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- 2026-05-14 01:01:06
- Policy
- Domestic authorization for the Quadrivial Adjuvant Flu Vac
- by Lee, Tak-Sun Sep 21, 2022 05:47am
- With the flu warning issued in September, the beginning of Autumn, an upgraded flu vaccine was also approved in Korea. It is a tetravalent Adjuvant vaccine that can be used for people aged 65 or older, and is a product of a pharmaceutical company called CSL Seqirus, which is still unfamiliar in Korea. The Ministry of Food and Drug Safety announced on the 19th that it has approved Meditip's Fluad Quadrivalent PFS (MF59 Adjuvant). Meditip, a pharmaceutical consulting firm, seems to have been granted the product on behalf of CSL Seqirus, which has not yet been licensed in Korea. CSL Seqirus is a vaccine company that combines the vaccine division of Australian pharmaceutical company CSL and the Novartis influenza division. CSL Seqirus established a domestic branch this year. The approved product is the Adjuvant flu vaccine. The Adjuvant flu vaccine has the advantage of improving the immune response of the elderly with a degraded immune system to increase the preventive effect. Recently, ACIP under the U.S. CDC recommended tetravalent high-performance vaccines, including Fluad Quadrivalent, which contains immune enhancers, for senior citizens aged 65 or older. Fluad Quadriental was licensed in Korea for the purpose of preventing two types of influenza A virus and two types of influenza B virus for the elderly aged 65 or older. In clinical trials, this product proved better preventive effect than existing trivalent products. Attention is focusing on whether CSL Seqirus, including Adjuvant-containing products, will become a new issue in the domestic flu vaccine market led by GC Pharma.
- Company
- RET-targeted anticancer drugs are being released in Korea
- by Whang, byung-woo Sep 21, 2022 05:47am
- By disease in patients, is a small but some hospitals were already prescribing patients ahead of the clinical site in anticipation that there is high. But now excluded from prescription for pay from entering that the burden of costs and likely to be consideration of the prescription side effects. According to the pharmaceutical industry on the 16th, RET (REarranged drug transmission) target treatments currently approved in Korea are Lilly's Retevmo and Roche's Gavreto. Retevmo is applied to adult patients with metastatic RET fusion-positive non-small cell lung cancer, adults with progressive or metastatic RET-mutant thyroid cancer and children over 12 years of age who are not compliant with radiation Iodine, have previous treatment experience with Sorafenib and/or Lenvatinib, and others requiring systemic therapy. Gavreto has been approved in Korea as a treatment for adult patients with RET fusion positive local progressive or metastatic non-small cell lung cancer and adult patients with RET mutation local progressive or metastatic medullary thyroid cancer that requires a strategy. However, since it is licensed around the same time as Retevmo, it is predicted that the release date will not show much difference. Currently, the indication that the two treatments are expected to be prescribed the most is non-small cell lung cancer. It is expected that only 1-2% of all patients have RET mutations, but compared to the thyroid gland, there will be more patients. However, it remains to be seen which of the two drugs will have the upper hand. This is because at the time of approval of the RET gene mutation target anticancer drug, experts also showed that there was no difference enough to choose. Experts say that the emergence of the two treatments is positive, given that chemotherapy is the only treatment option for patients with RET mutations so far. This is because at the time of approval of the RET gene mutation target anticancer drug, experts also showed that there was no difference enough to choose. As a result, experts predict that if the number of prescription options increases to two soon, side effects issues will play a greater role than effects. Hong Min-hee, a professor of oncology at Yonsei Cancer Hospital, said, "There is little difference in efficacy in choosing the two drugs and there is a difference in terms of adverse reactions." Professor Hong explained, "Retevmo seems to have more side effects of gastrointestinal relationships and Gavreto has more side effects of bone marrow suppression, so I think I will choose the patient group accordingly." In addition, Yoon Sung-hoon, a professor of respiratory medicine at Pusan National University in Yangsan, said, "Personally, only Retevmo has prescription experience in that Gavreto is not being used sympathetically due to drug supply and demand." Considering this, there is a possibility that experienced treatments that first appear in the market and enjoy the effect of preoccupying the market due to the characteristics of RET gene mutation target anticancer drugs with small patient groups. Since Gavreto is administered once a day, there is a view that it will be a little more advantageous for the younger patients who are relatively active in society. Retevmo and Gavreto are still not able to enter the benefit range, so cost issues are also expected to be hurdles for prescriptions. Retevmo failed to pass the cancer disease review committee, the first gateway to the standard review in May. Currently, Retevmo is known to cost about 7 million won a month. Professor A of oncology at advanced general hospital in Seoul said, "There are patients waiting for the use of RET gene mutation target anticancer drugs, but cost problems and periods vary from patient to patient." He went on to say, "I don't know if the patient group will be able to submit data necessary for the benefit standard, but I don't think it will be possible to enter the benefit when looking at NTRK mutant treatment." He added, "It may not be possible to enter the benefit right now, but we look forward to positive news in the future."
- Policy
- 23 items have been designated as Fast Tracks in 2yrs
- by Lee, Hye-Kyung Sep 21, 2022 05:47am
- Goal of completion of examination within 75% of general examination period. Over the past two years, 23 items of medicine have been designated as Fast track. Specifically, it appeared as 4 items in 2020, 11 items in 2021, and 8 items until July 2022, and the reason for the increase in Fast track designated drugs last year compared to the previous year is interpreted as the impact of the COVID-19 vaccine. The MFDS (Director Oh Yoo-kyung) published a "Fast Track Drug Review Report" on the 13th by launching the "Global Innovative Products on Fast Track (GIFT) Program" to support the development of innovative medical products in Korea. Since August 31, 2020, the Ministry of Food and Drug Safety has established a Fast Track department and has designated and reviewed Fast Track items for innovative products such as life-threatening diseases or treatments for rare and incurable diseases. The items designated as Fast Track for the first time in Korea were AstraZeneca's Selumetinib and Daewoong Pharmaceutical's DWP16001, an innovative pharmaceutical development new drug, applied simultaneously on October 23, 2020. The application for Fast Track designation requires active ingredients, mechanism of action, manufacturing method, preliminary clinical trial data to confirm clinical significance in the disease, and target indications, and the application for designation will be reviewed within 30 days. Over the past two years, a total of 17 items have been approved after the Fast Track designation, including 5 chemicals, 1 biopharmaceutical, 10 COVID-19 vaccines, and 1 biopharmaceutical, with the goal of completing the screening within 75% of the screening period. From August 31, 2020 to July 31, this year, a total of 25 applications for the designation of medical products Fast Track were designated, of which 23 were designated. One of the items applied for designation was not designated due to insufficient data to prove the effectiveness improvement compared to existing treatments, and one was voluntarily withdrawn. Among the Fast Track designated items, 12 treatments for life-threatening or serious diseases, 7 drugs for preventing or treating infectious diseases for public health hazards, and 4 new drugs for developing innovative pharmaceutical companies. By drug group, anti-malignant tumors were 56.5% (13 items), COVID-19 treatments and vaccines 30.4% (7 items), chemotherapy drugs 4.3% (1 item), circulatory mechanical drugs 4.3% (1 item), and diabetes solvents 4.3% (1 item). Of the 17 Fast Track item permits, COVID-19 vaccines accounted for a high proportion of 10 items and 5 items of anti-malignant tumor drugs. Eight of the designated items are currently undergoing screening, and one item has not applied for permission. The average number of fast track days for the COVID-19 vaccine was 26 working days, and the average number of items excluding the vaccine was 51 working days. 22 preliminary reviews have been conducted so far to shorten the period of approval before applying for item permits. In the case of occasional screening using the preliminary review system when performing Fast Track, COVID-19 vaccines such as AstraZeneca, Pfizer, and Janssen applied for the screening. The Ministry of Food and Drug Safety is planning to launch a GIFT program based on its Fast Track experience over the past two years. The GIFT program is a program that supports global innovative medical products from the beginning of development (clinical) to quickly commercialize them, and pharmaceutical companies review designations when applying for Fast Track targets and, if necessary, decide on GIFT targets after consulting the Fast Track expert council. The GIFTprogram targets will receive various support such as applying rolling reviews that examine the prepared data first, close communication between reviewers and developers, regulatory consulting, and clinical results for products with excellent innovation (improvement of safety and effectiveness), submission after market, and preemptive application of global screening standards such as ICH.
- Policy
- GOV engrossed in minimizing damage from US's Bio Initiative
- by Lee, Jeong-Hwan Sep 20, 2022 05:57am
- The Korean government is busy preparing measures to protect the Korean industry from the Executive Order signed in the US by President Biden to launch a National Biotechnology and Biomanufacturing Initiative that focuses on research and manufacturing of pharmaceuticals within the United States, As the US government has not yet finalized its direction in regulating other countries on bio-related matters, the Korean government has also not yet decided on specific measures other than to actively utilize the Korea-US dialogue channel. However, the authorities are planning to seek countermeasures by increasing the frequency of joint ministerial meetings after holding an industry inspection meeting in relevant ministries. On the 19th, the Ministry of Trade, Industry, and Energy announced plans to hold a joint meeting this week with the Ministry of Health and Welfare, Ministry of Food and Drug Safety, Ministry of Science and ITC, etc. to discuss countermeasures. The authorities that will be directly responding to the US's Initiative are MOTIE and MOHW. The MOTIE and MOHW have held individual review meetings with relevant industries and institutions upon US’s decision to launch the Executive Order to launch the Initiative (Bio Executive Order). The MOTIE had discussed countermeasures with KoreaBIO and bio companies, and the MOHW with pharmaceutical and bio companies including the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, based on which the ministries will be sharing results to establish future plans at the joint meeting. In particular, the MOTIE plans to convey the position of domestic pharmaceutical and bio companies at the scheduled ministerial-level dialogue with the US Secretary of Commerce. The Korean government is expected to first prepare measures to minimize the impact of the Bio Executive Order by utilizing all of the Korea-US dialogue channels in each ministry until the US government finalizes specific regulations. An MOTIE official said, “As only the broad framework of the biomanufacturing policy has been yet set by the US, we plan to continue holding joint ministerial and industry inspection meetings until a specific regulatory plan is announced. In order to maximize opportunities for Korean companies and minimize damage, we will discuss the issue through various dialogue channels including the ministerial-level Korea-U.S. supply chain and industry dialogue, etc.” he explained. The official added, “The executive order launched by the US this time has given more weight to promoting its own domestic industry rather than regulating industry of other companies. The MOTIE will be holding a joint meeting with the MOHW and other ministries based on the results of the review meeting it had held with KoreaBIO. As the case may be, the Executive Order may become an opportunity for domestic pharmaceutical and bio companies to advance into the US market.”
- Company
- Influenza alert in three years
- by Chon, Seung-Hyun Sep 20, 2022 05:57am
- The influenza (flu) alert, which disappeared after the spread of COVID-19, was issued. September 12 years after 2010, influenza alert has come. The pharmaceutical industry is Corona 19 that virtually died out after the spread of flu drug market to expect a revival of the atmosphere. According to the industry on the 19th, the Korea Centers for Disease Control and Prevention issued a flu epidemic warning nationwide on the 16th. The Korea Centers for Disease Control and Prevention issued a flu pandemic warning nationwide between September 4 and September 10 this year, with 5.1 suspected flu patients per 1,000 outpatients exceeding the epidemic standard (4.9). The number of suspected cases per 1,000 for the past 23 weeks, outpatient clinics, flu, the highest this year. 4.8 members leapt over the last 12 weeks. In previous years, the flu epidemic standard was set at 5.8 per 1,000 outpatients, but this year, COVID-19 and the flu are likely to spread at the same time. It is the first time in two years and six months that the number of suspected flu patients per 1,000 outpatients has exceeded five since the ninth week of 2020. It has never exceeded five since it recorded 6.3 in the ninth week of the first week of March 2020. This means that the flu has never been prevalent for more than two years. This is the aftermath of a significant decrease in the incidence of infectious diseases due to strengthening personal hygiene management such as hand washing and wearing masks after the spread of COVID-19. As social distancing was lifted this year, the number of flu patients gradually increased. In the last 24 weeks, the number of suspected flu patients per 1,000 outpatients was only 1.8 but tripled in three months. The pharmaceutical industry is expecting a rebound in flu treatments that have virtually disappeared since the spread of COVID-19. According to UBIST, a drug research institute, the amount of outpatient prescriptions for flu treatments in 2019 recorded 22.5 billion won. However, it fell to 8.8 billion won in 2020, and only reached 40 million won last year. In the past two years, the size of the flu treatment market has decreased by 99.8%. It was reduced by 99.9% in three years from 44.7 billion won in 2018. The flu treatment market recorded 8.4 billion won in the first quarter of 2020, but plunged 99.8% to around 10 million won in the second quarter when COVID-19 began to spread in earnest. The flu treatment market recorded less than 100 million won for nine consecutive quarters from the second quarter of 2020. In the first half of this year, the prescription for flu treatment was less than 100 million won. After the spread of COVID-19, the flu treatment market virtually disappeared as the number of flu patients decreased sharply due to strengthening personal hygiene management such as washing hands and wearing masks. The Oseltamivir market, which is most commonly used as a flu treatment, has virtually disappeared. Oseltamivir is the active ingredient of Tamiflu. In the first half of this year, Oseltamivir's out patient prescription market was only 92 million won. It was only 60 million won in the first quarter and 32 million won in the second quarter. The size of Oseltamivir prescription in 2019 recorded 22.4 billion won, falling to 8.7 billion won in 2020 and shrinking to 40 million won last year. Pharmaceutical companies expect the flu treatment market to rebound as the number of flu patients increases. An industry official said, "We will consider whether to expand the production and supply of treatments while looking at the trend of expanding flu patients in the future."
- Policy
- 37 Tenelia's generics will soon be listed
- by Lee, Tak-Sun Sep 20, 2022 05:57am
- Earlier this year, Tenelia's generics followed Galvus generics, and the generic drug market for DPP-4 diabetes treatments began in earnest. According to the industry on the 19th, the Ministry of Health and Welfare recently disclosed the registration of Tenelia's generics next month. Tenelia of material patent is expired on October 25th. A total of 37 items of next month to enter the generic market. DPP-4 inhibitor market has used a total of nine species of products had not been released, but a strong patent protection for markets are opening up generic. 18 current generic for Galvus are reimbursed. The DPP-4 generic market is expected to begin in earnest. As a result, it is analyzed that as competition among pharmaceutical companies intensifies, it will affect original drugs that maintained the existing monopoly. In particular, some analysts say that Galvus and Tenelia, which are allowed to compete generically, could weaken their competitiveness among the nine original DPP-4 types.
- Policy
- NHIS negotiations complete for Erbitux·Zerbaxa·Eylea
- by Lee, Tak-Sun Sep 20, 2022 05:56am
- The National Health Insurance Service’s pricing negotiations for Merck’s anticancer drug Erbitux and MSD’s next-generation antibiotic Zerbaxa among others have been completed. In the case of Erbitux, Merck has been conducting drug pricing negotiations with the NHIS upon the expiry of its risk-sharing agreement (RSA) contract. For Zerbaxa, its company, MSD, had been conducting pricing negotiations for its new reimbursement. As both agendas were not listed for deliberation at the MOHW’s Health Insurance Policy Deliberative Committee (HIPDC) meeting last month, industry analysis is that the agendas may likely receive reimbursement approvals at the HIPDC meeting this month. Merck’s Erbitux and Zerbaxa were included in the drug pricing negotiation completion list that NHIS disclosed on its webpage on August 31st. Erbitux (cetuximab) is an anticancer drug indicated for metastatic colorectal cancer and head and neck squamous cell cancer that was approved for reimbursement in March 2014 under the Refund-type RSA in Korea. The company had already succeeded in renewing the agreement once in 2018. Upon its expiry in June this year, Merck has been in negotiations with the NHIS to renew its agreement for the third time. Industry’s prospects on the possibility of RSA renewal have been increasing as Erbitux was included in the negotiation completion list of the NHIS, In the case of Zerbaxa, news of its negotiation completion had already been announced last month. As a result, it is expected that the drug will be added to the reimbursement list after going through the HIPDC review this month. The drug had attempted reimbursement since it was approved in April 2017 in Korea, but had difficulty being listed, being unable to demonstrate adequacy of its reimbursement. However, the government’s coverage expansion plan allowed antibiotics like Zerbaxa to also be included and be eligible to waive pharmacoeconomic evaluations, based on which Zerbaxa was recognized adequate for reimbursement at HIRA’s Drug Reimbursement Evaluation Committee meeting in June. Since then, MSD had been conducting drug pricing negotiations with the NHIS, which were successfully concluded at the end of last month. The NHIS’s disclosure of such has made the negotiation completion official. Zerbaxa is a next-generation antibiotic indicated for use in combination with metronidazole for complicated intra-abdominal infections (cIAI) and complicated urinary tract infections. The antibiotic is receiving particular attention as a ‘super antibiotic’ that can be used against multidrug-resistant bacteria. In addition, the NHIS also announced the completion of drug price negotiations for Takeda's anticancer drug 'Adcetris (brentuximab vedotin)' and Bayer's age-related macular degeneration drug ‘Eylea.’ The drugs have been in negotiations with the NHIS since June under category ‘Type B’ of the Price-Volume Agreement. PVA negotiations under Type B are applied every year when the claims amount increases by over 60% from the previous year, or the rate of increase is over 10% and exceeds KRW 5 billion for drugs in the same therapeutic class for which the maximum amount had already been adjusted according to type A or exceeded 4 years since its initial listing but had not undergone type A negotiations. The price of subject drugs are discounted within the 10% range after pricing negotiations with the NHIS.
- Company
- Patent term extensions for advanced biologicals under review
- by Kim, Jin-Gu Sep 20, 2022 05:56am
- The Korean Intellectual Property Office (KIPO) is pursuing a plan to apply the patent term extension system to advanced biological products that were left unattended within the system through law amendments. According to the pharmaceutical and biopharmaceutical industry on the 19th, KIPO prepared a systemic reform plan that contained the amendments above and is collecting industry opinion. Under the current Patent Act, the subjects eligible for the patent term extensions are stipulated in Article 7 of the Enforcement Decree of the Patent Act. However, the application of the regulation is limited to ‘drugs’ that are allowed marketing authorization under the Pharmaceutical Act or to ‘psychotropic substances’ under the Narcotics Control Act. When the Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals was separately enforced from the Pharmaceutical Affairs Act, it resulted in advanced biopharmaceuticals such as the latest gene and cell therapies being omitted from the extension list. In fact, Novartis had applied for two patent term extensions for Kymriah, which was approved as an advanced biopharmaceutical product, but its patent term extension is not being recognized due to the continued incomplete legislation. Industry concerns are rising over the confusion that would increase in the scene with more than 20 advanced biopharmaceuticals from pharmaceutical companies in Korea and abroad being approved one after another since Kymriah, including Novartis’s Zolgensma and Luxturna. To address this, KIPO is reviewing a plan to add ‘Advanced biopharmaceuticals approved under the Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ to subjects eligible for patent term extensions in Article 7 of the Enforcement Decree of the Patent Act This reform plan is expected to be discussed with the other reforms being prepared by KIPO, including ▲adjusting the number of patent rights that can be extended per item ▲introducing an upper limit on the duration of valid patent rights and ▲ introducing remedies after extension rejection decisions. However, unlike other reform plans, including advanced biopharmaceuticals in the patent term extension regulation, is expected to proceed more smoothly, as the position between the original and generic companies is not that different.
- Company
- 41 were vaccinated in 11 days with K-COVID-19 vaccines
- by Sep 19, 2022 05:57am
- SK Bioscience’s COVID-19 vaccine is being released To address the low vaccination rate for Korea’s first homegrown COVID-19 vaccine, SKYCovione, the government has greatly expanded the eligibility for the vaccine. With the expansion, whether allowing the use of domestic vaccines to those who received their 1st to 3rd vaccinations will increase utilization of homegrown vaccines is gaining attention. However, the release of the Omicron-specific vaccine in Kores that is scheduled for next month is expected to act as a variable. During the opening remarks made by the first general coordinator of the Central Disaster and Safety Countermeasures Headquarters, Ki-Il Lee (2nd Vice Minister of Health and Welfare), during the CDSCH meeting held on the morning of the 16th, Lee said, “The CDSCH will expand the scope of vaccine eligibility for SKYCovione from the primary (1st and 2nd) vaccination to 3rd and 4th booster shots.” With the decision, people may reserve their 3rd and 4th vaccinations with SKYCovione through http://ncvr.kdca.go.kr or the call center, or receive same-day vaccinations at public health centers or some assigned medical institutions. The government explained that SKYCovione can be used as booster shots as its safety and efficacy of the SKYCovione have been demonstrated. Clinical trials for SKYCovione booster vaccinations, an investigator clinical trial led by KDCA, are currently in progress, and its results have not yet been released. According to the interim results of the trial, SKYCovione induced neutralizing antibody responses an average of 11 times higher in the original COVID-19 virus (Wuhan strain), 51.9 times higher for Omicron BA.1, and 28.2 times higher for Omicron BA.5 after vaccination with SKYCovione in 5 treatment groups. After the CDSCH meeting, Young-rae Sohn, Head of the Social Strategy Unit of the Central Disaster Management Headquarters, explained, “We first recommend mRNA vaccines for those who are receiving booster shots, however, those who do not wish to further receive vaccinations with mRNA vaccines for various reasons, such as discomfort after receiving primary and secondary vaccinations with mRNA vaccines, may receive additional vaccinations with SKYCovione.” In other words, Pfizer and Moderna’s mRNA vaccines are first recommended as boosters until formal approvals are granted to SKYCovione in that indication, but those aged 18 years or older who cannot or do not want to receive mRNA vaccines can receive SKYCovione as boosters. Such a decision has been deemed to be made despite the non-availability of clinical trial results for the indication as a preemptive measure to increase the utility of domestic vaccines. Although vaccinations started for SKYCovione on the 5th, the rate has been very low. According to the KDCA, the cumulative number of people that received vaccination with SKYCovione as of midnight on the 16th was 41 (1st vaccination), a mere 5.8 persons per day. This is less than 0.1% of the initial lot of 609,000 SKYCovione vaccines of the 10,000,000 vaccines purchased in advance by the government. This is because 97% of those eligible for primary vaccinations with SKYCovione have already received vaccinations. On the other hand, as the vaccination rate dropped greatly to reach 75.1%, for the 3rd vaccination and 16.5% for the 4th vaccination, allowing the use of SKYCovione as such booster shots are expected to greatly increase the use of SKYCovione. However, one variable that lies in its use is that foreign vaccines targeting the Omicron variant have already arrived in Korea and will begin vaccinations next month. On the 15th, 805,000 doses of the bivalent vaccine by Moderna that targets both the original strain (Wuhan strain) and the BA.1 subvariant arrived in Korea. 806,000 courses of the bivalent vaccine additionally arrived on the 17th. Pfizer’s bivalent vaccine is also being reviewed. The KDCA has recommended the new bivalent vaccine as a priority for high-risk groups, such as those aged 60 years or older, those hospitalized or serving in long-term care facilities, and those who are immunocompromised, and as a second priority for people in their 50s, those with underlying diseases, and healthcare workers. In addition, group facility officials and adults aged 18 to 49 are also allowed to receive vaccinations but were excluded from subject recommendations. Therefore, it is expected that demand for the Omicron-targeting vaccines will become higher than that for SKYCovione in October. The demand for SKYCovione may increase in groups who are not subject to the recommendations made for the bivalent vaccines, but whether this alone will increase the vaccination rate for SKYCovione remains in question, as the overall will to receive vaccinations in itself had dampened greatly. According to the ‘COVID-19 vaccine awareness survey’ published by Byung Chul Chun’s team of the Department of Preventive Medicine and Vaccine Innovation Center at Korea University College of Medicine, less than half –45.7%-- of the 1,500 adult survey respondents over the age of 19 responded that they are willing to receive COVID-19 vaccinations this winter. 30.5% responded that they have no will to receive COVID-19 vaccinations at all. In other words, 3 of 10 respondents said they would not receive vaccinations. Furthermore, with Moderna and Pfizer hastening the introduction of their bivalent vaccines that target Omicron subvariants (BA.4/5), their gap with domestic vaccines is expected to widen further. The authorities are discussing the possibility of receiving marketing authorization for its Omicron subvariant-targeting bivalent vaccines that were approved by the US on the 31st of last month.
- Opinion
- [Reporter's view] Reform of the innovative system
- by Lee, Jeong-Hwan Sep 19, 2022 05:56am
- Will the "innovative pharmaceutical company certification system," which has been operating unchanged for 10 years since its introduction in 2012, be able to pave the way for reform through the disclosure of the reorganization plan? The Ministry of Health and Welfare announced plans to announce the reform of the innovative pharmaceutical company certification system at the end of the year. It is a relatively large reorganization plan, including subdivision of certification types and customized support measures, and attention is being paid to whether it can be a turning point to remove the stigma of the certification system that is low in effectiveness. Strengthening support for innovative pharmaceutical companies has been an agenda that has been needed for years. The pharmaceutical industry demanded that actual drug treatment or tax support for innovative pharmaceutical companies should be greater to encourage innovative pharmaceutical companies to develop new drugs and encourage non-selected companies to select new drugs, but the government has not been able to provide enough budget or come up with innovative drug measures due to trade friction. The Ministry of Health and Welfare continued to make efforts to improve the certification system for innovative pharmaceutical companies to resolve such criticism, and the reorganization plan, which will be unveiled at the end of the year, will be the first result to determine whether it will improve. First of all, the reorganization plan is expected to discriminate against the actual support method as the certification screening criteria for each size and type of pharmaceutical companies are different. As the customized support plan for innovative pharmaceutical companies has been discussed several times, such contents are expected to be included in the reorganization plan to be unveiled at the end of the year. More important than improving the framework and extension of the certification system is the government's reinforcement of support for innovative pharmaceutical companies, which is the purpose of operating the certification system. If designated as an innovative pharmaceutical company, the government should provide benefits such as preferential drug prices, tax support, and R&D support, but the pharmaceutical industry has long complained that it is difficult to expect sufficient benefits. Innovative pharmaceutical companies are given symbolic titles, but they do not have significant benefits that directly benefit from the development of new drugs. Among the companies selected by innovative pharmaceutical companies, there is also a pessimistic response that they will not be hit much even if the certification is canceled because they do not enjoy any practical benefits. The National Assembly also urges the government to strengthen support for innovative pharmaceutical companies every year. It is pointed out that the overall fostering of the domestic pharmaceutical industry can be achieved only when both the quantity and quality of support measures for innovative pharmaceutical companies are improved. The Ministry of Health and Welfare, which is set to unveil the certification system, also agreed with the criticism that the budget and policy support in line with the reorganization plan should follow, so we hope that the reform will be repeated starting with the reorganization plan.
