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- 2025-12-25 13:57:35
- Policy
- COVID-19 vaccine vaccination rate has exceeded 64%
- by Kim, Jung-Ju Mar 15, 2021 08:24am
- COVID-19 vaccine vaccination rate has exceeded 60%. As the AstraZeneca vaccine is recommended for those over 65 years of age, the quarantine authorities decided to introduce an additional 7 million doses (for 3.5 million people) from the end of May. Joon-wook Kwon, the 2nd vice-president of Central Disease Control Headquarters, explained this trend through a regular briefing of COVID-19 Central Disease Control Headquarters during the day (11th). According to him, as of today's 0 o'clock, an additional 51,100 new people were vaccinated, and the first dose of COVID-19 vaccine was completed for 500,635 people, and the inoculation rate reached 64%. By vaccination institution and target audience, 175,454 people (85.9%) in nursing hospitals, 75,690 people (69.7%) in nursing facilities, 27,226 people (36%) in the first responder, and 209,334 (62.3%) in medical institutions and above, and 12,931 (22.7%) people were vaccinated in COVID-19 patient treatment hospital. Looking at the current status of COVID-19 treatment administration, the treatment 'Veklury (Remdesivir)' was administered to 4,975 patients in 122 hospitals as of 0 o'clock on the 10th. COVID-19 antibody treatment 'Regkirona (Regdanvimab)' was administered to 381 patients in 44 hospitals based on the same criteria. The vaccination promotion team announced that it will introduce 7 million doses (for 3.5 million people) of AstraZeneca vaccine from the last week of May to the end of June. This is the amount of individual contracts that will be introduced as the second, following 1.57 million doses of this product, which was first introduced from February 24th to 27th. The quarantine authorities are continuing to negotiate with pharmaceutical companies to secure quantities of Moderna and Janssen products that will be used for vaccination starting in the second quarter. He said that in medical institutions such as nursing homes and hospitals, there were cases in which the vaccine could not be used due to an accidental deviation in the temperature of the vaccine due to problems such as negligence during the storage of the vaccine. He said, “Due to a breakdown in the refrigerator, an abnormal thermometer, and carelessness of the person in charge of vaccine management, 770 doses of vaccines have been suspended at 7 medical institutions so far. We will continue to strengthen the supervision of consignment medical institutions in cooperation with local governments and the Ministry of the Interior and Safety.” He added, “Please keep and manage the vaccine thoroughly so that it does not happen that the vaccine is discarded due to minor carelessness even at the consignment medical institution.”
- Policy
- Cases of Vivozon & Binex need ‘1+3 Regulation Act’
- by Lee, Jeong-Hwan Mar 15, 2021 06:29am
- Following Binex, Vivozon illegally manufactured medicines in violation of the Pharmaceutical Affairs Act. As a result, the '1+3 Regulation Act' legislation that directly limits the number of drug became valid. The reason was the domestic licensing system and regulatory environment in which too many generics could obtain marketing licenses. Vivozon's incident made ‘1+3 Regulation Act’ even more necessary. According to the National Assembly and pharmaceutical industry officials on the 12th, Binex and Vivozon incidents further necessitated a legislative 1+3 Regulation Act for generics and data submission drugs. 1+3 Regulation Act was proposed by Rep. Yeong-Seok Seo (Democratic Party of Korea) and Rep. Jeong-sook Seo (People Power Party)'s ‘Drugs for data-based re-evaluation 1+3 restriction' amendment to the Pharmaceutical Affairs Act is pending in the National Assembly. Drugs for data-based re-evaluation 1+3 restrictions were opposed by some pharmaceutical companies and the MFDS' opinion was cautious, but the generic 1+3 Regulation Act was approved by many pharmaceutical companies and the MFDS. It is expected to pass if only the opportunity for examination is obtained at the temporary National Assembly in March. If the generic 1+3 Regulation Act is passed, the data submission drug (IMD) 1+3 regulation, which will be discussed, will be also valid. Binex and Vivozon incidents are accelerating the legislation of Drugs for data-based re-evaluation 1+3 restriction. Rep. Seo Young-seok appealed to the necessity of expediting the passage of the 1+3 Regulation Act immediately after Binex crisis. An MA (Market Access) manager at a top domestic pharmaceutical company said, "In fact, many pharmaceutical companies and the KPBMA have been consensus for a long time in the joint bioequivalence 1+3 regulation to resolve the generic mess." "Only some small pharmaceutical companies that are difficult to test for their own bioequivalence were opposed," he said. "But, as the government's regulatory policy on generic drug prices, generics without bioequivalence testing will no longer be sold on the market." He said, "The passing of the generic 1+3 Regulation Act (by Seo Young Seok) due to the Binex and Vivozon incidents is a pre-determined fact. The ruling party, the opposition party, and the government have the same opinions, so it is highly likely to pass." He added, “The quality manipulation situation has further increased the validity of the regulatory bill. It is pointed out that too many drugs have been released in the market, and the regulatory authorities are also not able to manage quality.” An official from the National Assembly's Health and Welfare Committee said, "The generic 1+3 Regulation Act was a bill that had a great influence on the domestic pharmaceutical industry, front-line medical institutions, and pharmacies, but it was a bill that was not well understood by the public." "If public opinion raises a strong issue in the case of low-quality drug distribution or quality-manipulated pharmaceutical companies, the National Assembly will inevitably have a legislative law reflecting public opinion." He said, "It is not because of the public opinion that the examination of the bill changes, but the speed of examination and promotion of the bill will be faster. In addition, the interest of the National Assembly members will also increase. The results of the internal investigation by the MFDS will also affect the validity of the 1+3 bill."
- Policy
- AZ vaccination recommended for age 65 or older
- by Kim, Jung-Ju Mar 15, 2021 06:28am
- The Vaccination Specialist Committee recommended AstraZeneca COVID-19 vaccination for people 65 years of age or older. Accordingly, the quarantine authorities decided not only to immunize them, but also to immunize patients and workers in nursing hospitals and facilities during this month. The COVID-19 Vaccination Promotion Team (Director Eun-kyung Jung) announced on the 11th that it has decided in this way following the deliberation of the '6th Vaccination Specialized Committee in 2021' on the 10th. The committee reviewed the results of studies in the UK and Scotland and recommended the use of the AstraZeneca vaccine in hospitalization and severe prevention in the evaluation of the elderly. Previously, the UK said that Pfizer and AstraZeneca vaccines prevented similar levels of disease (about 70%) and confirmed the effect of preventing hospitalization among the elderly in their 70s or older. In Scotland, Pfizer and AstraZeneca vaccines showed up to 85% and 94% of hospitalization prevention effects, respectively. The COVID-19 Vaccination Promotion Team plans to immunize approximately 376,000 people aged 65 or older and workers in nursing hospitals and nursing facilities in accordance with the deliberation result of the Vaccination Committee. In addition, the Vaccination Committee deliberated on detailed implementation standards for the second vaccination for those who were confirmed as COVID-19 after the first vaccination and those who responded to anaphylaxis. As a result, the committee decided that if COVID-19 was confirmed among the first inoculations, the second inoculation should be performed, and that it is possible after the quarantine is lifted. For the timing of vaccination, if the confirmed person received passive antibody treatment, vaccination should be performed after at least 90 days, and otherwise, it was recommended to complete the vaccination according to the recommended vaccination interval for each vaccine. The recommended vaccination interval is 21 days for Pfizer vaccine and 8 to 12 weeks for AstraZeneca vaccine. Among the primary inoculations, the vaccination subjects with anaphylaxis reactions were decided not to perform the second vaccination because there is insufficient evidence for cross vaccination with another platform, Pfizer's mRNA platform, and AstraZeneca vaccine's viral vector platform vaccine. In addition, considering the current supply status of AstraZeneca vaccine and clinical trial results that the longer the vaccination interval, the longer the vaccination interval was applied, the 2nd vaccination schedule was decided to change to 10 weeks when the vaccination interval was applied. In fact, on the 10th of last month, WHO SAGE recommended that the vaccination interval of AstraZeneca vaccine is 8-12 weeks, considering that the longer the vaccination interval between the 1st and the 2nd vaccination increases, the more effective it is. The Vaccination Specialist Committee included in the 2nd quarter vaccination target group to block the outflow of mutant viruses for flight attendants who are subject to the exception of self-isolation, although they often come and go abroad due to their occupational characteristics. About 20,000 people, including crew members of international airliners belonging to Korean airlines, are covered. The COVID-19 Vaccination Promotion Team plans to establish a second quarter vaccination plan according to the deliberation result of the Vaccination Expert Committee and announce it next week.
- Policy
- MFDS drug review result to be disclosed within 2 months
- by Lee, Tak-Sun Mar 12, 2021 06:23am
- The pharmaceutical review result for new drug would be disclosed within two months from the completed date. Compared to four months taken at the moment, the information disclosure deadline would be cut by two months. Regardless of the affected company’s request for non-disclosure, the summarized information would be publicly opened to improve the people’s right to know. South Korea’s Ministry of Food and Drug Safety (MFDS) has convened an online seminar on pharmaceutical approval on Mar. 11 and explained the revised regulation. In last December, the ministry drew a guideline up and informed in advance of the information disclosure. Deputy Director Kim Byoung-sam at MFDS Approval Management Team explained, “The ministry has decided to disclose the relevant information due to the heightened social interest on the medical products with the growth in the healthcare industry, and increasing demand for transparency.” Even now, MFDS discloses an item approval review result on its website. The information disclosure scope not only includes new drug, but also the evidence-required drug and generics. However, the information disclosure has been frequently delayed by complicated procedure or even omitted when requested for confidentiality by the applicant company. MFDS is to shorten the time to information disclosure from four months to two months by streamlining the currently two-tracked pre and post-approval procedures into one. Particularly, the information disclosure subject review and report composition taking 60 days and company survey for the disclosure taking 30 days would be dropped. Instead, the ministry would survey the company’s opinion on the information disclosure while the approval review is ongoing, and the information would be posted on the official website after reviewing to opinion. And also the ministry would publish a summarized approval review report from now on, although it used to omit some information requested for confidentiality by the company. Deputy Director Kim elaborated, ”When the confidentiality request is adequate, the result could be undisclosed, but the summarized approval review would be disclosed.” The review summary report would include details on the final approval status, approval condition, incrementally modified drug designation, result of Central Pharmaceutical Affairs Deliberation Committee consultation, preliminary review summary and result, and review history.
- Policy
- 3 drugs including Baricitinib are covered for COVID-19 tx
- by Kim, Jung-Ju Mar 12, 2021 06:22am
- Baricitinib, Corticosteroids, low-molecular weight heparin, and anticoagulants are covered to be used to COVID-19 confirmed patients. Kaletra (Lopinavir + ritonavir), Hydroxychloroquine, and Ribavirin were decided to be removed from the benefit. The MOHW decided to partially revise the notification of details on the application standards and methods of pharmaceutical benefits for drugs in order to properly apply insurance for COVID-19 treatment drugs. and announced on the 11th that it will inquire industry opinions. The main goal of this amendment is to clearly define the target of confirmed patiens with COVID-19 in the COVID-19 treatment (general principle), and the main goal is to clarify the drugs to be covered by reflecting the opinions of the society and recommendations of clinical practice guidelines. Corticosteroids, low molecular weight Heparin and anticoagulants, and Baricitinib are newly added. According to the MOHW, Corticosteroid will be added in accordance with the recommendations for administration of Corticosteroid in severe COVID-19 patients in clinical practice guidelines. LMWH (Low-molecular-weight heparin) and new anticoagulants are recommended to be administered to hospitalized patients as COVID-19 increases the risk of blood clots in the opinions of related society and clinical practice guidelines. In the case of new anticoagulants, it was decided to be covered if the patient's condition is unable to administer low molecular weight heparin. In the case of Baricitinib, considering the fact that Remdesivir & Baricitinib can be administered as an alternative if Remdesivir cannot be administered in the clinical practice guidelines and related opinions of the society, it is planned to be added as a covered drug. Remdesivir decided to be covered when administered concurrently with Baricitinib. Kaletra, Hydroxychloroquine, and Ribavirin were excluded from treatment. The MOHW decided to delete it from the target drug due to the fact that it was not recommended in the clinical practice guidelines and the evidence for clinical usefulness was insufficient. and it is planning to inquire about the revised bill by the 24th and apply it as of April 1st if there are no specific issue, and conduct a review one year after the implementation.
- Policy
- SK-manufactured AZ vaccines for export exceeds domestic use
- by Lee, Tak-Sun Mar 12, 2021 06:22am
- The volume of AstraZeneca COVID-19 vaccine manufactured at SK Bioscience Andong plant for export cleared for lot release has exceeded the volume for domestic supply. The AstraZeneca Korea COVID-19 Vaccine manufactured by SK Bioscience was authorized on Feb. 10, which the National Lot Release cleared 1.57 million doses of it on Feb. 17. Since then, South Korea’s Ministry of Food and Drug Safety (MFDS) has been consistently approving the lot release for the export use. MFDS official reported on Mar. 10, 18 serialized batches were approved for export as of Mar. 9. As each serial number is given on 300,000 doses, basically about 5.4 million doses for export were cleared of lot release. The export volume triples the 1.57 doses approved of the lot release for domestic use. It means more of the domestically manufactured vaccines are supplied to foreign countries than to South Korea, as AstraZeneca is managing the batch distribution. An industry insider elaborated, “Apparently, they have stocked up COVID-19 vaccines manufactured at Andong plant. But because AstraZeneca, as a client for the consignment production, controls all steps from approval to lot release, it cannot be helped.” The exported lots are supplied as COVAX Facility, and recently those batches were designated to nearby Asian countries. Fortunately, South Korea would receive additional batch of AstraZeneca vaccines from COVAX Facility. The government announced AstraZeneca vaccine doses for about 350,000 people would be designated by COVAX Facility within this month and total doses for 1.05 million people, including the doses for 700,000 people in April through May, would be designated to South Korea. Highly likely the batches designated to South Korea would be manufactured by SK Bioscience. But the vaccine maker could speed up the approval process as the batch could be manufactured outside of South Korea. When applying for authorization in last January, AstraZeneca requested the authorization on two items—the vaccines made by SK Bioscience and imported from Italy.
- Policy
- Italy restricts export of AZ vaccine, including Korea
- by Lee, Tak-Sun Mar 11, 2021 06:07am
- It is an analysis that the EU's policy to restrict the export of the COVID-19 vaccine produced in Korea is highly likely to affect Korea. In particular, it is expected that the recent restriction on the export of AstraZeneca vaccine produced in Italy to Australia could directly affect the supply and demand of vaccines in Korea. This is because the AZ imported vaccine, which is currently undergoing approval review, is a product manufactured in Italy. According to foreign media, on the 4th, AstraZeneca requested export to Australia for 250,000 doses of COVID-19 vaccine produced at the Italian factory, but was rejected by EU authorities. The EU has a policy to allow export by examining the quantity requested for export other than the supply within the EU. The Italian-made AstraZeneca vaccine is also highly related to Korea. In January, AstraZeneca applied for a COVID-19 vaccine license, including a vaccine produced by SK Bioscience in Korea and two imported vaccines supplied by an Italian factory. Among them, COVID-19 vaccine produced by SK Bioscience received final approval on February 10, and the imported vaccine produced in Italy is currently under review. Some are raising the possibility of including Italian imported vaccines among the AZ vaccines supplied by COVAX for 1.05 million people that will be introduced from the end of this month to May. Therefore, it is interpreted that prompt product approval is necessary for the smooth supply of imported vaccines. It is known that the MFDS is also in a hurry to permit the AZ vaccine. However, even if permission is obtained prior to supply, it is analyzed that there is little possibility to receive normal supply as the EU restricts exports from overseas. Therefore, it is expected that all of AZ vaccines by Covax must be supplied as a product of SK Bioscience to relieve supply and demand anxiety. It is reported that the government is also in consultation with Covax for this purpose. An official from the government said, "There is a possibility that some imported vaccines will be included in the quantity of AZ vaccines by COVAX, so I know that the government is in consultation with COVAX. However, it is expected that an import license will come out soon, so even if the actual import volume arrives, it is unlikely that it will undergo special import procedures like the case of Pfizer vaccine."
- Policy
- MFDS reviews sales ban on Binex-manufactured generics
- by Lee, Jeong-Hwan Mar 10, 2021 06:27am
- The impact of the allegation on Binex manipulating the manufacturing method and active ingredient dosage in six drugs including antidiabetics and antidepressants is snowballing within the pharmaceutical industry. Source confirmed South Korea’s Ministry of Food and Drug Safety (MFDS) has started reviewing administrative measure to be ordered on generics produced by Binex Busan Plant 1 as a contract manufacturing organization (CMO), which was found to have violated the Pharmaceutical Affairs Act. The ministry has already ordered manufacturing and sales ban on the six products the company decided to voluntarily recall. On Mar. 9, MFDS official explained “The ministry is reviewing the necessity and validity of ordering manufacturing and sales ban or recall on bulk generics manufactured in the same manufacturing plant as six items Binex voluntarily reported of illegal change in manufacturing method. The decision in administrative measure would be officially announced promptly.” The health authority’s action would much complicate the impact the Binex incident has brought onto the South Korean pharmaceutical industry. Four out of six Binex items the ministry imposed the administrative measure were generics manufactured as CMO. CMO generics are drugs by a pharmaceutical company with marketing authorization and another manufacturer with production facility entrusted to manufacture the product. For instance, a pharmaceutical company wins a MFDS marketing authorization on a certain generic, and signs a consignment deal with another pharmaceutical company capable of drug production to manufacture the authorized generic. Basically, the products are made by the CMO, as entrusted by the authorized company, and because the generics made by the both companies are exactly the same, they are labeled as “bulk generics” or “twin drugs.” MFDS is now considering on imposing same level of administrative order as the six items on those bulk generics manufactured at Binex Busan Plant 1 under the consignment deal. On Mar. 7, the ministry imposed administrative measure on six Binex items including antidiabetic Amorin tablet (glimepiride), antidepressant Xelectin capsule and Xelectin 10 mg capsule (fluoxetine hydrochloride), antiarthritic Daxfen tablet (dexibuprofen), anti-inflammatory Rofsin 250 mg tablet (ciprofloxacin hydrochloride) and antihypertension Cadil 1 mg tablet (doxazosin mesylate). And four items—Amorin tablet, Xelectin capsule, Xelectin 10 mg capsule and Rofsin 250 mg tablet—are manufactured by Binex under consignment deals. Three pharmaceutical companies, 13 companies, 15 companies and seven companies have entrusted Binex to manufacture Amorin tablet, Xelectin capsule, Xelectin 10 mg capsule and Rofsin 250 mg tablet, respectively. These are twin drugs manufactured in the same production line at the Binex Busan Plant 1, where generics that accused of fabricating manufacturing method and ingredient dosage and received administrative order were manufactured. As the health authority is considering on ordering sales ban and recall on the bulk generics, the pharmaceutical companies with the products would take a massive hit on their business. MFDS official said, “A related department is currently reviewing the administrative measures on the bulk generics manufactured at Binex Busan Plant 1. The decision has not been made, yet. The on-site inspection at the Busan plant started from Mar. 8. And when the issue is confirmed, the department would make the final decision.”
- Policy
- Sales of 6 BINEX items have been temporarily suspended
- by Lee, Jeong-Hwan Mar 10, 2021 06:27am
- he MFDS decided on the 8th to temporarily suspend the manufacture and sale of six medicines manufactured by BINEX and to collect them. The MFDS is also launching an investigation into a factory located in Busan. Drugs subject to disposal are Amorin (Glimepiride), Xelectin (Fluoxetine), Daxfen (Dexibuprofen), Rofsin 250 mg (Ciprofloxacin), Xelectin 10 mg (Fluoxetine), Cadil 1 mg (Doxazosin). This measure was decided by the MFDS as a precautionary measure against BINEX's submission of a recovery plan for the item manufactured differently from the licensed or reported items to the MFDS, Busan Office. The MFDS policy is to conduct an investigation to confirm the overall manufacturing and quality control of the factory. The MFDS distributes safety bulletins to doctors, pharmacists, and consumers, asking experts such as medical and pharmacists to convert the products to other alternative medicines and cooperate so that product collection can be performed properly. The MOHW and the HIRA also requested restrictions on prescriptions for the product in hospitals and clinics. The MFDS said, "We plan to expedite on-site investigations and necessary measures for BINEX."
- Policy
- Promote disclosure of anticancer drug Expedite Review result
- by Kim, Jung-Ju Mar 09, 2021 06:24am
- A revision of the law is being promoted to revise up the relevant laws and regulations, so-called Fast Track (Expedite Review) for drugs that treat serious diseases, such as anticancer drugs and AIDS drugs, and make the review process transparently disclosed. On the 5th, Rep. Nam In-soon of the Democratic Party of Korea, a member of the National Assembly's Health and Welfare Committee, proposed a partial amendment to the Pharmaceutical Affairs Act on the 5th. The current law stipulates that the Minister of Food and Drug Safety permits the establishment of facilities for the pharmaceutical manufacturing industry or items prescribed by the Prime Minister's Ordinance, and conditional marketing authorization for drugs such as anticancer drugs is stipulated in the subordinate statute. It is necessary to increase the transparency of the review by disclosing the results of review, such as item approval for drugs designated by the ordinance of the Prime Minister, and to improve the accessibility of consumers and companies to review information. This amendment upgrades the conditional permission for drugs such as anticancer drugs to the law, secures procedural justification for conditional marketing authorization, etc. with the opinion of the Central Pharmaceutical Affairs Review Committee, and improves the understanding of the public, while serious diseases, etc. The main goal is to establish a legal basis for the disclosure of review results, such as conditional marketing authorization for medical treatment drugs, designation of priority treatment targets for treatment drugs such as serious and infectious diseases, and item approval. In addition to Rep. Nam In-soon, Rep. Kang Deuk-gu, Kang Seon-woo, Kang Jun-hyun, Kim Min-seok, Kim Young-ho, Park Seong-jun, Park Hong-geun, Yang Jeong-suk, Jung Chun-suk, Joo Chul-hyun, Choi Jong-yoon, Heo Jong-sik, and Hong Seong-guk participated.
