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- 2026-03-10 07:55:20
- Opinion
- [Reporter's View] Biotech policy must be consistent
- by Jun 04, 2025 06:17am
- What's the most critical factor in corporate management? It's challenging to pinpoint whether it's capital, talent, or technology. However, for all these elements to function, a prerequisite must be established: predictability. A company must be able to foresee the future to invest and endure risks to recruit and conduct R&D. South Korea is often evaluated as lacking predictability in its systems and policies. Industrial nurturing strategies and regulatory directions change dramatically with every government, and policy consistency between different ministries also tends to be inconsistent. It's common to see ministries offering different interpretations of the same issue or administrative decisions varying depending on the timing and the official in charge. The biotech industry is no exception. The Yoon Suk Yeol government began establishing control towers by launching organizations directly under the Prime Minister and the President; however, there some criticized that these two committees lost momentum after the presidential impeachment. A similar problem is found in the capital market, which drives the growth of the biotech industry. Listing criteria for public offerings change with every government transition. Such uncertainty is particularly detrimental to industries like biotech that require long-term investment. For companies, it becomes difficult to formulate long-term plans. Attracting investment is challenging when regulations and policies frequently change. Cases where existing strategies must be revised due to policy shifts also arise, and the efficiency of budget allocation and human resource management decreases. Ultimately, companies are but to adopt a conservative management approach, which leads to a slowdown in the overall pace of innovation within the domestic biotech industry. In the long term, there is a high probability of a downturn in the industrial ecosystem and weakened competitiveness in the global market. In other words, the lack of trust in policies and systems hinders the potential for industrial growth. The world has entered competition centered on 'biotech sovereignty.' China is rapidly expanding its presence on the global stage by investing massive national budgets. In response, the United States has moved to strengthen regulations, including securing domestic production capabilities. It's now imperative for South Korea to establish a system that allows biotech policies, separate from politics, to be pursued long-term within a neutral and stable structure. A new government will be launched. The government must promise consistency and predictability in policies not only to the public but also to the business sector. While governments may change, the principles and strategies for viewing the industry should remain consistent. These elements will establish the foundation for foreign companies to trust Korea and for domestic companies to develop long-term visions, ultimately sustaining the competitiveness of Korea's biotech industry.
- Opinion
- [Reporter's View] Addressing drug shortage, healthcare
- by Lee, Jeong-Hwan May 30, 2025 05:57am
- Ahead of Korea's early presidential election, scheduled for June 3, leading candidates have prioritized pledges to strengthen government support for essential medicines·address drug shortages. Lee Jae-myung, the candidate for the Democratic Party of Korea, included the resolution of a supply shortage of essential medicines in his top 10 pledges, suggesting the possibility of a partial introduction of generic name prescribing for drugs such as flu treatments and cold medicines. Kim Moon-soo, the candidate for the People Power Party, also promised to create a system for detecting drug supply shortages, establish a public electronic prescription system, and set up a drug supply management committee. Lee Jun-seok, the candidate for the Reform Party, also acknowledged that frequent drug shortages are a pressing concern for pharmacists, indicating his intention to establish an independent channel with the Korean Pharmaceutical Association (KPA) to discuss related solutions. Likewise, the inconvenience faced by pharmacies and patients due to shortages of frequently sought-after essential medicines has remained unresolved for several years, becoming a nationwide headache to the extent that presidential candidates have uniformly listed it as their top pharmacy-related pledge. While pharmacists review their drug shortage checklists every morning and respond to the chaos by exchanging drugs with nearby pharmacies through local communities and KakaoTalk, they are frustrated that the process remains haphazard. These are the reasons the KPA proposed to the presidential candidates the establishment of a government-level drug shortage management system. The aim is to advance beyond merely sharing information about some drug shortages through the Drug Utilization Review (DUR) service and for the government to establish a system that assumes social responsibility. The newly appointed president, following the election, and the new government need to design and implement policies with a mission to find fundamental solutions to drug shortage issues, thereby strengthening national health security and pharmaceutical sovereignty. The drug shortage problem arises due to the instability of active pharmaceutical ingredient (API) supply due to accelerating drug nationalism. To domestically produce APIs that have low profitability, the government must provide sufficient incentives. In other words, the government must exert its public role to the fullest, encouraging domestic approval and manufacturing of essential drugs by pharmaceutical companies to improve self-sufficiency rates and also advance the distribution lines of produced medicines. Suppose a system is also created that can quickly promote the supply of the relevant active ingredient/product or alternative drugs when sudden shortages occur in local pharmacies. In that case, the frequent occurrence of drug shortages being raised at the annual national audit will decrease. We anticipate the election of a president who will operate the existing public-private consultative body for drug shortages, thereby implementing policies and budgetary solutions into actual systems to ensure organic cooperation among the pharmaceutical industry, the pharmacy community, and drug distribution.
- Opinion
- [Reporter’s View] Reimbursing the only RET-targeted therapy
- by Eo, Yun-Ho May 29, 2025 05:52am
- News of a new drug failing to be listed for insurance reimbursement always upsets patients. The blow is even harder when it is the only treatment option available. Such was the case in 2023 when the National Health Insurance Service and Lilly failed to reach an agreement on the price of the RET-targeted anticancer drug Retevmo (selpercatinib). This was the only case of a drug price negotiation failure that year. This drug was the first treatment option for patients with RET fusion-positive non-small cell lung cancer and thyroid cancer, and the only drug that was being reviewed for reimbursement in Korea. With the reimbursement listing of Retevmo falling through, patients were left to endure an indefinite wait. Then, this year, the developer, Lilly Korea, finally reaffirmed its commitment. Lilly recently submitted a reimbursement application for non-small cell lung cancer along with an indication for thyroid cancer. This is the company’s third attempt. Prior to the approval of Retevmo, there were no targeted treatment options available for patients with RET-mutated NSCLC or thyroid cancer. Therefore, the Ministry of Food and Drug Safety approved Retevmo through a fast-track review for the treatment of:▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. Among the A7 countries that are used as Korea’s drug price reference countries, Retevmo is covered and used in 6 countries (US, Germany, Italy, UK, Switzerland, and Japan) other than France. However, despite the considerable time that has passed, it is still not reimbursed in South Korea. The MFDS has been operating an expedited review system to promptly launch and supply highly innovative drugs for life-threatening or serious conditions to the market and patients. However, only a handful of the 23 approved through the fast track is currently being reimbursed by insurance. This means that even after the drugs receive accelerated approval through fast-track review, it is difficult for cancer patients to receive treatment benefits without reimbursement. While regulatory authorities often determine that rapid introduction is necessary, it is frequently the case that insurance authorities remain cautious and conservative. When it comes to the introduction and improvement of systems, ‘effectiveness’ is always a top priority. This reporter hopes that policies aimed at improving patient access to innovative new drugs can achieve the intended effect.
- Opinion
- [Reporter's View] 'Samsung Epis' as independent firm
- by Whang, byung-woo May 23, 2025 05:51am
- Samsung Biologics officially announced on May 22 that its shareholders determined to conduct a spinoff of Samsung Bioepis and establish 'Samsung Epis Holdings.' The business independence of Samsung Bioepis, which expanded its focus on biosimilars, was conducted earlier than anticipated. It has been two years since Samsung Biologics acquired Biogen's entire share in Epis. The current spinoff is meaningful in a way more than simply reorganization of the firm. This indicates Samsung Bioepis' performance over 10 years, future market changes, and efforts to achieve the technological leap. Samsung Bioepis was established as a joint venture between Samsung Biologics and the biotech firm Biogen in 2012. In 2022, Samsung Biologics acquired 49.9% of the U.S.-based Biogen's share in Samsung Bioepis for approximately USD 2.3 billion, acquiring Epis as a 100% subsidiary. After that, Samsung Bioepis established a partnership-based collaborative structure that is flexible and strategic rather than simply a shareholder relationship. Its performance in the past two years can be seen as a period of testing the firm's 'independent survival.' Samsung Bioepis will become a completely independent entity after the spinoff. At the same time, Samsung Epis Holdings will strengthen its role in Samsung Group's biotech business. Samsung Bioepis' performance in the global market is notable. According to IQVIA, Samsung Bioepis ranked No.2 in the market share of Humira biosimilars as of 2023. However, the company's competitors are fiercely rising. For instance, Celltrion has established a competitive ground as it obtains approval and distributes new products in addition to existing biosimilars. Samsung Bioepis' new project is 'new drug discovery,' preparing beyond biosimilars. Whereas the past performance focused on proving equivalence against original products and expanding market presence, the company will likely focus on securing a proprietary new drug pipeline for the next 10 years. Samsung Bioepis has already started investing in R&D of proprietary new drug discovery. It has begun searching for next-generation technologies, such as establishing an AI-based new drug discovery platform and antibody-drug conjugate (ADC). However, the company's new drug pipeline for clinical trials has not been officially announced. The company will likely seek an R&D model that could balance profitability and risk rather than delving into new drug discovery, requiring time and funds but carrying low success. This approach has both pros and cons. This means there is an opportunity to choose and focus on an area with a high probability of success rather than taking risks and being reckless. Celltrion employs a similar strategy. Samsung Epis Holdings' establishment can be seen as Samsung Group entering a new stage of 'comprehensive biotech strategy' beyond biosimilars. This is likely to be followed by efforts to expand into fundraising, co-development with global big pharma, and the rare disease and vaccine sectors. There's still a long way to go. Their experience in new drug discovery remains in the early stages, and there are many challenges to overcome, such as securing high-value pipelines, navigating the regulatory environment, and securing talent. The company's journey was like 'starting from scratch' and turning question marks from external and internal sources into exclamation points. Conversely, it was also an expression of pride in leading the company to its current level with a relatively minor organization compared to large entities like Samsung Electronics and Samsung C&T. The launch of Samsung Bioepis Holdings signifies confidence in past achievements and represents a bold first step toward new challenges and responses. We anticipate Samsung Bioepis' continued strong presence in future competition, leveraging their 'original vision' and proven competitiveness in the biosimilar industry.
- Opinion
- [Reporter's View] Strengthening GMP for sterile drugs
- by Kim, Jin-Gu May 19, 2025 05:56am
- The government has reaffirmed its existing position on strengthening GMP standards for sterile finished drug products in December. The Ministry of Food and Drug Safety recently met with sterile drug factory managers and stated that there will be no postponement of the enforcement of the “Regulations on Drug Manufacturing and Quality Control” in December. Under these regulations, facilities producing sterile drug products must implement the following measures: ▲Establish and implement a systematic contamination control strategy for the manufacture of sterile drug products; ▲Develop individual good manufacturing practices (GMP) for advanced biopharmaceuticals; ▲Clarify the details of the specific dosage forms, evaluation procedures, and methods for determining compliance with the good manufacturing practices (GMP). The MFDS has been preparing for the implementation of these measures since joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2014. The MFDS believed that it was necessary to strengthen GMP standards for sterile products in line with international standards. To this end, the MFDS has provided the pharmaceutical industry with sufficient time. When revising relevant regulations in 2023, the MFDS required manufacturers of sterile finished drug products to replace outdated equipment within 2 years after the revision of the notice, and manufacturers of sterile APIs to do so within three years. Additional grace periods were granted for certain provisions. However, as the deadline for implementing the new regulations approaches, an increasing number of pharmaceutical companies are refusing to replace their outdated equipment. Instead of halting production of sterile drug products, they plan to shift production to contract manufacturing facilities. This is because replacing outdated equipment could cost tens of billions to hundreds of billions of won, depending on the facility. At first glance, this seems as if aseptic drug manufacturers are considering production halts to save equipment replacement costs. Additionally, given the sufficient timeframe provided, it seems that they have not been reacting for the past two years and only decided to halt production as the deadline for stricter regulations approaches. However, the story of sterile drug manufacturing plants is different. Their common claim is that the productivity of sterile drug manufacturing itself has become too low, regardless of the need to replace outdated equipment. In a situation where profits are almost nonexistent due to excessively low drug prices, they argue that they have no choice but to halt production, as additional costs of up to hundreds of billions of won would be required for replacements. For this reason, the pharmaceutical industry requested support for facility investment costs and improvements to the drug price structure during several recent meetings with the MFDS. However, the MFDS has drawn a line, saying that it will not provide investment support as it has already provided a sufficient grace period. Discussions on pricing sterile drugs have also stalled. If this situation continues, there are concerns that the supply shortage of sterile drug products will worsen by the end of the year. Already this year, 22 cases of injection supply discontinuations or shortages have been reported. It is known that about 10 sterile drug factories are seriously considering discontinuing production. If they discontinue their product supply by the end of the year, there are concerns that it will lead to a large-scale supply shortage. I agree with the policy direction that GMP should be strengthened to meet international standards. However, before doing so, we must first address the fundamental problem of low productivity. The MFDS must not dismiss the demands of sterile drug product manufacturers as “lack of preparation.” Unless the fundamental problems of excessively low drug prices and the resulting low productivity are resolved, it will be difficult to encourage sterile drug product manufacturers to participate, no matter how long the grace period is.
- Opinion
- [Reporter's View] Korea’s vaccination space: ups and downs
- by Eo, Yun-Ho May 15, 2025 06:23am
- Vaccines are at the forefront of localized pharmaceuticals in Korea. Leading domestic companies such as GC Biopharma and SK Bioscience are now responsible for vaccine production and supplying preventive vaccines for various diseases, including influenza. The commercialization of so-called “premium homegrown vaccines,” such as pneumococcal protein vaccines, cervical cancer vaccines, and shingles vaccines, is also progressing steadily and is set to be completed soon. However, despite the improvement in vaccine competitiveness, the vaccination fee cartel among doctors in South Korea remains unchanged. For example, if the purchase price of a vaccine (the price at which doctors buy vaccines from pharmaceutical companies) is KRW 100,000, the implicitly accepted appropriate inoculation fee among doctors is around KRW 200,000. However, after some time passes, some local clinics lower the vaccination fee to as low as KRW 150,000 in an attempt to sell more at lower prices. Some even abandon their margins altogether, offering even lower prices through promotional events. These clinics then face criticism from neighboring doctors. They are labeled as traitors who betrayed their colleagues for their own gain. Such controversies can escalate into disputes between different medical specialties. The medical society of the relevant specialty may launch a campaign claiming that people should be vaccinated by specialists in their respective field. The interesting point lies in the margins. For vaccines, the difference between the inoculation fee and the purchase price, minus approximately 30% tax, constitutes the doctors' income. If they receive the “appropriate price” they claim—KRW 200,000 per vaccination—the actual income may vary depending on tax reporting, but amounts to roughly 70,000 won. For some workers, this is equivalent to a day's wage. Even if they receive KRW 150,000, approximately KRW 35,000 margin remains. This is by no means a small amount. Private practitioners claim that after including vaccination fees and labor costs, nothing remains. Meanwhile, during the flu season, they engage in fierce competition to secure supplies of flu vaccines, where the purchase price is KRW 10,000, and an approximately KRW 12,000 margin remains per inoculation. Private practice doctors are self-employed. This is a fact. Therefore, it is understandable that they want a high income that commensurates with the effort they put into obtaining their medical license. Additionally, since vaccine prices are not fixed, they have the right to set their own prices. However, they should refrain from claiming that twice the purchase price is the “appropriate price” and form a cartel. I earnestly hope they will finally “recognize” that the era when doctors' words were unquestioningly accepted is now over.
- Opinion
- [Reporter's View] USIM data leakage incident is a warning
- by Kim, Jin-Gu May 02, 2025 05:55am
- The SKT USIM data leakage incident has spread anxiety throughout society. Previously, there have been countless personal data security breaches, but the latest incident is considered differently. The scale of the expected damage is so large that it’s hard to estimate. Long lines have formed in front of SKT stores as people wait to replace their USIM cards. This incident not only exposes gaps in telecom security but also serves as a reminder of the importance of personal data protection across all sectors. The pharmaceutical and biotech industry is no exception. The information handled by biopharmaceutical companies goes far beyond simple customer data. Health information of clinical trial participants, disease and genetic data, and records of drug responses are high-risk data that, if hacked, could cause irreparable damage. Moreover, such information is routinely shared through collaborations with external partners, including hospitals, research institutes, and CROs. Even a single vulnerability in the security framework could jeopardize the entire ecosystem. The biopharmaceutical industry has had personal data breaches before. In 2024, one firm was indicted for illegally collecting the names, diagnoses, and prescribed medications of 39,000 patients from four general hospitals. In 2023, another company suffered a hack that exposed sensitive data, such as physicians' and pharmacists' names, affiliated institutions, specialties, email addresses, and mobile phone numbers. Within companies, information security departments are often undervalued. They don't directly contribute to productivity, and the nature of their work means 'doing a good job' is frequently taken for granted. Yet data security is not solely the IT department's responsibility. Every organization member, from the CEO to the researchers, must be aware of 'data risks.' Especially now, as AI-driven drug development, digital health, and telemedicine expand data-driven business models, information protection becomes not just an obligation but a 'competitive advantage.' The SKT incident is a warning. The pharmaceutical industry should learn from it, audit its security frameworks, and strengthen its crisis-response capabilities. A single moment of neglect could make the biopharmaceutical industry the next victim. It can take years to build trust, but only a single day to lose it.
- Opinion
- [Reporter’s View] Consideration in legislating telemedicine
- by Lee, Jeong-Hwan Apr 30, 2025 06:07am
- Following the presidential election on June 3, which will determine the next president and new administration, one of the most urgent healthcare policies that would need to be addressed is ‘non-face-to-face treatment,’ or telemedicine. Currently, two bills to formalize telemedicine, which is currently under pilot programs, are pending in the National Assembly. Both bills were proposed by members of the People Power Party (Rep Bo-yoon Choi and Jaejun Woo). The Democratic Party of Korea is also preparing to introduce a bill to formalize telemedicine. Amid this situation, platforms that mediate telemedicine services have urged the National Assembly and the government to legalize telemedicine by fully permitting its use for all patients and to establish a system for delivering prescription medications to patients. They argued that implementing the Yoon Suk Yeol administration's unrestricted pilot program, which was launched with the goal of activating and fostering the telemedicine industry, as is, would minimize patient inconvenience and allow platforms currently operating as intermediaries to maintain and expand their revenue models. From the perspective of platforms that generate revenue by mediating telemedicine and prescription between medical institutions, patients, and pharmacies, calling for the institutionalization of telemedicine under a “negative approach” that maximizes the scope of its application is understandable. However, this conflicts with the fundamental principle of South Korea's healthcare system, which prioritizes in-person diagnosis and prescription, which is why the agenda requires careful consideration. Since telemedicine was permitted in Korea in February 2020 due to the COVID-19 pandemic, the platform industry has developed rapidly over the past 5 years. It is also a true that these platforms contributed to the stable implementation of telemedicine and preventing national and social panic caused by the spread of new infectious diseases. Nevertheless, the full legalization of telemedicine without clarifying distinctions between initial and follow-up visits or specifying the scope of application raises sufficient concerns that it could undermine or distort the domestic system built on the principles of in-person diagnosis and prescription. Furthermore, it is necessary for the executive and legislative authorities to carefully consider whether it is truly a top priority to dismantle regulations and legalize telemedicine so that all patients can receive telemedicine without any barriers, even in metropolitan areas such as Seoul and Gyeonggi Province, where medical institutions are abundant. In simpler terms, it is essential to closely examine the potential side effects that may arise if an environment is created where patients with minor illnesses can easily obtain prescription medications through telemedicine simply because they find it inconvenient to visit a hospital. The Ministry of Health and Welfare has already confirmed that non-face-to-face medical consultations have affected the overprescription of obesity drugs such as Saxenda during the pilot project, and has implemented supplementary administrative measures such as revising the list of prohibited drugs. Currently, the medical community and pharmacists are raising questions about the necessity of allowing telemedicine for conditions like hair loss or acne, which are relatively non-urgent and have low severity, as well as the need for medication prescriptions in such cases. Without properly understanding this reality, simply transferring the current unrestricted telemedicine system into legislation based on the fact that South Korea has implemented telemedicine for over 5 years could accelerate distortions in the medical delivery system or increase the risk of abnormal diagnostic and prescription practices. While radical reforms may sometimes be necessary to modernize outdated systems, such reforms inevitably come with corresponding side effects. Prior to the COVID-19 pandemic, South Korea's healthcare system had not faced significant issues, except for shortages in essential and regional medical care. Therefore, the legislative direction for the institutionalization of telemedicine to be discussed by the National Assembly after the 21st presidential election should focus on effectively resolving the collapse of essential and regional medical care, rather than promoting the telemedicine industry or developing platform business models. South Korea's healthcare system has been established and developed over the past 25 years since the separation of medical and pharmaceutical services in 2000, under the slogan “Diagnosis by doctors, dispensing by pharmacists.” If telemedicine policies are legalized solely based on the global and nationwide shock and damage caused by the novel infectious disease pandemic over the past few years, there is a risk that a system that disregards the domestic healthcare delivery system and pharmacy ecosystem may replace the current system that has been established since the separation of medical and pharmaceutical services. Given that the outcome of the June 3 presidential election will determine whether the current administration remains in power or changes, the specific direction of the telemedicine systemization will also be influenced by the results of the presidential election and subsequent legislative reviews in the National Assembly. The new president and government should prioritize making a social consensus on institutionalizing telemedicine in a manner that maintains and restores a safe and unbiased healthcare system, rather than focusing on telemedicine for the industry revitalization.
- Opinion
- [Reporter's View] Prescribing pre-reviewed new drugs
- by Eo, Yun-Ho Apr 30, 2025 06:06am
- New drugs that patients long-awaited are being reimbursed, but no hospitals are prescribing them. There have been various attempts at improving the system, but an issue related to new drug access remains unresolved in South Korea. Public petitions for reimbursement of a particular new drug are frequently listed, and more patient organizations are gathering petition signatures. Yet, new drugs that successfully overcome challenges to be listed often are not prescribed at hospitals even though there are no prescription requirements, often mandated for gene therapies, for these drugs. Although these are first-in-class drugs and quality for reimbursement, there are only a handful of drugs that become prescribed at medical institutes throughout the country half a year after inclusion to the reimbursement list. This often occurs because hospitals tend to be afraid of being responsible for high-cost drugs after administration of such drugs upon doctor's advice and having the risk of insurance deduction. Distributing companies often contribute to this matter. During the process of distribution, loss results in substantial financial loss. Many of these cases involve drugs that have undergone a pre-review system for reimbursement. The 'pre-review' system processes the appropriateness of reimbursement for high-cost orphan drugs before authorization. It has been established to consider strengthening patient drug access and protecting National Health Insurance finance. It conducts both pre-reviews of determining the appropriate patient pool and continuance of administration after approval through pre-review. In other words, especially for high-cost drugs, the system offers a pre-review to determine whether a drug is deemed reimbursable. Drugs that underwent pre-review can be prescribed during an emergency and under a doctor's advice. The problem is that the drug has been administered but is deemed not reimbursable afterward. It does not mean that hospitals and distributors must endure losses. However, these drugs have been added to the reimbursement list after substantial efforts and demands. Hospitals and distributors need to collaborate on the issue of 'risk-sharing.' These drugs entered the system after meeting the criteria for at least two types of risk-sharing agreement (RSAs). There is no time to hesitate, and we must find a solution.
- Opinion
- [Reporter's View] Enhanced GMP reg for sterile drug products
- by Lee, Hye-Kyung Apr 28, 2025 05:55am
- Starting December 27, production·good manufacturing practices (GMP) regulations for sterile medicinal products produced by aseptic processing will be strengthened. The Ministry of Food and Drug Safety (MFDS) amended the 'Regulations on Good Manufacturing Practices (GMP) for Medicinal Products' in 2023. The revision had been conducted to modify the production·good manufacturing practices (GMP) regulations for sterile medicinal products following the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) ahead of the reevaluation by the PIC/S. The guidelines state the establishment of contaminant management methods through GMP regulations and the latest sterile manufacturing equipment and technology. However, considering all pharmaceutical companies to have adequate preparation time to establish contaminant management methods, the MFDS announced the implementation of the regulations on sterile medicinal products two years after the notification. Companies must establish a contaminant management strategy for sterile medicinal products starting in December and undergo risk assessment for PIC/S regulations and gap analysis. To accomplish these tasks, manufacturing plants' divisions must begin working together 1-2 years before implementing the regulations. Research and related technology investments are needed to prepare for the 'Pre-Use Post Sterilization Integrity Testing (PUPSIT).' Until now, manufacturing companies that have not established contaminant management strategies will not be able to meet the standards for strengthened GMP measures starting in December. Due to this update, manufacturing companies with old manufacturing equipment announced suspending their productions. Several companies, including Pharma I, Pharma B, Pharma G, Pharma D, Pharma A, and Pharma K, have reported to the MFDS. These companies anticipated replacing old equipment following the PIC/S would cost billions in Korean won. Therefore, they resorted to switching to CMO and discontinuing injectable line facilities that do not generate profits compared to investments due to low reimbursement ceiling caps. In fact, there were calls for facility investment costs and pricing support even during the briefings held for manufacturers ahead of the revision of the sterile medicinal products GMP regulation. However, the MFDS believed that the 2+1-year grace period would give manufacturers sufficient time to adapt, and it did not introduce any additional support measures. As the regulation’s enforcement date approaches, companies are beginning to withdraw from injectable production, and organizations such as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) have stepped in to survey the state of the industry. There are currently approximately 110 aseptic-preparation manufacturers in South Korea. Of these, about 10% have already announced plans to suspend production. If many manufacturers shut down their facilities simultaneously before the implementation date, there could be a shortage of injectable products. If this includes designated National Essential Medicines, the crisis could escalate uncontrollably. Instead of pointing to the fact that the MFDS already completed briefings, public comment, and a grace period during the regulation revision process, it needs to listen to what manufacturers require. Related parties must jointly consider support measures for aseptic‐preparation companies, such as assistance with developing contamination‐control strategies and options like price increases for injectable products. There will inevitably be challenges in securing new personnel or installing new facilities under the new system, such as freeze dryers and sterilization equipment.
