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- 2025-12-19 05:32:21
- Opinion
- [Reporter's View] Regarding the obesity drug craze
- by Son, Hyung Min Nov 08, 2024 05:46am
- There is one research and development item that is gaining explosive popularity among both global and domestic pharmaceutical companies –obesity treatment. The use of obesity drugs has also increased dramatically with the significant rise in the number of obese people around the world. Global sales of obesity drugs reached USD 6.68 billion (about KRW 9 trillion) last year, up 145.6% from USD 2.72 billion in 2022. In particular, the success of glucagon-like peptide (GLP-1) receptor agonist obesity drugs such as Saxenda, Wegovy, and Zepbound has attracted the attention of domestic and foreign pharmaceutical companies to GLP-1 drug candidates. Saxenda posted sales of KRW 1.225 trillion last year, up 9.8% YoY. Wegovy’s sales surpassed KRW 300 billion last year despite facing supply difficulties. GLP-1 was originally developed as a diabetes treatment. However, GLP-1 drugs took a major turn when Novo Nordisk's liraglutide and semaglutide showed effect in weight loss. During clinical trials of its antidiabetic drug liraglutide (trade name Victoza), Novo Nordisk noticed a weight loss effect among its enrollees. Based on the findings, the company changed the dose of liraglutide and developed Saxenda, a GLP-1 drug for obesity. The company used the same mechanism to develop Wegovy with semaglutide (Ozempic). Both Saxenda and Wegovy are now in the global market, and their non-reimbursement prices have surged with their increasing popularity. The problem is that the promise of effective weight loss through simple injections has led to increased use for cosmetic and dieting purposes. There has been a significant increase in prescriptions for weight loss in people who are not overweight and obese or chronically ill. The popularity of dietary supplements with unproven efficacy and side effects is also on the rise. However, manufacturers only highlight the weight-loss benefits of GLP-1 drugs and neglect to warn consumers about their side effects. GLP-1 receptor agonists are associated with various side effects. Side effects of GLP-1 class drugs include muscle loss, acute kidney disease, nausea, vomiting, and diarrhea. In the United States, a recent case of acute pancreatitis was reported as a side effect of an anti-obesity drug, resulting in death. Unlike diabetes, obesity is not classified as a disease and is therefore treated without reimbursement benefits. Although it is classified as a risk factor for various metabolic diseases, such as dyslipidemia and hypertension, it is not regarded as a condition that requires medication. The first treatment recommended for obese patients who visit an endocrinologist is lifestyle modification. If the weight remains uncontrolled after lifestyle modification, doctors will consider using a medication, but they are cautious about doing so because of the side effects that come with it, including rebound weight gain. While the overprescription of obesity drugs for cosmetic purposes is a serious problem, the lack of information on its side effects seems to be a major contributor to the misuse and abuse of obesity drugs. The role of the pharmaceutical industry, which has developed and is developing obesity drugs, is also important. While it is necessary to publicize how much weight loss is achieved with the use of each drug, it is also time for the public to be fully informed about their side effects. “Miracle drugs” that can dramatically reduce weight are not free from side effects.
- Opinion
- [Reporter's View] Address Actions to drug substitution
- by Lee, Jeong-Hwan Nov 01, 2024 05:51am
- "We will foremostly activate drug substation to resolve the drug shortages issue," Cho Kyoo-hong, Minister of Health and Welfare (MOHW), promised during the parliamentary audit session commenced by the National Assembly's Small Committee for Health and Welfare. This is an answer from the MOHW director to an issue of essential medicines frequently in shortage, leading to chaos in pharmacies and lower patient access to medications. The issue has been unresolved for several years. Rep. Seo Youngseok and Rep. Nam In-soon of the Democratic Party of Korea have requested the implementation of active ingredient prescriptions for cold medicines and essential medicines to resolve the issue of frequent drug shortages. Minister Cho repeatedly answered that he would improve the current situation by enabling drug substitution rather than active ingredient prescription, as the latter requires agreements between officials. According to Minister Cho, activating drug substitution beyond the current 'lower-cost drug substitution incentive' policy by the Health and Welfare Committee requires specific administrative actions, policy establishment, and implementation. In other words, their plan cannot be attained by the way MOHW said to actively participate in the legislative session to review the National Assembly submitted bill for simplifying drug substitution procedure. Passing the plenary session of the National Assembly for the bill for implementation of drug substitution that has been submitted to the National Assembly would take several months after undergoing the legislative process. It has not been considered for the Legislation and Judiciary Small Committee for Health and Welfare. During the legislative procedure, it is unknown whether the bill would face opposite opinions, overcome oppositions, and pass all legislative hurdles. During the parliamentary audit, the MOHW answered a question about the restricted implementation of active ingredient prescriptions for cold medicines by stating, "It is the terms of the medical reform agreement. Therefore, the issue requires societal discussion and a procedural agreement." Then, the MOHW must consider detailed and active administration to implement drug substitution to resolve frequent drug shortages of cold medicines and pediatric medicines. In particular, lower-cost drug substitution must be increased because the government provides incentives to strengthen the stability of the National Health Insurance finance. According to the Health Insurance Review and Assessment Service (HIRA), the incentive for drug substitution increased temporarily during the COVID-19 pandemic. After the announcement of 'With COVID-19," it returned to that of pre-COVID-19. It shows that drug substitution policy has been conservative and passive unless drug substitution is inevitable, such as during the pandemic period. Not only during this audit but also during the previous parliamentary audit, the MOHW had agreed to the necessity of supporting drug substitution and increasing the incentive rate for lower-cost drug substitution. However, the concern is that they have not suggested a concrete method to specifically address when and how drug substitution can be actively implemented. As Minister Cho promised during the parliamentary audit that he would actively implement drug substitution to resolve the drug shortages, the MOHW must provide incentives and establish an administrative policy so that pharmacies can dispense drug substitution for drug shortages without hesitation. We must not passively wait for the legislative procedure after agreeing to the bill to simplify drug substitution, which is to be reviewed by the National Assembly. Aside from passing the bill to the National Assembly, we hope to hear about MOHW's updated policy to support drug substitution in resolving the drug shortage issue by actively implementing it.
- Opinion
- [Reporter's View] Super precision medicine
- by Eo, Yun-Ho Oct 30, 2024 05:53am
- Super Precision medicine. New drugs have been developed to selectively target with more significant efficacy than before. Lately, news articles related to anticancer agents have frequently covered keywords related to genetic mutations, including MET, RET, ALK, EGFR, and ROS1. Customized treatments are becoming available, where effective treatments can be provided depending on the patient's particular genetic mutations. Pharmaceuticals targeting HER2, ALK, and EGFR have been developed, and they show superior effects in patients with particular conditions. Lately, pharmaceuticals have been developed selectively targeting difficult-to-develop gene mutations, such as ROS, NTRK, and RET. Such development of super precision medicines suggests that prescription criteria will likely change from 'disease' to 'genes'. A customizable healthcare era has arrived. However, it is still unfamiliar. Will the South Korea successfully incorporate these drugs that show efficacy regardless of cancer type once gene mutations in patients are confirmed? Previously listed targeted anticancer drugs and immune checkpoint inhibitors have faced difficulties in expanding reimbursement. One such difficulty is the high costs. However, when a drug's new use is discovered, the values and the volume of usage must be re-assessed. The process is required by the National Health Insurance system in South Korea. However, recently developed new drugs target very few patients; in other words, the number of identified gene mutations cases is few. This means that not many patients are likely to be prescribed for these new drugs. In South Korea, patients with rare diseases comprise below 1% of overall solid cancer cases. Less than 200 patients are diagnosed. Experts explain that these types of patients do not respond well to standard therapies (conventional drugs). The problem is reimbursement. Anticancer agents targeting gene mutations mentioned earlier have already been approved domestically. However, most of these drugs are still non-reimbursable. Pharmaceutical companies have continued to apply for coverage, but their attempts 'failed.' It is time to consider a reimbursement track for super precision medicine. Rather than going against the current system, we must establish different reimbursement review criteria for drugs that can be used in patients regardless of their cancer types.
- Opinion
- [Reporter’s View] Deadlines are set for a reason
- by Eo, Yun-Ho Oct 17, 2024 05:51am
- The definition of ‘deadline’ is a time limit set in advance. So what is the right thing to do if the deadline has ended without a conclusion being made? Providing a justifiable explanation is very important in administrative affairs. Explanations are necessary not only in the course of introducing or abolishing a system, but also when exceptions occur in the process of applying regulations. However, no explanation has been given when the drug price negotiation term between the NHIS and pharmaceutical companies have been extended beyond the deadline. The parties involved point to the ‘confidentiality clause’ as the reason for the lack of explanation. They do not disclose whether the negotiations will be extended or terminated. This is despite the fact that more and more drugs are entering into extended negotiations beyond the deadline. In the era of the so-called “high-priced” drugs, so many good but high-priced drugs are being released, therefore, it may be difficult for the government and pharmaceutical companies to reach an agreement within the 60-day deadline. But a deadline is a promise. Moreover, the deadline was offered as a ‘benefit’ by the government, as it has announced a plan to shorten the review deadline for homegrown new drugs. The reduced deadline was a device that limits the final negotiation period and speeds up the approval process while providing a sense of timing for the companies. However, the responsibility lies with both sides. At some point, the prolongation in negotiations becomes pervasive, and the sense that an expensive and difficult medicine can't be finished in a single term, as well as the lack of a mindset of delivering results on time, has been leading to the repetition of exceptional cases. If discussions have become difficult, the conditions for initiating the negotiations should be strengthened. The NHIS should receive strong pressure to discuss in advance the necessary documents for pharmaceutical companies to prepare at the Health Insurance Review & Assessment Service stage before the start of negotiations and to complete them within the deadline. In the end, the patient is left to wait. Patients who hear that drug price negotiations are left to just wait without promise. After 3-4 months of await, no news is heard of the drug’s reimbursement. Even when the patient calls the government and pharmaceutical companies, the only response he or she can get is that “They cannot comment on the matter.” It is understandable that the HIRA stage, which evaluates the adequacy of a drug’s reimbursement based on clinical efficacy and cost-effectiveness, and the drug price negotiation stage, which is directly related to the “financial condition” of the parties involved, can be more sensitive phases for governments and pharmaceutical companies. But one has to wonder how long the ‘confidential’ clause can be seen as a just reason. Times have changed. Patients and their families will no longer stand on the sidelines.
- Opinion
- [Reporter's view] Expanding NIP to include 9-vHPV
- by Whang, byung-woo Oct 16, 2024 05:50am
- Several treatment-related agenda items were discussed during this year's parliamentary audit of the Ministry of Health and Welfare (MOHW). Various current measures, including improvements to the drug pricing system and blood cancers, have been discussed. One is the necessity of including human immunodeficiency virus (hereafter referred to as, HPV) in the National Immunization Program (NIP). Several argued that Gardasil 9, an HPV9 included in the government's plan, should be included in the NIP. Since 2016, the nationwide HPV vaccination has been provided to girls aged at least 12. Then, since 2022, it has been expanded to include female·juveniles of 12-17 years of age, and low-income females aged at least 18-26. 2-valent‧4-valent vaccines have been included in the program, whereas 9-valent vaccine is not supported. The current issue is whether to expand the vaccination program to male juveniles. During last year's parliamentary audit, Rep. Nam In-soon of the Democratic Party of Korea requested an expanded scope of the NIP for HPV vaccines based on 'The current record of patients undergoing treatments for head and neck cancer or oropharyngeal cancer.' Rep. Suh Myung-ok, a member of the People Power Party, has presented a 'Legislative bill for partial revision of the prevention and management of infectious diseases.' The question of whether the shingles vaccine Shingrix would be included in the NIP program has drawn attention again. The remaining issue is the cost. On average, the cost of a 1-dose vaccination for Gardasil 9 and Shingrix is about KRW 200,000, thereby referred to as 'Premium vaccines.' The majority of opinions is that the problems of cost-effectiveness, regardless of the benefits brought by vaccines, hinder the government's plan to pursue this policy. However, other opinions suggest a different view towards including premium vaccines in the NIP may be necessary. This means that, beyond the cost issue, people need to consider the effects comprehensively since the preventative effects of these vaccines are proven. An effective distribution of funds may be considered because vaccinations for Shingrix have already been supported by local governments, irrespective of the current discussions within the Korea Disease Control and Prevention Agency (KDCA). Kim Yea-ji, a member of the Health and Welfare Committee (People Power Party), and Rep. Nam have emphasized that the inclusion of vaccines, such as Gardasil 9, in the program could reduce people's medical costs in the long term. However, cost-related issues remain a burden on the government, as the Korea Disease Control and Prevention Agency (KDCA)'s budget for the NIP program next year has been markedly reduced. Pharmaceutical companies may need to voice their opinions during discussions about future implementation. Considering the nature of NIP vaccines, a 'good value' approach is inevitable. Vaccines are continuously being developed, and their preventative effects are increasing. Although premium vaccines present a dilemma for NIP inclusion, changes to repeating discussions are demanding. We anticipate the government's varied approaches and discussions.
- Opinion
- [Reporter's view] Creating a virtuous cycle for K-bio growth
- by Son, Hyung Min Oct 11, 2024 05:54am
- The research and development (R&D) trend in the biopharmaceutical industry is focusing on new anticancer drugs. The field is gaining interest, especially following the clinical success of Yuhan Corp's Leclaza (ingredient: Lazertinib) and HLB's rivoceranib. In particular, most biotech companies in South Korea are confirming the clinical potential of drugs in combination with Keytruda. Keytruda is an immune checkpoint inhibitor developed by MSD and a successful blockbuster medicine with over 30 indications in South Korea alone. Keytruda's global sales this year are expected to amount to KRW 3.5 billion. Almost all biotech companies in South Korea aim to out-license their technologies to MSD through clinical trials of combination therapy with Keytruda. A combination therapy involving medicine with proven effects is highly likely to be commercialized. However, R&D in the Korean industry seems to be focusing only on anticancer drugs for the purpose of out-licensing them to a big global pharmaceutical company. To date, several biopharmaceutical companies in South Korea are reporting confirmation of the efficacy of their drugs in combination with Keytruda through preclinical trials or early-stage clinical trials. However, there have been no reports of entering late-stage clinical trials, thereby nearing commercialization, or of outstanding out-licensing. In addition to Keytruda, the next target of the biopharmaceutical industry in South Korea is Enhertu. A second-generation antibody-drug conjugate, Enhertu (ingredient: trastuzumab deruxtecan), has demonstrated efficacy and is effective for breast cancer, gastric cancer, non-small cell lung cancer, and colorectal cancer. The biopharmaceutical industry in South Korea is exploring the market for ADC anticancer drugs. Even the long-standing pharmaceutical companies and the biotech industry have shown interest in ADC development. Several companies have already begun clinical trials involving combination therapy with Enhertu. It is common for Korean companies to pursue out-licensing as it allows them to secure funds for investments in other pipelines through out-licensing and provides opportunity to discover new drugs. However, if the industry continues to chase after blockbuster new anticancer drugs, it will lead to a difficult system to develop new innovative drugs domestically. Consequently, companies must explore new fields besides anticancer drugs. Instead of pursuing a partner in a combination therapy involving a well-selling drug, they should explore a field with unmet needs to create various out-licensing opportunities. The R&D costs in the biopharmaceutical industry in South Korea are incomparably smaller than those of global pharmaceutical companies. A stable source of funds is essential to sustain a virtuous cycle. Running a company by continuously developing competitive new drug candidates and successfully out-licensing is almost impossible. As a result, it is important to have experience collaborating with other companies to secure Korean and Asian rights when discussing out-licensing agreements with a global pharmaceutical company. Pharmaceutical companies can only sustain stable earnings through selling drugs. The biopharmaceutical industry is one of the industries with a large gap between Korean and global companies. The biopharmaceutical industry cannot benefit from good deals because it cannot produce good products and sell them cheaply. Now, the biopharmaceutical industry in South Korea must consider challenging various fields and creating a system to profit from selling new drugs. Clinical trials involving combination therapy containing new drugs are already supersaturated.
- Opinion
- [Reporter's View]Industry expectations rise with new changes
- by Eo, Yun-Ho Oct 10, 2024 05:50am
- The criteria for innovative new drugs that are eligible for the flexible application of the ICER threshold and the measures for the expansion of the risk-sharing agreement (RSA) have been revealed. As always, the industry expressed a mix of expectations and concerns. The disclosed ‘Detailed evaluation criteria for new drugs etc. subject to negotiations’ goes as follows. Firstly, the requirements for ‘innovativeness’ to qualify for the flexible application of the ICER threshold were established. A new drug is regarded as ‘innovative’ when it satisfies all of the following criteria: ▲ there is no substitutable or therapeutically equivalent product or treatment ▲ a significant clinical improvement, such as prolonged survival, is recognized in the final outcome, ▲ the new drug is approved by the MFDS under Article 35(4)(2) of the Pharmaceutical Affairs Act through expedited review or is recognized as equivalent by the committee. The criteria are not very different from what was proposed in the ‘Preferential treatment measures for innovative new drugs’ that was first released last year. The difference is that in that draft, the U.S. FDA Breakthrough Therapy Designation (BTD) and the European EMA Priority Review (PRIME) were required, but this time, only the MFDS’s GIFT (Global Innovative products on Fast Track) designation is required. This is certainly encouraging. Of course, most truly innovative drugs receive BTD and PRIME designations. However, the fact that only MFDS’s GIFT is required as a criterion is, in many ways, removing the hurdle for innovative new drug designations. The most notable changes were made in the RSA eligibility criteria. The amendment expands the scope of the second condition in the RSA criteria, which was ‘drugs eligible for special calculation or equivalent,’ to further specify the ‘or equivalent’ diseases. The ‘or equivalent’ part was specified to severe diseases that do not qualify for the special calculation but are difficult to cure, irreversible disability or organ damage due to the progression of the disease, and hold a significant disease burden. In addition, if the expected additional claim amount for refund-type RSA-type drugs is less than KRW 1.5 billion within the scope of the reimbursement standard expansion, the drug may omit Drug Reimbursement Evaluation Committee evaluations and conduct NHIS negotiations. However, if the drug falls under the second RSA criteria, a new condition was added, stipulating that the expenditure cap must be applied even if it is not a pharmacologic evaluation exemption drug. This raises the potential for a number of issues. Firstly, the removal of the ambiguous phrase ‘special cases or equivalent’ is welcome. The clinical criteria of irreversible disability and organ damage also seem to be specific enough. However, it is unclear how many drugs will be eligible for less than KRW 1.5 billion additional claims criteria. Simplifying the process of expanding the RSA reimbursement criteria has been long desired by the industry, the problem is that while there weren't many drugs that exceeded that 'total amount' in the past, things have changed as we've entered the era of high-priced drugs. Furthermore, the criteria that set all drugs that fall under the second condition to be applied the expenditure cap RSA is a concern. In fact, recently listed drugs are being contracted with combined type RSA that includes the expenditure cap type. The problem is that while there weren't many drugs that exceeded that 'total expenditure cap’ in the past, things have changed as we've entered the era of high-priced drugs. In this situation, it remains to be seen whether the unilateral application of the ‘expenditure cap’ for drugs falling under the second criteria will lead to smooth reimbursement listing.
- Opinion
- [Reporter’s View]Contradictions in the CSO reporting system
- by Kim, Jin-Gu Oct 07, 2024 05:48am
- The implementation of the CSO reporting system is now just 2 weeks away. It means that after the 19th of this month, no one will be able to engage in sales and promotion activities in the pharmaceutical industry without a CSO report certificate. Although there are only 2 weeks left until the law takes effect, there is still confusion among CSOs and pharmaceutical companies that entrust the CSOs with promotion and sales tasks. This is because the specific implementation rules for the system are yet to be set. This lack of preparation was highlighted during a Briefing Session on the CSO Enforcement Rules that was held on the 2nd of this month. The Ministry of Health and Welfare held the briefing session jointly with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. The briefing was livestreamed on KPBMA’s YouTube channel. The session attracted much attention, with more than 2,000 online viewers. However, in the YouTube comment section, most people expressed frustration. It was hard to find viewers who found the MOHW’s explanation helpful. In particular, many people were frustrated with the process of filing the CSO report. The MOHW’s explanation of the process was contradictory. According to the MOHW, it is illegal for CSOs who have not completed their registration before the 19th to conduct promotional activities. The problem is that the report certificate cannot be issued before the 19th. Without the certificate, the activities are illegal, but the certificate cannot be issued on the date, which causes a contradiction. On this, the MOHW explained that since the law comes into effect on the 19th, local governments cannot issue certificates before the date. The MOHW’s workaround to the dilemma was issuing a ‘receipt.’ Companies that need the certificate before the 19th can submit the necessary documents then to their respective local public health centers, receive a receipt certificate, and use it until the report certificate is issued. For pharmaceutical companies and CSOs, this means that they will have to sign double consignment contracts. Moreover, even this is not possible in the immediate future. In order for the MOHW to ask local governments to issue a receipt certificate instead of a report certificate, an enforcement rule must be promulgated, but the MOHW is still in discussions with the Ministry of Government Legislation on how to prepare detailed enforcement rules. This grows doubt on whether the government really did prepare for the system for over 3 years. The MOHW promoted the enactment of the CSO reporting system in September 2021 through a lawmaker's proposal. In April last year, the CSO reporting system was introduced with the amendment of the Pharmaceutical Affairs Act. In other words, there was at least a year to at most 3 years for the government to prepare for the system. Nevertheless, there are now 2 weeks to go before the system’s implementation, and detailed rules for implementing the law are still not in place. In addition to the certificate issue, there are still no detailed regulations on who needs to report, the scope of economic benefits that may be provided, and training obligations. The MOHW has said it expects to issue the implementation rules within the next week. Even if the rules are promulgated a lot of confusion will remain in the field. The scheme, which aims to stamp out illegal rebate practices, has been bogged down since its inception. Can the system really be implemented in two weeks?
- Opinion
- [Reporter’s View] How to increase the new drug approval fee
- by Whang, byung-woo Sep 26, 2024 05:51am
- The Ministry of Food and Drug Safety (MFDS) decided to significantly raise its new drug approval fee to expand its capability for the prompt review of newly developed drugs. The fee for new drug approval, which was previously KRW 8.83 million, was increased 48 times to KRW 410 million based on the benefit principle. Despite the dramatic increase, there has been little backlash as Korea’s drug approval fee has been relatively low compared to overseas. The MFDS aims to raise the new drug approval fee from next year after a 60-day administrative notice period. As the pharmaceutical industry has been actively supporting the realization of the fee, there have been more expectations than concerns. Rather, the industry's concern is whether the fee hike will have an immediate effect. The MFDS plans to use the increased fees to recruit specialized review personnel and expand the proportion of high-competency reviewers, such as doctors, pharmacists, and those with at least 3 years of postdoctoral experience, from the current 31% to 70%. However, whether the government can secure the required specialized personnel remains in question. While the MFDS emphasizes the importance of securing human resources by allocating half of the fee hike to labor costs, it is unclear at what point it will be able to recruit the desired amount of human resources. This is also a concern for pharmaceutical companies. While there is no doubt that the fee hike will speed up approvals, there is also concern that pharma companies will not immediately see the benefits of their inputs. As a result, some pharmaceutical companies are considering accelerating their submission plans and applying for approval before the fee hike. For example, there are concerns about whether the review process for new drug approvals will change dramatically before and after the fee increase, or whether the new system will take time to settle in. In the end, the pharmaceutical industry needs the MFDS to preemptively establish a system so that the increased fees can be utilized as intended. Apart from the consensus on the KRW 400 million increase in review fees, the system should not have a backward-looking investment structure that raises fees and then uses them to increase the number of reviewers. With the expected improvement in the system is expected, attention is likely to be focused on the first case of their application. In the bigger picture, the MFDS is hoping that the fee hike will also prevent the poke-and-see applications without sufficiently demonstrating safety and efficacy, in addition to shortening the review period. In other words, it could act as a hurdle to prevent companies from using Korea’s regulatory authorities as sort of a consulting window. However, the pharmaceutical industry is also hoping that the MFDS’s review will also include consultation at the approval stage, as the authorities are requesting new drug fees at the level of FDA and EMA. The increase in drug approval fees is expected to bring about many changes in the domestic regulatory environment. As the saying goes, 'the beginning is half the battle', so we expect thorough preparation and changes to be made to meet the purpose of the MFDS’s new drug approval innovation plan.
- Opinion
- [Reporter’s View] The new drug approval fee hike
- by Lee, Hye-Kyung Sep 19, 2024 05:48am
- The Ministry of Food and Drug Safety has announced an amendment to the “Fee Regulations for the Approval of Drugs, etc.” that will significantly increase the fee for new drug approvals from KRW 8.83 million to KRW 410 million. This is the first time in 4 years that the government has decided to increase the new drug approval fee, which is in line with the previous four-year cycle fee hike. In 2016, the fee was raised from KRW 6.82 million to KRW 8.83 million in 2020, and this time in 2024, another 4 years later, the fee is being raised to KRW 410 million. The MFDS’s fee hike announcement was received with surprise in the industry. The MFDS had been conducting a study to increase the fee for new drug approvals, so there had been a widespread assumption that the fee would be increased within the year. However, few thought that the increase, which had been 30% four years ago, would soar to 4500% and exceed KRW 400 million. No one expected the MFDS to raise the drug approval fee to a level similar to Europe and Japan at once. Most had expected the government to raise the fee in phases as before. When considering the fees charged by advanced regulatory agencies abroad, Korea's current KRW 8.83 million is unreasonable, to say the least. Even the industry acknowledged this. In Japan alone, which has a similar GDP per capita level, the PMDA KRW 430 million, the European EMA KRW 490 million, and the Canadian HC KRW 550 million. The US FDA charges KRW 5.3 billion, therefore, the MFDS’s administrative notice of raising the fee to 410 million is appropriate to align the fee to a realistic price at the global level. In particular, it has been pointed out the MFDS’s new drug approval fee is much lower than that of advanced regulatory agencies overseas, leading global pharmaceutical companies to apply for approval in a ‘testing the water’ type of manner. Before applying for approval to the FDA or EMA, the companies first apply to the MFDS, and then add the supplementary data requested by the MFDS before applying to regulatory agencies abroad. There has also been a feeling that MFDS is being regarded as a ‘consultant’ for overseas regulators. The damage caused by the understaffed reviewers reviewing the data of false applications was the delay in review, which was ultimately borne by domestic pharmaceutical companies that needed new drug approvals. The increase in the new drug approval fee seems to mean that MFDS will no longer act as a ‘consultant’ and fulfill its purpose as a proper regulator. Moreover, it seems like the government decided to foster the development of new drugs by domestic pharmaceutical companies rather than global pharmaceutical companies as the new amendment specifies the benefits provided to such by the MFDS, such as a 50% reduction in fees for domestic pharmaceutical companies and a 90% reduction in fees for modifications made to existing drugs. Although the new drug approval fee seems to have suddenly risen to KRW 410 million, this was an inevitable raise that had to be made to meet the global level sooner or later. The MFDS announced that the new drug approval period will be shortened from 420 days to 295 days with this increase. If it goes as planned, new drugs developed by domestic pharmaceutical companies will be able to enter the market a little faster. However, it would be necessary to expand the number of expert staff to accommodate this. The MFDS has set aside half of the increased fees for labor costs. The amount may seem like a lot, but it will be used as a basis for expanding the number of reviewers. If the increase in the number of expert staff can actually shorten the time it takes to approve a new drug, the fee increase would have been necessary sooner or later.
