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- 2025-12-23 05:34:14
- Policy
- Reviewing the removal of outdoor masks
- by Lee, Jeong-Hwan Apr 28, 2022 06:06am
- Photojournalists of the Presidential Transition CommitteeThe presidential transition committee announced its position to examine the COVID-19 situation in late May, a month after the launch of the new government, and then decide to release the outdoor mask. The new government plans to promote quarantine policies based on scientific evidence and prepare governance to respond to infectious diseases centered on experts' opinions and on-site judgment. Ahn Cheol Soo, the chairman of the transition committee made the remarks at a briefing on the announcement of comprehensive measures by the Health and Medical Division of the COVID-19 Emergency Response Committee at a joint press conference in Tongui-dong, Jongno-gu, Seoul on the morning of the 27th. Chairman Ahn announced four key tasks, including ▲strengthening compensation due to side effects of vaccines, ▲ scientific quarantine using big data, ▲reorganization of the medical system, including the establishment of hospitals specializing in infectious diseases, and▲ preparation of measures to protect the elderly and medical staff. Chairman Ahn has defined the government's quarantine as "non-scientific political quarantine." He emphasized that it is "scientific quarantine" to automatically calculate the severity and quickly process bed allocation by establishing a platform that collects data on infectious diseases. Chairman Ahn also came up with a plan to reform the medical system that responds to infectious diseases at all times. He said he would secure 7,700 beds in advance and establish a method of treating patients centered on general hospitals. Protection for high-risk groups and vulnerable groups of COVID-19 will be strengthened. The transition committee said that hospitals and facilities have been vulnerable to infection, but it will significantly improve the ventilation structure in the future and convert them into safe facilities for infection through infection education for workers. In the case of high-risk groups, a medical response fast-track policy is prepared to enable rapid testing and rapid treatment. The transition committee said it will secure enough treatments to relieve public anxiety and increase its responsiveness to infectious diseases. The new government will secure a total of 2.071 million people by introducing an additional 1,009,000 treatments and expand the scope of administration to those with underlying diseases aged 12 or older so that they can receive prompt treatment. It will also expand compensation and support for adverse vaccine reactions. Support for medical expenses will be increased from 30 million won to 50 million won, and death compensation will be increased from 50 million won to 100 million won. Support will be provided after basic reviews such as reducing the burden on the public and the causal agenda for the responsibility to prove abnormal reactions. It also plans to shorten the processing period to 120 days. Chairman Ahn said, "People must be most curious about when they take off their masks outdoors, but they are trying to judge by looking at the situation in late May." He explained, "Now, the number of confirmed cases in Korea is still the largest worldwide, making it difficult to compare directly with other countries that can take off masks outdoors." Chairman Ahn said, "We will make a decision around late May on whether to make it mandatory to take off the mask outdoors but wear an indoor mask when entering the building." He said, "The mandatory indoor masks will continue for the time being. If raking off a mask indoors, it will be evidence that our daily life will almost completely recover, he said.
- Policy
- The transition team operates biohealth regulatory sandboxes
- by Kang, Shin-Kook Apr 27, 2022 06:03am
- The presidential transition committee established the Pharmaceutical Bio Innovation Committee, which was the pledge of Yoon Seok-yeol, and presented deregulation through biohealth regulatory sandboxes as a policy task. Baek Kyung-ran, a member of the transition team's social welfare division, said on the 25th that he will recognize the biohealth sector as a future food industry and open the 'BioHealth Korea Era' through a briefing on vaccine development and state affairs. Member Baek said, "This morning, elected Yoon visited the headquarters of SK Bioscience, which is developing the COVID-19 vaccine," adding, "The purpose of the on-site visit is to encourage everyone who has participated in the development of the COVID-19 vaccine. It was to express our willingness to actively support the bio-health sector." "Yoon said that there is enormous national potential, food, economy, and health security in the vaccine treatment lab," Baek said. "In the future, the government will provide all support to companies that develop vaccines and treatments to respond to pandemics." He said, "The Yoon Seok-yeol government recognizes the bio-health sector as an axis of the future food industry and establishes national tasks with the aim of opening the 'Bio-Health Korea Era' by making it a field that takes a step ahead and leads other countries." "First of all, we will create an environment where our bio-health companies can leap into the world, we will establish a pharmaceutical bio innovation committee to strengthen biohealth governance so that basic research, hospitals and companies can cooperate together and related ministries can gather wisdom together." In addition, he said, "We will create a global mega fund that supports our pharmaceutical industry to develop innovative new drugs by our own strength beyond the limitations of technology exports." "We plan to actively train key personnel such as medical scientists and AI professionals and operate biohealth-specific regulatory sandboxes to improve regulations in the biohealth sector at all times," Baek said. It also unveiled measures to foster the digital healthcare industry. "To strengthen the industrial competitiveness of digital healthcare products such as electronic drugs, digital treatment devices, and AI diagnostic assistance, we will strengthen R&D," she said. "We will build a medical MyData platform that allows medical institutions, pharmacies, and insurance companies to flow." "We will also strengthen the legal basis so that new technologies and data platforms can be safely used without concerns over personal information infringement," Baek said. "We will establish a system that enables discriminatory support for areas directly related to health and security like infectious diseases. The U.S. invested about $10 billion immediately after the outbreak of COVID-19 to make its first vaccine in 350 days." Even after COVID-19, a new type of new infectious disease can occur again at any time. We also need a system that supports in a different and innovative way than ever before," she said. "We will fundamentally reorganize the R&D system by establishing a dedicated organization to minimize administrative regulations such as preliminary feasibility systems and provide rapid support," Baek said. "Biohealth is not only a promising field of our economy, but also a key area to improve the health and quality of life of the people. We will try to lead the growth and job creation of our economy by converging industry, science and technology, and medical care around the people and becoming a "second semiconductor," he stressed.
- Policy
- Betamethasone's permission change is expected
- by Lee, Hye-Kyung Apr 27, 2022 06:03am
- As a result of reviewing safety information on drugs containing the skin disease treatment Betamethasone, precautions for use such as Pheochromocytoma are expected to be added. The MFDS' Pharmaceutical Safety Evaluation Division prepared a change (draft) of permission based on the results of the European Medicines Agency's review of safety information on drugs containing "Betamethasone." This change includes both Betamethasone PO and Betamethasone Inj. "Pheochromocytoma, which could be fatal, were reported after administration of systemic corticosteroids. Patients suspected or confirmed to have Pheochromocytoma should be administered only after evaluating the appropriate risk and benefit of Corticosteroids.' For injections, general precautions include oral medications, while the terms of administration for pregnant women and lactating women added, "The study showed an increase in the risk of neonatal hypoglycemia after short-term treatment of Betamethasone before childbirth." The MFDS will receive an opinion inquiry by the 6th of next month regarding the establishment of such precautions. Betamethasone-containing PO products include Sinil Betamethasone, Ceretasone, Dexmin, Dongkoo Bio's Betamethason, Betaramin (for export), Cebita, Cerestar (for export), Almetamine (for export), Didstarsone, Benoramin, Arlico Betathro, Betomin, Young IL BETALOMIN, Gestar, and Betaclon. Betamethason-containing Inj. products include Betamethone Sodium Phosphate Injection Medica, Betamethasone Injection Jeil, Globetamethasone Injection, Betamethasone Sodium Injection Huons, Betamethasone, Tamezon, Betamethasone Sodium Injection Tab. Daewon, Betasone Injection Dongkwang and Hanall Betamethasone Inj.
- Policy
- Phase III for development of Alecensa & Keytruda
- by Lee, Hye-Kyung Apr 26, 2022 06:11am
- Roche Korea and MSD Korea are accelerating clinical trials to develop combination therapy for non-small cell lung cancer treatments. On the 22nd, the MFDS approved phase 3 clinical trials of MSD's Keytruda and Keytruda SC and Roche's Alecensa. All of these pharmaceutical companies begin clinical trials to confirm the safety and effectiveness of combination therapy using two or more drugs together. Alecensa received domestic permission for the treatment of patients with ALK-positive local progressive or metastatic non-small cell lung cancer. Phase 3 clinical trials will be conducted at Seoul National University Bundang Hospital, Asan Medical Center, and Seoul National University Hospital to evaluate the efficacy and safety of various treatments in the cohort of patients with stage 3 non-small cell lung cancer. Clinical trials are conducted to utilize multi-drug therapy along with comparative studies of Keytruda SC and Keytruda IV. In March, it was decided to expand insurance benefits as the primary treatment for non-small cell lung cancer in Korea and apply Keytruda's insurance benefits to recurrent or refractory typical Hodgkin lymphoma. This phase 3 clinical trial will be conducted at Korea University Guro Hospital, Chungnam National University Hospital, and Hwasun Chonnam National University Hospital to compare pharmacokinetics and safety of Keytruda SC administered with platinum-based two-drug chemotherapy in the primary treatment of metastatic squamous or non-squamous cell lung cancer patients. With the recent increase in targeted anticancer drugs that can be used to treat non-small cell lung cancer, the development of combination therapy using more than one drug is in full swing.
- Policy
- Exclude drugs that have increased due to COVID-19 from PVA
- by Lee, Tak-Sun Apr 25, 2022 06:08am
- It is reported that the pharmaceutical industry plans to officially propose to the government to exclude respiratory treatments that have increased their use due to the increase in COVID-19 patients from PVA. It is asked to reflect that the explosive increase in the use of the drug is inevitable due to the increase in the number of patients with infectious diseases, and that it has tried to meet the supply according to the government's policy. According to the industry on the 24th, the KPBMA will listen to the opinions of its members and suggest that respiratory treatments, which have increased in use due to the treatment of COVID-19 patients, should be excluded from PVA. An association official said, "As the number of home-based patients increased in the aftermath of Omicron, demand for respiratory treatments increased significantly, and in response to the government's request, we operated the factory two to three times more than usual to produce drugs. We plan to request that the public-private consultative body, which will be held at the end of this month, be excluded from the PVA" The NHIS revised in December 2020 to correct the use of drugs that have been confirmed to be used to treat infectious diseases when negotiating PVA. Correction was possible only when a temporary increase in use was confirmed among drugs designated by the head of the KDCA that stable securing and supply were needed to prevent and treat infectious diseases. The pharmaceutical industry is asking for the revised guidelines to be greatly expanded and reflected in this respiratory treatment. An official from the pharmaceutical industry stressed, "It is unreasonable and unfair to cut the drug price by targeting PVA for drugs that have exploded in use for a short period of time in the aftermath of Omicron." PVA is a system that adjusts drug prices as usage increases after drugs are listed to manage financial uncertainty, and if they exceed a certain level of expected claims agreed with the NHIS or a certain level of claims in the previous year, drug prices will be reduced by up to 10%.
- Policy
- Boryung’s Gemzar switches to domestic production
- by Lee, Hye-Kyung Apr 25, 2022 06:07am
- In 2 years since Boryung Pharmaceutical acquired the domestic rights for Lilly’s anticancer treatment ‘Gemzar (gemcitabine HCl)’ in Korea, the company switched all its items to domestic productions. According to the Ministry of Food and Drug Safety, Boryung Pharmaceutical withdrew its import license for ‘Gemzar’ on the 21st, and switched the name of its domestic generic ‘Boryung Gemcitabine HCl Injection’ to the original name, ‘Gemzar,’ The company had co-promoted Lilly Korea’s Gemzar since 2014 and signed an agreement to transfer and acquire the rights of Gemzar, an anticancer treatment, in the local market with Eli Lilly in May 2020. Under the agreement, Boryung Pharmaceutical acquired the total rights of Gemzar in Korea including its sales and marketing authorization rights from the US company. Boryung and Lilly had been co-promoting Gemzar in Korea since 2015 Gemzar is indicated as a mono- or combination therapy in the first- and second-line treatment for pancreatic cancer, non-small cell lung cancer, bladder cancer, breast cancer, ovarian cancer, and biliary tract cancer. According to the market research firm IQIVA, Gemzar had sold ₩9.5 billion in 2016, which increased by around ₩3 billion in 5 years to record ₩12.44 billion in 2020. Gemzar’s sales account for 2-3% of Boryung’s total pharmaceutical sales every year, and sales are expected to increase due to cost reduction with the company converting all its imported products to domestic productions. Since 2019, Boryung had started driving the anticancer drug business and tripled its existing anticancer drug production facilities with the completion of its Yesan plant. Boryung plans to accelerate its anticancer drug business by introducing new products and expanding co-promotion products. Last year, the company had signed another contract to acquire and transfer assets for the schizophrenia treatment Zyprexa (olanzapine) with Lilly. Zyprexa had raised ₩14 billion in the domestic olanzapine market last year and is the No.1 prescribed product that holds a 50% share of the market. The agreement was made as part of Boryung’s LBA strategy it announced while conducting a capital increase of ₩98.5 billion in July last year. In addition to Gemzar and Zyprexa, Boryung plans to expand its portfolio by acquiring the domestic marketing approval of off-patent anticancer drugs that raise around ₩15 billion every year. Currently, the company is selecting candidates for digestive cancer, women's cancer, blood cancer, and lung cancer, and will also work to individual develop new anticancer drugs in the long term to strengthen its anticancer drug lineup.
- Policy
- Chong Kun Dang salt modified Entresto will be released soon
- by Lee, Hye-Kyung Apr 25, 2022 06:07am
- The market launch of Sacubitril/Valsartan Calcium, developed by Chong Kun Dang is imminent. According to the pharmaceutical industry on the 21st, Chong Kun Dang filed an application with the MFDS for permission for the drug developed by changing Valsartan Sodium, the main ingredient of Novartis' chronic heart failure treatment Entresto. This drug is likely to be a candidate substance called CKD-349, which was completed in June and October last year by conducting phase 1 clinical trials at Chungnam National University Hospital and H Plus Yangji Hospital, respectively. CKD-349 was tested with Entresto as a control drug. Entresto is the first double-inhibitor ARNI-based treatment that combines ARBI Valsartan and Sacubitril that inhibits Neprilsysin, and is currently recommended as a standard treatment in domestic and foreign heart failure treatment guidelines. As Entresto, which was approved for items in April 2016, was officially released in October 2017 after being listed, 13 domestic companies, including Hanmi Pharmaceutical and Chong Kun Dang, filed for patent judgment last year. On December 23, 2020, the Korean Intellectual Property Tribunal sided with generic companies by making a judgment on the establishment of the claim in a passive confirmation of the scope of rights of Entresto's crystalline patents filed against Novartis by 13 companies, including Hanmi Pharmaceutical and Chong Kun Dang. Entresto is protected by a total of five patents, including salt patents expiring in November 2026, use patent expiring in July 2027, crystalline patent expiring in September 2027, composition patent expiring in November 2028, and composition patents expiring in January 2029. If domestic companies succeed in targeting patents for use, they will be able to launch generics for Entresto early, which will end PMS on April 13. Entresto's outpatient prescription amounted to 32.3 billion won last year, up 37.3% from 23.5 billion won last year. This is the first achievement in four years since its release in October 2017.
- Policy
- Expansion of benefit standards such as Tenofovir/Baricitinib
- by Kim, Jung-Ju Apr 24, 2022 06:33pm
- As the scope of benefit of registered drugs such as chronic hepatitis B oral drug Vemlidy expands, the benefit standards for these drugs will also be expanded and changed. In addition, the standards for Baricitinib PO such as oluminant 2mg will be expanded to patients with chronic severe atopic dermatitis. The MOHW unveiled the "revised notification of details on the standards and methods of applying medical care benefits" and began to inquire about opinions until the 27th. ◆As the permission of the MFDS for= Tenofovir, an oral chronic hepatitis B treatment such as Vemlidy, is changed, the insurance benefit standards will also be expanded. Insurance authorities will expand and apply standards to non-target liver cirrhosis and liver cancer in consideration of excluding country permits, textbooks, clinical treatment guidelines, clinical research documents, and related academic opinions (expert opinions). In detail, the standard of "Besifovir and Tenofovir do not recognize non-subjective cirrhosis and liver cancer" among the benefit clues is changed to the phrase "Besifovir does not recognize non-subjective cirrhosis," and Tenofovir recognizes medical care benefits in patients with non-subjective cirrhosis. ◆ Antibiotics, PPI PO, Bismuth PO, Clarithromycin PO, Levofloxacin PO= Antibiotics, as well as Bismuth PO such as PPI PO and Denol, Clarithromycin PO, and Levofexin PO will be expanded. Insurance authorities were required to apply benefits to "after endoscopic resection of gastric adenoma" by referring to domestic and foreign permits, related literature, and academic opinions. ◆The benefits of Baricitinib PO will also be expanded to patients with Upadacitinib PO= chronic severe atopic dermatitis such as Olumiant 2mg and Rinvoq SR. However, the authorities may change the standards depending on the results of the MFDS review related to the safety of JAK I. In addition, due to insufficient grounds for replacement administration, it was decided not to admit replacement administration between Dupilumab and JAKI and replacement administration between JAK I. ◆ Everolimus PO such as Certican and Sirolimus PO= will also be applied to kidney transplant patients in the future. In addition, benefits are recognized for combination therapy with Tacrolimus for renal transplant patients beyond the scope of the MFDS' permission. ◆Guselkumab injections such as Tremfya Prefilled Syringe, etc.,= will be added to the MFDS' permission, and related standards will be expanded accordingly. In March last year, the drug added indications of "psoriatic arthritis." As a result, standards are also extended. Specifically, it is active and progressive healthy arthritis. A combination of newly listed items will be added to the benefit standard of the oral system for high blood pressure and hyperlipidemia. Starting next month, five Atorvastatin compound PO products such as Amlodipine, Candesartan, and Cantabell, and Telmisartan, Rosuvastatin and eight items of Ezetimbe PO complex such as Duowell Plus are scheduled to be listed, the combination of the drug ingredients will be added. ◆Tenofovir oral drugs such as K-Cab and K-CAB ODT 50mg will be newly registered next month, and this drug will also be added to the relevant benefit standards. The MOHW plans to implement the revision of the notice from May 1st if there is nothing unusual.
- Policy
- Expanding the use of Paxlovid with underlying dz over 12 yrs
- by Lee, Jeong-Hwan Apr 20, 2022 06:05am
- COVID PO Tx PaxlovidThe government said it is considering expanding the scope of the prescription for Paxlovid, an oral treatment for COVID-19, to "underlying patients aged 12 or older." However, considering the fact that there are side effects, it is said that various decision-making processes such as collecting opinions from experts should be carried out. This revealed the government's position on the presidential transition committee's announcement that it is considering expanding the prescription of the treatment to those with underlying diseases over the age of 12. Lee Sang-won, head of the epidemiological investigation and analysis team at the Central Disease Control Headquarters, explained at a regular briefing on the 19th, "Paxlovid, PO treatment, is undergoing clinical trials in other countries overseas and is reviewing data. I understand that there are no special abnormalities overseas regarding problems such as side effects," he said. "We are confirming that there are no problems such as securing supplies. We are currently considering expanding the target of the treatment from people aged 60 or older, immunocompromised, underlying patients in their 40s and 50s to underlying patients aged 12 or older, and expanding local clinics." Regarding the recent decline in the COVID-19 epidemic, the fatality rate does not fall below 0.1%, Lee said, "It is because the main class where the incidence of patients is decreasing is young and the age of 60 or older is decreasing, but the rate of decline is relatively slow compared to other age groups." Among the cumulative COVID-19 deaths, the proportion of the elderly aged 60 or older exceeds 95%, with most of the deaths occurring in the elderly aged 60 or older, which is a high-risk group.
- Policy
- MFDS requested supplementary data of Mifepristone
- by Lee, Hye-Kyung Apr 19, 2022 05:52am
- 'The MFDS is conducting a comprehensive review including the need for Bridging Study data. A year and four months have passed since the abortion crime was abolished, but drugs that have been applied for permission by domestic pharmaceutical companies are still being reviewed. According to the press release of the MFDS on the 18th, the MFDS requested the submission of supplementary data of Mifepristone applied by Hyundai in July last year. The MFDS said, "We asked the company to submit supplementary data because we needed to supplement some data during the screening process, and the company has requested a postponement of the deadline for submitting supplementary data." At the Central Pharmaceutical Review Committee held last year, the need for a Bridging Study clinical trial to verify safety and effectiveness by conducting clinical trials on Koreans again was discussed, but the MFDS has yet to give specific opinions. At the time, the Korean Association of Obstetrics and Gynecology said that the Bridging Study should be conducted, but most members reportedly concluded that the Bridging Study clinical trial was unnecessary. Accordingly, the MFDS said, "We are comprehensively reviewing the data submitted by the company, including whether or not bridging study data is necessary," adding, "It is difficult to answer because the approval schedule cannot be predicted." Regarding the criticism that obstetricians and gynecologists were excluded from the committee, the committee held last year said that obstetricians attended the committee as members The MFDS explained, "When the Central Pharmaceutical Center was held, obstetrics and gynecology specialists were also present as members in accordance with related regulations, and the Korean Association of Obstetrics and Gynecology attended and submitted opinions." Regarding the drug item license and safety use plan, the MFDS said, "Check safety, effectiveness, and quality, and use it safely during the examination process, and we will come up with measures such as educational materials for experts and patients and post-marketing investigations to ensure that abortion drugs can be used in a legally stable environment, and we will actively support the National Assembly's law revision process. On April 11, 2019, the Constitutional Court made a constitutional nonconformity decision on the abortion of the criminal law to respect women's right to self-determination of the body, and the abortion crime has been invalidated since January 1 last year.
