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- 2026-05-04 12:09:26
- Policy
- The MFDS announced the designation of 4 temporary narcotics
- by Lee, Hye-Kyung Jul 07, 2022 05:54am
- The MFDS (Director Oh Yoo-kyung) announced on the 5th that it will designate four types, including 1V-LSD, which are used as substitute substances for drugs. 1V-LSD is newly designated as Class I temporary drug, and CH-PIATA is newly designated as Class II temporary drug. 1V-LSD has a structure similar to that of LSD and is a material which may cause hallucinations and other effects. LSD is a powerful hallucinogenic agent that causes severe physical and mental dependence when misused. CH-PIATA is a synthetic hemp-related substance that has been confirmed to be distributed for misuse and abuse in Korea. Among the current Class II temporary narcotics, two types of Flubromazolam and Cumyl-4CN-B7AICA, which expire on September 9, will be re-designated as Class II temporary narcotics. The temporary narcotics designation system is to name substances that are abused as narcotics substitutes and may harm public health for up to three years. Since 2011, a total of 243 types have been designated by implementing a temporary drug designation system, and 150 types, including "THF-F," have been designated as narcotics after evaluating dependence. Substances designated as temporary drugs are handled and managed in the same manner as drugs from the date of designation notice. The substance is entirely prohibited from possession, possession, use, management, import and export, manufacture, sale, sale, mediation, receipt, etc., and can be seized. After being designated and announced as temporary drugs, the import, manufacture, sale, trade, mediation, or receipt of temporary drugs in Class I will be sentenced to life or imprisonment for more than five years. Exporting, importing, or manufacturing a Class II temporary narcotic will be punished with imprisonment for up to 10 years or a fine of 100 million won at maximum. Trading or brokering it will be punished with imprisonment for up to five years or a fine of 50 million won at maximum. The MFDS said it expects the announcement of new designation and re-designation of temporary drugs to block the distribution of new drugs and help public health. In addition, the MFDS said it will continue to do its best to protect public health from new and illegal drugs in cooperation with related agencies such as the prosecution, police, and customs offices.
- Policy
- Antiepileptic perampanel’s adverse event rate at 32%
- by Lee, Hye-Kyung Jul 05, 2022 05:59am
- Results of the 6-year post-marketing surveillance (PMS) on the antiepileptic ingredient perampanel showed that 17 cases of serious adverse reactions whose causal relationship cannot be ruled out were reported. As 287 cases of unexpected adverse reactions whose causal relationship cannot be ruled out were also reported, the indication for perampanel is set to be updated to account for these changes. The Ministry of Food and Drug Safety had announced that it had recently released an order (draft) to change the indication for 16 perampanel items owned by Eisai Korea, Whanin Pharmaceutical, and Myung In Pharm according to the reassessment results, and will be conducting an opinion inquiry on the proposed changes until the 14th. Eisai Korea received marketing authorization for its Fycompa Film Coated Tab on July 10th, 2015. Fycompa Film Coated Tab is indicated as monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients 4 years of age and older, and as adjunctive therapy for the treatment of primary generalized tonic-clonic (PGTC) seizures in patients 7 years of age and older with idiopathic generalized epilepsy (IGE). Results of the PMS that was conducted on 3,354 patients for 6 years for the reassessment in Korea showed that the rate of reported adverse events, regardless of casualties, was 32.62% (1094 /3354 subjects, 1376 cases in total). Among the reported adverse events, the rate of serious adverse reactions whose causal relationship cannot be ruled out was 0.51% (17/3354 subjects), and neurological disorders such as dizziness, mental disorders such as suicide attempts, as well as encephalitis, anemia, and spontaneous abortion were found to occur. Unexpected adverse reactions whose causal relationship cannot be ruled out such as memory impairment, cerebrovascular accidents, sleep disorders, fever, abdominal pain, eye pain, weight loss, erectile dysfunction, and palpitations were reported at a rate of 7.87% (264/354 subjects, 287 cases). Also, the rate of adverse events reported when perampanel is not administered according to the approved dosage and regimen was rather high, at 44% (85/193 subjects). The MFDS plans to change the indication for perampanel after conducting the opinion inquiry and issuing a preannouncement notice for the change order (draft).
- Policy
- The revaluation of Streptokinase could be maintained for 1yr
- by Lee, Tak-Sun Jul 05, 2022 05:59am
- The pharmaceutical industry expects some components to be suspended in this year's benefit revaluation. The benefit revaluation of Streptokinase and Streptodornase, which are scheduled to submit a report on clinical revaluation results next year, could be suspended for one year. However, the final plan is expected to be decided through deliberation by the Drug Benefit Evaluation Committee of the HIRA, which will be held on the 7th. An official from the pharmaceutical industry said on the 4th, "Streptokinase and Streptodornase, which are components subject to benefit reevaluation this year, are also discussing a one-year grace period." "However, I understand that it is not a confirmed issue," he explained. Streptokinase and Streptodornase are enzyme drugs such as Hanmi Pharmaceutical's Mucolase and SK Chemical's Varidase. Since 2017, the drug has been conducting clinical re-evaluation by the MFDS, and the previous indications of sinusitis and thrombosis have been deleted. Next year, it is scheduled to submit a report on the results of clinical re-evaluation of the difficulty of ventilation accompanied by respiratory diseases. Accordingly, the industry suggested that the re-evaluation of the drug should be suspended until the clinical re-evaluation of the drug is completed. This is because the cost of clinical trials that were in progress cannot be compensated. However, the HIRA said that benefit revaluation and clinical revaluation are different. On the 14th of last month, Kim Ae-ryeon, head of the HIRA's Pharmaceutical Price Benefit Division, explained, "The review of benefit adequacy may include the target of clinical revaluation by the MFDS by selecting the target according to the selection criteria." She said, "It is difficult to consider arbitrarily delaying the evaluation of benefit adequacy only for components subject to clinical revaluation in terms of equity with other components." It remains to be seen whether the re-evaluation of Streptokinase and Streptodronase salary will be postponed as the industry suggests. Industries are also predicting some re-evaluation results. In the case of Celltrion's liver disease solvent Godex, which has the highest benefit claim among the ingredients this year, it is uncertain whether it will be maintained, and on the contrary, the antacid Almagate is likely to be maintained. In the case of Eperisone HCl, pain muscle contraction accompanied by musculoskeletal disease, which is the first indication, is likely to maintain, but it is uncertain about stiffness paralysis due to nervous system disease, which is the second indication. However, another industry official said, "The HIRA maintains strict security this time, so little has been confirmed in the industry." "It is said that only two of the six target ingredients will be maintained," he said. Since the announcement of the benefit adequacy revaluation plan in March, The HIRA received data from the pharmaceutical company and conducted a practical review on whether each ingredient meets the evaluation criteria. Therefore, on the 7th, the results will be announced after the first deliberation by the Pharmaceutical Benefit Evaluation Committee with the results. After that, during the fourth quarter, the Post-Pharmaceutical Evaluation Committee and the Pharmaceutical Benefit Evaluation Committee will be held once more to deliberate on the final plan.
- Policy
- Support for online conferences will be extended for 1 yr
- by Kim, Jung-Ju Jul 05, 2022 05:58am
- On-off events can be supported on an offline basis if certain conditions are met Temporary support for online academic conferences in medical, pharmaceutical, and medical devices will be extended for another year. This is because infectious diseases such as COVID-19 and monkeypox continue to occur, leaving room for reinforcement of social distancing. However, in the case of online and offline parallel academic conferences, which are called hybrid, flexibility has been increased so that they can apply on an offline basis by setting a certain standard in a rigid method that was previously applied only on an online basis. Branches and online academic conferences held by individual nursing institutions, which have been evaluated as having poor support effects in the industry, will not be able to apply except for exception collection support. The Fair Trade Commission recently approved a one-year extension by partially revising the "temporary support extension plan for online academic conferences." The support for online academic conferences is the first extension in 2021 and the second extension this time since temporary approval was made due to the outbreak of COVID-19 in 2020. In response, the Fair Trade Commission explained, "Despite the end of the limited time period to support online academic conferences, we decided to extend the support period in consideration of the situation where non-face-to-face events will continue as COVID-19 becomes commonplace and the academic exchange environment changes." Subject to the support are academic conferences held by affiliated organizations, medical societies, and pharmacological branches under the articles of association of the Medical Association and the Hospital Association. It also includes academic societies (including overseas societies), academic institutions, organizations, research institutes, and organizations approved and recognized by doctors' associations, dental societies, oriental medicine societies, pharmacological societies, and herbal societies. The most noticeable change in this extension is the change in the existing policy that was supported online at both online and off-line events. If more than 20% of the total participants, including the speaker, attend offline academic conferences, they will be supported on an offline basis and up to two offline booths will be installed. In addition, the cost can be provided to the society by 2 million won to 3 million won per booth and 500,000 won to 1 million won for nursing institutions. However, in the case of academic conferences held by organizations affiliated with individual academic societies, branches, and individual nursing institutions, it was stipulated that they would not apply except for exception collection. The Fair Trade Commission and the MOHW decided to discuss again if the government's policies, such as re-strengthening social distancing, make it impossible to hold offline academic conferences.
- Policy
- Korea joined the COVID-19 vaccine development country
- by Lee, Hye-Kyung Jul 04, 2022 05:54am
- As SK Bioscience's COVID-19 vaccine SKY Covione received an item permit today (29th), Korea has become a country with both COVID-19 treatments and vaccines along with Celltrion's COVID-19 treatment Regkirona. Oh Yu-kyung, Minister of Food and Drug Safety announced on June 29 that it decided to grant item permission on condition that SKY Covione, a COVID-19 vaccine developed by SK Bioscience and applied for permission to manufacture, sell, and item, submit a final clinical trial result report. SKY Covione is a COVID-19 vaccine that induces an immune response by administering antigen proteins made using gene recombination technology. This product was licensed for the purpose of preventing COVID-19 in adults over the age of 18. For usage/dose, 0.5mL of an antigen vial mixed with the immune enhancer (AS03) is inoculated twice every four weeks. SKY Covione is a COVID-19 vaccine developed and manufactured by a domestic company, and is a hot topic as it is approved by the MFDS for the first time in the world. The MFDS operated vaccine projects to support the development of the domestic COVID-19 vaccine quickly amid the COVID-19 situation, intensively and systematically. Since September 2020, a permission review team consisting of reviewers with extensive experience in screening has been set up to support the development and commercialization of COVID-19 vaccines and treatments, and customized consultations and preliminary reviews by non-clinical, clinical, and quality stages. It supported the design of clinical trials by preemptively introducing an immunogenic comparative clinical trial method so that phase 3 clinical trials, which are a key stage of product development, can be carried out scientifically and quickly. It led discussions in meetings and workshops between regulatory agencies so that the immunogenic comparative clinical method could be recognized internationally, and reflected in the WHO guidelines published in March. Unlike the previously approved COVID-19 vaccine, the COVID-19 vaccine permit is also significant in that the MFDS evaluated safety, effectiveness and quality of the COVID-19 vaccine developed by Korean companies throughout the development stage. The MFDS held a final inspection committee at 10 a.m. on the 29th, which is the final screening stage for SKY Covione The MFDS received an application for SKY Covione on April 29, and the COVID-19 treatment and vaccine permission review team focused on data necessary for permission such as non-clinical, clinical, and quality. The clinical trial review evaluated safety and effectiveness through a total of two data, including one clinical trial (phase 1) conducted in Korea, one clinical trial (phase 3) conducted in six countries, Korea, the Philippines, Ukraine, Thailand, Vietnam, and New Zealand. In addition to reviewing data such as manufacturing methods, standards, and test methods, GMP implementation of domestic manufacturing plants were evaluated whether they had facilities and management systems that could consistently produce quality through on-site inspections. With the approval of SKY Covione, we can expect Korean companies to enter the global vaccine market in earnest in the future. SK Bioscience is pushing for the registration of the WHO Emergency Use List (EUL) and plans to prepare for the supply of vaccines through COVAX FACILITY. This licensed vaccine can be stored in a refrigerated storage (2 to 8℃), so even countries that do not have ultra-low temperature distribution equipment can expect effective use in quarantine. The MFDS said, "We launched a commercialization strategy support group to support rapid entry into the market of public health crisis drugs, new concepts, and new technology drugs, linking development, non-clinical, clinical trial, and licensing reviews, and strengthening the function of providing professional services for clinical trial design." It added that a total of 22.6 billion won (2022) was invested in building infrastructure through vaccine safety technology support centers, and that it is expected to have synergy effects in supporting drug development companies by promoting basic counseling on vaccine development, quality and clinical training. Oh Yu-kyung, Minister of Food and Drug Safety said, "The MFDS has thoroughly verified safety and effectiveness through a triple advisory process and approved SKY Covione of SK Bioscience." "In the future, we will work with various institutions to preemptively respond to future infectious diseases," she said.
- Policy
- Evusheld granted emergency use for preventing COVID-19
- by Lee, Hye-Kyung Jul 01, 2022 05:50am
- With the emergency use authorization has been granted for ‘Evusheld Inj,’ the first-ever preventive antibody therapy for COVID-19 in Korea, the drug is expected to be used in immunocompromised patients who are unlikely to mount an adequate response to COVID-19 vaccinations. The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) announced on the 30th that the ministry decided to grant emergency use authorization for 20,000 courses of the antibody therapy ‘Evusheld Inj (tixagevimab, cilgavimab) that was developed by AstraZeneca to prevent COVID-19 infections. The authorization was made after deliberation by the Medical Product Safety Management and Supply Committee for Public Health Emergency Response in comprehensive consideration of its need in immunocompromised patients that are unlikely to mount an adequate response to COVID-19 vaccinations, the MFDS’s safety, efficacy, and quality review results, and results from the expert advisory meeting. The Evusheld that received EUA today will become the first-ever antibody therapy authorized in Korea for COVID-19 prevention and is expected to contribute to the prevention of COVID-19 infections in blood cancer patients who may not mount an adequate immune response to COVID-19 vaccinations, as well as patients receiving immunosuppressant therapy after organ transplantation, etc. Evusheld has been granted emergency use authorization (EUA) in the US in December last year, then granted marketing authorization in Europe in March this year. Evusheld is a neutralizing antibody combination that binds to the spike protein of SARS-CoV-2 to inhibit virus penetration into bodies. Evusheld is approved for use in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to blood cancer, or immunosuppressive therapy after organ transplant that may not mount an adequate immune response to COVID-19 vaccination that are not currently infected with or had recent known exposure to a person infected with SARS-CoV-2. Evusheld is administered as an IM dose of tixagevimab (150㎎) and cilgavimab (150㎎) in two separate, consecutive injections. The emergency use authorization is a system that allows manufacturers and importers to supply unauthorized medical products in Korea to respond to a public health crisis. The Korea Disease Control and Prevention Agency requested for the EU A of Evusheld Inj. To the Ministry of Food and Drug Safety on June 10th this year. After the EUA, the MFDS will additionally make safety measures and collect information on adverse events arising from Evusheld’s use. The ministry also ordered its domestic importer to actively collect and report on its safety information in Korea and abroad, and established a system so that healthcare professionals and patients (and patient families) can report adverse events by phone or online. The ministry will continuously analyze and assess the safety information in Korea and abroad to promptly take safety measures when necessary.
- Policy
- Follow-up of impurity inspection
- by Lee, Hye-Kyung Jul 01, 2022 05:49am
- The MFDS received the results of testing and testing of Nitrosamine impurities from domestic pharmaceutical companies, and prepared safety management guidelines as a follow-up measure. This guideline is for safety management of N-Nitrosamines, a mutagenic and carcinogenic impurity among drugs, and it should be implemented by raw and finished drug manufacturers and importers to reduce or prevent impurities within the daily intake allowance. Starting with high blood pressure medicine (Valsartan) in 2018, tuberculosis medicine (Rifampicin) in 2021 as Nitrosamines were detected in drugs every year until Rifampicin), and new mutagenic impurities were recently detected, the MFDS received a test report of the company's own test on the evaluation items that may occur until the 31st of last month. The MFDS will continue to review impurities that may be included in medicines through close cooperation with overseas regulators and recommend appropriate measures to related pharmaceutical companies. According to the guidelines, apart from the MFDS' review of impurities, pharmaceutical companies should closely examine the raw material drug synthesis process and the manufacturing process of finished drugs using currently available science and technology to evaluate the potential cause and possibility of impurity generation. Pharmaceutical companies should check all impurities that may occur in the process of synthesizing and storing raw materials, manufacturing and storing finished drugs, evaluate the mutagenicity of the impurities, and if mutagenicity or carcinogenicity is confirmed, the risk of carcinogenesis is less than 1/100,000. (Q)SAR methods can be used to predict bacterial mutagenicity test results using a computer, appropriate management methods can be applied based on structural warnings, or bacterial mutagenicity tests can be conducted directly for specific impurities Nitrosamines impurities are compounds with potential carcinogenicity or mutagenicity that can occur mainly when they are combined under conditions where Amine and Nitrosating agent can react. The causes of Nitrosamines impurities in drugs identified so far can be classified as risk factors related to the manufacture and storage of raw and finished drugs, and there are also risk factors related to GMP. When detecting impurities, pharmaceutical companies should report data on the possibility of occurrence to the MFDS, the cause of occurrence (including the estimated cause), the detection amount, and the daily intake allowance. According to the step-by-step measures prepared and distributed by the MFDS, pharmaceutical companies should compare the amount of impurity detection and acceptance criteria, take necessary measures such as voluntary recovery and reduction of impurities in the market, and submit related matters to the MFDS. It will review necessary measures based on information collected from pharmaceutical companies' reporting of impurity detection and overseas regulatory agencies. If it is deemed necessary for the safety management of drugs in circulation in Korea, it is planned to instruct to evaluate the possibility of impurities and conduct test tests on specific drugs.
- Policy
- Opdivo succeeded in setting the standard as the first treatm
- by Lee, Tak-Sun Jul 01, 2022 05:49am
- Ono's Opdivo succeeded in setting the benefit standard as the first treatment for gastric cancer for the first time as an immuno-cancer drug. The HIRA held its sixth meeting in 2022 on the 29th and set the standard for the efficacy of Opdivo's primary treatment for gastric cancer. This is the first time that immuno-cancer drugs have passed the deliberation committee as the first treatment for gastric cancer patients. The deliberation committee established a combination of Opdivo's Fluorouracil system and platinum-based chemotherapy as the primary treatment for progressive or metastatic gastric cancer, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma. However, the standard was not established for combination therapy with Ipilimumab as the primary treatment in adult patients with dermatoma among malignant pleural patients who cannot be operated, which is another indication of Opdivo. On this day, Celgene's Revlimid also succeeded in setting the benefit standard for maintenance therapy for patients who received newly diagnosed autologous hematopoietic stem cell transplants among multiple myeloma. Imbruvica and Glivec Film Coated Tab, which started to expand the benefit standard, failed to set the standard. Janssen's Rybrevant and BMS Korea's Inrebic, which newly applied for benefits, failed to set the standards, making it necessary to try again.
- Policy
- SKY Covione is promoted the registration of the WHO EUL
- by Lee, Hye-Kyung Jul 01, 2022 05:49am
- SKY Covione, a COVID-19 vaccine developed in Korea and approved, is conducting a rolling review to promote the registration of the WHO Emergency Use List (EUL) and to go through the European EMA approval process. The MFDS (Director Oh Yoo-kyung) held a briefing at 2 p.m. today (29th) and announced that it decided to approve the product on June 29th on the condition that SK Bioscience submitted a final clinical trial report for COVID-19 vaccine SKY Covione. At the briefing, Park In-sook, head of the bio-drug review department at the National Institute of Food and Drug Safety Evaluation, explained the future commercialization schedule of SKY Covione, where item permission was granted. Director Park said, "Even if the vaccine is already approved, the quality will be tested once more in the country before each developer ships it. If SK Bioscience applies for approval for shipment in Korea at the time of shipment of SKY Covione, the MFDS will conduct a quality test and use it according to the health authorities' vaccination plan." Regarding overseas use, Director Park said, "It will be used a lot in other countries only when the WHO's approval is made," adding, "SK Bioscience has submitted an application to the WHO and the EMA is also preparing a pre-rolling review to get permission." Although the first COVID-19 vaccine in Korea has been released, pharmaceutical companies that are currently conducting clinical trials to develop the COVID-19 vaccine are also appearing one after another. Director Park said, "Since most of the basic vaccinations are in place in Korea, pharmaceutical companies are changing their strategies rather than stopping the development of vaccines themselves." He said, "We are preparing for development before additional vaccinations, not basic vaccinations, and the MFDS also held two meetings with developers to prepare guides for the development of additional vaccinations. Guidelines will come out soon," he said. At the briefing, Oh Yoo-kyung, head of the MFDS, said, "SKY Covione is the first domestic COVID-19 vaccine approved by the MFDS." In other words, the clinical trial plan was quickly approved by forming a permission review team to apply a customized pre-consultation system for each non-clinical, clinical, and quality stage, and introduced an immunogenic comparative clinical trial method to expedite a large-scale clinical trial. The MFDS said it has approved SKY Covione for the first time in the world with the same licensing requirements and screening criteria as advanced countries such as the United States and Europe, and has established a test method necessary for vaccine testing at the same time. Director Oh said, "With this permission, Korean companies' ability to develop COVID-19 vaccines has been proven internationally." She emphasized, "We can expect to enter the global vaccine market in the future."
- Policy
- SK Bioscience gets final approval for SKYCovione
- by Lee, Hye-Kyung Jun 30, 2022 05:52am
- Permission for the item COVID-19 Vaccine No. 1 developed and manufactured in Korea is imminent. As a result of discussing SKYCovione's safety and effectiveness, the Central Pharmaceutical Review Committee said that it was recognized for the purpose of preventing COVID-19 based on the immunogenic clinical results compared to Vaxzevria, which was already approved, and that the item could be approved. The MFDS (Director Oh Yoo-kyung) explained the progress of item approval for the COVID-19 vaccine SKYCovione (GBP510) developed and manufactured by SK Bioscience in Korea at 10 a.m. on the 27th. SK Bioscience applied for a preliminary review of quality data on April 15, and an application for item permission was received on April 29. A meeting of the Central Pharmaceutical Affairs Review Committee was held at 4 p.m. on the 26th to advise on the safety and effectiveness of SKYCovione. Based on the submitted data such as clinical trial data for SKYCovione, the committee acknowledged the safety and effectiveness of the drug and discussed whether the item permission was appropriate. In particular, experts' comprehensive opinions were exchanged on overall permits, such as overall views on the effectiveness and safety of vaccines and measures to secure safety after approval. As a result of discussing whether SKYCovione's safety and effectiveness were recognized, safety such as abnormal cases that occurred in clinical trials was judged to be acceptable. However, there was an opinion that the predicted adverse reactions in the local and systemic areas were more likely to be caused by vaccinations such as fatigue, muscle pain, headache, chills, fever, joint pain, nausea, vomiting, and diarrhea in adults younger than the first dose. Unforeseen adverse events related to vaccine administration (4 weeks after administration) occurred in about 13.3% (402/3029 patients) of the vaccine group, the main symptoms were injection site hyperplasia, dizziness, pain, etc., and the control group was about 14.6% (145/996). The serious abnormalities were similar to 0.5% (15 cases, 15 cases) in the vaccine group and 0.5% (5 cases, 9 cases) in the control group, and there was 1 rapid progressive glomerulonephritis, which cannot be excluded from vaccine administration, but it was recovering at the time of submission of clinical trial data. In the immunogenicity results comparing already approved Vaxzevria with a control vaccine, neutralization antibodies formed 2.93 times after 14 days of administration every four weeks over the age of 18, and serum conversion rate was 98.06% in the vaccine group and 87.30% in the control group. It was suggested that the overall safety security plan is appropriate, and it is reasonable to observe and evaluate abnormal cases of special interest similar to existing vaccines as a risk management plan after approval. The Ministry of Food and Drug Safety said, "When compiling the opinions of the committee, it was agreed that SKYCovione could be approved." The MFDS received advice from the COVID-19 treatment, vaccine safety, and effectiveness verification advisory group on June 21 to enhance the expertise and objectivity of the COVID-19 vaccine licensing review process. The effectiveness for permission is recognizable, and safety during clinical trials is acceptable, and abnormal cases of special interest should be observed and information should be collected after permission. The MFDS will review SKYCovione's submission data, comprehensively judge expert opinions, efficacy, effectiveness, dosage, and recommendations obtained from the advice of the COVID-19 vaccine safety and effectiveness committee, and hold a final inspection committee to make a final decision.
