the convenience store industry, problems such as rule violations on the sellers’ part are also being raised. He said, "Some media outlets have covered how seller compliance violations are made in almost 85% of the cases, and that there is demand for legislation to strengthen seller education and reinforce enforcement of regulations. The lack of a systemic system for dispensing SRADs at convenience stores also acts as a burden.” When a policy signal is issued, pharmacists’ associations deliver the news to local pharmacist societies, but no clear systematic delivery route for such news exists for SRADs in convenience stores. Director Ha said, “Patient convenience is of course most important, but please do understand that national statistics on such a demand are not clear and we have to prioritize patient convenience while ensuring the safety of the healthcare system."
- Policy
- Biogen’s Alzheimer’s disease TX entry unclear in Korea
- by Lee, Hye-Kyung Aug 04, 2022 06:05am
- Introduction of the world’s first Alzheimer’s disease treatment, ‘Aduhelm (aducanumab),’ has virtually become unclear in Korea. The results of the Central Pharmaceutical Affairs Council meeting that was held on July 12th that was recently disclosed by the Ministry of Food and Drug Safety showed that the expert advisory board concluded that the application data filed for an Alzheimer’s disease treatment "was not sufficient to be accepted as a confirmatory clinical trial." Although the deliberated product's name and ingredient were not disclosed in the minutes of the meeting, one committee member mentioned, “Since the FDA approval, the US news had covered how the ‘Biogen's statisticians used magic' to become up with much analysis favorable to Biogen, which it had submitted for accelerated approval.” From the comment, it can be inferred that the item that was deliberated was Aduhelm, for which Biogen submitted an application for approval in July last year. Aduhelm received conditional approval from the U.S. FDA in June last year with a post-approval trial required to verify that the drug provides the expected clinical benefit. The conditional approval made in the US was in itself not easy. In November 2020, the company was unable to satisfy the primary endpoints in the EMERGE and ENGAGE trials, due to which the FDA advisory committee had decided to recommend non-approval due to insufficient evidence proving its effectiveness. However, Biogen further analyzed its clinical data and received conditional approval from the FDA based on efficacy validated in the high-dose group. The clinical trial results that Biogen submitted for marketing authorization in Korea were data that did not satisfy the primary and secondary efficacy endpoints. One committee member said, “It is not reasonable to discuss approval when the data submitted did not achieve the primary efficacy endpoint. The members of the FDA advisory committee opposed to the approval, but clinicians’ position was that the drug should be approved as there is no other treatment available and the biomarkers showed an effect. Many of the advisory board members resigned, opposing the approval.” Another member said, “It is understandable that such discussions arise because there are currently no treatments available in the field of dementia treatment, but from a statistical point of view, there is no controversy that the data submitted was from a failed clinical trial. We will not be accepting additional analysis results on the submitted data after declaring the data non-acceptable.” Most of the members agreed that the clinical data alone cannot be accepted as confirmatory clinical results, and the committee chair also said, “The biomarker part will be discussed afterward. The conclusion that was made this time is that the Phase III clinical trial results cannot be accepted as a confirmatory trial.” Meanwhile, iBiogen’s CEO Michel Vounatsos had resigned at Biogen’s 2022 Q1 earnings release in May, taking responsibility for Aduhelm's poor performance, upon which Biogen announced that it would substantially eliminate its commercial infrastructure for Aduhelm.
- Policy
- Mandatory notification for correctional facilities
- by Kim, Jung-Ju Aug 02, 2022 06:02am
- A bill that stipulates that the MFDS should also notify the MFDS of narcotics prescriptions conducted at correctional facilities and military units will be promoted. Representative Choi Yeon-sook of the People's Power represented the partial revision bill of the Drug Management Act. With the increase in the handling of medical narcotics, the MFDS is reporting related matters from drug handlers through the integrated drug management system to manage the handling of narcotics. It is pointed out that the integrated drug management system cannot confirm the prescription of drugs in the correctional facility, and that it is difficult to confirm the prescription of drugs in the Ministry of National Defense under the current law. The main purpose of this amendment is to prevent misuse of narcotics and to resolve blind spots by stipulating to the MFDS about the prescription of narcotics and prescription of narcotics in the Ministry of National Defense. This bill is based on the premise of the resolution of the "Partial Amendment of the Act on the Execution of Sentences and the Treatment of Detainees" proposed by Choi. Therefore, if this bill is not resolved or revised, it must be adjusted accordingly. This initiative will be joined by Rep. Choi, Kang Min-guk, Kwon Eun-hee, Seo Byung-soo, and Chung Chang-min, Kim Min-seok of the Democratic Party of Korea, Rep. Ryu Ho-jung, and Rep. Lee Eun-joo of the Justice Party , Independent Party Yang Jung-sook and Yang Hyang-ja.
- Policy
- Daewoong sells the original Ebixa
- by Lee, Tak-Sun Aug 01, 2022 09:16pm
- Daewoong Pharmaceutical, which once sought to develop a high-dose dementia treatment Ebixa, sells original drug in Korea instead of giving it up. Ebixa 20mg, a higher dose than the existing product, is expected to greatly improve the convenience of taking it because patients only need to eat one dose a day. According to the industry on the 29th, Daewoong Pharmaceutical, which has signed a joint sales contract with the original company Lundbeck since 2019, will also carry out a copromotion of Ebixa 20mg, which will be listed on August 1. Ebixa 20mg will be listed at 1, 606 won starting August 1. It is twice the price of the existing Ebixa at 803 won. However, it improves the ease of use. Existing Ebixa requires two tablets a day, but Ebixa 20mg, which has increased the dose, requires only one tablet a day. Daewoong Pharmaceutical is conducting domestic sales and marketing of Ebixa in all sectors, including hospitals, hospitals, and clinics, while conducting a copromotion between Lundbeck and Ebixa in 2019. Ebixa is an NMDA receptor antagonist and has a mechanism to alleviate symptoms by inhibiting excessive NMDA receptor stimulation in the brain of Alzheimer's patients. It is the second most commonly used drug after Eisai's Aricept. Based on UBIST last year, Aricept was 86.1 billion won and Ebixa was 16.9 billion won. Lundbeck is counting on this Ebixa 20mg to close the gap with Aricept. It is calculated that as the convenience of taking has improved, the number of Rxs will increase. Daewoong Pharmaceutical also expects Ebixa 20mg to help improve the market share of dementia drugs in Korea. In particular, Daewoong Pharmaceutical attempted to develop 20mg of Memantine directly before Ebixa 20mg was approved in Korea. In April 2020, the MFDS approved a phase 1 clinical trial under the name DWJ1458, which is known as the development of Memantine 20mg.Daewoong Pharmaceutical stopped clinical research after two months of clinical approval. There were various interpretations of this at the time, but the original Ebixa 20mg copromotion solved the curiosity neatly. Aricept had the domestic license right. After that, the license was transferred to Handok, and Daewoong is currently registered as a consignment producer. Daewoong entered the dementia treatment market directly from Ebixa. Ebixa's propaganda is also needed to make up for the reduction in benefit through re-evaluation of its affiliate, Daewoong Bio's brain function improvement drug Gliatamin.
- Policy
- MFDS Minister promises COVID-19 vaccineˑTx support
- by Lee, Hye-Kyung Aug 01, 2022 05:58am
- The Minister of Food and Drug Safety Yoo-Kyung Oh met with COVID-19 vaccine and treatment developers and relevant associations and promised support in the future. On the 29th, the MFDS held an MFDS-Industry roundtable meeting for the COVID-19 vaccine-treatment development support. The meeting was held to discuss the difficulties experienced by developers in conducting clinical trials and MFDS’s measures of support in situations where the development of a homegrown vaccine or treatment becomes imperative due to an epidemic. At the event, the MFDS introduced its measures for support in commercializing such products, listened to the difficulties that the industry experienced in the process of developing COVID-19 vaccines, and discussed measures of MFDS support for the development of vaccines and treatments. Minister Oh said, “Korea is an established leader in the pharma-bio sector that owns both a vaccine and treatment for COVID-19. The MFDS will continue to innovate regulations in the field to support the rapid commercialization of homegrown COVID-19 vaccines and treatments." Also, Oh mentioned that it has been linking development-non-clinical trials, clinical trials-approval & review processes while providing professional support on clinical trial design through the commercialization strategy support task force that had been established in April. Minister Oh said, “We plan to seek more efficient operation of the approval and review process for COVID-19 vaccines and treatments through rapid review, rolling review, etc. while thoroughly reviewing their efficacy and safety through close review and expert advice." Companies and related associations that participated in the meeting expressed their gratitude to the MFDS for enabling easier export of products upon domestic approval, which has advanced its regulations through safety-based regulatory innovation and commercialization support efforts and asked for the ministry’s continued support for rapid vaccine development against variants and clinical trial subject recruitment. The companies said, “It is imperative that the MFDS recruits more review personnel to enable rapid development of the second, third homegrown vaccines and treatments. We ask the MFDS to increase their review personnel and strengthen its expertise.” The MFDS expects the meeting to help identify various difficulties experienced in development and come up with support measures. The ministry added it will do its best to support the rapid development of domestic vaccines and treatments by operating programs specialized for COVID-19 and commercialization strategy support teams - such as ‘Our Vaccine Project’ and the ‘Development-focused support council’ - for the prompt development of homegrown vaccines and treatments.
- Policy
- MFDS announces a series of tasks for innovation
- by Lee, Hye-Kyung Jul 29, 2022 05:51am
- “If the 3 strategies set for the direction of the food and drug administration are the three mountains to conquest for the Ministry of Food and Drug Safety, the 100 National Tasks Roadmap that will be announced soon is like the 100 trees that we will be planting on the 3 mountains." Yu-Kyoung Oh, Minister of Food and Drug Safety, announced so at the ‘Briefing on the Standards for Globally Leading Innovative Food and Drug Administrative Measures ’ that was held at 1:30 p.m. on the 28th. After holding a public debate on regulatory innovation for the pharmaceutical sector on the 21st and the food sector on the 25th, the MFDS finally announced the measures for food and drug administrative innovation at the briefing. The 100 regulatory innovation tasks that will form the detailed tasks under the innovative measures, will be established and announced in line with the 100th day of President Suk-Yeol Yoon’s inauguration. The MFDS’ administrative measures for innovation will be to innovate its regulatory capabilities to a global level, support the global entry of new technologies with guaranteed safety, and enable the public to quickly enjoy the benefits of new technologies. Minister Oh said, “Global entry of drugs in the past had been difficult because the private companies had to seek their own paths of entry after the MFDS completes the approval process. As it is a regulated industry, each country has its own and diverse regulatory barriers." Therefore, the MFDS plans to analyze the global food and drug regulatory policies and operate a strategy task force to allow the industry to enter the global market after penetrating the regulatory barriers set for each country. Yoon-Joo Park, Director-General of the MFDS’s Drug Evaluation Department, said, “New product development has been increasing in the biohealth industry with scientific innovations like AIs as well as environmental changes. We will raise our regulatory capabilities so that passing the regulatory scientific standards set by the MFDS would mean that it could pass those set by global regulatory institutions.” Also, the operation of the three-tier system for regulatory relief that includes outside experts had been further explained at the briefing. (From the left) Yu-Kyoung Oh, Minister of Food and Drug Safety; Sang-Bae Han, Director General for Planning & Coordination; Oh-Sang Kwon, Director-General of the Food Safety Policy Bureau; Yoon-Joo Park, Director General of the Drug Evaluation Department; Sang-Bong Kim, Director General of Biopharmaceuticals and Herbal Medicine Bureau; Nam-Hee Lee, Director-General of the Medical Device Safety Bureau; Suk-Yeon Kang, Director-General of the Pharmaceutical Safety Bureau Sang-Bae Han, Director General for Planning & Coordination, said, “When a company requests regulation relief, the relevant departments first respond and make evaluations at the first tier. If the request is not accepted at in first tier, the company’s request goes on to the second tier and is applied the regulatory verification responsibility system.” The second tier mainly consists of civilian experts who will be determining whether the deregulation request should be accepted. Han said, “If the request is again not accepted at the second tier, we apply the last and final third tier, where the Minister of Food and Drug Safety directly checks the facts and seek for alternatives.” Regarding the ‘WHO Listed Authorities (WLA)’ that is being promoted, Minister Oh said, “The WHO has high regards for Korea’s regulatory capabilities and is reviewing Korea as the first candidate for WLA listing. We will be listed on the WLA at the end of this year at the earliest, and by next year at the latest. Suk-Yeon Kang, Director-General of the Pharmaceutical Safety Bureau, said, “We have started receiving the WLA review from March this year, and 56 countries are currently on the tentative list. Korea is also on the tentative list, but we are being reviewed as the first candidate as the WHO recommended that we receive evaluations as the most qualified country for listing.”
