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- 2026-05-09 18:06:16
- Policy
- A set of three bills about COVID-19 was passed
- by Lee, Jeong-Hwan Feb 28, 2020 06:01am
- The National Assembly held a plenary session at 2 pm on the 26th and passed 'a set of three bills about COVID-19' and a proposal for a special committee for countermeasures against the COVID-19. A set of three bills about COVID-19 came into effect after government promulgation, and the ruling & the opposition parties had the authority to act immediately upon the resolution of the National Assembly. Thus, if the price of quarantine goods such as medicines rises rapidly or there is a shortage of supply due to the first-class infectious disease, the Minister of Health and Welfare may prohibit the export or export of goods such as masks and antiseptics for a certain period of time. A legal basis has also been established to enforce inspection, self-assessment, and treatment of COVID-19 Super spreader #31 If a person who is concerned about an infectious disease epidemic or who has stayed or passed through an infected disease area refuses to take measures such as self-containment, facility isolation, symptom check, investigation, and medical examination, he or she may be sentenced to jail for less than one year or fined up to ₩10 million. The number of quarantine officials at the health ministry would rise to more than 100 from the current 30. In some cities, counties, and districts, there is a legal basis for mandatory epidemiological investigators. In addition, it is mandatory for medical institutions and pharmacies to operate the International Traveler Information System (ITS) at all times. Even if the law is violated, there is no administrative provisions such as penalties. The amendment to the Quarantine Act allows the Minister of Health and Welfare to ask the Minister of Justice to prohibit or suspend entry for persons entering or transiting from areas where epidemic or epidemic is prevalent. The Medical Law passed by the plenary has established the name and definition of medical infections, and strengthened the medical institution's infection monitoring system and self-reporting provisions.The COVID-19 Special Committee of the ruling and opposition parties has also completed the procedures necessary for the formation and launch. The parliament agreed to form a special committee for the COVID-19, and the chairman, Han Pyo Kim was appointed by the Democratic Party. The Special Committee decided to devise comprehensive measures at the parliamentary level, such as resolving the instability of the COVID-19 and supporting budgets and institutions to minimize economic damage. It is also the task of the Special Committee to strengthen quarantine measures, improve response manuals and develop support measures. Including Kim in the Democratic Party and a special committee secretariat, Dong-min Ki, also the ruling party Health and Welfare Commissioner, Nine members like Sang-hee Kim, Eui-rak Hong, Seung-rae Cho, Ki-joon Shim, Jung Park, Young-ho Kim, and Yun-jeong Hur were included in the committee. the United Future Party was elected by Senator Seung-hee Kim, former Minister of the MFDS, with Sang-jin Shin, Kyung-won Na, Chae-ik Lee, Dae-chul Park, Sun-rye Kim, Seung-ju Baek, and Tae-ok Jung. Representative Kwang-soo Kim participated in the Minsaeng Party, which was created by three Honam parties, including the Barennmirae Party, the New Alternatives Party, and the Party for Democracy and Peace. The task force of the special committee is until May 29, when the 20th National Assembly ends.
- Policy
- What is the solution to the COVID-19 crisis?
- by Lee, Jeong-Hwan Feb 28, 2020 06:01am
- To reduce the number of serious and death patients, the burden on medical institutions should be minimized. Abandoning the idea that a hospital should see a minor patient unconditionally, and dispatching a medical team, but it is possible to efficiently manage infection by securing a management bed of a serious patient. (Professor Jung-sik Eom, Gachon University Gil Medical Center) As COVID-19 reached the critical stage of crisis warning, experts from the medical field of infectious diseases met with President Moon and urged to address the shortage of quarantine items such as screening of serious and severe patients and masks. On January 24, Cheongwadae said it held a top aide meeting presided over by President Moon from 2pm to 4pm. There were ten members including Kyung-ran Baek, Chairman of the Korean Society of Infectious Diseases , Dong-hyun Kim, Chairman of the Korean Society of Epidemiology, Tak Hur, Chairman of the Korean Society of Emergency Medicine, Seong-ran Kim, Chairman of the Korean Association of Infection Control Nurses, and Committee working TF official. The promotion of public hygiene regulations has led to the need for the public to cooperate with the medical staff at the forefront. Another suggestion was to expand the mitigation policy by focusing on the outbreak of infections in Daegu and Gyeongbuk. Kyung-ran Baek, Chairman of the Korean Society of Infectious Diseases said, "We should apply mitigation policies to minimize damage to Daegu, Gyeongbuk, Busan, and Gyeongnam, and rather than washing your hands vaguely, must specify this way of publicity that you wash your hands frequently with soap, for more than 30 seconds, and cover your mouth and nose with a tissue or sleeve when you cough or sneeze". Sang-il Kim, the TF chief of the Pan-Academic COVID-19 Countermeasures Committee, said, “it is necessary to change people's awareness. The people are one axis, not the target of the quarantine system. It is not just hard to wash hands, but it is very necessary for the people's efforts”. Dong-hyun Kim, Chairman of the Korean Society of Epidemiology, said that several stage upgrades were appropriate, but organizational changes should not occur. Changes in policy and response are needed. Also, he added that it is urgent to make local people dissemination behaviors, and it is important to cooperate with civil society in the mitigation policy. The message that the situation can be overcome should come from many communities, organizations and groups. There were also opinions on the need for prevention and treatment strategies to further shape the role of hospitals for treating mild and severe patients. Hee-Jin Chung, Vice Chairman of the Korean Society for Antimicrobial Therapy, said, “We need a strategy for local governments to quickly designate the role of critically ill hospitals among patients who are diagnosed, and maintaining the existing medical system, but the gap between local governments, suggests the operation of a special advisory group at the central measures headquarters in the prime minister". Professor Jung-sik Eom, Gachon University Gil Medical Center also said, "The treatment of mild patients needs special measures. If a patient is self-isolated at a specific facility, such as Koreans withdrew from Wuhan, the medical staff can go to the facility and can secure the bed". He said that it's a different idea to reduce infections in hospitals, If the hospital burden increases, one seriously ill person can infect the whole like Cheongdo Daenam Hospital. Even medical institutions lamented that they were suffering from supply of protective equipment for infectious diseases such as masks. Seong-ran Kim, Chairman of the Korean Association of Infection Control Nurses, said, “even medical institutions are hard to find protective equipment, so they use masks little by little, and please consider the way to produce and control the protective equipment at the national level to share goods". Eun-hwa Choi, vice chairman of the Korean Society for Pediatric Infectious Diseases, said, “The spread of community infections can cause children to infect the community. Although the school delayed a week, children are often cared for by older grandparents, who are susceptible to infection. It is needed to introduce paid vacation for parents to care for them at home”.
- Policy
- Remdesivir to promote domestic clinical trials for COVID-19
- by Lee, Tak-Sun Feb 27, 2020 06:33am
- Gilead developed the Ebola treatment 'Remdesivir' in preparation for a clinical trial in Korea. The MFDS plans to review the Phase III clinical trial plan from Gilead promptly. Eui-Kyung Lee, the Minister of the MFDS explained on the 25th at the regular briefing on the COVID-19 Central Disaster and Safety Headquarters, "COVID-19 drugs are being developed in Korea, and Phase I clinical trials have been completed and are currently being developed". According to the MFDS, this drug is called Remdesivir, an Ebola treatment developed by the global pharmaceutical company Gilead. Remdesivir is a drug that has become famous after embarking on a clinical trial in China for patients with COVID-19. The drug is already being used as the first patient in the United States to confirm the symptom improvement effect, and is attracting attention as a treatment for COVID-19. In China, clinical trials are underway in 308 mild to moderate patients. There are no detailed plans such as specific subjects and medical institutions in Korea. An official from the Food and Drug Administration said, "We are discussing the domestic clinical trials with Remdesivir by Gilead". Meanwhile, 'Avigan' (Favipiravir), which is being used as a treatment for COVID-19 in Japan, is considering importing domestic income through an emergency introduction system. The emergency introduction system is a special provision on preventive and therapeutic medicines in the case of national emergency situations under Article 85-2 of the Pharmaceutical Affairs Act, and it contains information that can be imported in the event of a pandemic. Avigan is an antiviral drug developed by Fujifilm Toyama Chemical, Japan, and is used for flu patients who are ineffective against existing antiviral agents in Korea, no product license has been obtained yet, and there are no ongoing clinical trials. The MFDS is considering urgent introduction at the request of the Center for Disease Control. In addition, the MFDS is introducing emergency syrups for Kaletra (Lopinavir/Ritonavir, Abbi), an AIDS treatment that is currently used in patients with COVID-19 in Korea. Kaletra syrup has already been purchased through the Korean Orphan & essential Drug Center.
- Policy
- Betmiga lowers pricing with PVA, Tazime keeps original price
- by Kim, Jung-Ju Feb 27, 2020 06:32am
- Hanmi Pharmaceutical’s bacterial blood infection and meningitis treatment Tazime 2 g injection has been exempted from automatic pricing reduction as its competing item is removed from the tentative reimbursement listing. The price of Astellas Pharma Korea’s blockbuster drug Betmiga PR tablet would be lowered from Mar 1 due to price-volume agreement (PVA) system. Successfully signing risk sharing agreement (RSA), the price of Bayer Korea’s metastatic colorectal cancer and gastrointestinal stromal tumor (GIST) treatment Stivarga 40 mg tablet (regorafenib) would be reduced by 7 percent to 34,045 won, starting from June 1. Janssen Korea’s Invega ER tablet, AbbVie Korea’s Jurnista 4 mg SR tablet and LG Chem’s AspoV Nail Lacquer are to be removed from the reimbursement listing from Mar 1, as the respective companies have voluntarily dropped the item approval. But the reimbursement would be provided until August 31 for the treatment access of patients. Ministry of Health and Welfare (MOHW) finalized the said changes on the List of Reimbursed Drugs and Maximum Reimbursed Price. First, Hanmi Pharmaceutical’s Tazime 2 g injection would maintain the reimbursed price as another listed option was removed from the listing. Korea Prime Pharm’s Tofdin 2 g injection was supposed to be competing against and affecting price of Tazime 2 g injection. The competing injection had applied for tentative reimbursement as it was scheduled to launch on Mar. 21. It would have automatically lowered the price of Tazime 2 g injection to 16,400 won per vial from Mar. 21. But upon request by Korea Prime Pharm, Tofdin 2 g injection was dropped from the tentative listing and left Tazime 2 g injection with its original listing price. Accordingly, MOHW has decided to keep the existing reimbursed price of 18,082 won per vial for Tazime 2 g injection. Also, Hanwha Pharma’s Muteran syrup, two doses of Seoul Pharma’s Sebron syrup, and two doses of Kolon Pharmaceutical’s Turant syrup would maintain the initial reimbursed pricing as first generic in the class, because no other company has registered a generic in the class for over a year. It would come in effect from Mar. 1. Indicated to treat metastatic colorectal cancer, GIST and hepatocellular carcinoma (HCC), Bayer Korea’s Stivarga 40 mg tablet is lowering its price with renewed RSA from June 1. Stivarga 40 mg tablet engaged in renegotiation with National Health Insurance Service (NHIS) and successfully renewed the RSA by lowering the price by 7 percent to 34,045 won. Negotiated with NHIS over PVA, Astellas Pharma Korea would lower the price of 50 mg and 25 mg PR tablets of Betmiga to 712 won and 475 won, respectively, from Mar. 1. Due to expanded indication, Takeda Pharmaceuticals Korea is proactively lowering the price of Adcetris injection by 3.6 percent from 3,262,400 won to 3,144,953 won, starting from the beginning of next month. 34 items would be automatically unlisted from reimbursement listing as the pharmaceutical company voluntarily withdrew their item licenses. The following items are included among the 34 items; Janssen Korea’s Topamax sprinkle capsule and Invega ER tablet; Abbvie Korea’s Lucrin 3.75 mg depot injection and Jurnista 4 mg SR tablet; LG Chem’s AspoV Nail Lacquer; CTCBIO’s Newtiro tablet, Lastrin tablet, Zetis tablet and Protera 2 mg tablet; Union Korea Pharm’s Union Ofloxacin eye drop; Chem Tech Research Inc.’s Highpure eye drops 0.1%; Binex’ Epinis tablet; Sam Il’s Valsarodin tablet; Cosmax Bio’s Cosvix tablet, Nizamax 150 mg capsule and Cosbamin tablet, Maxtop tablet, Cosrid tablet, Cosverin tablet, Cosulon capsule, Cos 2 mg DR tablet, and Clycin dry syrup; NBK Pharm’s Pendes tablet; and Korea Global Pharm’s Thioctad 200 mg tablet. The drugs above would be removed from the List of Reimbursed Drugs from Mar. 1, but the government would continue to provide the reimbursement for the medications until Aug. 31 for the sake of patient’s treatment accessibility and predictability.
- Policy
- National Assembly also shocked by COVID-19
- by Lee, Jeong-Hwan Feb 26, 2020 06:29am
- Parliament and politicians were also shocked by COVID-19. Recently, the plenary session was urgently canceled as the delegation of the debate held at the congress hall in the parliament building was confirmed by COVID-19, and a 24 hour closure measure was established for defense. Representative Jae-cheol Shim and a member Jeon Hee-kyung, who were known to have contacted COVID-19 infected patients, also moved to the hospital for COVID-19 test. On the 24th, the National Assembly decided to conduct full-scale protection of the National Assembly and members of the House of Representatives in order to respond to COVID-19 crisis. The two buildings will begin quarantine at 6 pm on the day and will be temporarily closed for 24 hours. As a result, the plenary session scheduled for 25th was automatically canceled. The main building and the House of Representatives decided to open again on Wednesday 26th at 9 am. A spokesman for the National Assembly, Min-soo Han, held an emergency briefing at the National Assembly's controversial hall, explaining that "attendees at the event turned out to be COVID-19 confirmers and conduct full-scale protection of the parliament hall and main building". The measures are in accordance with Article 47 of the Act on the Prevention and Management of Infectious Diseases. It is a provision that allows necessary measures such as temporary closure and disinfection of sites where they are considered to be contaminated with infectious disease pathogens. The background of the National Assembly's entry into the sphere of influence of COVID-19 was that Yoon-su Ha, chairman of the Korean Federation of Teachers' Associations, was confirmed in a few days after a debate held in the House of Representatives. Charman Ha and his wife were both confirmed COVID-19, and it was reported that Jae-cheol Shim, representative of United Future Party and Hee-kyung Chun, a member sat next to them during the debate. The United Future Party urgently canceled the general assembly, which was scheduled for the 24th, and the plenary session, which was scheduled to be held at 2:00 pm, and the government questions in politics, diplomacy, reunification and security. It was the result of the Democratic Party's proposal to postpone after hearing about the infection news, which the Unification Party accepted. As expected, the ruling party was expected to handle the agenda at the plenary session, including electing the National Assembly's permanent chairman (chairman of information and chairman of the education), handling appointing candidates for the Supreme Court Justice Tae-ak Roh, electing a member of the National Rights Commissioner, and organizing the National Assembly COVID-19 special committee. Subsequent questions were scheduled in the fields of politics, diplomacy, and unification security.
- Policy
- Only 6% of domestic medical staff received the vaccines
- by Lee, In-Bok Feb 25, 2020 06:12am
- A large number of university hospital staff in Korea are treating patients without even receiving a preventive vaccine recommended for medical workers. Even 93.5% of administrators for Hospital Infection did not have all the recommended vaccines. As most of the reasons for the difficulty in vaccinating are the cost burden, the government needs financial support. #The Korean Society Healthcare-associated Infection Control & Prevention (KOSHIC) conducted a large-scale national investigation of vaccinations among infection managers and healthcare personnel at member hospitals and published the results in the Journal of korean medical science on the 24th (doi.org/10.3346). /jkms.2020.35.e76). Since May 2018, researchers have surveyed vaccination status in a self-administered questionnaire in 652 member hospitals, of which 200 responded to specific surveys. The questionnaire includes the designation of an administrators for Hospital Infection, a hospital-level immunization policy, and the recommended immunization. The recommended vaccinations included influenza, MMR (measles, mumps, and rubela), TDAP (tetanus, diphtheria, pertussis mixed vaccines), and hepatitis vaccines, jointly recommended by the KCDC and the KSID. As a result, 172 hospitals (86%) have a vaccination policy, and there is an infection control room and medical staff to plan this. Of the 200 hospitals, 151 (75.5%) said they had a screening program for at least one antibody before recruitment. The most common screening program was hepatitis B, which was conducted at 74 % of hospitals before recruitment, with rubella (19%), measles (18%) and mumps (17%). However, less than 6% of the hepatitis A infections were tested beforehand. #196 (98%) hospitals were given vaccination against at least one vaccine related to the recommended vaccination. The most common is influenza vaccine, with 97.5% being inoculated, followed by hepatitis B vaccine with 69%. However, only 24.5% of MMR vaccines were vaccinated, 18.5% had chickenpox, and 11% had TDAP. Only 6.5% of hospitals included all five vaccines recommended by the KCDC and the KSID. 93.5% of hospitals have only one or two vaccines. As a result, as of 2017, 43 cases of medical staff were exposed to infectious diseases. Chicken pox was the most common (15 cases) and hepatitis B (11 cases). As such, each hospital was passive in vaccination because of the cost. When asked what was the biggest obstacle to implementing the recommended vaccination policy, 77% said it was due to financial burden. In addition, 21% of the respondents said that the awareness of vaccination was less than expected, and 21% of hospitals said they were due to the absence of vaccination campaigns. #In fact, the influenza vaccine, for example, the more the number of beds tended to increase the inoculation rate. As for the percentage of free vaccination projects, more than 700 beds recorded 100%, but 500 ~ 699 beds were 81.3%, 200 ~ 499 beds were 77%, and less than 200 beds were 72.1%. Sung-ran Kim, a professor of infectious medicine at Kyunghee University Hospital, who conducted the study, said, “The exposure to infectious diseases in hospitals is a serious problem that can lead to paralysis of hospital function. It is a big threat to the situation". Professor Kim said, “The biggest obstacle to the recommended immunization policy was the hospital's financial burden,and this means there is a limit to lowering these barriers without financial support from the government".
- Policy
- Nocdurna SL benefits are newly established
- by Kim, Jung-Ju Feb 25, 2020 06:09am
- Nocdurna SL tab’s identification picture (Source: the KPIC)The new benefit standard for the pituitary hormone, Nocdurna Sublingual tab (Desmopressin acetate), which is used for the treatment of nocturnal urine, will be applied from next month. However, because The drug’s benefit would be limited to only for idiopathic nocturnal polyuria, and it is not eligible for primary urination and nocturnal polyuria. The MOHW issued an administrative notice on amending ‘Pharmaceutical Reimbursement Listing Standard and Method’ on Feb 20 and released pharmaceutical standard. Ferring's Nocdurna SL is approved for the treatment of nocturia due to idiopathic nocturnal urination in adults. 50μg for males and 25μg for females are administered sublingually without water 1 hour before bedtime. Increasing dosed of desmopressin is not recommended in older patients 65 years or older, The drug has been included in the Desmopressin acetate formulation benefit standard, while receiving benefits from the Ministry of Health. However, it would be limited to idiopathic symptoms, and is not allowed to receive benefits for primary nocturnal enuresis 5 years and older. In addition, the treatment of nocturia symptoms associated with adult nocturnal urination is limited to use because it is applied only for idiopathic salary. The start date will be on March 1st. Desmopressin acetate preparations include Minirin by Korea Ferring, Demoresin Powder by Hanmi, Newlitan by Nexpharm Korea, Denerin fine granule by Pharmbio, and Demorin Fine Granule by Doonkoo.
- Policy
- The ruling & opposition parties agreed to COVID-19 committee
- by Lee, Jeong-Hwan Feb 24, 2020 06:27am
- The parliament barely agreed to form a special committee for the COVID-19. It will be officially launched when it is processed at the plenary session on the 24th. The official name was the National Assembly COVID-19 special committee, and the chairman was appointed by the Democratic Party. On the 20th, a member of the Democratic Party, Huduk Yoon, a member of United Future Party, Han Pyo Kim, and Jung-sook Chang, the head of the parliamentary negotiating group's three-party leader, made an emergency meeting at the National Assembly headquarters. COVID-19 chairman is chaired by the Democratic Party, the most seated. The proportion of members is nine Democrats, eight United Future Party, and one Democratic Unity Assembly. In addition, the ruling and opposition parties decided to act as the head of the National Assembly's intelligence chairman in the Democratic Party and the chairman of the education council in the United Future Party. The ruling and opposition parties will deal with the constitution of COVID-19 special committee, the selection of the chairman of the standing committee, and the agreement to appoint a justice of the Supreme Court,Tae-ak Noh.
- Policy
- Welfare committee passed a set of three bills about COVID-19
- by Lee, Jeong-Hwan Feb 24, 2020 06:25am
- The parliamentary welfare committee approved the three measures about COVID-19 at the plenary session on the 20th morning Three bills about COVID-19 were thus reviewed by the Legislation-Judiciary Committee. After passing through the judiciary committee, the final plenary session must be resolved before the final promulgation can be made. A revision to the infectious disease act calls for permitting the government to provide face masks for free to people who are vulnerable to infections when the country's contagious disease alert level is raised to the level above "caution", the measure also calls for doctors and pharmacists to check patients' records of foreign travel via a shared information program when they prescribe medication, for the establishment and monitoring of medical-related infections, and the increase in the number of epidemiological investigators. On the 20th, the Committee decided on 13 amendments in the Infectious Disease Prevention and Management Act, Medical Law and Quarantine Act. ◆Amendment to the Prevention and Control of Infectious Diseases Act=When a warning of abnormality was issued under the Basic Act on Disaster and Safety Management due to the spread of infectious diseases, a bill was issued to provide free masks to the vulnerable people such as children and the elderly who use social welfare facilities. In order to prevent recurrence of problems such as mask purchase disturbances, a bill that prohibits the export or export of goods such as masks and antiseptics during the period announced by the Minister of Health and Welfare if a sudden rise in prices or supply shortages such as medicines occurs due to the first-class infectious disease epidemic passed by the Welfare Committee The number of quarantine officials at the health ministry would rise to more than 100 from the current 30. In some cities, counties, and districts, there is a legal basis for mandatory epidemiological investigators. The bill also stipulates that health professionals, who are directly involved in patient care, prescription, and medication, such as medical workers, pharmacists, and heads of health care institutions, can check the patient's overseas travel information system at all times. However, the bill will not be punished even though it is not followed because the penalty clause has been deleted. ◆Amendment to the Medical Law=A bill was proposed to change the name of hospital infections to medical-related infections and legislation was passed to establish and embody justice. Evidence for compliance with medical institutions for the prevention of medical infections is also established. The medical system infection monitoring system was strengthened, and legal basis for self-reporting of infection control of medical institutions was also established. The extension of the designation and mandate of infection control personnel to all medical institutions, including local clinics, was removed from the subcommittee. ◆Amendment to the Quarantine Act=The point of Quarantine Act is that allows the Minister of Health and Welfare to ask the Minister of Justice to ban or suspend the entry into or through a country where a person is confirmed. The government has secured a legal basis for prohibiting the entry and entry of confirmed or suspected suspects in case of new infectious diseases such as COVID-19. The Minister of Welfare, Neunghoo Park, expressed his appreciation for the resolution of a set of three bills about COVID-19 by th Welfare committee. In particular, The Minister, Park requested adjustment only for the timing of the implementation of some provisions, and the Commission decided to accept the final decision. The Minister, Park said, "Some of the bills have been in force for six months after the promulgation. In consideration of the urgency and importance (of COVID-19), some provisions should be adjusted immediately and the penalty clause should be adjusted to one month of promulgation, and the provisions that define the definition of suspects, the self-containment facilities for suspected infectious diseases, and the provision of overseas travel history information provisions should be promptly promulgated, and the relevant penalties need to be adjusted one month after the promulgation".
- Policy
- Full inspection on BTX manufacturers and vaccine distributor
- by Lee, Tak-Sun Feb 24, 2020 06:23am
- Korea's Ministry of Food and Drug Safety (MDFS) plans to pin-point inspect 'botulinum toxin manufacturer' and 'chicken pox vaccine cold chain.' The focused inspection on biopharmaceutical would be completed by the first quarter. MFDS posted the 'Biopharmaceutical Manufacturer and Distributor Management Master Plan 2020 (biopharmaceutical, Korean medicine (herbal medicine), cosmetics, quasi-drug, and human tissue) on its website on Feb. 18. ◆ Special inspection on botulinum toxin and chicken pox vaccine cold chain: For the subjects of the focused inspection, MFDS headquarter and regional offices would audit botulinum toxin product manufacturer for their manufacturing and quality control in the first quarter. Currently, Medytox, Daewoong Pharmaceutical, Hugel, Huons, Pharma Research Bio, and BMI Korea are the six licensed botulinum toxin manufacturers in Korea. And the ministry plans to inspect all of them. Based on the report by a whistle-blower, the health regulators inspected the manufacturing facilities of Medytox and found quality control issue, which the company had to recall the products for. The ministry decided to further inspect every botulinum toxin manufacturers and aims to improve the credibility of the biopharmaceuticals. Previously, the regulator used to focus the chicken pox vaccine cold chain inspection on distributor, but the regulator would, for this year, inspect all process of cold chain from distributor to healthcare institute to confirm quality maintenance system and to seek improvement measures. Within the first quarter, the ministry headquarters, regional office and local government offices would cooperate to monitor the cold chain management of chicken pox vaccine. ◆ Regular inspection on seven biopharmaceutical GMPs: The three-year regular on-site inspection for the biopharmaceutical GMPs would be conducted as well. The subjects for this year’s regular inspection are Medipost (finished pharmaceutical product (FPP)), S. Biomedics (FPP), Eubiologics (FPP), CJ Healthcare (finished pharmaceutical ingredient), Corestem (FPP), Daewoong Pharmaceutical second plant (finished pharmaceutical ingredient) and TKM (FPP). ◆ Monitoring illegal advertisement of Saxenda-like self-injections: Charged for exaggerated advertisement in last year, appetite suppressant Saxenda injection and other prescribed self-injection’s mass media advertisement and illegal distribution would be monitored all year round. The mass media advertisement on poster, billboard, leaflet and online pop-up and banner ads on hospital, clinic and pharmacy website are subjects for monitoring. Also online advertisement, influencer advertisement and illegal online distribution through new media like social media channel, Youtube and Afreeca TV, are also subjects for the monitoring. ◆ Special inspection and quality test on respirator: Respirator, struggling to meet surged demand due to COVID-19, would be inspected thoroughly as well. Especially the manufacturers neglected from last year’s inspection for being temporary or permanent closed are included for this year’s inspection. The ministry would also monitor any toxic substance found in distributed respirator, and 90 cases of quality test conducted last year would be increased to 200 cases. The ministry and local government offices would cooperate and each test quality on 100 items all year. Online and offline retail stores would be monitored all the time as well.
