- LOGIN
- MemberShip
- 2025-12-22 15:40:06
- Policy
- The flu-coronavirus outbreak has been predicted
- by Kim, Jung-Ju Sep 15, 2022 05:55am
- Amid the prevailing pessimistic outlook that flu and COVID-19 will be all the rage at the same time this fall, quarantine authorities stressed that flu and COVID-19 vaccines should be vaccinated respectively. This is due to similar symptoms such as headaches and fever, which can be mistaken, and people are confused by rumors that "if getting the flu vaccine, pts don't have to get the COVID-19 vaccine." Jung Ki-seok, head of the COVID-19 Special Response Team at the Central Disaster and Safety Countermeasures Headquarters, explained this in a Q&A session at a regular COVID-19 briefing this morning (14th). According to Jeong, the flu and COVID-19 are not often distinguishable from symptoms, but the expected flu is not much different from the influenza A types H1N1 and H3N2 that they have experienced before, so the symptoms are not expected to be significantly different. "The flu has a very typical symptom that only the flu has," Jeong said. "It starts with a sudden fever, aching body, and a headache, and it is effective to take medicine within 48 hours, when the virus is relatively less proliferation," he explained. "Not all flu symptoms follow typical symptoms," Jeong said. COVID-19 Some patients may suddenly have a fever and get sick, but doctors may know a lot from experience because the symptoms of the typical flu and the typical COVID-19 are very different. However, in order to ensure accuracy and not to rely on experience, the test must be performed," he stressed. Jeong dismissed the false information such as "the COVID-19 vaccine helps prevent the flu," as "a groundless rumor." "Children should receive both vaccines at the same time as they do every season," he said. "On the day they visit the hospital, they can get both vaccines to arms at the same time." Jeong then recommended simultaneous vaccination, saying, "The Korea Centers for Disease Control and Prevention will soon announce the national vaccination project, and if the second flu vaccine comes out in early October, it can be received along with the COVID-19 vaccine."
- Policy
- Lowest price falls to PVA
- by Lee, Tak-Sun Sep 14, 2022 05:50am
- Despite the increase from 1.5 billion won to 2 billion won based on claims, the industry "needs small and medium-sized pharmaceutical remedies." Some products fell to the lowest price under PVA this year. Most of the products of small and medium-sized pharmaceutical companies lost money. According to industries on the 12th, some products such as Dongkoo's Glyforce fell to the lowest price in the same formulation due to this PVA. Glyforce fell 7.7% from 482 won to 445 won under the PVA. As a result, it has become the lowest price among 51 capsules of Choline alfoscerate 0.4g, a brain function improvement. Richwood Trading Company's single-use Hyalon Eye Drops also saw two products fall to their lowest prices. Hyalon Eye Drops (single use 0.35 mg/0.35 mL) fell 9.6% from 198 won to 179 won. Hyalon Eye Drops (0.45mg/0.45mL for a single use), which has been equally reduced, is also the lowest price among 26 identical products. Arlico's hyperlipidemia drug Pitavastatin 2mg also became the lowest-priced product. This product fell 9.6% from 561 won to 507 won. The lowest price due to PVA cuts is mainly from small and medium-sized pharmaceutical companies. The NHIS raised the standard for product claims from 1.5 billion won to 2 billion won while improving the exclusion target of PVA. The move was aimed at relieving small and medium-sized pharmaceutical products with low sales. However, there are still opinions that want to improve as a number of small and medium-sized products are included in the PVA cut. The NHIS is also conducting research services to improve PVA by the end of the year.
- Policy
- GOV·Pharma starts work to localize 57 essential medicines
- by Lee, Jeong-Hwan Sep 13, 2022 05:52am
- The government and the pharmaceutical industry have entered the final stages of localizing the finished drug products and active pharmaceutical ingredients that are essential for national disease control and prevention as well as the treatment of emergency patients. The supply of such products and ingredients has been mainly dependent on imports despite the evident need to be manufactured and produced in Korea due to low profitability. Among drugs that are imported from 3 or fewer countries and therefore are vulnerable supply-wise, those from highly export-dependent countries of China, Japan, and India will be finally confirmed, upon which the government and the pharmaceutical industry plan to cooperate in securing domestic production technologies. The movement bears significance as it is the first time the government and the pharmaceutical industry joined forces to fundamentally increase the self-sufficiency rate of rare or essential drugs that are subject to stable supply measures in Korea. On the 12th, the Korea Orphan & Essential Drug Center (KODC) announced that it has tentatively finalized the list of 21 finished drugs and 35 APIs that are deemed to be in need of domestic technology development after discussion with the Ministry of Food and Drug Safety (MFDS) and Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), and will be collecting opinions from the industry as its last step. After collecting and reviewing opinions submitted by pharmaceutical companies, the KODC will hold an expert advisory meeting and finalize the list. Indications for the 21 tentatively confirmed finished drugs that were chosen due to the diseases’ difficulty in treatment or rarity of their patient group were treatments for emergency hypertension, ulcerative colitis, multiple myeloma, phosphorus excretion, acute heart failure or bradycardia, iron deficiency in patients unable to take oral medications, parasitic infection, adrenogenital syndrome, malignant hyperthermia, iron intoxication, methanol intoxication, Dravet syndrome, etc. Subject products were: Nitroprusside injection, mesalamine suppository·powder, melphalan tablet, bromocriptine oral tablet, sevelamer powder, etomidate injection, amiodarone injection, imiquimod cream, isoproterenol injection, ferric carboxymaltose hydroxide Injections, clarithromycin injections, pentamidine injections, fludrocortisone tablets, nisoldipine tablets, amiodarone hydrochloride tablets, dantrolene sodium injections, deferoxamine injections, dehydrated ethanol injections, stiripentol capsules, anakinra injections, etc. The 36 active pharmaceutical ingredients that were imported from countries with high import-dependency such as China, India, and Japan, are used for Brucellosis tularemia plague, Wilms' tumor, anthrax·plague·tularemia, drug-induced dystonia, Parkinson's disease, acute and chronic diarrhea, hypothyroidism, invasive fungal infection, supraventricular tachycardia, sepsis, tuberculosis, patent ductus arteriosus in preterm infants, Cushing's syndrome, atrophic vaginitis kraurosis vulvae, etc., that pose a fatal threat due to terrorism risk or in disease control and prevention in the nation, or have a rare patient group. The subject ingredients are Levodopa/benserazide tablet, loperamide capsule, liothyronine tablet, lincomycin hydrochloride capsule, voriconazole injection, bisoprolol tablet, salbutamol inhalent, adenosine injection, amiodarone tablet, amikacin injection, Amphotericin B injection, edaravone injection, ethambutol tablet, captopril tablet, clindamycin injection·capsule, pyridoxine injection, albendazole tablet, ketoconazole tablet, etc. The KODC plans to finalize the selection of drugs in need of stable supply after holding an expert advisory meeting on their selection criteria and considering their individual need for development, etc. In addition, in consideration of the potential for domestic development, industry interest, and the international supply network status of drugs that are not on the candidate list, the KODC will be collecting opinions on finished drugs and APIS that the industry believes are in need of domestic manufacturing technologies. A KODC official said, “We ask pharmaceutical companies that have separate opinions on our drug list selection, such as addition or deletion of items or the need for priority development, to submit their reviewed opinions and reasons. We will also be identifying pharmaceutical companies that are willing to produce products that are not yet approved for the manufacture of finished pharmaceuticals on paper, such as APIs in the Drug Master File system that are only being imported in Korea.”. Meanwhile, KODC is in charge of the MFDS’s research project on establishing a stable supply system for products with concerns over unstable supply and demand, focusing on National essential medicines that are used in public health crises.
- Policy
- Paxlovid is contraindicated with other concomitant meds
- by Lee, Tak-Sun Sep 13, 2022 05:51am
- PaxlovidPiroxicam was excluded from the list among drugs that should not be taken with Paxlovid, an oral COVID-19 treatment. As a result, the number of combination contraindications has decreased to 16, but there are many contraindications, making it difficult for patients with chronic diseases who take drugs every day to take Piroxicam. The HIRA announced on the 5th that it will delete the Piroxicam-containing drug among the concomitant of the drug Paxlovid (Nirmatrelvir+Ritonavi) and Pfizer Pharmaceutical, which were approved for emergency use in COVID-19. Piroxicam is a nonsteroidal anti-inflammatory drug and] is used to relieve inflammation such as arthritis. Until now, Piroxicam has been one of the 17 contraindicated drugs for Paxlovid. This drug should not be taken with Paxlovid due to severe respiratory inhibition or hematological abnormalities. The KDCA last week ordered related ministries to exclude Piroxicam from contraindicated drugs according to overseas safety information, which is believed to have been reflected by the Ministry of Food and Drug Safety and the HIRA in the DUR. Although Piroxicam is excluded, Paxlovid is contraindicated with drugs which are Amiodarone, Ergotamine, Pimozide, Sildenafil, Simvastatin, Flecainide, Lovastatin, Alfuzosin, Pethidine, Ranolazine, Dronedarone, Colchicine, Clozapine, Triazolam, Propafenone, Methylergonovine.
- Policy
- Approval of Boryung’s new SCLC drug Zepzelca imminent
- by Lee, Hye-Kyung Sep 08, 2022 05:58am
- Boryung Pharmaceutical’s new drug for small-cell lung cancer (SCLC), 'Zepzelca inj, (lurbinectedin) is soon to be granted marketing approval in Korea. Currently, Hycamtin inj (topotecan)’ and ‘Camtobell Inj (belotecan)’ are approved for second-line use in Korea. According to industry sources on the 7th, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Zepzelca recently. With the safety and efficacy review complete for the drug, it is highly likely that Zepzelca will be approved soon if no variables arise. Zepzelca is an anticancer drug for which Boryung owns exclusive rights to development and sales in Korea. After signing a technology introduction agreement with the Spanish pharmaceutical company Pharmamar in 2017, the company has been coordinating the period for its domestic introduction after the drug received FDA marketing approval on June 15th, 2020. The FDA approved Zepzelca for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Zepzelca 3.2 mg/m2 is administered as a 60-minute infusion every 21 days, and treatment is continued until disease progression or unacceptable toxicity. The drug may be administered in an outpatient setting when appropriate, and the 21-day administration schedule has the advantage of reducing the time required for treatment in the hospital compared to its other options.
- Policy
- MOHW to provide premium pricing support for innovative drugs
- by Lee, Jeong-Hwan Sep 07, 2022 05:52am
- The Korean government has emphasized the need to enact subordinate statutes to give preferential treatment to new drugs manufactured by Korea Innovative Pharmaceutical Companies and promises to prepare policy support. This announcement reflects the authorities’ determination to find a way to provide preferential treatment for drug prices based on the “Research service for the preparation of subordinate statutes for preferential pricing of drugs developed by Korea Innovative Pharmaceutical Companies that correspond to the international trade order.” However, the government had also expressed practical difficulties in its implementation, as providing pricing support for specific pharmaceutical companies, despite its legal basis, can lead to trade conflict. On the 6th, MOHW answered so to the written inquiry submitted by the People Power Party member Jong-Sung Lee regarding the preferential pricing of drugs developed by Korea Innovative Pharmaceutical Companies. NA member Lee inquired on the reason why no actual support is being provided for such companies despite legal grounds provided under the Special Act On Fostering and Support of Pharmaceutical Industry, and the MOHW’s opinion on the need for subordinate statutes to support the legal grounds. To the inquiry, the MOHW answered that although a clause for providing pricing premiums to Korea Innovative Pharmaceutical Companies does exist, the authorities must exercise caution in providing support to specific companies as this can lead to international trade conflict under international trade laws. If the final supports implemented under the act are concentrated on Korean companies, other countries may file a complaint under the WTO subsidy agreement, etc. In particular, the ‘Premium drug pricing system for global innovative new drugs’ that had been announced on July 7th, 2016, to provide preferential treatment for drugs developed by such companies, had been deleted in December 2018 as a discriminatory factor as a result of negotiations on amendments and modifications of the US-Korea (KORUS FTA). Despite such realistic difficulties, the MOHW expressed its will to enact subordinate statutes for the preferential drug pricing clause of the Special Act On Fostering and Support of the Pharmaceutical Industry. In addition, the MFDS said it will prepare measures for policy support that aligns with the international trade order and does not trigger trade conflict. The MOHW said, “We agree on the need to enact subordinate statutes to foster the Korean biohealth industry. However, the matter needs to be approached in comprehensive consideration of its impact on the domestic pharmaceutical industry, its compliance with the international trade order, its fiscal impact on NHI finances, etc.." It added, “We will also contemplate preparing policy measures for preferential pricing of new drugs manufactured by Korea Innovative Pharmaceutical Companies. And examine various angles to prepare drug pricing support that complies with the international trade order. The authorities also announced their operation plan for the Roadmap on supporting homegrown new drugs. The MOHW explained, “The government will support the full cycle of new drug R&D processes, investing ₩2.2 trillion through the pan-government National New Drug Development Project (2021-2030). With the support, we will start introducing a smart clinical trial system in 2022 to establish an environment for large-scale clinical trials and new drug development.” "We are also reviewing preparing measures to support continous new drug development for pharmaceutical companies by establishing large-scale funds in the pharma and bio industry."
- Policy
- What's patient-centered safety in the biopharmaceutical era?
- by Lee, Hye-Kyung Sep 07, 2022 05:52am
- Along with the application of the world's first CAR-T cell therapy Kymriah and Zolgensma, an alternative treatment for spinal proximal phagocytosis (SMA), the biopharmaceutical era has opened in Korea. Controversy over safety and accessibility has not yet been resolved in the process of innovative biopharmaceuticals being developed and used to treat patients. Seo Kyung-won, director of NIFDS, who attended the debate, said, "It seems to be the first session related to patient safety during the 8th session of the GBC," adding, "Thinking about how and at what point patients' opinions should be contained should begin from now on." Director Seo said, "Although it was not actually implemented due to the spread of COVID-19, we wanted to provide a place to listen to the stories of patients who participated in clinical trials of anticancer drugs developed in Korea at expert meetings such as the Central Pharmaceutical Review Committee." Director Seo expressed his willingness to directly hold the patient's opinion, saying, "It is a task I really want to do in the future." What is the controversy over biopharmaceutical safety and accessibility? Lee Hyung-ki, a clinical pharmacology professor at Seoul National University Hospital who was in charge of the topic presentation, pointed out safety problems such as unexpected side effects in clinical trials on patients due to the nature of biopharmaceuticals. Professor Lee said, "A skin injection reaction that did not occur in a preclinical trial of an innovative biopharmaceutical company in Korea occurred in a clinical trial of a patient," adding, "Biopharmaceuticals have unexpected problems, and the safety of long-term administration has not been clinically confirmed." Professor Lee's opinion is that as more innovative biopharmaceuticals have been developed and used to treat patients, the issue of safety should not be underestimated after approval. Regarding biopharmaceutical safety, the industry showed a slightly different idea. Choi In-hwa, executive director of Roche Korea, said, "Stability is under follow-up management such as management and post-marketing management to carefully review data when the Ministry of Food and Drug Safety approves products." Executive Director Choi said, "There are drugs that have been approved in foreign countries, but have not been approved in Korea, and in some cases, benefits are applied after two to three years of approval due to complicated benefit processes." Executive Director Choi said, "We have no choice but to be upset from the perspective of patients who are threatened with rare and incurable diseases or lives." Choi added, "There are products from the introduction of innovative new drugs such as rapid approval system, rare disease designation system, permit-drug link system, rare disease law, RSA, and PE exemption, but improvement is needed because there are not enough systems that reflect patient opinions." Critics of drug accessibility were also pointed out by patient groups. Lee Eun-young, director of the Korean Association of Patient Organizations, said, "The right to access drugs should start with permission." She noted, "Kymriah took more than a year to get approval from the Ministry of Food and Drug Safety after FDA approval, and it took 13 months to register benefits." Director Lee said, "Quick permission and benefit registration are important issues," adding, "The Yoon Seok-yeol government will be established and the Ministry of Health and Welfare will carry out pilot projects and main projects so that approval and drug price negotiations can be carried out at the same time for rapid registration." An important phrase here is the establishment of a cooperative relationship with the Ministry of Food and Drug Safety. Director Lee said, "If the Ministry of Food and Drug Safety does not grant prompt permission, rapid registration is useless," adding, "If a pharmaceutical company applies for an item permission, the Ministry of Food and Drug Safety must approve it and then go through the HIRA and the NHIS procedures." At this time, he emphasized that "the accessibility of new drugs will be stabilized only when patients are centered, and it will be a patient-centered policy that the Ministry of Food and Drug Safety is talking about." The association also agreed that the Ministry of Food and Drug Safety's patient-centered policy can be realized only when patients have access to new drugs. Park Jung-tae, vice chairman of the Korea Biopharmaceutical Association, said, "In foreign cases, patient safety is reflected in the policy," adding, "It is important to secure therapeutic access to patients by opening the way for active participation in regulatory science." The Ministry of Food and Drug Safety also expressed a consensus on this point, but explained why it is practically difficult. Jung Hyun-chul, head of the Ministry of Food and Drug Safety's bio-policy department, said, "The keywords of today's debate are the same as rapid screening and rapid approval," adding, "With the introduction of the Breakthrough Designation system in the U.S. in 2015, Korea also enacted the Breakthrough Drug Development Promotion Act the following year, but it was scrapped." The scrapped bill calls for introducing an occasional review to review the results of each product development process even before applying for permission to boost the development of miracle drugs and shorten the approval period. It also includes the basis for the conditional permission system, such as priority screening before other drugs so that innovative drugs can be supplied to terminal cancer patients in a timely manner, submitting clinical trial data that can confirm the effectiveness of the drug, or prescribing only specific trained medical personnel. "Because rapid approval and screening are really necessary for high-tech biopharmaceuticals, the 2019 Advanced Biopharmaceutical Act was passed, and a bill related to drugs responding to the public health crisis was prepared due to the spread of COVID-19 in 2020," said Jeong. He said, "As it requires a lot of manpower as well as the burden of reviewers, recruitment of manpower should be done." There was also an explanation for the approval of the therapeutic purpose of overseas clinical trial drugs currently being promoted. "Overseas clinical trial drugs are expected to be used for a small number of patients," Jeong said. "The problem is that there should be a great burden as the KFDA judges have to proceed with permission only with doctor's medical certificates and opinions without seeing any non-clinical data and quality data."
- Policy
- Antiemetic Emend's generic benefit after 15 yrs since origin
- by Lee, Tak-Sun Sep 07, 2022 05:51am
- Emend As the generic of Emend will be applied starting this month, the burden of drug prices for patients is expected to decrease. It is the first time in 15 years that generic for Emend capsule has been reimbursed since the original was listed. According to industries on the 5th, Acepharma's Atant 80mg and Atant 125mg have been registered as benefits since the 1st of this month. Emend of MSD Korea is used in combination with corticosteroids and 5-HT3 antagonists, and was registered in April 2007. The 5-HT3 antagonist which ends with Setron is a popular drug. The market size is also large, so generics have also come out a lot in 5-HT3 antagonists. Aprepitant has not been released in the meantime, perhaps because of its strong partner drug nature, which is used in combination with 5-HT3 antagonists. Of course, the market size is also smaller than the 5-HT3 antagonist. Based on IQVIA, Emend's sales peaked at 6 billion won in 2019, followed by 5.2 billion won in 2020 and 4.8 billion won in 2021. Acepharma started developing generic for Emend in 2018 and succeeded in obtaining the first generic license among domestic pharmaceutical companies in January. And it was registered as of the 1st of this month. As Emend's generic Attant is registered, the burden of drug prices for patients is also reduced. Emend 80mg is listed at 11,044 won and Emend 125mg at 13,570 won. Atant was listed at 59.5% of the original price due to the addition of First Generic, with a big difference of 6,571 won for 80mg and 8,074 won for 125mg. Of course, the drug price is expected to be lowered to 70% before the addition of the original Emend is completed due to the registration of the generic. Acepharma received a license for the drug import business in 2016 and received a total of four import items, including anticancer drugs. The office is located in Munjeong-dong, Songpa-gu, Seoul.
- Policy
- Enactment of preferential pricing sublaws slow
- by Lee, Jeong-Hwan Sep 06, 2022 05:51am
- The enactment of subordinate statutes for the so-called ‘preferential drug pricing for Korean Innovative Pharmaceutical Companies’ clause of the ‘Special Act On Fostering and Support of Pharmaceutical Industry’ is hardly picking up speed. Although the research service ordered by the Ministry of Health and Welfare and the Korea Health Industry Development Institute and conducted by Professor Mi-Hye Park’s research team at the School of Pharmacy at Sungkyunkwan University, has been completed, the authorities are known to be having difficulty in preparing the specific provisions for the statute. On the 5th, the MOHW responded that it is “supplementing the final result reports, including survey results, etc” to the separately written inquiry submitted by the NA Health and Welfare Committee regarding the results of the research service on the preparation of subordinate statutes for preferential pricing of drugs developed by Korean Innovative Pharmaceutical Companies. The study had been conducted after specific subordinate statutes under the ‘Special Act On Fostering and Support of Pharmaceutical Industry (hereinafter “Special Act for the Pharma Industry”) for preferential pricing of drugs developed by Korean Innovative Pharmaceutical Companies had not been established for several years. The MOHW had previously pointed to how preparing subordinate statutes for the preferential treatment of Innovative Pharmaceutical Companies could trigger international trade conflict due to the violation of WTO and FTA agreements. However, the MOHW had initiated related studies through KHIDI after receiving much criticism at the NA audit from members of NA’s Health and Welfare Committee, including In-Soon Nam and Byung-Won Kang of the Democratic Party of Korea, and Byung-Won Kang of the People Power Party. 국내 제약사들은 혁신형 제약기업이 만든 의약품의 보험가격을 우대하는 제약산업특별법 제17조의2 조항이 위임한 하위법령이 수 년째 공백상태인 현실을 개선해 약가를 지원해야 한다는 입장이다. The study was completed earlier this year and the result report was submitted to KHIDI in May, but the results have not been disclosed to the public yet. With the research results undisclosed for nearly 4 months, some have been speculating that the government may not have been able to come up with a clear policy to provide drug pricing support for Korean Innovative Pharmaceutical Companies that do not cause trade conflict. In fact, the MOHW had agreed on the need for a drug pricing support policy for Korean Innovative Pharmaceutical Companies in line with the international trade order to reinforce technology innovation and financial competitiveness of Korean companies to foster them to become global leading companies and lay the mid-to-long term foundation for the development of innovative new drugs but was unable to present the research results. The research was conducted to survey the current status of drug pricing policy in Korea and abroad, collect opinions on drug price support for Korean Innovative Pharmaceutical Companies, review the need to provide pricing support for Korean Innovative Pharmaceutical Companies, prepare a pricing support policy measure for Korean Innovative Pharmaceutical Companies that align with the international trade order, and analyze data requested by organizations involved in establishing pricing support policiies for Korean Innovative Pharmaceutical Companies. However, on its key results, the MOHW is only repeating the explanation that it is supplementing the final result report, including the industry survey results, etc. An official from a domestic pharmaceutical company said, “It will be hard to come up with a clear plan to support drug pricing for drugs developed by Korean Innovative Pharmaceutical Companies without sparking trade conflict. The research team is known to be specifically contemplating measures to provide preferential treatment to Korean Innovative Pharmaceutical Companies with the industry survey results.” The official added, “Whether the policy research results will be publicly disclosed and lead to the enactment of subordinate statutes of the Special Act for the Pharma Industry will depend on what measures the research team, MOHW, and KHIDI will come up with. It will be significant if this leads to essential drug pricing support for products produced by Korean Innovative Pharmaceutical Companies, even if at a relatively narrow range."
- Policy
- The goal shorten the development of mRNA vaccine to 100 days
- by Lee, Hye-Kyung Sep 06, 2022 05:51am
- SK Bioscience, which developed Korea's No. 1 COVID-19 vaccine, aims to shorten the development period of the mRNA vaccine to 100 days and create innovative technology that can be supplied to the world within six months. #1 Choi Chang-won, vice chairman of SK Discovery's CEO, gave a keynote speech at the "2022 Global Bio Conference" held at Grand InterContinental Parnas in Seoul on the 5th on the importance of global cooperation to respond to the next pandemic. SK Discovery is a holding company of SK Bioscience. SK Bioscience obtained the item license for the COVID-19 vaccine SKYCovione from the Ministry of Food and Drug Safety for the first time in Korea on June 29, and has been vaccinated in earnest since the 5th. Vice Chairman Choi said, "SKYCovione is a remarkable and innovative achievement in that it has shortened the development of vaccines that take more than 10 years to two years while developing global products with high safety and effectiveness." "This is the result of global and domestic collaboration in all processes, including funding, R&D, clinical trials, production and licensing, and supply in the early stages of development," he analyzed. The development of the nation's No. 1 COVID-19 vaccine is the result of cooperation and support from the Korean government and global partners. Vice Chairman Choi added, "We will make efforts to secure the long-term and sustainability of SK Bioscience as well as global healthcare in Korea and developing countries with a sense of debt." Referring to the delay of one to two years from the SKYCovione development process to the WHO application, he said he would make efforts to develop vaccines within 100 days required by the CEPI and to provide global fairness within 6 months required by the Gates Foundation. Vice Chairman Choi said, "Speed seems to be the most important thing to prepare for the Next Pandemic based on various experiences," adding, "We have shortened the vaccine development period from 10 years to 2 years, but innovative technologies are absolutely needed as we have to shorten it to 100 days." Although there seem to be many impossible tasks like when the COVID-19 vaccine was developed, Vice Chairman Choi believes that the development period can be shortened if it is prepared in advance. SK bioscience explained that it is preparing to maintain active and close global partnerships, develop innovative technology platforms, strengthen research and production infrastructure, and strengthen clinical and licensing capabilities. In particular, by 2024, Pangyo R&D Center will be relocated to Songdo to become a global R&PD (Research & Process Development) center, which is five times larger, and Andong Plant will be expanded to more than double the production of products that meet GMP standards. Choi said, "The goal is to double the production of Andong plants by 2024 and triple by 2026. "If global cooperation proceeds, flexible production facilities such as Andong plant are needed." He said, "We will produce and supply the necessary vaccines in each region, and we will convert them as soon as a pandemic occurs to make a pandemic vaccine." Vice Chairman Choi said, "For the 100-day vaccine development operation, preparation is needed at the clinical and approval stage." "At the government level, the Ministry of Food and Drug Safety should prepare and train for the next pandemic by strengthening investment and cooperation in the bio R&D ecosystem and greatly increasing manpower," he said.
