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- 2026-04-11 21:14:16
- Opinion
- [Reporter’s View] MFDS opens up, discloses contact info
- by Lee, Hye-Kyung Aug 16, 2022 05:46am
- The Ministry of Food and Drug Safety is changing. The ministry's efforts to transform into an ‘Open MFDS’ as emphasized by Minister Yu-Kyoung Oh since her day of appointment on May 27th, is showing results. After holding 7 ‘ultimate debate’ sessions in June this year, the MFDS also held 16 roundtable meetings and discussion sessions with the industry, associations, and academia, as well as 2 separate public debates for the medical and food sector to prepare '100 tasks for regulatory innovation.' Based on the feedback accrued, the MFDS announced the final 100 tasks for regulatory innovation on the 11th. The Korea Chamber of Commerce and Industry and the Korea National Council Consumer Organization attended the announcement, signifying the deep public-private communication that had been made in its process. A bigger change is that the contact information for each department in the organizational chart on the MFDS’s webpage that had been hidden since February 22nd last year was disclosed again. At the time, the MFDS deleted the contact information of the officials in charge, deciding that regular business was difficult due to the flood of inquiries and complaints made by the general public regarding COVID-19 vaccines and treatments. Complaints followed this deletion of contact information, but the MFDS only repeated its response that it has prepared a main representative number system for inquiries to resolve the difficulty of making contacts arising from the absence of officials in charge and to increase focus on the ministry's review work. Therefore, the inconvenience caused by the lack of communication was entirely borne by the complainant. The introduction of the ‘core time system’ to allow officials to focus on their regular work, had further caused hardships in reaching MFDS officials. However, the contact information for each department in the organizational chart on the MFDS’s webpage has been disclosed since the 8th. Although the core time system will still be in place, the MFDS decided to reduce its period from the previous 7 hours (10:00 a.m.-5:00 p.m.) to 4 hours (11:00 a.m.-3:00 p.m.). On the day of her appointment, Minister Oh said, “The MFDS needs to become a science and technology expert, crisis management expert, and public communications expert. Communications between ministries, departments, and various stakeholders, as well as internal inter-field and inter-function communication, must be encouraged for growth. I will create an open MFDS in which employees can actively communicate, and one that encourages public-private communication and cooperation." Minister Oh had constantly emphasized communication during her official appearances. She said she will listen to various opinions in the process of preparing and implementing the 100 tasks for regulatory innovation. In 100 days after her appointment, Oh’s determination for communication is coming to fruition in various ways. The reporter hopes that the MFDS’s efforts for ‘open communication’ continue.
- Policy
- Why AZ’s vaccine was used as comparator for SKY Covione
- by Lee, Hye-Kyung Aug 16, 2022 05:46am
- The minutes of the Central Pharmaceutical Affairs Council’s meeting that reviewed the first homegrown COVID-19 vaccine - SK Bioscience’s 'hasCovione multi inj.’ – have now been disclosed. The minutes contained discussions on the reason why a vaccine from a different platform was selected as the control vaccine for SKY Covione, whether its safety is acceptable, and on the adequacy of post-approval safety assurance measures. The CPAC meeting that was held on June 26th, whose minutes were disclosed by the MFDS recently, sought counsel on the safety and efficacy of the homegrown COVID-19 vaccine SKY Covione, which applied for manufacture, sale, and marketing authorization in Korea. An employee from SK Biosience’s Andong L House is filling the Sky Covione formulation (Pic: SK Bioscience) On why a vaccine from a different platform was selected as a control vaccine for SKY Covione, the MFDS explained, “Although it is best to use a comparator from the same platform, a recombinant vaccine using the same platform had only been approved in January this year in Korea, and at a similar period in Europe as well.” “The clinical trial for SKY Covione had been approved in August last year, and no approved vaccines were using the same platform at the time. Therfore, the company had to find the most appropriate control vaccine among available vaccines, all of which were being supplied by the state. The multinational pharmaceutical companies have not approved the use of their vaccines as control vaccines, therefore, AstraZeneca’s vaccine was used as control vaccine in consideration of the approval status and availability of vaccines.” The World Health Organization also states that although using vaccines from the same platformas a control vaccine is advisable if the company cannot secure a vaccine from the same platform, it may use other vaccines as control as long it can demonstrate clear immunogenicity compared to that control vaccine. The MFDS said, “Unlike in the past, all of the vaccines for COVID-19 are being contracted and used by the state. This was why it was difficult for latecomers to obtain a control vaccine, and only AZ’s vaccine was available for use as a control vaccine." Explaining how vaccines based on bridging immunogenicity data are approved under the condition that it submits efficacy evaluations, the MFDS added, “The Ministry will add a condition for the drug’s approval to follow-up for a certain period post-approval to evaluate how much infection is prevented after actual vaccination."
- Company
- Will the situation in the Atozet market improve?
- by Kim, Jin-Gu Aug 16, 2022 05:46am
- With the revision of guidelines for treating hyperlipidemia in Korea announced, attention is focused on how it will affect the prescription performance of major drugs. The pharmaceutical industry predicts that the Atorvastatin and Ezetimibe market, which has recently been growing rapidly, will benefit the most from the revision of the guidelines. Domestic pharmaceutical companies that have recently entered this market are also in the midst of preparing marketing and sales strategies with guidelines in mind. ◆ Proactive treatment for patients with high-risk hyperlipidemia According to the pharmaceutical industry on the 9th, The Korean Society of Lipid and Atherosclerosis is planning to officially announce the fifth edition of the "2022 dyslipidemia treatment guidelines" in September. The core of the new guidelines is active treatment for high-risk patients. Patients in stages 1 to 3 of CKD are regarded as high-risk groups and their LDL-C is actively lowered. Currently, the LDL-C level of high-risk patients is lowered to 70, but the revised guidelines lower this target to 50. ◆ The pharmaceutical industry expects Atorvastatin and Ezetimibe to benefit In the case of Ezetimibe, it is expected that its use as a combination therapy with statins will expand in the primary treatment of high-risk patients who are not controlled by Statins alone. In this process, it is predicted that the use of Statin + Ezetimibe will increase. Atorvastatin has a lower burden on the mechanical kidney than other statin drugs such as Rosuvastatin. This is because it is an mechanism of action that is excreted by the liver, not the kidney. Given that the new guidelines see patients with chronic kidney diseases in the first to third stages as high-risk groups, Atorvastatin, which can be used regardless of whether they have kidney disease, is expected to benefit. In the case of Rosuvastatin, as a precaution in use, it is stated in the product manual that do not administer it to patients with severe renal failure. Pitavastatin also includes patients with moderate to severe renal impairment among patients. Atorvastatin and Simvastatin do not include this in the administration indication. ◆Announcement of competitive heating of hyperlipidemia compound, preparing the details that match the guidelines If the guidelines are revised, it is predicted that competition in the Statin+Ezetimibe combination's hyperlipidemia complex market will intensify. According to UBIST, a pharmaceutical market research firm, the performance of Rosuvastatin and Ezetimibe in the first half of the year was 232.9 billion won, up 11.4% from the first half of last year. During the same period, prescription performance of Atorvastatin and Ezetimibe increased 80.6% from 50.3 billion won to 90.8 billion won. The market for Atorvastatin and Ezetimibe is growing explosively with the addition of a large number of generics last year. Until 2020, the Atorvastatin·Ezetimibe combination was one item of Atozet by Organon Korea. Since Chong Kun Dang was approved for Lipilouzet, in October 2020, 113 pharmaceutical companies have entered the Atojet market with generic licenses until June last year. The revision of the guidelines is raising expectations for the growth of the Atorvastatin and Ezetimibe markets. At the same time, it is in the midst of preparing marketing and sales strategies tailored to the revision of guidelines. An official from a pharmaceutical company selling the item said, "We are aware of the revision of the guidelines," adding, "If the guidelines are revised as scheduled, we plan to focus on this part in the second half of the year to further increase prescription performance." Another pharmaceutical company official said, "We expect changes due to the revision of the guidelines to appear first in general hospitals." He explained, "In the local area, we are preparing related details to expand prescriptions tailored to the new guidelines."
- Policy
- The regulation for shortening the period will be revised
- by Lee, Hye-Kyung Aug 16, 2022 05:46am
- As announced by the government, if the RSA-applied drugs are subject to PE submission, the registration period will be shortened, and even drugs that have proven improvement in children's quality of life will be excluded. The HIRA will pre-announce the "Partial Amendment Regulations on the Evaluation Standards and Procedures for Medical Care Benefits" containing such information and receive opinions by the 30th of next month. The revised regulations are designed to promote national tasks such as shortening the listing period of drugs related to diseases that threaten survival and strengthening access to patients through the expansion of risk-sharing systems. In accordance with Article 11-2 (1) of the Medical Care Benefit Standard, the legal processing period for insurance registration is within 120 days, and in the case of the world's first new drug approved in Korea, the processing period is within 100 days. However, in the case of drugs that manufacturers under Article 7 (2) of the Decision and Adjustment Standard or drugs that fall under Article 13 of the Medical Care Benefit Standard, the treatment period was 150 days, and the drugs evaluated as Table 2 (b) and (c) of the Decision and Adjustment Standard were shortened by 30 days. The HIRA said, "We have prepared an amended regulation to shorten the legal deadline for insurance registration of PE submission exemptions, which are methods of evaluating expensive anticancer drugs and treatments for severe and rare diseases." In addition, PE-submitted omitting drugs included "when there is no product or treatment that is used in children with equal therapeutic location, and clinically meaningful improvement in quality of life or other committees recognize it." The HIRA explained, "Even drugs to prove the quality of life for children can be omitted to submit PE data, allowing RSA to be expanded."
- Company
- Wakix, a new narcolepsy drug, can be prescribed at Big 5
- by Eo, Yun-Ho Aug 12, 2022 05:58am
- Wakix, a new narcolepsy drug, can be prescribed at the Big 5 General Hospital. According to the industry, it is Mitsubishi Tanabe Pharma's Wakix recently passed the DC of the Big 5, including Samsung Seoul Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Wakix has been on the insurance benefit list since February, forming a confrontation with Nuvigil of Handok Teva. The pay standard for this drug is that in adult patients over the age of 19 who have been confirmed to have narcolepsy, CSF hypocretin-1 immunoreactivity level corresponds to one or more of the patients with hypocretin deficiency measured to be less than 1/3 of the normal level or less than 110 pg/mL. Wakix, a counteracting and antagonist that selectively binds to histamine H3 receptors, is a new mechanism drug that increases histamine concentration in the brain. Nuvigil, an active isomer of sleep seizure treatment Provigil, activates dopamine in the brain to promote awakening and improve the duration of existing drugs. Narcolepsy, a rare and intractable disease, has limited treatment options in Korea. In the United States and Europe, Modafinil, Sodium Oxybate, Solriamfetol, and Pitolisant are used as narcolepsy treatments, but only Modafinil and isomer Armodafinil are permitted in Korea. Narcolepsy is a sleep disorder disease characterized by confusion in the sleep awakening cycle and abnormal expression of REM sleep due to the loss of neurons that produce a neurotransmitter called hypocretin in the brain. Chronic Daytime Sleepiness (EDS) and cataplexy, in which REM sleep is expressed in awakening conditions Cataplexy is known to appear in 70% of narcolepsy patients. Wakix is the first treatment in Korea to be approved for demonstrating clinical efficacy and safety of cataplexy.
- Opinion
- [Reporter’s View] Seek industry opinion before implemention
- by Lee, Tak-Sun Aug 12, 2022 05:58am
- Although the government announced measures to reinforce patient access to high-priced severe disease treatments on the 20th of last month, the pharmaceutical industry’s response to the new measures has been lukewarm at best. Moreover, the industry is ferociously criticizing how the government presented the measure without collecting industry opinion. The main point of implementing the new measure was to reduce the reimbursement period while reinforcing post-marketing management, however, the industry is claiming that the measure will have little effect in reducing the reimbursement period while focusing too much on drug price reduction, ultimately further impeding patient access. The government plans to reduce the reimbursement review period of treatments for life-threatening conditions by 60 days through the concurrent operation of reimbursement evaluation and pricing negotiations, among other measures. On this, the Korean Research-based Pharmaceutical Industry criticized, “Reducing 60 days from a review period that already takes up to 3 to 4 times the actual statutory period (210 days) will be insignificant from the patient’s perspective in feeling any improved access. The industry added, that preparing a pharmacoeconomic evaluation exemption regulation for treatments with a small number of patients and improving the maximum discount rate of the Price-Volume Agreement system from the current 10% will only lower motivation for new drug development or reimbursement. The problem is that the government did not seek the pharmaceutical industry’s opinion before announcing the measure. KRPIA also expressed concern regarding this matter, saying that “It is a shame that the government, which had been emphasizing private-public cooperation, disclosed a major policy that may affect the whole field without conferring it with the biopharmaceutical industry.” Since early last year, the government and pharmaceutical associations have been meeting every month through a private-public consultative body established to improve the drug pricing system. However, the measure for improving access to high-priced drugs that had been announced was found to have never been discussed at the meetings. It is difficult to properly implement or promote a policy that is unilaterally announced without collecting the opinions of its users and suppliers. The ‘Lowering the elementary school entry age to 5 years’ policy that was recently withdrawn due to opposition from the education community, was also aborted due to this non-collection of opinions from the education community. Why the Ministry of Health and Welfare, which lacks a head, made such a hasty decision to announce an important policy without collecting opinions from the industry remains in question. If the government respects the pharmaceutical industry as its future driver of growth, it should not exclude the industry in the process of making such serious policies.
- Policy
- The Price of 4 Xarelto will be cut from the 22nd as planned
- by Kim, Jung-Ju Aug 12, 2022 05:58am
- As the court sided with the government for the four items of the Bayer Korea Xarelto (Rivaroxaban) series, which the government has lowered the insurance drug price through ex officio adjustment and ended the additional application, the drug price cut schedule was set. On the 22nd, the drug price will fall as originally planned by the government. The 11th part of the Seoul High Court recently sided with the Ministry of Health and Welfare in the case of the Xarelto Drug Abatement Cancellation Action (2021-Guhap 65811) filed by the company against the Ministry of Health and Welfare. As the company filed a lawsuit, the price was lowered as the suspension of execution of the drug price cut, which the court accepted, was lifted. Earlier, on May 24, 2021, the Ministry of Health and Welfare lowered the price of four items of the drug series through the revision of the Notice of the Drug Benefit List and the upper limit amount table (Notification No. 2021-147). The government is ex officio adjusting the upper limit price of products with the same administration route, ingredients, and formulations as the first registered products and the lowest registered products when registered as generics. If the first genomic is registered, it is 53.55%, which is added to 70% for one year after adjustment. At that time, the Ministry of Health and Welfare decided to reduce the Xarelto 10mg content, 15mg, 20mg, and 2.5mg content by 30% each, and to drop 23.5~23.6% each as of May 1, 2022, a year later. As a result, the company protested and the suspension of execution has continued for about a year along with the lawsuit. With this close, the price will fall to the official price at the time, and the fixed date will be on the 22nd. However, the Ministry of Health and Welfare said it will inform the company further if there is a change in the price because the possibility of appeal remains, and the court may accept the suspension of execution again.
- Policy
- CKD completes acquiring 3 exclusive licensed items
- by Lee, Tak-Sun Aug 12, 2022 05:58am
- Chong Kun Dang completed the acquisition process for the three items that it signed exclusive sales agreements for with foreign pharmaceutical companies last year. All three items are known to have a prior history with Chong Kun Dang. According to industry sources on the 11th, Chong Kun Dang has been receiving insurance reimbursement for the tranquilizer drug ‘Valium 5mg Tab. (diazepam)’ starting this month. The approval and reimbursement rights for the drug had previously been owned by Roche Korea. However, after the global commercial rights of the drug were transferred from Roche to Pharmanovia, Chong Kun Dang signed an exclusive sales agreement for Valium in Korea with Pharmanovia in August last year. Under the agreement, Chong Kun Dang transferred and acquired the license for Valium Tab. 5mg in Korea, and the reimbursement entity was also changed accordingly. The sales right for the epilepsy treatment Rivotril (clonazepam) in Korea, whose license was also held by Roche Korea, had also been transferred to Chong Kun Dang through a transfer and acquisition process prior to Valium. Accordingly, Rivotril’s reimbursement entity was switched from Roche Korea to Chong Kun Dang in March this year. , whose sales rights was transferred from Roche Korea to Chong Kun Dang In March last year, Chong Kun Dang acquired the exclusive domestic sales right for Rivotril from Cheplapharm, which owns the global commercial rights to Rivotril. Cheplapharm had purchased the global commercial rights for Rivotril from Roche. Both of the drugs had previously been sold by Chong Kun Dang under a joint sales agreement with Roche Korea. Therefore, the interpretation is that the company acquired the exclusive domestic sales right of the two drugs to sell in its pre-established sales networks. In June, the company also completed the transfer and acquisition of the domestic sales right for the anticancer drug ‘Leustatin Inj. (cladribine) ' which had been previously owned by Janssen Korea. Its global commercial rights are also owned by Pharmanovia, and an exclusive domestic sales agreement had been signed for the drug in October last year. This is not the first time Chong Kun Dang had signed exclusive domestic sales agreements with new owners of drugs after the transfer of global commercial rights. The company had previously signed an exclusive sales agreement and acquired the sales rights for the antihypertensive drug ‘Dilatrend’ and obesity treatment ‘Xenical' from Cheplapharm. Chong Kun Dang owns the license and right to reimbursement for the drugs in Korea.
- Policy
- Ceprotin, Takeda's rare dz, gives 11 yrs for reexamination
- by Lee, Hye-Kyung Aug 12, 2022 05:57am
- On the 2nd, Takeda's Ceprotin, which was first approved as a treatment for severe congenital protein C deficiency in Korea, was given an 11-year review period after marketing. Severe congenital protein C deficiency is a rare genetic disease that causes fatal defects in blood clot control due to a lack of protein C, a type of vitamin K-dependent anticoagulant, and is defined when protein C levels are less than 1% (less than 1 IU/dL), and the incidence rate is estimated to be 1 in 4 million newborns. Ceprotin is the first human protein C drug approved for patients with severe congenital C protein deficiency and was approved for "prevention and treatment of venous thrombosis and fulminant purple hemiplegia in patients with severe congenital protein C deficiency in children and adults." Prior to Ceprotin's approval, the Central Pharmaceutical Review Committee's Pharmaceutical Affairs Subcommittee-Rare Medicine Subcommittee discussed the validity of the re-examination period when licensing biopharmaceutical items. On this day, the committee members decided that it was appropriate to set a period under the Rare Disease Control Act in consideration of the prevalence rate as an item prescribed for rare diseases. It also said that 11 years of re-examination, including pediatric indicators, should be given to secure sufficient safety information. It is reasonable to grant a 10-year re-examination period, including a pediatric indication, and a 10-year re-examination period, which was consulted by the central pharmacy, considering the pharmacological law, the re-examination system, and the characteristics of rare diseases. "It is difficult to judge that there is no appropriate treatment for severe congenital protein C deficiency because there are standard treatments," a member said. "However, it is confirmed that there are limitations on standard treatments and risks to be applied to children." The opinion is that it is difficult to evaluate post-marketing safety due to a lack of patients by granting a 4-6 year review period for congenital genetic diseases, which have symptoms mainly in the early stages of newborns and have a very high mortality rate from complications. Considering the nature of special diseases and the characteristics of the domestic medical environment, a total of 11 years of re-examination period, including pediatric diseases, will be given.
- Company
- Verquvo for CHF, aims to enter insurance benefits
- by Eo, Yun-Ho Aug 11, 2022 06:03am
- Verquvo, a new drug for heart failure, aims to enter insurance benefits. dksl According to related industries, Bayer Korea has submitted an application for payment of Verquvo, a water-soluble guanylate cyclase (sGC) promoter that promotes the synthesis of intracellular cyclic Guanosine (cGMP). Verquvo was recently approved in December last year as a combination therapy to reduce the risk of death from cardiovascular disease and hospitalization due to heart failure in patients with symptomatic chronic heart failure, whose left ventricular ejection rate, which experienced intravenous diuretic administration, has decreased to less than 45%. Existing heart failure treatments have been a method of blocking harmful effects from the natural neurohormone system activated by myocardial and vascular dysfunction. Verquvo has a new mechanism to improve myocardial and vascular function by promoting the synthesis of intracellular cyclic monophosphate guanosine (cGMP), which regulates heart contraction, vascular tension, and heart remodeling with a water-soluble sGC stimulant. It was approved as the world's first-in-class chronic heart failure treatment as an sGC promoter. Verquvo demonstrated efficacy through phase 3 clinical VICTORIA The VICTORIA study was conducted in 5, 050 patients with high-risk heart failure with NYHA Class (Grades 2-4) and reduced left ventricular ejection rate to less than 45% who were hospitalized due to heart failure or experienced intravenous diuretic administration outpatient. 59.7% of the patients who participated in the study were undergoing three-drug therapy, and 41% of severely ill patients with NYHA grades 3 and 4. Patients were administered placebo or up to a target maintenance dose of Verquvo 10 mg in combination with other heart failure treatments. As a result, Verquvo had about 10% lower risk of first hospitalization due to cardiovascular disease death or heart failure during 10.8 months (median value) of follow-up, with an annual Absolute Risk Reduction of 4.2%, meeting the primary evaluation variable. The annual absolute risk reduction rate of hospitalization due to heart failure was 3.2%, and as a result of comprehensive evaluation of hospitalization due to death from all causes or heart failure, Verquvo group showed a 10% risk reduction compared to the placebo group. Heart failure is a disease that appears as a final complication of various cardiovascular diseases such as coronary artery disease and high blood pressure without delivering as much oxygen as necessary to the peripheral organs due to structural or functional abnormalities of the heart. Heart failure is a major cause of hospitalization for patients aged 65 or older, and the prevalence of heart failure in Korea has been steadily increasing over the past decade as the population ages. Heart failure is at high risk of worsening over time, and about 50% of patients diagnosed with heart failure have a low survival rate, with death within five years.
