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- 2025-12-22 15:40:06
- Policy
- MOHW's advisory council to respond to US’s Bio initiative
- by Lee, Jeong-Hwan Sep 21, 2022 05:47am
- The government has organized a trade advisory council to address the trade issues that may arise from the National Biotechnology and Biomanufacturing Initiative that the Biden administration launched via an Executive Order. Through the council, the government plans to strengthen communication with the pharmaceutical and bio industry and promptly respond to rising issues. The advisory council, which consists of trade experts, will hold regular meetings every quarter and actively collect industry opinions to reflect on trade policies established in the healthcare and the pharmaceutical industry. Until a specific plan is set to regulate the pharmaceutical and bio industry by the US government, the Korean government will preemptively draw up a policy framework that reflects the difficulties expressed by the industry and establish an organic public-private consultative body. On the 20th, an MOHW official said, “We organized a trade consultative council with domestic industries including the pharmaceutical and bio industries, and held the first trade policy meeting on its regular operation.” Members of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Pharmaceutical Traders Association, Korea Medical Devices Industrial Cooperative Association, Korea Medical Devices Industry Association, Korea Cosmetics Association, and Korean Research-based Pharmaceutical Industry Association attended the policy meeting that was held at the Korea Chamber of Commerce and Industry (KCCI) office by the MOHW and the Korea Health Industry Development Institute (KHIDI). The MOHW recently evaluated that US’s Executive Order for the National Biotechnology and Biomanufacturing Initiative was made to protect its industries and reduce dependence on foreign countries such as China in the pharmaceutical and bio sectors, in addition to the measures it had previously made in the semiconductors and electric vehicles sector. Korean companies that heavily rely on exports to the US are expected to have a negative impact if the US promotes and reinforces domestic manufacturing, but MOHW believes its immediate impact will be limited due to its characteristics, being pharmaceuticals products. The MOHW plans to analyze the impact the Bio Executive Order will have on Korea’s pharmaceutical and bio markets from various angles and strengthen the role of domestic supply networks that have price and technological advantages. In addition, through external expansion of the advisory council by adding industry opinions, the government will enhance its response to trade frictions and regularize roundtable meetings between the government and the pharmaceutical and bio industry around the trade advisory council to respond promptly to trade issues that may arise. An MOHW official said, “The response to the US bio executive order will be decided through pan-ministerial discussions with not only the MOHW but also the Ministry of Trade, Industry, and Energy, etc. Starting with the trade advisory council that covers both the pharmaceutical and bio fields in healthcare, we plan to hold as many meetings with the industry as possible." The official added, “We will hold the first healthcare trade forum this October. Then, we plan to institutionalize, regularize, and activate this forum in the future. Then, we plan to regularly hold forums to share information and inform the industry of the government's direction of response in advance when trade issues arise for their rapid and efficient response.” At the trade meeting, a KHIDI official explained, “The meeting was held to explain the government’s course of direction regarding the difficulties that the pharmaceutical and bio industry may face with regards to the Biden administration’s Bio Executive Order. As it may be difficult for the associations and pharmaceutical and bio industries to take individual action, there was also a request for the government to take the lead in making such response.” The official added, “The trade support counter within KHIDI acts as a channel for communication that responds to questions and requests made by associations and companies for rising trade issues. It will act as part of a network that will be established to directly convey opinions of the Trade Advisory Council.”
- Policy
- Domestic authorization for the Quadrivial Adjuvant Flu Vac
- by Lee, Tak-Sun Sep 21, 2022 05:47am
- With the flu warning issued in September, the beginning of Autumn, an upgraded flu vaccine was also approved in Korea. It is a tetravalent Adjuvant vaccine that can be used for people aged 65 or older, and is a product of a pharmaceutical company called CSL Seqirus, which is still unfamiliar in Korea. The Ministry of Food and Drug Safety announced on the 19th that it has approved Meditip's Fluad Quadrivalent PFS (MF59 Adjuvant). Meditip, a pharmaceutical consulting firm, seems to have been granted the product on behalf of CSL Seqirus, which has not yet been licensed in Korea. CSL Seqirus is a vaccine company that combines the vaccine division of Australian pharmaceutical company CSL and the Novartis influenza division. CSL Seqirus established a domestic branch this year. The approved product is the Adjuvant flu vaccine. The Adjuvant flu vaccine has the advantage of improving the immune response of the elderly with a degraded immune system to increase the preventive effect. Recently, ACIP under the U.S. CDC recommended tetravalent high-performance vaccines, including Fluad Quadrivalent, which contains immune enhancers, for senior citizens aged 65 or older. Fluad Quadriental was licensed in Korea for the purpose of preventing two types of influenza A virus and two types of influenza B virus for the elderly aged 65 or older. In clinical trials, this product proved better preventive effect than existing trivalent products. Attention is focusing on whether CSL Seqirus, including Adjuvant-containing products, will become a new issue in the domestic flu vaccine market led by GC Pharma.
- Policy
- 23 items have been designated as Fast Tracks in 2yrs
- by Lee, Hye-Kyung Sep 21, 2022 05:47am
- Goal of completion of examination within 75% of general examination period. Over the past two years, 23 items of medicine have been designated as Fast track. Specifically, it appeared as 4 items in 2020, 11 items in 2021, and 8 items until July 2022, and the reason for the increase in Fast track designated drugs last year compared to the previous year is interpreted as the impact of the COVID-19 vaccine. The MFDS (Director Oh Yoo-kyung) published a "Fast Track Drug Review Report" on the 13th by launching the "Global Innovative Products on Fast Track (GIFT) Program" to support the development of innovative medical products in Korea. Since August 31, 2020, the Ministry of Food and Drug Safety has established a Fast Track department and has designated and reviewed Fast Track items for innovative products such as life-threatening diseases or treatments for rare and incurable diseases. The items designated as Fast Track for the first time in Korea were AstraZeneca's Selumetinib and Daewoong Pharmaceutical's DWP16001, an innovative pharmaceutical development new drug, applied simultaneously on October 23, 2020. The application for Fast Track designation requires active ingredients, mechanism of action, manufacturing method, preliminary clinical trial data to confirm clinical significance in the disease, and target indications, and the application for designation will be reviewed within 30 days. Over the past two years, a total of 17 items have been approved after the Fast Track designation, including 5 chemicals, 1 biopharmaceutical, 10 COVID-19 vaccines, and 1 biopharmaceutical, with the goal of completing the screening within 75% of the screening period. From August 31, 2020 to July 31, this year, a total of 25 applications for the designation of medical products Fast Track were designated, of which 23 were designated. One of the items applied for designation was not designated due to insufficient data to prove the effectiveness improvement compared to existing treatments, and one was voluntarily withdrawn. Among the Fast Track designated items, 12 treatments for life-threatening or serious diseases, 7 drugs for preventing or treating infectious diseases for public health hazards, and 4 new drugs for developing innovative pharmaceutical companies. By drug group, anti-malignant tumors were 56.5% (13 items), COVID-19 treatments and vaccines 30.4% (7 items), chemotherapy drugs 4.3% (1 item), circulatory mechanical drugs 4.3% (1 item), and diabetes solvents 4.3% (1 item). Of the 17 Fast Track item permits, COVID-19 vaccines accounted for a high proportion of 10 items and 5 items of anti-malignant tumor drugs. Eight of the designated items are currently undergoing screening, and one item has not applied for permission. The average number of fast track days for the COVID-19 vaccine was 26 working days, and the average number of items excluding the vaccine was 51 working days. 22 preliminary reviews have been conducted so far to shorten the period of approval before applying for item permits. In the case of occasional screening using the preliminary review system when performing Fast Track, COVID-19 vaccines such as AstraZeneca, Pfizer, and Janssen applied for the screening. The Ministry of Food and Drug Safety is planning to launch a GIFT program based on its Fast Track experience over the past two years. The GIFT program is a program that supports global innovative medical products from the beginning of development (clinical) to quickly commercialize them, and pharmaceutical companies review designations when applying for Fast Track targets and, if necessary, decide on GIFT targets after consulting the Fast Track expert council. The GIFTprogram targets will receive various support such as applying rolling reviews that examine the prepared data first, close communication between reviewers and developers, regulatory consulting, and clinical results for products with excellent innovation (improvement of safety and effectiveness), submission after market, and preemptive application of global screening standards such as ICH.
- Policy
- GOV engrossed in minimizing damage from US's Bio Initiative
- by Lee, Jeong-Hwan Sep 20, 2022 05:57am
- The Korean government is busy preparing measures to protect the Korean industry from the Executive Order signed in the US by President Biden to launch a National Biotechnology and Biomanufacturing Initiative that focuses on research and manufacturing of pharmaceuticals within the United States, As the US government has not yet finalized its direction in regulating other countries on bio-related matters, the Korean government has also not yet decided on specific measures other than to actively utilize the Korea-US dialogue channel. However, the authorities are planning to seek countermeasures by increasing the frequency of joint ministerial meetings after holding an industry inspection meeting in relevant ministries. On the 19th, the Ministry of Trade, Industry, and Energy announced plans to hold a joint meeting this week with the Ministry of Health and Welfare, Ministry of Food and Drug Safety, Ministry of Science and ITC, etc. to discuss countermeasures. The authorities that will be directly responding to the US's Initiative are MOTIE and MOHW. The MOTIE and MOHW have held individual review meetings with relevant industries and institutions upon US’s decision to launch the Executive Order to launch the Initiative (Bio Executive Order). The MOTIE had discussed countermeasures with KoreaBIO and bio companies, and the MOHW with pharmaceutical and bio companies including the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, based on which the ministries will be sharing results to establish future plans at the joint meeting. In particular, the MOTIE plans to convey the position of domestic pharmaceutical and bio companies at the scheduled ministerial-level dialogue with the US Secretary of Commerce. The Korean government is expected to first prepare measures to minimize the impact of the Bio Executive Order by utilizing all of the Korea-US dialogue channels in each ministry until the US government finalizes specific regulations. An MOTIE official said, “As only the broad framework of the biomanufacturing policy has been yet set by the US, we plan to continue holding joint ministerial and industry inspection meetings until a specific regulatory plan is announced. In order to maximize opportunities for Korean companies and minimize damage, we will discuss the issue through various dialogue channels including the ministerial-level Korea-U.S. supply chain and industry dialogue, etc.” he explained. The official added, “The executive order launched by the US this time has given more weight to promoting its own domestic industry rather than regulating industry of other companies. The MOTIE will be holding a joint meeting with the MOHW and other ministries based on the results of the review meeting it had held with KoreaBIO. As the case may be, the Executive Order may become an opportunity for domestic pharmaceutical and bio companies to advance into the US market.”
- Policy
- 37 Tenelia's generics will soon be listed
- by Lee, Tak-Sun Sep 20, 2022 05:57am
- Earlier this year, Tenelia's generics followed Galvus generics, and the generic drug market for DPP-4 diabetes treatments began in earnest. According to the industry on the 19th, the Ministry of Health and Welfare recently disclosed the registration of Tenelia's generics next month. Tenelia of material patent is expired on October 25th. A total of 37 items of next month to enter the generic market. DPP-4 inhibitor market has used a total of nine species of products had not been released, but a strong patent protection for markets are opening up generic. 18 current generic for Galvus are reimbursed. The DPP-4 generic market is expected to begin in earnest. As a result, it is analyzed that as competition among pharmaceutical companies intensifies, it will affect original drugs that maintained the existing monopoly. In particular, some analysts say that Galvus and Tenelia, which are allowed to compete generically, could weaken their competitiveness among the nine original DPP-4 types.
- Policy
- NHIS negotiations complete for Erbitux·Zerbaxa·Eylea
- by Lee, Tak-Sun Sep 20, 2022 05:56am
- The National Health Insurance Service’s pricing negotiations for Merck’s anticancer drug Erbitux and MSD’s next-generation antibiotic Zerbaxa among others have been completed. In the case of Erbitux, Merck has been conducting drug pricing negotiations with the NHIS upon the expiry of its risk-sharing agreement (RSA) contract. For Zerbaxa, its company, MSD, had been conducting pricing negotiations for its new reimbursement. As both agendas were not listed for deliberation at the MOHW’s Health Insurance Policy Deliberative Committee (HIPDC) meeting last month, industry analysis is that the agendas may likely receive reimbursement approvals at the HIPDC meeting this month. Merck’s Erbitux and Zerbaxa were included in the drug pricing negotiation completion list that NHIS disclosed on its webpage on August 31st. Erbitux (cetuximab) is an anticancer drug indicated for metastatic colorectal cancer and head and neck squamous cell cancer that was approved for reimbursement in March 2014 under the Refund-type RSA in Korea. The company had already succeeded in renewing the agreement once in 2018. Upon its expiry in June this year, Merck has been in negotiations with the NHIS to renew its agreement for the third time. Industry’s prospects on the possibility of RSA renewal have been increasing as Erbitux was included in the negotiation completion list of the NHIS, In the case of Zerbaxa, news of its negotiation completion had already been announced last month. As a result, it is expected that the drug will be added to the reimbursement list after going through the HIPDC review this month. The drug had attempted reimbursement since it was approved in April 2017 in Korea, but had difficulty being listed, being unable to demonstrate adequacy of its reimbursement. However, the government’s coverage expansion plan allowed antibiotics like Zerbaxa to also be included and be eligible to waive pharmacoeconomic evaluations, based on which Zerbaxa was recognized adequate for reimbursement at HIRA’s Drug Reimbursement Evaluation Committee meeting in June. Since then, MSD had been conducting drug pricing negotiations with the NHIS, which were successfully concluded at the end of last month. The NHIS’s disclosure of such has made the negotiation completion official. Zerbaxa is a next-generation antibiotic indicated for use in combination with metronidazole for complicated intra-abdominal infections (cIAI) and complicated urinary tract infections. The antibiotic is receiving particular attention as a ‘super antibiotic’ that can be used against multidrug-resistant bacteria. In addition, the NHIS also announced the completion of drug price negotiations for Takeda's anticancer drug 'Adcetris (brentuximab vedotin)' and Bayer's age-related macular degeneration drug ‘Eylea.’ The drugs have been in negotiations with the NHIS since June under category ‘Type B’ of the Price-Volume Agreement. PVA negotiations under Type B are applied every year when the claims amount increases by over 60% from the previous year, or the rate of increase is over 10% and exceeds KRW 5 billion for drugs in the same therapeutic class for which the maximum amount had already been adjusted according to type A or exceeded 4 years since its initial listing but had not undergone type A negotiations. The price of subject drugs are discounted within the 10% range after pricing negotiations with the NHIS.
- Policy
- Empagliflozin's permission changes
- by Lee, Hye-Kyung Sep 19, 2022 05:56am
- Epilepsy neurosurgery is added to the abnormal reaction of a formulation containing Empagliflozin, an SGLT-2 inhibitor used to treat type 2 diabetes. The Ministry of Food and Drug Safety announced a change in permits based on the results of a review of safety information on Empagliflozin-containing drugs by EC and EMA. The drugs that announce the change of permits are 104 items such as Jardiance, an Empagliflozin-based drug of Beringer Ingelheim Korea, 106 items such as Jardiance Duo, an Empagliflozin and Metformin complex, and SGLT-2, an Empagliflozin and Linaglipin complex. As a result of a review by the Ministry of Food and Drug Safety, "interstitial neurosurgery" is added to the abnormal response term for both Empagliflozin and complex drugs. Serum Li concentrations should be observed more frequently after administration and dose change of Empagliflozin, and patient care should be referred to the doctor who prescribed Li for observation of serum lithium concentrations. The review opinion inquiry on the change of permission (proposal) will be held until the 30th. Meanwhile, SGLT-2 inhibitors, which started as type 2 diabetes treatment, are expanding their scope to heart failure. Last year, SGLT-2 inhibitors were recommended as a major drug for chronic heart failure treatment in domestic heart failure treatment guidelines.
- Policy
- Drug price negotiation completed 307 drugs in 2022
- by Lee, Tak-Sun Sep 16, 2022 05:53am
- The number of drugs that completed drug price negotiations between the NHIS and pharmaceutical companies increased significantly from 15 years ago. As drug price negotiations began in earnest in 2007, the expansion of PVA negotiations is believed to be the cause. According to the NHIS' recent list of drugs that completed drug negotiations, the number of drugs that completed drug negotiations exploded from only 10 in 2007 to 307 in 2020. Drug price negotiations began in May 2006 with the introduction of a "plan to optimize drug costs" to stabilize health insurance finances. At the end of that year, guidelines for drug price negotiations were enacted, PVA negotiations as well as new drug drug negotiations, and later RSA were introduced. Looking at the number of drugs that have completed annual drug price negotiations, the number exceeded 100 for the first time in 2009 and surpassed 200 in 2011. 2020 is the only drug that has completed more than 300 negotiations. Last year, 238 drugs completed drug price negotiations, and 273 drugs have already completed drug price negotiations by August this year. As 172 items completed negotiations in the PVA multi-type negotiations in August, the number of drugs that completed drug negotiations has already exceeded last year. This year, Lutathera, Vitrakvi , Rozlytrek, Lorviqua, Zolgensma, Fexuclue, Donerion patch, Zerbaxa also successfully completed drug price negotiations. However, the number of drug price negotiations completed is increasing, but there are also disappointing opinions in the pharmaceutical industry. In particular, there are many calls for quick registration of salaries by shortening the duration of drug price negotiations. The corporation recently revised the guidelines for drug price negotiations, predicting that drug price negotiations will be shortened from 60 days to 30 days for treatments for severe and rare diseases without alternative drugs.
- Policy
- “GOV to prove causal relationship of vaccine side effects"
- by Lee, Jeong-Hwan Sep 16, 2022 05:53am
- The ruling party has set out to enact a Special Act to obligate the nation to compensate for damages caused by COVID-19 vaccinations. The Special Act was proposed because the compensation for damages caused by COVID-19 vaccinations currently implemented by the government is too passive in recognizing the causal relationship between vaccination and its side effects. To address this, the new law strengthened the government’s duty of post-vaccination management by obliging the Commissioner of the Korea Disease Control and Prevention Agency to bear the burden of proof when a dispute related to side effects, such as diseases caused by vaccination, arises. On the 14th, People Power Party member Gi-yun Kang submitted a bill to enact a ‘Special Act on Compensation for Damages from COVID-19 Vaccinations’ as a representative. Currently, vaccinations are being conducted and the damage compensated by the state under the “Infectious Disease Control and Prevention Act” to prevent the spread of infectious diseases and to promote public health. NA Rep. Kang pointed out that the current national compensation system is very passive in recognizing the causality between adverse reactions from vaccinations and vaccine’s side effects. To address this, Kang proposed a bill that can provide compensation to victims by including the adverse events and side effects from vaccinations as damages caused by vaccinations. If passed, the bill will prioritize compensation for damages arising from vaccinations above other laws. Also, for damages caused by vaccination, the state will pay national compensation after deliberation and resolution by the Vaccination Committee. In particular, in resolving disputes about damage caused by vaccination, the burden of proof will be borne by the Commissioner of the Korea Disease Control and Prevention Agency. Also, the Special Act included a provision to establish a Vaccination Committee that can check the causal relationship between vaccination and arising diseases to raise the public’s credibility.
- Policy
- The introduction of Moderna COVID-19 vaccine has begun
- by Kim, Jung-Ju Sep 16, 2022 05:53am
- Moderna's omicron mutation (BA.1) bivalent vaccine of 1.611 million doses will be introduced in Korea sequentially from today (15th). According to the Korea Centers for Disease Control and Prevention, 805,000 doses will arrive at Incheon International Airport on the 15th and 806,000 doses on the 17th, respectively, and will be used for winter vaccinations in October after the Ministry of Food and Drug Safety approves the lot release. The vaccine to be introduced this time is a divalent vaccine containing two antigens (the virus and omicron mutation BA.1), and was approved by the Ministry of Food and Drug Safety on the 8th. The detailed implementation plan for winter vaccinations using divalent vaccines will be announced at the end of September when divalent vaccines are prepared. The government will continue to closely consult with pharmaceutical companies for a stable supply of vaccines, and will promptly guide the additional supply schedule as soon as it is set. The authorities have contributed to the international community through overseas donations along with related ministries such as the Ministry of Foreign Affairs, and have donated a total of 4.86 million doses to nine countries since last year. In addition, 4.83 million doses of the AZ vaccine, which was distributed through COVAX, were also provided to COVAX without introduction in Korea.
