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- 2026-04-17 06:15:02
- Policy
- HIRA clears 4 out of 5 Spinraza reimbursement pre-approvals
- by Lee, Hye-Kyung Apr 02, 2020 06:26am
- Korean health authority has passed four out of five preliminary applications submitted last month to treat spinal muscular atropy (SMA) with reimbursed use of Spinraza. Even the one denied case would likely to be cleared, if the applicant submits additional evidential data of patient’s onset symptoms of SMA. In every four months, Spinraza users receiving reimbursement have to submit monitoring report prior to maintenance administration. And the health authority has approved all ten monitoring reports submitted. On Mar. 31, Health Insurance Review and Assessment Service (HIRA, President Kim Seung-taek) posted the results of pre-administration approval on four listed items—Spinraza, Soliris, ventricular assist device (VAD) and hematopoietic stem cell transplantation (HSCT)—Treatment Review and Assessment Committee deliberated in February. Spinraza’s reimbursed use standard stipulates patients are eligible for reimbursement when qualifying all conditions—positive genetic testing of a deletion or mutation in the survival motor neuron 1 (5q SMN-1) gene, onset of SMA symptoms from age three or less and not on permanent ventilator (more than 16 hours a day for over 21 consecutive days). The reimbursed use of the drug has to be assessed before the initial administration, after administering initial dosage (four doses) but before the fifth dose, and every maintenance dose then after based on clinical evaluation (development stage, motor function and respiratory function). Before the Spinraza review, the committee reviewed pre-administration applications on reimbursed use of Soliris (eculizumab). All three to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) were cleared, but one case of atypical hemolytic uremic syndrome (aHUS) treatment was denied. The rejected aHUS case was to treat 67-year-old patient, who visited an emergency room for nausea and vomiting and was hospitalized due to acute renal failure and observation of symptoms like thrombocytopenia, anemia and schistocyte but continued to have thrombotic microangiopathy (TMA) despite receiving steroid and therapeutic plasma exchange (TPE). Nevertheless, it was ultimately rejected, as the doctor’s record of the patient’s schistocyte and thrombocytopenia did not coincide with the TMA described in the reimbursement standard notice. Other details of the Treatment Review and Evaluation Committee’s deliberation can be found on HIRA website.
- Company
- Hemlibra's indications are expanded
- by Nho, Byung Chul Apr 02, 2020 06:25am
- As a global new drug, indications & dosage standards for Hemlibra, a hemophilia preventive drug, have been expanded. JW Pharmaceutical said on the 31st, that Hemlibra (Emicizumab), which dramatically improves the convenience of administration, is additionally approved by the MFDS as a routine preventive therapy for non-antibody patients. Hemlibra is a genetic recombination drug that is a routine preventive therapy for hemophilia A caused by the deficiency of factor VIII of blood clotting. It is a first in class drug that bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective hemostasis. Following the change in the permit, Hemlibra expanded the scope of treatment to severe A hemophilia patients who did not have antibodies within a year after being approved as a preventive treatment for hemophilia A with antibodies earlier this year. Hemlibra is currently marketed in more than 90 countries, including the United States, Japan, and Germany, and is recognized worldwide for its drug effect as a first in class drug. It has already been approved for antibody patients in over 90 countries, and has been approved for prescription in non-antibody patients in over 70 countries. In addition, the indications and dosages are not limited to the existing once-weekly subcutaneous injection method, and the dosage interval can be increased at the discretion of the medical staff. All of the prophylactic treatments released so far had to be intravenously administered 2-3 times a week, but Hemlibra can be administered subcutaneously once a week, once every two weeks, and up to once every 4 weeks, dramatically improving patient dosing convenience. Helimbra is the only drug in Korea that has been approved for the prevention of hemophilia, which is administered directly subcutaneously (under the skin) rather than intravenously (intravascular). Helimbra was also designated as an orphan drug for the first time in February, as a treatment for severe non-antibody hemophilia. According to the MFDS' notice, △ diseases where the number of patients in Korea is 20,000 or less △diseases that do not have appropriate treatment methods or drugs, or only drugs with significantly improved safety or effectiveness than existing alternative drugs are designated as orphan drugs An official from JW Pharmaceutical said that the company has been continuously pushing for permission to improve the quality of life for people with hemophilia A who need treatment for a lifetime. And, since most patients with hemophilia A do not have antibodies, he expects more patients will be able to benefit from treatment by expanding the indications. The domestic hemophilia treatment market size is estimated to be about ₩150 billion (Source: the HIRA). Hemophilia is classified according to the type of insufficient blood coagulation factor, and type A hemophilia caused by the lack of factor VIII of blood clotting accounts for more than 80% of all hemophilia. As of 2018, there were a total of 1889 patients with hemophilia A in Korea, 51 patients (3%) with double antibody and 1838 patients (97%) with non-antibody.
- Policy
- Co-pay rate of advanced hospitals for cold patients to 80%
- by Lee. Chang jin Apr 01, 2020 06:21am
- As soon as the plan to reorganize the medical delivery system, which has shown a lull in the event of COVID-19, is expected to be presented to the Health Insurance Policy Deliberative Committee during this month. In particular, it is noteworthy that a plan to increase the outpatient co-payment rate of minor patients, such as simple colds using advanced hospitals, from 60% to at least 80%. As a result of covering on the 1st at the Medical Times, it was confirmed that the Ministry of Health and Welfare is preparing to propose The Health Insurance Policy Deliberative Committee, which will be held in April to improve the short-term countermeasures of patients with minor illnesses, which is a short-term measure, among the plans to reorganize the medical delivery system. The Ministry of Health and Welfare is considering a plan to increase the burden of co-pay for advanced hospitals for people with mild illnesses such as colds. This is the briefing of the director of the health department, Hong-in Noh.#Earlier, Noh Hong-in, head of the Ministry of Health and Welfare, announced the plan to improve the medical delivery system in September of last year. In order to prevent the use of advanced hospitals for mild patients such as colds, a strong penalty was given only to medical institutions. If so, what will happen to minor patients, such as colds, who are receiving outpatient treatment at an advanced hospital? According to the Enforcement Decree of the National Health Insurance Act, the rate and amount of the burden of partial co-payment (separate table), the co-payment rate of outpatient care for general patients at advanced hospitals is 60%, 50% for general hospitals, 40% for hospitals, and 30% for clinics. The Ministry of Health and Welfare is actively considering ways to increase the out-of-pocket rate of outpatient care for patients with mild illness from 60% to at least 80% in parallel with the penalty of senior general hospitals. Outpatient out-of-pocket rates for general patients at senior general hospitals specified in the National Health Insurance Act#The strategy is to increase the effectiveness of the plan to improve the medical delivery system only if the minor patient's burden is increased than the current situation. Personnel from the Ministry of Health and Welfare said that there is no change in the policy to improve the health care delivery system by applying 0% of the classification rate of senior general hospitals as a short-term measure and excluding medical quality evaluation support funds. He said that they are looking into ways to strengthen the current co-payment rate by more than 60% to minimize outpatient use of advanced hospitals for minor patients such as colds. In this case, the question is how to judge a mild patient. For first-time patients, the application of the classification rate and co-payment is the same as the present, and if the diagnosis is confirmed as a mild disease after examination, the method of applying the classification rate of 0% and the co-payment increase from the reign is predominant. The Ministry of Health and Welfare is planning to propose a plan to improve the medical delivery system through the Health Insurance Policy Deliberative Committee in April. #An official from the ruling party said that it was problematic to impose a penalty only on advanced hospitals when discussing plans to improve the medical delivery system between the administrations in September last year. Although there were objections from patient groups, he agreed that increasing the burden of minor patients such as colds would contribute to re-establishing the medical delivery system and improving consumer behavior. The plan to change the name of the senior general hospital to 'severe general hospital' will be promoted through a bill in the second half of the 21st National Assembly standing committee after the general election in April in that it is necessary to revise the medical law. Another official from the Ministry of Health and Welfare said that the importance of infection management has increased as a result of the COVID-19 incident, and that they are considering a medical delivery system and a separate infection management delivery system. He said that it could take some time for both the quarantine, infection and medical policies to be discussed.
- Policy
- Bioequivalence reevaluation may hinder drug license renewal
- by Lee, Tak-Sun Apr 01, 2020 06:21am
- Korean pharmaceutical industry is voicing their concerns about the Ministry of Food and Drug Safety’s (MFDS) plan to revive bioequivalence reevaluation and to toughen the item license renewal review procedure. Arguing the government’s redundant review could harm them, the industry claims the ministry should set down more consistent review approach to avoid having a series of contradicting review results. The industry sources reported on Mar. 31, MFDS has unveiled the first Master Plan for Pharmaceutical Safety Management (valid from 2020 to 2024) containing details of reviving bioequivalence reevaluation and strengthening license renewal review. The ministry means to enhance credibility of approved drug quality through strenghtened bioequivalence test system for prescription drugs. Basically, the ministry is bringing back the regular bioequivalence reevaluation that was removed in 2018 due to the newly implemented renewal system. MFDS would finalize a master plan for bioequivalence reevaluation by 2024, after compiling a list of reevaluation subjects within this year. Some of the pharmaceutical industry agrees that bioequivalence reevaluation on already-approved items would be unavoidable due to the expanded bioequivalence test policy. Oral drugs would be required submit bioequivalence test results from this year, injection and sterile medicinal products from 2021, and all drugs from 2022. Already-approved drugs without qualifying bioequivalence test result would need to submit the test result to maintain their original pricing. However, the industry points out reviving the bioequivalence reevaluation, after the government has replaced the old reevaluation procedure with the current renewal system, would become a redundant procedure. An insider in government affairs explained, “An item approved through bioequivalence reevaluation could fail to renew and lose its license, because it was not listed in a foreign pharmacopoeia.” At the movement, the item renewal review prioritizes listing on an overseas pharmacopoeia. Apparently, some drugs have had their license revoked unfairly, only because they were not listed on overseas pharmacopoeia. Pharmaceutical industry expert groups argue the renewal review should have its own review standards, instead of relying on pharmaceutical status in other countries. Another government affairs associate criticized, “The Korean government should step away from outdated style of depending on certificate of pharmaceutical product (CPP) issued by an advanced country, but rather it should set forth an independent review standards,” and “the safety management master plan does specify its objective, but it is missing detailed standards.” Seemingly conscious of these criticisms, MFDS has announced the license renewal review would be updated through the master plan. From 2021, the ministry would mandate submission of prompt and regular report on safety issues including adverse event, data analysis and evaluation result, and safety control report. And from 2023, the ministry would also mandate collection and analysis of safety issue data from home and abroad and submission of post-marketing safety management report. However, the pharmaceutical industry predicts that items with mediocre sales and limited safety profile data would have gap in data submission, compared to originals with high overseas sales. This is the reason why the industry is concerned possible discrimination in the renewal review procedure. The industry insider in government affairs said, “Amid COVID-19 outbreak, it is frustrating to see the communication channel between the government is cut, when we need to discuss about tools to fill up the gaps it unfolds the new policy.” The insider added, “The government should convene a meeting to exchange questions and answers instead of disseminating information.”
- Policy
- Coverage on COVID-19 treatments to last a year
- by Lee, Hye-Kyung Apr 01, 2020 06:20am
- Despite the expedited review, the health insurance reimbursement on the off-label drug would be reassessed a year after due to the COVID-19 outbreak. Korea’s Health Insurance Review and Assessment Service (HIRA) disseminated a press release on Mar. 30 and stated, “Taking in account the latest medical case studies and expert recommendation, the healthcare reimbursement listing standards on COVID-19 related treatments were reviewed in the shortest period. The decision was made to promptly provide treatments according to patient symptoms.” Interferon (including peg interferon), Kaletra (lopinavir plus ritonavir), hydroxychloroquine, ribavirin, human immunoglobulin G (IVIG), oseltamivir and zanamivir are currently used off-label with coverage to treat patients with COVID-19. The treatments are used on either confirmed or suspected cases for seven to 14 days. Typically, the reimbursement review takes approximately 80 days. Nevertheless for the COVID-19 treatments, HIRA reported to the Ministry of Health and Welfare (MOHW) the reimbursement standard set based on the recommendation made by Korean healthcare experts on Feb. 3. And immediately, the ministry issued related notice on the day after. The additional reimbursement standard was again reported to MOHW on the day after the healthcare experts submitted an additional recommendation on Feb. 19, and the related notice was issued immediately. The reimbursement standard set amid COVID-19 outbreak would be reassessed for reimbursement adequacy a year after according to MOHW’s notice (No. 2020-37). Director Kim Ae-ryun of Pharmaceutical Management Department at HIRA said, “Regular reimbursement standard review generally takes more than 80 days, but the review on COVID-19 treatments were rapidly processed due to the fast spreading infectious disease. The agency would do its best to provide safe and effective treatments to the people by promptly reviewing reimbursement standard at times of infectious disease outbreak.” Although there is no drug developed to specifically treat COVID-19, HIRA has established the standard based on latest medical case studies and expert’s advice, considering the urgency of the outbreak. Moreover, HIRA plans to accumulate evidential data in the future, and constantly accept related academic societies’ recommendations to consolidate adequacy of the current reimbursement standards. Meanwhile, HIRA is planning to swiftly review reimbursement listing and standard for Ministry of Food and Drug Safety (MFDS)-approved drugs, using the outcome of clinical trials conducted as a part of pharmaceutical rediscovery research project for COVID-19 treatment.
- Product
- 7 out of 10 doctors, the government was wrong with COVID-19
- by Kang, Shin-Kook Apr 01, 2020 06:17am
- Seven out of ten doctors found that the government's response to the COVID-19 was wrong. The Korean Medical Association (Chairman Dae-Zip Choi) conducted a questionnaire survey on the COVID-19 events through the doctoral survey on the 20th to 24th, and published the results on the 30th. As a result of the survey, 39.1% (621 people) of the respondents answered that 'correct responses were not achieved at all' and 29.8% (473 people) answered that 'correspondence was somewhat insufficient' It was found that 68.9% of all respondents in the year were negatively evaluated. On the other hand, 16.6% (264 people) said that 'it worked to some extent' and 6.1% (97 people) said that they responded very well. In particular, the negative evaluation of doctors in the Daegu area, which suffered the most, was 83.2%, which is the only city in the country that has surpassed 80%. Regarding the 'restriction on the total entry of people via China', 84.1% (1337 people) of respondents said that 'there was a need to restrict the entry of people via China at the beginning of the situation'. Following this, 12.6% (200 people) said that 'there was no need to expand the limit of immigration via China' and 3.3% (52 people) said 'I don't know', and there were overwhelmingly negative opinions on the government response in the early stages of the situation. As for the KMA's response to the COVID-19 incident, the percentage of respondents who answered 'comparably appropriately responded' and 'very appropriately responded' was 44.6% (706 people) and 17.9% (284 people), respectively, accounting for 62.5% (990) People) as appropriate. On the other hand, 14.0% (221 people) had an opinion that 'the response was somewhat insufficient', and 7.6% (120 people) had an opinion that 'were wrong', and 21.6% answered negatively. Spokesperson Park Jong-hyuk of the KMA said that the survey was conducted to confirm the members' thoughts in response to the government's response to the COVID-19 incident, based on the results of the survey, it is used as a reference for preparing practical measures. Meanwhile, 1589 medical doctors nationwide participated in the survey, with Seoul accounting for the most with 33.9% (538 people), followed by Gyeonggi 17.4% (277 people), Daegu 8.3% (131 people), and Busan 8.2% (130 people).
- Company
- GC LabCell to develop COVID-19 treatment using NK cell
- by Lee, Seok-Jun Apr 01, 2020 06:17am
- GC LabCell is developing a COVID-19 treatment using natural killer (NK) cell. The Korean company is tentatively planning to start a clinical trial in Korea and the U.S. later this year. On Mar. 30, GC LabCell announced the company and the U.S.-based biotech company KLEO Pharmaceuticals are collaborating on a research for the COVID-19 treatment development project utilizing GC LabCell’s NK cell treatment technology and KLEO’s antibody recruiting molecules (ARMs). The project is based on two-track approach. First, the NK cell-based COVID-19 treatment would be developed to let the cells attack the infected cells and activate other immunocytes to induce their long-term immune response. And another COVID-19 treatment development would utilize the ARMs’ function of neutralizing antibody along with NK cell’s function. The initial research would be conducted with National Institute of Allergy and Infectious Diseases (NIAID), operating under the U.S. National Institute of Health (NIH), and Professor Choi Young Ki’s team at Chungbuk National University. The Korean company plans to start the first-in-human trial after June this year. GC LabCell’s NK cell treatment is a unique treatment type made from allogeneic NK cell that could be mass produced. Other NK cell treatments cannot be mass produced as it extracts the cells from a patient’s body.
- Company
- Samsung Epis, made a surplus of ₩122.5 billion
- by Chon, Seung-Hyun Apr 01, 2020 06:16am
- Samsung Bioepis has made a surplus for the first time since its inception. It has been in deficit every year since its inception in 2012, but it recorded operating profit of ₩122.5 billion due to the growth of biosimilars in overseas markets. Sales also grew more than twice that of the previous year. According to Samsung Bioepis' audit report submitted to the Financial Supervisory Service on the 29th, the company's operating profit last year was ₩122.5 billion, which turned to surplus compared to the previous year. It was the first surplus since it was founded in 2012. Sales Trend of Samsung Bioepis Sales by Year (Unit: KRW 100 million, Source: The Financial Supervisory Service) Since 2010, Samsung Biologics and Samsung Bioepis have been established in April 2011 and February 2012, respectively, after designating biopharmaceuticals as promising business in 2010. Samsung Bioepis' largest shareholder is Samsung Biologics, which holds a 50% stake. Samsung Bioepis recorded a deficit every year due to huge research and development costs. In the first year of 2012, it suffered an operating loss of ₩43.8 billion, and in 2015, 2017, and 2018, the loss amount exceeded ₩100 billion. By 2018, the cumulative operating loss amounted to ₩631.9 billion. In the early days of Samsung Bioepis, Samsung Biologics was invested by Samsung Group through a paid-in capital increase by allocation to stockholder, and some of them were invested in Samsung Bioepis. Samsung Biologics received a total of ₩1178.4 billion from the group through 11 paid-in capital increase from July 2011 to July 2015. Of these, ₩578.4 billion was invested in Samsung Bioepis as a paid-in capital increase method. Samsung Bioepis received a total of ₩640.5 billion in investments from the major shareholder Biogen's participation in paid-in capital increase. Since then, Samsung Biologics has invested ₩400 billion in Samsung Bioepis twice in the ₩2.25 trillion raised on the stock market in November 2016. The total amount of funds Samsung Bioepis has invested from a company is ₩1.04 trillion. The reason behind Samsung Bioepis' strong performance last year is the sales of biosimilars in overseas markets. Samsung Bioepis has launched three biosimilars, Benepali, Flixabi, and Imraldi in the European market. Samsung Bioepis Pipelines (Source: Samsung Biologics) According to Biogen's performance last year, three types of biosimilars such as Benepali, Flixabi, and Imraldi made a total of $838 million in sales last year. In 2018, sales were 35% higher than $550 million, making the highest sales ever. Biogen, the second largest shareholder of Samsung Bioepis, is responsible for distribution and sales of biosimilars in Europe. Although Benepali's sales growth slowed, Imraldi’s sales rose sharply. Benepali, Enbrel's biosimilar, posted sales of $ 486.2 million last year. This is similar to $ 485.2 million in 2018. Benepali led the growth of all biosimilars with 2018 sales up 30.9% year over year. Benepali has the largest share in Europe's Big 5 countries such as Germany, France, the United Kingdom, Italy and Spain. In the past four years, it has accumulated cumulative sales of a total of ₩1.6 trillion in the European market. Humira's biosimilar, Imraldi, posted sales of $ 184 million last year. It's more than 10 times higher than $ 16.7 million in 2018. In October 2018, Imraldi was released to major European countries such as the United Kingdom, France, Germany, Spain and Italy when Humira's material patent expired. The sales volume of Samsung Bioepis has also expanded significantly. The company's sales last year were ₩765.6 billion, more than doubled from the previous year's ₩368.7 billion. Last year's sales were close to 80% of the cumulative sales of ₩974.7 billion for 7 years from 2012 to 2018.
- Product
- Korea’s first epidemiological report on COVID-19 deaths
- by Lee, in-bok Mar 31, 2020 06:29am
- A study analyzed deaths from COVID-19 in Korea and found male patients in 70s with chronic cardiac disorder like hypertension were critically affected. Apparently, most of them had died in average 10 days after the onset COVID-19 symptoms, and their average time to death was unaffected regardless of underlying illness. First epidemiological report by Korean Society of Infectious Diseases on death due to COVID-19 in Korea Korean Society of Infectious Diseases (KSID) has investigated 53 deaths, as of Mar. 15, from 7,513 patients infected by coronavirus in Korea and published the outcome on the Journal of Korean Medical Science on Mar. 30 (doi.org/10.3346/jkms.2020.35.e132). #Accessing data through Korean Centers for Disease Control and Prevention (KCDC), the researchers conducted a ten-day-long epidemiological investigation on 54 death caused by COVID-19. The investigation found, as of Mar. 15, total 5,833 cases resulted in death among 156,400 confirmed cases of COVID-19 around the world, which recorded 3.7 percent mortality rate. In Korea, the rate was at 0.7 percent with 54 deaths. On Feb. 19, the 104th confirmed case of COVID-19 in Korea has been deceased and was reported as the first COVID-19 caused death in Korea on the next day. And the 443rd case was the first death reported to have been confirmed positive posthumously on Feb. 21. Other than the two, the investigators highlighted the 1,443rd case reported on Feb. 27, as the patient was the first death reported during their self-isolation period. On Mar. 3, the 32nd case has reportedly been deceased without an underlying illness. The investigators also emphasized the descending trend of mortality rate while the number of confirmed cases has exponentially surged since the first death reported. They pointed out it indicates the management over patient with high severity is taking its place. In fact, on Feb. 20 when the first death was reported, the case fatality rate (CFR) was at 1.22 percent. But the CFR was dropped to 0.04 percent, as of Mar. 10. #And as of 12 a.m. Mar. 30, the COVID-19 CFR in Korea was at 0.7 percent. Categorized by each region, the number of deaths was highest in Daegu and Northern Gyeongsang Province, where 85 percent of confirmed cases were concentrated in. Daegu along had 38 patients died from COVID-19, but 13 have lost their lives in Northern Gyeongsang Province. However, the researchers pointed out the statistic figures are not an absolute indicator as a patient from Gangwon Province has died in a Northern Gyeongsang Province hospital, and patients from the Northern Gyeongsang Province have been treated at National Medical Center. Male patients in 70s with underlying health condition, three key words in COVID-19 death So who is most vulnerable to COVID-19? First, the investigators set down three key words—70s, male and underlying cardiovascular disorder. Analyzing critical cases resulted in deaths, the investigation found the median age at death was 75.5. And the mortality rate was higher in male patients at 61.1 percent than in female patients. The most prevalent underlying health condition was cardiovascular disease. The CFR analysis in the report supports the findings clearly. The CFR in male patients was at 1.16 percent with 33 deaths among 2,852 cases, but the rate was at 0.45 percent in female patients with only 21 deaths within 4,661 cases. The gap between sexes was even more significant in the older age group. The mortality rate in male patients 60 and over was at 4.73 percent with eight deaths in 592 cases, where as the rate in female patients in the same age group was at 1.88 percent with 19 deaths in 1,013 cases. # The report claimed the virus-induced death was also closely related to the age group. The CFR in age group of under 20 and 20s to 50s were at zero percent and 0.05 percent, respectively. But from the age group of 50 and up, the CFR was increased to 1.72 percent. Most of the deaths were reported with underlying health condition. Within 90.7 percent of deaths with underlying illnesses, 59.3 percent of them had cardiac disorder like hypertension, making it the most prevalent underlying disorder followed by diabetes and neurologic disease like dementia. The median time from onset symptoms to death of the particular patient group was ten days, regardless of their sex. And also the underlying illness has not affected the duration of survival time. The investigators explained, “Mortality rate is the most crucial indicator to consider when setting the prioritization of infectious disease control. Although it is too early to compare the tendencies with different countries, mortality rate ascending after identifying a mass infection was a meaningful finding.” “The most vital strategy is to maintain the capability of hospitals treating patients in initial stage to severe state by carefully and appropriately reviewing the disease,” and “As these key words from the investigation are the most significant key words as the mortality rate around the world is surging, an improved response with broader perspective based on them is needed.,” the investigators added.
- Policy
- Renewal of Marketing Approval for drugs, will be reinforced
- by Lee, Tak-Sun Mar 31, 2020 06:29am
- Renewal System of Marketing Approval for Drugs ongoing since 2018 will be further reinforced. The system which gives a 5 year validity for each category respectively, renews allowance after reviewing safety and effectiveness. However, it is criticized that the screening does not properly evaluate the safety and effectiveness of pharmaceuticals. Accordingly, the MFDS decided to strengthen the renewal review by comprehensive review of ingredients and formulations, refrain from renewing unsold items, and compulsory submission of post-market safety data. According to the industry on the 30th, the MFDS recently released the first comprehensive plan for drug safety management (from 2020 to 2024). In the comprehensive plan of the MFDS, the drug renewal system is currently reviewing and evaluating safety, efficacy, and quality data for each drug, but the need for comprehensive review and evaluation by ingredient and formulation is increasing. The background of the plan to strengthen the item update was explained. Furthermore, the MFDS explained that worries exist because even though they have eliminated not produced or not imported items during the 5 year validity from the renewal objects, cases where after the minimum quantity is manufactured and imported for the purpose of passing through the renewal, in which the legal compliance (quality management, safety management after marketing) is not observed, are occuring. Accordingly, the MFDS suggested strengthening ▲the submission of safety data for items subject to renewal ▲ evaluating safety and effectiveness of each ingredient and formulation ▲ not being able to update drugs without sales within the expiration date. First, from 2021, it was decided to submit safety information promptly and regularly, including side effects during the expiration date, and to analyze and evaluate the information and data on safety management measures. In addition, from 2023, it is a policy to collect and analyze safety information at home and abroad for some items and to submit a comprehensive report on safety management after marketing. The MFDS also announced that when reviewing the renewed ingredients for the first time this year, the entire domestic review of the same ingredients and formulations will be conducted to prepare a comprehensive review and continuously update. In particular, from 2023, it was obliged to submit action plans, including comparison and analysis of domestic and foreign permits, and changes to permits for some items. Drugs without sales records could not be renewed. Currently, only the results of manufacturing and imports are reported during the renewal examination. The MFDS is planning not to renew even if it has not been manufactured, imported, or sold during the validity period (5 years) of the item permission and notification from 2021. It is expected that the burden of pharmaceutical companies will increase if it is mandatory to submit safety data after marketing and items without sales records are not allowed to be renewed.
