The Blue Vanguard Vol. 27

Page 1


Yonsei Student Pharmacist

MAIN ARTICLES

Pharmaceuticals

Yejoo lee, The Future of GLP-1 Agonists in Metabolic Disease Treatment

Column

Dakyung Baik, Conflicts between Pharmaceutical Patent Protection and the Right to Life and Health

National issues

Jiwoo Kang, Policy changes affecting pharmacies from 2025

International issues

Junghyun Yoon, Access to medication and inequality

EDITOR’S NOTE

Hello Readers!

It is my great pleasure to present the 27th issue of THE BLUE VANGUARD, a collective reflection of our team’s curiosity, commitment, and critical insight into the ever-transforming pharmaceutical landscape.

In this issue, we take you through a sweeping journey—from the impact of the AI era on pharmaceutical companies, to paradigm-shifting discussions on patent ethics, drug accessibility, and the evolving role of pharmacists. You’ll find comparative analyses between major regulatory agencies, explorations into the future of GLP-1 agonists and non-opioid painkillers, as well as in-depth looks into AI-driven drug development and nano drugdelivery systems.

We also examine pressing national issues: from policy changes affecting pharmacies from 2025 and rare disease drug development to Korea’s generic drug pricing and the instability of supply chains. Internationally, our writers investigate global disparities in medication access, manufacturing problems, and how the pharmaceutical industry is adjusting to changing patient needs.

On campus, we spotlight Yonsei University’s Quantum Week 2025 and the growing interest in quantum computing-based pharmaceutical research. Each article in this issue is a product of thoughtful discussion, rigorous research, and sincere collaboration. We’re proud to share it with you, and we hope it sparks new conversations, questions, and visions.

With every page, may you feel the energy and intent behind our words.

Warm regards,

CONTENTS

Interview

• The Impact of the AI Era on Pharmaceutical Companies

Pharmaceuticals

• The Future of GLP-1 Agonists in Metabolic Disease Treatment

• The Evolution of Non-Opioid Painkillers: Unafra, Journavx, and the Future of Pain Management

• Development of AI and Pharmaceuticals

• Prescription with Precision: Nano Drug-Delivery

Systems Revolutionizing Targeted Therapy

• Drug Approval Process: A Comparative Analysis of FDA and MFDS

Column

• Public Perception of Over-the -Counter Drug Sales

Outside Pharmacies in South Korea

• Pharmaceutical Patent Protection vs. The Right to Life and Health

• Pharmacists’ Strategies in the Era of the Fourth Industrial Revolution

National issues

• Policy changes affecting pharmacies from 2025

• Prices and Accessibility of Korean Generic Drugs

• challenges in developing drugs for rare disease

• Drug Shortages and Supply Instability

International issues

• Access to medication and inequality

• The Pharmaceutical Industry: Evolving to Meet Changing Patient Needs

• Medicine Shortages and manufacturing problems

CAMpus Life IssueS

• Yonsei Quantum Week 2025 and quantum computers

The Impact of the AI Era on Pharmaceutical Companies

Journalist l Yoo Bee l yubi7516@yonsei.ac.kr

Designer l Minseo Choi l mminseo@yonsei.ac.kr

The rapid advancement of artificial intelligence (AI) is driving innovation across various industries, particularly in the pharmaceutical sector. AI is revolutionizing how drugs are discovered, improving research efficiency, and accelerating the development of new treatments. This technology has the potential to overcome the limitations of traditional pharmaceutical processes, which are often time-consuming and costly. I will be interviewing with an expert to discuss the impact of AI adoption on the pharmaceutical industry. This interview aims to provide an in-depth exploration of how AI is transforming the pharmaceutical industry. I will discuss the real-world impacts of AI adoption, its opportunities and the challenges that must be addressed for successful implementation. Through insights from industry experts, we seek to understand how AI is shaping the future of pharmaceuticals.

Q1. How do you think AI adoption will positively impact and limitations on the future growth potential of pharmaceutical companies?

A1.

AI can be extremely helpful, especially in the early stages of drug discovery. It can process and analyze large datasets quickly, helping to identify promising drug candidates more efficiently. For instance, AI can predict the potential effectiveness of drugs based on existing data and discover new candidates that might not have been identified otherwise, significantly improving the drug development process.

The biggest limitation is the difference between prediction and actual results. While AI can make predictions based on past data, those predictions don’t always match the actual outcomes. For example, AI might predict a drug will be effective, but the real-world testing and clinical trials might yield different results. So, while AI can help identify promising drug candidates, it can’t replace the need for actual experimental and clinical data to confirm effectiveness.

AI is an incredibly powerful tool, but human judgment and experience are still crucial. AI can rapidly discover many drug candidates, but it’s up to humans to determine if those candidates are truly effective and commercially viable. The results from preclinical and clinical testing cannot be fully predicted by AI, so human expertise is essential when making final decisions. In essence, AI and humans need to collaborate: AI can assist in the discovery phase, but humans are needed to validate and test these discoveries.

AI can contribute greatly by accelerating the drug discovery process through data analysis, but ultimately, determining whether a drug is effective requires human experimentation and clinical trials. The collaboration between AI and humans is what makes the process most effective.

Q2.

How can digital transformation and AI technology improve the profitability of pharmaceutical companies?

A2.

Especially in the preclinical stage, AI and digital technologies can be extremely helpful. For instance, when verifying efficacy and safety through in vitro experiments, AI and digital tools could accelerate this process. By running multiple experiments simultaneously and processing data more efficiently, the initial stages of drug development could be shortened.

AI excels in data analysis and prediction. It can help design experiments or efficiently test multiple candidate compounds at once. This means we could evaluate efficacy and safety more quickly than before. Since the preclinical stage is so crucial in the overall development process, shortening this phase could have a significant impact on reducing the total time needed for development.

Take, for example, the intense competition in developing ADCs (antibody-drug conjugates) or immune-oncology drugs. In this market, being the first to succeed is extremely important. The same applies to other drugs—time is ultimately what gives you a competitive edge. While AI and digital technologies can speed up the preclinical stage, later stages of development still require significant time and effort. That said, saving time in the early stages could still have a positive impact on profitability.

Q3. What do you believe is the most significant advantage that personalized medicine will bring to the future pharmaceutical industry?

A3.

CDX (Cell-Derived Xenograft) and PDX (Patient-Derived Xenograft) models are types of personalized medicine, especially in cancer treatment. These models can help tailor treatments to individual patients’ needs. In my work with cancer drugs, I see these models as essential in developing more effective and personalized treatments. It mainly works in diseases like cancer, where treatment can be more precisely targeted. The challenge with diseases like the cold is that they don’t have the same complexities that cancer does, which makes personalized treatment difficult.

The balance between efficacy and safety is critical in drug development. For personalized medicine, I believe the focus will naturally lean towards efficacy. By finding more effective treatments, we may be able to use lower doses or shorten the treatment duration. This would result in reduced costs and a lighter burden for the patient.

In the long run, if personalized treatments are developed and become more widely available, the cost burden on patients could decrease. Although initially, personalized treatments might only be accessible to a select few due to high costs, over time, as they become more widespread, the financial burden on patients could lessen. The key is reducing the physical burden on patients, not just the financial one. B

The Future of GLP-1 Agonists in Metabolic Disease Treatment

Obesity and its associated metabolic disorders have become one of the most important public health challenges of the 21st century. The World Health Organization predicts that by 2035, nearly 1.9 billion individuals will be living with obesity, likely creating a future global economic burden exceeding $4 trillion. While lifestyle interventions are still essential, pharmacological solutions have gained increasing importance considering the complex, chronic, and relapsing nature of obesity. Among these, GLP-1 receptor agonists (GLP-1RAs) have emerged not only as treatments for type 2 diabetes but as highly effective agents for weight loss and broader metabolic regulation.

GLP-1 agonists are transforming obesity treatment

GLP-1 is a gut-derived hormone which helps control blood sugar and appetite. It increases insulin secretion, reduces glucagon levels, slows down how quickly food leaves the stomach, and sends satiety signals to the brain. GLP-1RAs mimic the body’s natural mechanisms to restrain caloric intake and improve glycemic control. Drugs such as semaglutide (Wegovy) and tirzepatide (Zepbound) have shown impressive weight loss results, from 15% to 22% in long-term studies. These drugs were initially used for type 2 diabetes, but now they are being used to help treat obesity as well. Recently, researchers have started to explore their potential in other diseases, such as cardiovascular disease, nonalcoholic steatohepatitis (NASH), and even neurodegenerative disorders such as Alzheimer’s disease. Their dual efficacy in weight reduction and metabolic improvement has proved that GLP-1RAs could improve overall metabolic health.

Safety concerns and the need for better treatment strategies

Even though GLP-1RAs are highly promising, they still have some limitations. Many people experience side effects like nausea, vomiting, and bloating. In rare cases, they can also cause pancreatitis or make diabetic eye problems worse. Another concern is the loss of muscle during fast weight loss, which can be risky, especially for older adults. Also, when people stop taking the medication, their weight often comes back, which shows the need for long-term treatment plans. Since most of these drugs are injections, it can be hard for some patients to keep using them. So the pharmaceutical companies are working on new types of GLP-1 therapies. These include multi-receptor agonists like retatrutide, which targets GLP-1, GIP, and glucagon, oral drugs like orforglipron and danuglipron, and long-acting injections such as MariTide by Amgen. Others, like Rivus Pharmaceuticals, are trying different approaches such as mitochondrial uncoupling to stimulate the metabolism without losing muscle. Some are even starting early research on gene-based treatments.

The rise of GLP-1 therapies in the pharmaceutical market

The global pharmaceutical market is reacting rapidly to the growing use of GLP-1 therapies. According to EvaluatePharma, semaglutide and tirzepatide will generate over $70 billion in total sales by 2025, making them the fastest-growing drug group in the world. Therefore, Eli Lilly and Novo Nordisk are expected to rise significantly in global prescription drug revenue rankings. But this trend is not only financial. It also reflects a bigger change in disease treatments. In the previous decade, cancer drugs were the main focus for many pharmaceutical companies. Now, incretin-based drugs like GLP-1RAs are becoming key tools for managing long-term diseases. These drugs are no longer just used for weight or blood sugar, and they are now being studied for heart problems, brain diseases, and more. As new research continues in areas like Alzheimer’s, heart failure, and liver disease, treating obesity is becoming part of a bigger picture that includes overall metabolic health.

Conclusion

GLP-1 receptor agonists represent a paradigm shift in how obesity and metabolic diseases are treated. By replicating natural processes in the body, they have become powerful and flexible tools for handling complex, interconnected health conditions. Still, there are important challenges like sustained efficacy, tolerability, and patient adherence. The future of metabolic treatment probably won’t depend on just a single drug, but on many new therapies that are based on what GLP-1RAs have started. They will reshape how we treat chronic diseases in general. B

The Evolution of Non-Opioid Painkillers

:

and the Future of Pain Management

Background: The Emergence of Non-Opioid Painkillerst

For decades, opioid analgesics have been a cornerstone in the management of moderate to severe pain, particularly in postoperative care, cancer treatment, and chronic pain management. Opioids are defined as compounds that bind to and activate opioid receptors in the brain and spinal cord to suppress pain perception. Common examples include morphine, fentanyl, oxycodone, hydrocodone, and tramadol.

While effective, the use of opioids comes with a high cost. Their pharmacological action not only reduces pain but also produces euphoria, which contributes to their high potential for addiction and abuse. In addition, opioids can lead to respiratory depression, constipation, nausea, and the development of tolerance, meaning higher doses are needed over time to achieve the same effect. These risks have culminated in what is now known as the opioid crisis, a public health emergency that has led to hundreds of thousands of overdose deaths particularly in North America and parts of Europe. According to the Centers for Disease Control and Prevention (CDC), over 100,000 Americans died from drug overdoses in a single year, with the majority involving opioids.

This alarming trend has highlighted the urgent need for painkillers that offer effective relief without the addictive potential or life-threatening side effects of opioids. As a result, pharmaceutical research has increasingly turned toward non-opioid analgesics as a safer alternative for managing both acute and chronic pain.

Definition and Types of Non-Opioid Painkillers

Non-opioid analgesics, unlike opioids, do not activate opioid receptors but rather act through various peripheral and central mechanisms to manage pain. They include nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, antidepressants (such as duloxetine), anticonvulsants (like gabapentin and pregabalin), and newer categories targeting specific neurological pathways. Recent developments have introduced highly specialized non-opioid analgesics targeting novel mechanisms, minimizing side effects, and significantly reducing dependency risks.

Unafra (Opiranserin VVZ-149): Dual-Target Non-Opioid Innovation from South Korea

Unafra is a promising non-opioid analgesic developed by Vivozon Inc., a South Korean biotechnology company. Its active compound, Opiranserin (VVZ-149), is a dual-acting molecule that simultaneously inhibits glycine transporter type 2 (GlyT2) and serotonin receptor subtype 5-HT2A. By targeting these two mechanisms, the drug effectively disrupts pain signaling at both spinal and cortical levels.

What makes Opiranserin notable is that it bypasses the opioid system entirely, significantly reducing the risk of addiction or overdose. In clinical trials, Unafra has shown strong efficacy in managing postoperative and neuropathic pain—comparable to that of conventional opioids. Patients receiving Opiranserin reported meaningful pain relief without experiencing common opioid-related side effects such as respiratory suppression, sedation, or nausea.

Unafra has recently completed PhaseIII clinical trials in both South Korea and the United States. Pending regulatory approval, it could soon be introduced into international markets, offering a new standard of care for pain management that prioritizes safety as well as efficacy.

Journavx (Suvegeprizine VX-548): Next-Gen Sodium Blocker from the United States

Journavx is another groundbreaking non-opioid analgesic currently in late-stage development. Developed by Vertex Pharmaceuticals in the United States, its active compound—Suvegeprizine (VX-548)—targets the voltage-gated sodium channel Nav1.8. This channel is predominantly expressed in peripheral sensory neurons responsible for transmitting pain signals.

By selectively blocking Nav1.8, VX-548 reduces the sensation of pain at its source without impacting the central nervous system. Thanks to its high specificity, the drug avoids the cognitive and respiratory side effects typical of opioids.

Clinical trials have yielded encouraging results. In PhaseII studies, Journavx demonstrated strong analgesic effects in patients undergoing bunionectomy and abdominoplasty procedures. The drug was well-tolerated, with a safety profile that makes it suitable for a broad range of patients, including those at high risk for opioid complications. PhaseIII trials are currently underway across North America and Europe, and the company is optimistic about seeking regulatory approval in the near future.

Future of Pain Management

The development of non-opioid analgesics like Unafra and Journavx marks a transformative moment in the field of pain medicine. As governments tighten restrictions on opioid prescribing and as public awareness of opioid dangers grows, the demand for safer alternatives continues to rise.

These novel treatments offer a glimpse into a future where pain can be effectively managed without the devastating social and medical consequences of opioid addiction. Their mechanisms—targeting glycine transport, serotonin receptors, or sodium channels—represent a more rational, receptor-specific approach to analgesia.

Nonetheless, there are hurdles ahead. High development costs, limited insurance coverage, and entrenched clinical practices favoring opioids may slow the adoption of these drugs. Furthermore, more long-term studies are needed to understand the effects of prolonged use. Collaborative efforts among researchers, policymakers, clinicians, and patient communities will be essential to ensure that non-opioid alternatives become accessible and widely accepted. In conclusion, while opioids will likely retain a role in certain medical scenarios, the future of pain management lies in innovative, safer therapies like Unafra and Journavx. These advancements not only address the shortcomings of past treatments but also pave the way for a new era of compassionate, responsible care. B

Development of AI and Pharmaceuticals

Journalist | Donghyeon Lee | eastlight@yonsei.ac.kr

Designer | In Jeong | jeong.in@yonsei.ac.kr

On October 9, 2024, The Royal Swedish Academy awarded the Nobel Prize in Chemistry to David Baker, Demis Hassabis, and John Jumper. AlphaFold 2, which awarded them the Nobel Prize in Chemistry, is a program that predicts the three-dimensional structure of a protein using only amino acid sequences. AlphaFold 2 drastically shortened the time required for protein structure studies and changed the paradigm of protein research, although it took many years to identify through experiments.

How AlphaFold 2 predicts protein structure

The multiple sequence alignment (MSA) algorithm is the fundamental principle of Alpha Fold 2. For the past few decades, biologists have identified and compiled proteins in humans, mice, cockroaches, and amoebas into a database. We already know the structure and amino acid sequences of about 200 million proteins on Earth. Even the same protein has slightly different amino acid sequences depending on the species. The more closely related organisms, the more similar the sequences. The MSA algorithm lists things that are similar to a given amino acid sequence in order of similarity. Then, we can find co-evolution pairs that always change together when amino acid sequences vary from species to species. When a protein is made from that amino acid sequence, the co-evolution pairs are interpreted as points that adhere to each other on a three-dimensional structure.

Based on the co-evolution pair, it is easy to predict the structure of a previously unknown protien by ‘folding’. This is the core idea of the MSA algorithm. AI is superior to humans in its ability to detect regularity in bundles of seemingly random data. AlphaFold uses AI system to quickly find co-evolution pairs in tens of thousands of amino acid sequences. It also uses the rule that co-evolution pairs are attached to each other in a three-dimensional space to find out the structure of the entire protein.

Medicaid Co-payment System Shifts to Proportional Rate

However, this algorithm soon became the limitation of AlphaFold 2. If there are only a few similar protein sequences in the existing protein structure database, not many co-covalent pairs can be found. As a result, while the structure of a protein common to various organisms can be predicted accurately, the structure of a protein that can only be found in humans and mammals is relatively less accurate. Google developed Alpha Fold 3 on May 8, 2024, to address this issue.

2024 Nobel Prize

AlphaFold 3

Alpha Fold 3 overcomes the limitations of the existing Alpha Fold by using a newly applied diffusion model. The diffusion model predicts the structure of chemicals by predicting the spatial arrangement pattern between atoms. It doesn’t matter if there are few similar proteins in the protein structure database. A more delicate structure can be known by using the diffusion model by immediately obtaining the coordinates of each atom that makes up the protein.

It doesn’t even matter if it’s a molecule, not a protein. Therefore, RoseTTAFold, a competitor of AlphaFold, has been applying the diffusion model since 2022. Alpha Fold 3’s strength is that it can predict not only protein-

Process of AlphaFold 3

An orange arrow indicates the process of entering information. When an amino acid sequence, ligand, DNA information, etc. of a protein are entered, similar protein structure, protein genetic information data, and linkage data (conformer) of atoms in the protein are searched. The ‘informer’ stage integrates the searched information.

The process of constructing a protein structure is actually described by the blue arrow. The overall protein structure is drawn using a structure module, an MSA module, and a pair of formers. The green arrow is the final process of constructing a protein structure using a diffusion model.

Future of Alpha Fold 3

Having overcome its’ weaknesses, the future is bright for Alpha Fold 3. The market is moving. According to the report titled “The advent of the new AI normal era and the development of new drugs” released by the Korea Pharmaceutical and Biotechnology Industry Association in July 2023, the global AI new drug development market, which was worth 609.8 million dollars in 2022, is expected to grow by an annual average of 45.7 percent every year to reach 4.035 billion dollars by 2027. B

Prescription with Precision

Nano Drug-Delivery Systems Revolutionizing Targeted Therapy

Journalist | Junseo Park | junseopark@yonsei.ac.kr

Designer | Seonu Hong | hsw5020@yonsei.ac.kr

Be precise. A lack of precision is dangerous when the margin of error is small.

- Donald Rumsfeld, the former US Secretary of Defense. Many would agree when I say that the margin of error is smallest when it comes to defending the vessels that hold our souls. Medicine holds this exact purpose in modern society. None do it like Nano-based Drug Delivery Systems (NDDS), which take on a pivotal role in enhancing precision and efficacy of targeted therapies.

Targeted Therapies

Before discussing NDDS, we must fully understand what targeted therapies are. They are medical treatments that use drugs and substances to identify and attack disease-causing cells (prominent e.g. cancer) without harming normal healthy cells. They hold significance in the sense that they overcome the traditional challenge of drugs’ negative influence toward all cells in the range of influence (e.g. chemotherapy). Targeted therapy avoids this by specifically interfering with molecular targets involved in harmful diseases. For example, monoclonal antibodies, by binding to specific antigens on the surface of diseased cells, decrease growth signals related to cancer cell proliferation and increase immune responses.

Despite its benefits, there are visible drawbacks to targeted therapy that make it a risk in some cases. The said “risks” are as follows:

- Drug resistance: Cancer cells can develop mutations that render targeted therapies ineffective over time.

- Off -target toxicity: Despite specificity, targeted therapies may affect normal cells.

- Limitation: Targeted therapies have a limited ability to cross biological barriers (e.g. the blood-brain barrier).

- Poor solubility and stability: Present in only some drugs, but heavily affect efficacy.

Nano-based Drug Delivery Systems (NDDS)

Nanocarriers, which are often 1-1000 nanometers in size, transport drugs directly to specific cells / tissues. This specificity, along with some NDDS’ abilities to carry out a controlled release of drugs, notably increases targeting capabilities (both passive and active, mentioned in later paragraphs). Additionally, NDDS aids in increasing drug solubility, stability, bioavailability (including ability to bypass biological barriers), and therapeutic efficacy while reducing side effects. This results in biocompatibility with the biological systems that ingested the chemical compounds. Lastly, its small size may enhance biodegradability.

Some types of NDDS are as follows:

· Liposomes are spherical vesicles composed of one or more phospholipid bilayers surrounding an aqueous core. This amphiphilic architecture enables the encapsulation of both hydrophilic and hydrophobic drugs, making liposomes highly versatile carriers in nanodrug delivery systems (NDDS). In addition to their structural adaptability, liposomes exhibit enhanced biocompatibility due to their ability to merge with cellular membranes. They also increase bioavailability by protecting drug molecules from enzymatic degradation and facilitating site-specific delivery, rather than releasing drugs systemically during transport.

· Metallic nanoparticles, such as those made from gold, silver, or iron oxide, are valued for their unique physical and chemical properties. Their large surface-area-to-volume ratio enables high drug-loading capacity, and their surfaces can be functionalized with targeting ligands for selective delivery. Some also exhibit antimicrobial effects or serve as imaging contrast agents. However, issues like biocompatibility and potential toxicity must be carefully addressed to ensure safe use.

· Dendrimers are highly symmetrical, branched nanostructures with internal cavities and modifiable surface groups for drug loading and targeting. They enhance solubility, stability, and bioavailability while lowering toxicity, and support high loading efficiency with controlled, stimulus-responsive release—the controlled release of a substance, like a drug or a bioactive cargo, from a carrier material in response to a specific external or internal stimulus. Their biological compatibility makes them strong candidates for precise, targeted therapies.

NDDS in Targeted Therapy

Nano-drug delivery systems dramatically improve the precision and effectiveness of targeted therapy by enhancing drug solubility, stability, and site-specific delivery. They reduce systemic toxicity and side effects by concentrating therapeutic agents at the disease site while limiting exposure elsewhere. NDDS also overcome biological barriers, such as the blood–brain barrier and the gastrointestinal barrier, expanding the range of treatable conditions.

A key strength of NDDS lies in their ability to minimize off-target toxicity through two mechanisms: passive targeting and active targeting. Passive targeting leverages the enhanced permeability and retention (EPR) effect, where leaky vasculature and poor drainage in tumor tissues allow nanoparticles to accumulate more readily than in normal tissue. Active targeting builds on this by modifying nanoparticle surfaces with ligands—such as antibodies or peptides— that bind specifically to overexpressed receptors on diseased cells, enabling precise cellular uptake. Together, these approaches improve drug localization, reduce dosage requirements, and increase therapeutic outcomes.

Nano-drug delivery systems are transforming modern medicine by improving drug targeting, reducing systemic side effects, and enhancing therapeutic outcomes across a variety of diseases. In oncology, NDDS enable tumor-specific drug delivery, minimizing harm to healthy tissues by concentrating treatment at the disease site. For neurological disorders, they offer the unique advantage of crossing the blood–brain barrier, a critical feature for treating conditions like Alzheimer’s and glioblastoma. In infectious diseases, NDDS enhance drug delivery to intracellular pathogens such as HIV and tuberculosis, improving efficacy. Similarly, in autoimmune and inflammatory diseases, they can be tailored to target inflamed tissues while sparing healthy cells, reducing side effects and preserving immune balance.

Beyond disease targeting, NDDS also improve drug solubility, reduce required dosages, extend stability and shelf life, and support multifunctional applications such as combined imaging and therapy. However, to realize their full potential, challenges such as technical complexity, high manufacturing costs, and unresolved safety concerns—including long-term biocompatibility and biodegradation—must be overcome. Ongoing research is exploring personalized nanomedicine, stimuli-responsive systems, theranostics, and AI-driven design to address these hurdles. With continued innovation, NDDS are poised to redefine disease treatment at a fundamental level.

Ultimately, NDDS mark a pivotal leap forward in targeted therapy—and in the complex systems of the human body, precision is not just valuable, it’s essential. B

Drug Approval Process: A Comparative Analysis of FDA and MFDS

Designer

mid rapid advancements in pharmaceuticals, drug approval plays a crucial role in safeguarding public health. In South Korea, this process is overseen by the Ministry of Food and Drug Safety (MFDS), while in the United States, the Food and Drug Administration (FDA) serves a similar function. Both agencies are committed to assessing the safety, efficacy, and quality of pharmaceuticals before they reach the market. However, their processes differ in scope, requirements, and timelines, posing challenges for pharmaceutical companies aiming for global expansion. This article provides an overview of the drug approval processes in South Korea and the United States, highlights their key differences, and explores potential insights for improving Korea’s regulatory framework.

Key Stages of Drug Approval for MFDS

The Ministry of Food and Drug Safety of South Korea undergoes the following steps to ensure that only safe and effective drugs are available to the public.

1 . Preclinical Research

Prior to human trials, potential drugs undergo laboratory and animal studies to evaluate their safety and biological activity.

2. Investigational New Drug (IND) Application

Before initiating clinical trials, sponsors must submit an IND application to the MFDS, detailing preclinical data and proposed study protocols. An IND application refers to the process of undergoing official review and approval from regulatory authorities to conduct clinical trials using a specific pharmaceutical product on human subjects.

3. Clinical Trials

Conducted in three phases, these trials assess the drug’s safety, dosage, efficacy, and side effects in human subjects.

4. New Drug Application (NDA) Submission

Upon successful clinical trials, an NDA is submitted, providing comprehensive data on the drug’s safety and effectiveness for MFDS evaluation.

5. MFDS Review and Approval

The MFDS thoroughly reviews the NDA, consulting with the Central Pharmaceutical Affairs Advisory Committee (CPAC) if necessary, to decide on approval.

6. Post-Marketing Surveillance

After market approval, the MFDS monitors the drug’s safety and efficacy in the general population, ensuring ongoing compliance with regulatory standards.

Key Stages of Drug Approval for FDA

1 . Preclinical Research

In this stage, potential drugs are evaluated through laboratory experiments and animal studies to assess their fundamental safety and biological effects.

2. Clinical Research

Human trials are conducted to determine the drug’s effectiveness, optimal dosage, and potential side effects.

3. FDA Review

Regulatory experts at the FDA conduct a comprehensive assessment of all submitted data to determine whether the drug meets the necessary safety and efficacy standards for approval.

4. FDA Post-Market Safety Monitoring

Once a drug is available to the public, the FDA continuously tracks its safety profile, monitoring for any previously undetected adverse effects.

Key Differences Between FDA and MFDS

While both the FDA and MFDS share the common goal of ensuring drug safety and efficacy, their regulatory frameworks differ in several key aspects.

FDA MFDS

Standard review: 10-12 months

Approval Timeline

Clinical Trial Requirements

Expedited Approval Programs

Post-Market Surveillance

Priority review: 6 months

Requires multiregional clinical trials. Emphasizes diverse population data.

Offers Fast Track, Breakthrough Therapy, Accelerated Approval, and other expedited pathways

Uses the FDA Adverse Event Reporting System

High-risk drugs may require REMS (Risk Evaluation and Mitigation Strategies)

General review 6-10 months

Focuses on Korean population data May require additional domestic trials even if global data is available

Provides Priority Review and Expedited Review, but with fewer options than the FDA

Operates a Reexamination System (typically 6 years) to continuously assess safety and efficacy

International Recognition

Considered the global standard Accepted in many countries without additional approval

Highly trusted but may require additional country-specific approvals for global expansion

These differences highlight the unique regulatory challenges for pharmaceutical companies aiming for global expansion. By adopting best practices from both agencies, South Korea’s MFDS could refine its approval system, enhancing efficiency while maintaining rigorous safety standards.

A Call to Action

For pharmaceutical companies pursuing international growth, understanding the differences between the FDA and MFDS is essential. Designing clinical trials to comply with both FDA and MFDS regulations can help shorten approval timelines. Additionally, utilizing expedited approval programs can accelerate the process of bringing new drugs to market. Given the emphasis on post-market surveillance, companies must also establish strong pharmacovigilance systems to ensure long-term safety. Additionally, enhancing regulatory harmonization and expanding the acceptance of multiregional clinical trials could improve South Korea’s competitiveness in the global market. By adopting a strategic, globally-minded approach, pharmaceutical companies can navigate regulatory challenges more effectively and bring innovative treatments to patients faster. B

Public Perception of Over-the-Counter Drug Sales Outside Pharmacies in South Korea

Journalist | Hyemin Park | aeternamarbar@naver.com

Designer | Yein Oh | yeinoh@yonsei.ac.kr

The accessibility of over-the-counter (OTC) drugs varies significantly across countries. While some nations allow OTC drugs to be sold in supermarkets and convenience stores, others restrict their sales to pharmacies to ensure professional oversight. This column explores public perception toward OTC drug sales outside pharmacies, examining both the benefits and concerns associated with such policies.

Support for Expanding Non-Pharmacy Sales: Benefits of Selling OTC Drugs Outside Pharmacies

1. Increased Accessibility

Not only allowing over-the-counter (OTC) drugs increases convenience for consumers who particularly those living in rural or underserved areas where pharmacies may be scarce, but also, in emergencies, such as late-night fevers, headaches, or allergic reactions, people can quickly obtain essential medications from nearby convenience stores or supermarkets rather than waiting for a pharmacy to open.

2. Reduced Healthcare Costs

When OTC drugs are easily available, people can self-treat minor ailments (e.g., colds, mild pain, allergies) instead of visiting a doctor, reducing unnecessary healthcare expenditures. This also helps healthcare systems by alleviating the burden on hospitals and clinics, allowing medical professionals to focus on more serious cases.

3. Consumer Independence

Readily available OTC medications empower individuals to take control of their own health without relying on prescriptions for common conditions. This is possible because with the rise of online health resources has enabled people to educate themselves about minor illnesses and appropriate medications. This independence is particularly valuable for frequent travelers, night-shift workers, and those who may not have easy access to a healthcare professional at all times.

Concerns Over Non-Pharmacy OTC Sales

1. Misuse and Overdose Risks

Without pharmacist guidance, individuals may overuse medications or take them incorrectly, leading to health risks. Furthermore, some drugs, like painkillers (e.g., ibuprofen, acetaminophen), can cause liver damage or kidney failure if taken in excess.

Cough syrups and sleep aids containing sedatives can be misused, potentially leading to addiction or dependency. Children and teenagers, who don’t have enough knowledge and judgement skill, in particular, may misuse OTC drugs for recreational purposes if they are easily accessible.

2. Lack of Professional Advice

Pharmacists provide valuable guidance on dosage, interactions with other medications, and potential side effects. Without professional supervision, people may misdiagnose their symptoms and choose inappropriate medication. For example:

A persistent cough could be a symptom of a more serious condition (like pneumonia), but a person might just buy cough syrup instead of seeking medical help.

Someone taking multiple medications might not be aware of dangerous drug interactions (e.g., mixing NSAIDs with blood thinners).

3. Quality and Counterfeit Issues

In countries with weaker regulations, counterfeit or expired drugs might circulate in supermarkets or online platforms.

Unlike pharmacies, which are legally required to store medicines under specific conditions, supermarkets or convenience stores might improperly store drugs, reducing their effectiveness. Online sales of OTC drugs pose an additional risk, as fraudulent sellers may distribute unsafe or unapproved medications without proper regulation.

In fact, the World Health Organization (WHO) has reported that in some low- and middle-income countries (LMICs), especially in parts of Africa, Asia, and Latin America, up to 10% of medicines in circulation are counterfeit, leading to ineffective or harmful treatments due to weak regulatory frameworks and limited enforcement capacity.

The key challenge for OTC drugs is to find a balanced approach that ensures convenience without compromising public safety. Some countries address this by limiting non-pharmacy sales to only certain medications (e.g., paracetamol in supermarkets), while others maintain strict pharmacy-only policies for better regulation.

OTC Drug Sales in South Korea

In South Korea, the sale of OTC drugs outside pharmacies is a highly debated topic. The government has implemented strict regulations to ensure medication safety, but there has been increasing demand for greater accessibility. Currently, only a limited selection of OTC drugs, known as safety-approved OTC drugs, can be sold in convenience stores. These include:

• Acetaminophen-based pain relievers (e.g., Tylenol)

• Digestive medicines (e.g., Smecta)

• Cold medications (e.g., Panpyrin-T)

However, stronger medications and prescription drugs remain available exclusively in pharmacies. The restriction aims to prevent misuse, ensure proper guidance from pharmacists, and maintain high safety standards.

Public Perception in South Korea

Public opinion in South Korea regarding the sale of OTC drugs outside pharmacies is positive. However, the reason why the government and experts are extremely reluctant to sell OTC drugs outside of pharmacies in South Korea is as follows; a combination of historical, and regulatory factors. Unlike countries where consumer autonomy in self-medication is prioritized, South Korea places greater emphasis on professional oversight and public health safety. Several key reasons explain why South Korea has developed a different stance compared to other nations:

1.HistoricalInfluenceofaStrongPharmacySystem

South Korea has historically maintained a pharmacy-centered approach to medication distribution. In the past, there was an incident caused by unregulated drug sales-in 1973 pharmaceutical products were contaminated with barium carbonate which is a toxic substance-leading to misuse and counterfeit drugs and subsequently reinforcing strict governmental control over where and how medications could be sold. Accordingly, the Pharmaceutical Affairs Act, implemented to regulate the sale of medications, continues to restrict non-pharmacy OTC drug sales, ensuring that pharmacists play a gatekeeping role in drug distribution.

2.InfluenceoftheNationalHealthInsuranceSystem

South Korea has a highly efficient and accessible national health insurance system, which allows citizens to visit doctors and pharmacies at a low cost. Since medical consultations are affordable, there is less pressure for people to self-medicate compared to countries with expensive healthcare systems. Plus, pharmacists are seen as healthcare professionals rather than just retailers, making South Koreans more inclined to seek pharmacist advice rather than rely on self-diagnosis.

Conclusion

Public perception of OTC drug sales outside pharmacies reflects a balance between accessibility and safety. In South Korea, the debate over OTC drug sales outside pharmacies continues. While some consumers advocate for greater accessibility, healthcare professionals and policymakers emphasize the importance of safety and proper drug use. Compared to countries with more relaxed regulations, South Korea maintains a stricter approach, but the growing demand for convenience suggests that future policy changes may be considered.

As the global landscape of healthcare evolves, South Korea will need to find a balance between accessibility and public health safety, ensuring that any expansion in OTC drug availability does not compromise medical oversight and consumer well-being. B

Pharmaceutical Patent Protection vs. The Right to Life and Health

l Dakyung Baik l dakyungbaik@gmail.com

Designer l Minseo Choi l mminseo@yonsei.ac.kr

The protection of pharmaceutical patents and the right to life and health are two fundamental -yet often conflicting - principles in global healthcare policy. Pharmaceutical patents grant exclusive rights to drug manufacturers, allowing them to control production and pricing. While patents incentivize innovation by ensuring financial returns on research and development (R&D), they also create monopolies that can drive up drug prices, limiting access to life-saving medicines, particularly in low-income countries. On the other hand, the right to life and health, enshrined in international human rights frameworks, mandates that individuals have access to essential medical treatments. This conflict presents a critical ethical and legal challenge: how to balance the need for innovation with the imperative of equitable access to healthcare.

The Role and Importance of Pharmaceutical Patents

Pharmaceutical companies invest substantial resources in R&D, clinical trials, and regulatory approvals before bringing a drug to market. The patent system is designed to reward such investments by granting exclusivity for approximately 20 years, enabling firms to recoup costs and fund future innovations. Without patents, companies may lack incentives to invest in developing new drugs, particularly for diseases that require complex research and extended testing periods.

Moreover, patents play a role in fostering competition and medical advancement. The potential for high financial returns drives companies to create innovative drugs that can treat or cure previously untreatable conditions. The discovery of breakthrough medications for diseases such as cancer, diabetes, and rare genetic disorders has been largely facilitated by the patent system. However, while patents encourage innovation, they also pose challenges regarding the affordability and accessibility of essential medicines.

The Right to Life and Health: The Issue of Accessibility

The right to life and health, recognized by the Universal Declaration of Human Rights (Article 25) and the International Covenant on Economic, Social and Cultural Rights (Article 12), highlights the obligation of states to ensure access to necessary healthcare services, including essential medicines. High drug prices due to patent monopolies can severely limit this access, particularly in low-income and developing countries.

A notable example is the case of HIV/AIDS treatment in the 1990s and early 2000s. Antiretroviral drugs were patented and sold at high prices, making them inaccessible to millions in sub-Saharan Africa and other regions heavily affected by the epidemic. In response, several countries utilized legal mechanisms such as compulsory licensing to allow the production of generic versions at a fraction of the original cost, thereby saving millions of lives. This case highlights the potential harm of strict patent enforcement on global health outcomes.

Current Policies and Ongoing Debate

To mitigate the negative effects of pharmaceutical patents on access to medicines, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, overseen by the World Trade Organization (WTO), includes provisions for compulsory licensing. This mechanism allows governments to authorize the production of a patented drug without the consent of the patent holder under certain conditions, such as public health emergencies. Countries like India, Brazil, and Thailand have utilized compulsory licenses to produce affordable generics for diseases such as HIV/AIDS, cancer, and hepatitis C.

However, pharmaceutical companies argue that compulsory licensing undermines their ability to recover R&D costs and discourages future investment in new drug development. The industry contends that alternative solutions, such as tiered pricing strategies (whereby drugs are sold at different prices based on a country’s economic status), should be prioritized over compulsory licensing. This debate underscores the ongoing struggle between protecting intellectual property rights and ensuring the right to health.

Recent global developments indicate a shift toward addressing these conflicts through international collaboration and policy reform. The COVID-19 pandemic highlighted the urgency of equitable drug distribution, with countries facing disparities in vaccine and antiviral treatment access. The push for a temporary waiver on COVID-19 vaccine patents under the TRIPS Agreement was supported by many developing nations and humanitarian organizations, emphasizing the need for flexible intellectual property regulations during public health crises.

While pharmaceutical companies resisted the waiver, citing concerns about innovation disincentives, some agreed to technology-sharing initiatives to facilitate global vaccine production. This development illustrates the potential for a middle-ground approach, where patent protections exist alongside global health imperatives.

Finding the Delicate Balance Between Innovation and Accessibility

The conflict between pharmaceutical patent protection and the right to life and health is a complex issue requiring a delicate balance. While patents drive medical innovation and economic investment in new drugs, they also create barriers to affordable healthcare access. Policies such as compulsory licensing, stricter regulations against evergreening, and increased public funding for drug research can help reconcile these competing interests. Furthermore, international cooperation, as seen in the response to COVID-19, demonstrates the potential for more equitable solutions. Moving forward, governments, pharmaceutical companies, and global health organizations must collaborate to ensure that medical advancements benefit all, rather than being restricted by profit-driven exclusivity. The ultimate goal should be a healthcare system where innovation thrives without compromising human lives and dignity. B

Pharmacists’ Strategies in the Era of the Fourth Industrial Revolution

In modern society, where the Fourth Industrial Revolution is rapidly transforming industries and professions, one of the most frequently asked questions among pharmacists is, “Is the future of pharmacists promising?”

The accelerating advancement of artificial intelligence(AI), machine learning, and automation technologies has sparked both optimism and concern within the pharmacy community. Many predict that the roles traditionally performed by pharmacists will diminish, leading to a gradual decline in their professional status. This anxiety stems from the fear that machines and software might replace human pharmacists, making their skills redundant. On the other hand, a growing number of experts argue that pharmacists will remain essential and irreplaceable, provided that they adapt and redefine their roles in response to technological change.

The Importance of Defining the Role of Pharmacists

The primary reason for these opposing perspectives lies in how the role of a pharmacist is conceptualized and defined. If the responsibilities of pharmacists are narrowly confined to simple, repetitive tasks such as counting pills, dispensing medications, or providing standard medication counseling, then the likelihood of being replaced by AI systems is indeed high. In such scenarios, machines, which can perform these tasks faster and more accurately, would naturally take over. However, if pharmacists are seen as professionals who perform high-level cognitive and emotional functions — such as critical thinking, clinical decision-making, empathy-driven patient counseling, and complex therapy management — then the situation changes drastically. These are areas where AI currently struggles to match human capabilities. While AI excels in processing massive amounts of data and identifying patterns, it lacks the nuanced understanding of human emotions, ethical considerations, and individualized patient care that human pharmacists provide. Therefore, the way we define the core competencies of pharmacists will determine whether they are at risk of being replaced or whether they will thrive in the future healthcare landscape.

The Need for Evolution: Expanding Pharmacists’ Roles

Historically, many people have perceived pharmacists primarily as dispensers of medications and providers of brief medication advice. This limited view has persisted despite the fact that pharmacists receive extensive education and training in areas such as pharmacology, therapeutics, patient care, and healthcare systems. Unfortunately, the routine nature of dispensing and the operational focus of many pharmacies have often overshadowed pharmacists’ more complex skills, leading to an underappreciation of their broader clinical capabilities. As the Fourth Industrial Revolution advances, routine tasks like dispensing, inventory management, and basic counseling are becoming increasingly susceptible to automation. Robots can now fill prescriptions with remarkable speed and accuracy. AI chatbots can provide standardized medication information to patients. In this changing environment, pharmacists must reposition themselves not just as medication suppliers, but as essential healthcare providers who use technology to enhance, not replace, their clinical judgment and human touch.

Future pharmacists should leverage AI and other emerging technologies to assist in analyzing vast and complex datasets, such as patient health records, genetic profiles, and drug interaction databases. By doing so, they can design personalized medication plans tailored to each patient’s unique biological and lifestyle factors. Furthermore, pharmacists can take on more active roles in interdisciplinary healthcare teams, collaborating closely with physicians, nurses, and other healthcare professionals to develop comprehensive care plans. In this capacity, pharmacists’ ability to empathize, educate, and motivate patients becomes even more critical, as they help patients adhere to complex treatment regimens and navigate their healthcare journeys.

Conclusion

Ultimately, pharmacists must establish themselves as professional, systematic medication experts who engage directly and meaningfully with patients. They should not view technology as a threat, but rather as a valuable tool that can amplify their effectiveness and broaden their impact on patient health. By actively integrating cutting-edge technologies to improve efficiency and precision, pharmacists can transition from performing isolated, repetitive tasks to participating in collaborative, team-based healthcare delivery. This shift will enable them to provide higher-quality pharmaceutical services that address the complex and evolving needs of modern patients.

Pharmacists should not fear the Fourth Industrial Revolution. Technological advancement is inevitable, but it also presents immense opportunities for growth and innovation. By embracing AI and automation for routine functions and simultaneously focusing on developing more advanced, patient-centered roles, pharmacists can reinforce their indispensable position within the healthcare system. Their expertise in medication management, combined with human qualities like empathy, ethical reasoning, and clinical insight, ensures that pharmacists will continue to be critical contributors to improving patient outcomes in an increasingly digital world. The future of pharmacy is not about resisting change, but about leading it. By redefining their roles, expanding their skill sets, and embracing technology as an ally, pharmacists can secure a thriving and meaningful future in the healthcare landscape of tomorrow. B

Policy changes affecting pharmacies from 2025

2025 Brings Significant Regulatory Changes to the Pharmaceutical Industry

The year 2025 marks a period of significant regulatory changes in the pharmaceutical industry, with new policies impacting pharmacy management, operations, and public health services. In the first half of the year, the sale of customized health functional foods in smaller, personalized portions will officially begin, introducing a new service to meet diverse consumer health needs. In the latter half of the year, the simplification of indemnity insurance claims will extend to pharmacies, streamlining the process for patients. Additionally, the government will unify the operation of public late-night pharmacies, and for the first time in 17 years, the co-payment system for Medicaid patients will shift from a fixed amount to a proportional rate. These changes are expected to have a direct impact on pharmacy management and pharmacists’ responsibilities.

Full-scale Implementation of Customized Health Functional Food Dispensing

Starting in January 2025, the customized health functional food dispensing business will be fully implemented in South Korea. This initiative allows consumers to purchase health functional foods in tailored portions based on their specific needs, rather than in standardized packaging.

The new system enables the division of health functional foods into customized portions based on dosage, form, and consumption cycle. Consumers will no longer need to purchase a full month’s supply at once but can receive pre-portioned products in accordance with their daily intake needs. This also facilitates the creation of personalized health packages by combining multiple supplements, allowing for small-scale production of diverse product assortments. The Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) are spearheading this initiative to enhance consumer convenience, improve accessibility, and prevent adverse effects caused by excessive intake.

To ensure the safety and reliability of this system, the government has established strict standards and guidelines. Businesses intending to operate in this sector must obtain approval from the MFDS and comply with strict hygiene and quality control standards during the dispensing process. The repackaged health functional foods must be individually wrapped and clearly labeled with essential information, including ingredients, repackaging date, expiration date, and usage instructions. Additionally, an electronic tracking system will be implemented to monitor and oversee the distribution process in real-time.

The initiative is expected to not only reduce consumers’ financial burden but also offer companies a new business model, revitalizing the market. Consumers will have the flexibility to select only the ingredients they need, minimizing unnecessary costs while also reducing risks associated with overconsumption. Companies, in turn, can enhance their competitiveness by catering to diverse consumer demands through personalized services, positioning customized dispensing as a new growth driver.

Experts anticipate that this initiative will mark a paradigm shift in healthcare services. The integration of artificial intelligence (AI) and big data with personalized health management platforms could further amplify its impact. However, challenges remain in the early stages, including regulatory compliance, consumer awareness, and quality control. If the government and industry collaborate to establish a safe and trustworthy environment, 2025 could be remembered as the inaugural year of the personalized health functional food era. This policy initiative is regarded as a strategic move by the government to expand market diversity and enhance consumer health management efficiency.

Medicaid Co-payment System Shifts to Proportional Rate

The Ministry of Health and Welfare has announced a reform of the Medicaid co-payment system, shifting from a fixed amount to a proportional rate, which is expected to impact pharmacies as well. The Medicaid program, designed to alleviate medical expenses for low-income individuals, has maintained a fixed co-payment system for 17 years, leading to concerns over excessive utilization of medical services and increased financial strain on the healthcare system. To address these issues, the government has decided to transition to a proportional co-payment model to improve efficiency and ensure financial sustainability.

Under the current system, Medicaid Type 1 recipients pay a fixed amount: KRW 1,000 for clinic visits, KRW 1,500 for hospital and general hospital visits, KRW 2,000 for tertiary hospital visits, and KRW 500 for pharmacy prescriptions. However, starting in 2025, these patients will instead pay a percentage of their medical expenses: 4% for clinic visits, 6% for hospital and general hospital visits, and 8% for tertiary hospital visits. The fixed co-payment system will still apply for medical expenses under KRW 25,000, and the maximum pharmacy co-payment will be capped at KRW 5,000.

The government expects this change to raise cost awareness among Medicaid recipients and curb unnecessary medical visits, often referred to as “medical shopping.” However, resistance from patients is anticipated, as the pharmacy co-payment, previously KRW 500, may increase up to KRW 5,000. Following the announcement, civic groups have continued to demand the repeal of the reform, suggesting ongoing debate on the issue.

Government Unifies Operation of Public Late-night Pharmacies

Public late-night pharmacies play a crucial role in ensuring medication accessibility during late hours and holidays while providing professional medication counseling. Previously operated under both local and central government oversight, these pharmacies will be unified under government management starting in 2025, with a total of 220 locations nationwide.

Under the new system, financial support for these pharmacies will be evenly split between the central government and local governments. Additionally, the hourly subsidy for pharmacists, which previously varied by region, will be standardized at KRW 40,000 per hour. Although standard operating hours will generally be from 10 PM to 1 AM, variations may apply depending on regional circumstances.

This unification is expected to enhance the systematic operation of public late-night pharmacies and improve public access to medication. However, experts emphasize that further efforts are needed to ensure the sustainability and expansion of the program. Effective promotion and the recruitment of additional participating pharmacies will be necessary to fully realize the intended benefits of the initiative. In particular, support for pharmacy establishments in remote areas such as islands and mountainous regions is essential to achieving the program’s ultimate goal of improving medication accessibility.

The year 2025 is poised to bring transformative changes to pharmacy operations, elevating the professional and public service roles of pharmacists. Pharmacies are evolving beyond mere dispensaries into comprehensive healthcare service platforms, playing a crucial role in public health. These regulatory changes will demand new expertise from pharmacists while also providing opportunities to engage more closely with the public. As the industry adapts, pharmacies are expected to establish themselves as key pillars in safeguarding public health, marking 2025 as a pivotal year for the profession. B

Prices and Accessibility of Korean Generic Drugs

What are Generic Drugs?

Generic drugs are copy drugs released after the patent of the original drug expires. They have the same efficacy and safety as the original drug while being biologically equivalent to the original drug. The most important roles of generic drugs are to reduce prices and improve the accessibility of drugs.

When a new drug is developed, it monopolizes the market during the term of protection with a high price. However, after the term of patent protection on the drug expires, many pharmaceutical companies produce bioequivalent copy drugs and sell them at relatively low prices. This allows patients to obtain the same therapeutic effects as when taking the original drug while reducing the financial burden of drug costs. In this way, the entry of generic drugs into the market plays a pivotal role in securing medical accessibility for people who have low-income or those who have difficulty applying for insurance.

It also plays a role in significantly reducing the government’s medical expenses by lowering the prices of drugs covered by insurance. In fact, there is a case in the United States where the positive effects of generic drugs are evident. The United States had to reduce its drug spending because drug costs had increased faster than the economic growth over the past several decades. As part of their strategy, they explored the generic drug market, and consequently, the U.S. healthcare system was able to save $1 trillion as the prescription share of generic drugs increased from 57% in 2004 to 86% in 2013. However, there are some countries where generic drugs do not perform their original role properly, and one of them is South Korea.

Challenges in Generic-pricing in Korea

South Korea introduced a policy that regulates the price of original drugs whose patents have expired and generic drugs to 53.55% of the first price of original drugs after one year of launch. However, despite implementing this policy for 10 years, it failed to induce pharmaceutical companies to sell drugs at lower prices. In addition, since patients pay the same amount of money regardless of which drug they use under the Korean health insurance, there is a lack of interest in which drugs they choose to use. That is, there is a lack of a mechanism for voluntarily price-reducing. Generic drugs are generally 30-50% cheaper than original drugs, but in Korea, generic drugs are much more expensive, and in some cases, Korea’s generic drugs even surpass the prices of original drugs. When comparing the generic drug prices in Korea to 15 foreign countries, the prices of original drugs were similar, but the prices of generic drugs in Korea were generally higher than those in other countries. Unlike other countries, generic drug prices are formed at a similar level to those of original drugs, or there is little difference between them, and there are limits to the impact of the launch period, market share, and number of competing products of generic drugs on the price level. The average price of generic drugs in foreign countries is 41-54% of the price of generic drugs launched in Korea. In particular, despite the fact that Germany and the UK do not directly regulate drug prices, the use of generics exceeds 80%, while the sales share is only around 35% in both Germany and the UK, indicating that the use of generics is high, and the prices are greatly reduced.

Solutions

In comparison, the price of domestic generic drugs remains high at 78.75% of the launch price 10 years after the entry point. The reason why generic drug prices are highly calculated is because the use of relatively expensive first-generation generic drugs is high. Among buyers, expensive products tend to be preferred, and accordingly, expensive drugs account for around 80% of the use in the pharmaceutical market.

There are various problems that can arise from this phenomenon. For individuals, the financial burden that patients feel when purchasing drugs increases. Even after the patent period has expired, they must continue to purchase drugs at high prices, and this problem is a great burden, especially for patients with chronic diseases who continuously need drugs.

It also causes great losses at the national level. If the government continues to pursue policies to lower the price of generic drugs, but prices do not actually decrease, trust in the government’s policies will decline. In addition, in the field of medical policy or insurance, because expensive drugs must be used, health insurance financial expenditures are not reduced, and social costs are lost.

And for pharmaceutical companies, producing generic drugs at high prices can earn high income by producing and selling only copy drugs without necessarily developing new drugs. Thus, their will to develop new drugs may disappear. These can become obstacles to the development of pharmaceuticals in the future, so continuous efforts to resolve them with interest are necessary.

The government is regularly lowering the prices of generic drugs through domestic and international generic drug price post-management systems (negotiations linking the amount of use and drug price, actual transaction price reduction, advance reduction when the scope of use is expanded, drug price reevaluation, etc.). In this way, the government’s continuous generic drug price regulation and policy supplementations are necessary. Individuals should discard their prejudices about generic drugs and choose drugs after fully understanding them, and in order to do so, a process of correcting the public’s perception of generic drugs is necessary. In this way, when the country, individuals, and companies all work together, there will be synergy in solving the problem. B

CHALLENGES IN DEVELOPING DRUGS

Journalist | Jungbin Shin | jungbin@yonsei.ac.kr

Designer | Hyeokwon Kim | wonwoner@yonsei.ac.kr

Introduction

Developing drugs for rare diseases is a difficult and costly endeavour worldwide, but South Korea faces unique challenges that further complicate the process. Despite advancements in biotechnology and various government initiatives, pharmaceutical companies still struggle to bring treatments for rare diseases to market. The main obstacles can be grouped into four key areas: regulatory hurdles, financial and market limitations, government policies and incentives, and restricted access to clinical trials.

Regulatory Challenges in South Korea

The regulatory approval process is one of the biggest roadblocks in rare disease drug development in South Korea. The Ministry of Food and Drug Safety (MFDS) is responsible for approving new drugs, and while there is a system in place for orphan drug designation, the approval process remains lengthy and highly stringent. In contrast to regulatory bodies like the U.S. FDA and the European EMA, which have implemented more streamlined pathways for orphan drugs, South Korea still requires extensive clinical trial data, making the approval process slow and costly for pharmaceutical companies.

Additionally, South Korea’s regulatory system is still catching up to international standards. Many rare disease treatments developed in other countries must undergo additional testing before they can be sold in South Korea, delaying their availability to patients who need them most. As a result, those suffering from rare diseases often have to wait years before they can access new treatments that are already available elsewhere.

Financial and Market Limitations in Korea

Developing drugs for rare diseases is extremely expensive, requiring heavy investment in research, clinical trials, and production. However, South Korea’s relatively small market makes it difficult for pharmaceutical companies to justify these costs. Unlike treatments for common illnesses, which can be sold to a broad patient base, rare disease drugs serve a much smaller population, making it hard for companies to turn a profit.

This issue is worsened by the lack of venture capital and private-sector investment in South Korea’s pharmaceutical industry. Large multinational drug companies may have the resources to take on the financial risk, but smaller biotech firms in Korea often struggle to secure the funding needed for rare disease drug development. Without sufficient financial backing, progress in researching and developing new treatments slows significantly

Government Policies and Incentives

Recognising the challenges, the South Korean government has introduced various policies to encourage the development of orphan drugs. The Korean Orphan Drug Center was established to support research and development, and tax incentives are available for companies working on orphan drugs. Additionally, the government has implemented a fast-track approval process for certain rare disease treatments to help speed up their market entry. Despite these efforts, the current incentives may not be strong enough to attract significant investment. In comparison, the U.S. Orphan Drug Act offers more comprehensive benefits, including longer market exclusivity, tax credits, and grant funding. According to the article by BioSpace, the orphan drugs market size in the US is expected to reach USD 541.3 billion by 2032, whereas it is only USD 4.1 billion in South Korea. As a result, many pharmaceutical companies prioritize larger markets with stronger financial incentives rather than investing in rare disease drug development specifically for South Korea.

Limited Access to Clinical Trials

Another major issue in South Korea is the difficulty of conducting clinical trials for rare disease drugs. Since rare diseases affect only a small number of people, recruiting enough participants is already challenging. The country’s lack of specialized research centers and infrastructure compounds this problem, making it even harder for companies to run trials effectively.

As a result, many patients with rare diseases in South Korea must travel abroad to participate in clinical trials, which places a significant financial burden on them and their families. Additionally, there are relatively few specialized doctors and researchers focusing on rare diseases in the country. Unlike nations with well-established rare disease research networks, South Korea’s ecosystem for rare disease drug development is still in its early stages. Greater collaboration between hospitals, universities, and pharmaceutical companies is needed to improve access to clinical trials and accelerate the development of new treatments.

Conclusion

Although South Korea has taken steps to support the development of rare disease drugs, significant challenges remain. Lengthy and complex regulatory processes, financial and market limitations, insufficient government incentives, and limited access to clinical trials all create barriers for pharmaceutical companies and patients alike. To address these issues, South Korea must work towards a more efficient regulatory framework, introduce stronger financial incentives, and invest in the necessary research infrastructure. By doing so, the country can improve access t o life-saving treatments and position itself as a leader in rare disease drug development. B

Drug shortage and supply instability

Journalist | JunHeon Lee | junheon23@yonsei.ac.kr

Designer | In Jeong | jeong.in@yonsei.ac.kr

Recently, various epidemics such as COVID_19 has proliferated rapidly due to the expansion of trade. People also suffer from lifestyle diseases such as diabetes since they have unhealthy and unbalanced eating habits. In this situation, various medicines are in short supply, and there are cases in which they are not properly provided to those in need. Why does this shortage occur and how should it be resolved?

What is drug shortage?

Drug shortage refers to a phenomenon in which essential drugs necessary for diagnosis and treatment are out of stock and cannot be supplied properly. You may think that it is okay to replace it with a drug containing the same ingredient, but if one drug goes out of stock, it is only a matter of time before others follow.

Why is the drug shortage a problem?

The reason why the drug shortage is a problem is that the supply of drugs is insufficient, while prescriptions and demands continue. In the case of doctors who give prescriptions, there is a possibility that the prescription may continue while the drug is insufficient due to lack of information on the supply condition of the drug. Even when alternative drugs are purchased, the shortage phenomenon persists as demand continues. Trading out-of-stock drugs at a higher cost is common in the pharmacist community. Various pharmaceutical companies increase the production of drugs in shortage, causing other drugs to be in short supply. As a result, patients are not provided with appropriate and necessary drugs, and pharmacists have a negative impact on public health as they have to pay attention to the purchase of drugs as well as drug manufacturing and medication guidance.

How do we solve these problems?

The first solution is for the government to raise drug prices. In the case of acetaminophen preparations, etc., the production motivation was insufficient due to low-priced drugs. If the government comes up with a plan to increase drug prices, allowing for appropriate profit-making, which in turn can boost drug production and supply. At this time, it can be said that it is important to reduce the actual expenditure of the people through health insurance.

Second, there is a method of prescribing under the ingredient name or raising the standard for prescription. If prescribing a drug for a certain family rather than specifying a specific drug is implemented, it can prevent the occurrence of shortage of certain drugs. In addition, it is necessary to think about ways to reduce the consumption of unnecessary drugs by increasing the prescription standards for various drugs

Third, the most fundamental method, is to increase or distribute the supply itself evenly. If the supply of drugs is stabilized and sufficient, it is unlikely that the shortage will occur. Therefore, one solution may be to increase the supply itself by improving the production motivation of various pharmaceutical companies or imposing coercion on the production of essential drugs. In addition, if drugs are evenly distributed according to the circumstances of various regions, drugs will be provided to necessary regions and people to prevent drug shortages from occurring.

Personal perspective

The drug shortage is a problem not only for pharmacists, but also for the health of all the people, so quick countermeasures and solutions should be prepared. In order to improve the quality of people’s health, it is hoped that short- and long-term solutions to the drug shortage will be sought and progressed. B

Access to medication and inequality

Access to medicines and vaccines

Few months have passed since a tragic disaster struck our community. Until COVID-19, the issue of vaccine accessibility was not publicized. But after COVID-19 emerged, the vaccine supply led to issues of inequality. It took more than a year for Republic of Korea to begin vaccinating after the first vaccination in the U.K, which was held on Dec. 8, 2020. The vaccine supply is not just a problem in Korea. Take Africa, for example, another country whose vaccine supply was insufficient. In South Africa, the country most affected by Covid-19 on the continent, the vaccination rate reached around 64 per 100 population in Oct 26, 2023. This means that there is a time gap between countries that have developed vaccines, countries that have fewer economic resources.

The time gap may have occurred for multiple reasons. In the case of the UK, for example, as the country that developed AstraZeneca, it is in an environment that is easy to receive vaccines. In the case of countries far from the UK, this means that they have to spend a lot of capital to purchase vaccines. This can act as an entry barrier in other developing countries.

Vaccine and medication inequality

In 2021, according to NBC news, Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance, mentioned in a email that “as long as large portions of the world’s population are unvaccinated, variants will continue to appear, and the pandemic will continue to be prolonged”. Especially, developing countries are vulnerable to new pandemics. Just 1 in 4 front-line health workers on the Africa continent were fully vaccinated. However, wealthy nations like the United States did not have the same problem. They’d already vaccinated the public except for those who were hesitant and ineligible.

Not only vaccine supply is a problem to developing countries. Access to insulin for diabetes, antiretroviral drugs for HIV and essential vaccines remains limited. Also, those who live in the rural sites at developing countries have a dilemma to choose between buying food or paying for necessary medicines. Then the problem of vaccines being concentrated only in rich countries and the lack of active drug supply in the suburbs can also be seen as contributing to the emergence of the variant. What should pharmaceutical companies do?

Pharmaceutical companies’ responsibilities

Pharmaceutical companies are critical players in the global issues of medication. Pharmaceutical companies are also in a position to generate revenue, but high vaccine prices eventually create inequality that makes it impossible for other countries to have the same benefits. The demand for profit often outweighs the need for adequate healthcare, which further creates variation of the disease. In a pandemic, pharmaceutical companies’ most important responsibilities are to supply sufficient vaccines and to cooperate with the WHO to reduce the gap between countries. However, this cannot be achieved only by companies.

Governments’ responsibilities

Pharmaceutical companies’ primary goal is to make profits and simultaneously address inequality. However, there is a contradiction between pursuing profits and lowering prices to improve inequality. The government’s intervention is necessary at this time. The government should reduce the economic burden on pharmaceutical companies to develop vaccines and drugs.

For example, The Korea Centers for Disease Control and Prevention (Director Ji Young-mi) announced in 2024 that the exemption from the preliminary feasibility study (referred to as the ‘mRNA vaccine project’) has been confirmed to secure a vaccine platform with a remarkably fast development speed. The U.S. and CEPI (Infectious Disease Innovation Alliance) are already investing in mRNA vaccine technology to develop customized vaccines within 100 days of the pandemic, and Japan also succeeded in developing a COVID-19 mRNA vaccine in 2023. Japan’s main success factor is that it selected potential private pharmaceutical companies, invested 930 billion won in the entire process from initial development to clinical trials and production, and strongly supported by the government.

Conclusion

The disparity in access to essential medications, whether due to high costs or lack of infrastructure, affects vulnerable populations, exacerbating health inequalities. The establishment of a response system for new diseases, laws to supply vaccines to other countries, and systems to supply vaccines to remote areas should be established in other countries as well. In the case of the Republic of Korea, SK Bioscience shipped its own flu vaccine ‘Sky Cell Flu’ to countries in the southern hemisphere such as Southeast Asia and Latin America. This means that efforts to supply vaccines to remote countries are still ongoing. This way, even if not completely eliminated, it can be hoped that at least a large number of casualties due to lack of vaccine and drug supply can be prevented. B

The Pharmaceutical Industry:

Evolving to Meet Changing Patient Needs

Journalist | Jiyoon Lee | jiyonle@yonsei.ac.kr

Designer | Jiyoon Lee | jiyonle@yonsei.ac.kr

The pharmaceutical industry is at a pivotal moment, shaped by the convergence of artificial intelligence (AI), personalized medicine, and decentralized clinical trials. These technological advances are fundamentally changing how companies approach drug discovery and development. AI and machine learning, in particular, have enabled researchers to analyze vast datasets, identify novel therapeutic targets, and optimize early-stage development. Recent industry reports show that AI-powered platforms have reduced early-stage drug development timelines by up to 40%, with some experts projecting that AI could halve overall development timelines by 2025 (Saarthee, 2025). This acceleration not only lowers costs but also increases the probability of successful candidates progressing to clinical trials, ultimately benefiting patients through faster access to innovative therapies.

Patient-Centric Approaches and Decentralized Trials

A significant transformation is underway in how pharmaceutical companies design and conduct clinical trials. Patient-centric approaches, which actively incorporate patient feedback and real-world evidence, are leading to therapies that better address actual patient needs and preferences. Decentralized clinical trials (DCTs) leverage digital tools and remote monitoring to make participation more accessible and less burdensome. Studies have demonstrated that patient-centric trials achieve recruitment goals 15% faster and improve participant retention compared to traditional models (PubMed Central, 2024). These innovations not only enhance the clinical trial experience but also improve data quality and trial efficiency.

Value-Based Healthcare and Market Dynamics

The shift toward value-based healthcare is redefining market expectations. Pharmaceutical companies must now demonstrate not only the clinical efficacy of their products but also their economic value and impact on patient outcomes. This has prompted the development of more sophisticated pricing and market access strategies, with comprehensive evidence packages that address both clinical and economic considerations. The entrance of new digital health players and startups is further disrupting traditional market dynamics, pushing established firms to embrace digital transformation and adopt more patient-centric business models.

The Rise of Advanced Therapeutic Modalities

Advanced therapeutic modalities—such as cell and gene therapies, RNA-based treatments, and precision medicine—are rapidly gaining prominence. The development pipeline for these therapies has expanded by approximately 25% annually over the past three years, reflecting significant industry investment and momentum (Ricci et al., 2025). These innovative treatments offer the promise of more effective and personalized options, particularly for diseases that have been challenging to treat with conventional approaches.

Environmental Sustainability: From Green Chemistry to Sustainable Packaging

Environmental sustainability has become a strategic imperative for the pharmaceutical industry. Companies are adopting a wide range of sustainable practices to reduce their environmental impact and improve operational efficiency. For example, the use of green chemistry—such as safer reagents, renewable resources, and enzyme catalysts—has minimized hazardous waste and pollution (Pharmaceutical Technology, 2024). Lean manufacturing and process optimization have led to manufacturing cost reductions of up to 20%, while renewable energy adoption and advanced wastewater treatment are further reducing environmental footprints (Xtalks, 2023-2024; Uhlmann, 2024). Sustainable packaging initiatives, including recyclable and reusable materials, are also gaining traction, reflecting a holistic approach to sustainability across the product lifecycle (ABPI, 2023).

Globalization, Strategic Integration, and Regulatory Adaptation

The global pharmaceutical landscape is becoming increasingly interconnected, with emerging markets expected to account for 35% of global pharmaceutical spending by 2025 (Ricci et al., 2025). Expanding healthcare access and rising middle-class populations in these regions are creating new growth opportunities, but also require companies to navigate diverse regulatory environments and adapt to local healthcare needs. Successful integration of emerging technologies and sustainable practices demands strategic investment, alignment with organizational capabilities, and proactive engagement with evolving regulatory frameworks. Regulatory bodies such as the FDA and WHO are updating their guidelines to accommodate advanced therapies and sustainability requirements, underscoring the need for flexibility and responsiveness in compliance strategies (World Health Organization, 2024). Companies that can effectively align innovation, sustainability, and regulatory compliance will be best positioned to thrive in this dynamic global market.

Conclusion

The pharmaceutical industry stands at the threshold of a new era, defined by rapid technological innovation, increasing patient empowerment, and a heightened focus on sustainability. As AI, personalized medicine, and decentralized trials become standard practice, companies are not only accelerating drug development but also delivering therapies that are more closely aligned with patient needs. The rise of advanced therapeutic modalities and the expansion into emerging markets are reshaping the competitive landscape, creating both challenges and unprecedented opportunities. At the same time, the integration of sustainable practices is transforming manufacturing and supply chains, yielding both environmental and economic benefits.

To succeed in this evolving environment, pharmaceutical organizations must embrace change at every level— investing strategically in new technologies, prioritizing patient-centricity, and embedding sustainability into their core operations. Navigating complex and shifting regulatory frameworks, especially as the industry globalizes, will require agility and foresight. Ultimately, those companies that can harness innovation, adapt to local and global market demands, and lead on sustainability will not only maintain a competitive edge but also play a pivotal role in shaping the future of healthcare for patients worldwide. B

Medicine Shortages and manufacturing problems

Medicine shortage, today’s serious worldwide problem

Medicine plays a crucial role in today’s healthcare system, as new medicine technologies such as gene therapy and targeted therapy are being developed. Also, we developed many innovative medicines for illnesses that we have been thinking we couldn’t treat. Although medicine became one of the most significant parts of today’s treatment, the problem of medicine shortage is becoming increasingly serious throughout the world. In Korea, the Ministry of Food and Drug Safety announced that reports of medicine discontinuation or shortage grew by 23.4 percent compared to the previous year. Similarly, in the United States, general medicines such as painkillers are in short supply in many states this year. There may be many reasons for the shortage of medicines, but the manufacturing problems are one of the most significant reasons for this situation.

Seriousness of the problems that medicine shortage can cause

The shortage of medicines is causing great difficulty not only for pharmacists but also for patients. When medicine is in short supply, patients may need to spend a significant amount of time searching through pharmacies or hospitals to find the drugs that they need. This makes it difficult for healthcare providers to offer prompt proper treatment, and at the same time, patients may have to wait a long time before receiving the medications that they urgently need. This leads to a delay in treatment and could even threaten a patient’s health. Therefore, the issue of medicine shortages should be considered as a critical issue that can lower the healthcare quality. That is why we need to understand the reason for the medicine shortage and find useful solutions to them.

Causes of the medicine shortage, API shortage regarding its manufacturing and reliance

One of the main causes of the medicine shortage is the unstable supply of Active Pharmaceutical Ingredients (API). API is the essential component for manufacturing medicines that we commonly rely on. And these medicines made from API usually play a crucial role in determining the effectiveness of medications. However, there have been various issues in the production of APIs recently. Manufacturing problems like disruptions in the manufacturing chain, increased cost of the raw materials, and half production in factories have led to an unstable API supply. This manufacturing instability makes it difficult to produce the medicines we need in a timely manner, therefore it leads to medicine shortages.

Another significant factor in the medicine shortage is the world’s heavy reliance on a few countries for API production. Currently, about 60% of API is produced in China and India. Particularly in the United States, over 90% of essential medicines such as antiviral drugs and antibiotics are produced abroad. The concentration of production in a limited number of countries makes the supply chain extremely vulnerable. If production in a specific country is disrupted due to geopolitical tensions, natural disasters, or other external factors, the consequences can influence globally.

Why do we need to rely on API supply in a few countries? The reason lies in economic factors. Producing APIs generates lower profits compared to the development of new drugs for treating incurable diseases. Developing new treatments brings in higher revenue, which leads large pharmaceutical companies to invest more in research and development (R&D). On the other hand, API production offers relatively lower profit margins, which is why many pharmaceutical companies outsource API production to countries with lower labor costs. As a result, pharmaceutical companies in advanced countries focus mainly on developing new medicines while leaving API production to countries with cheaper labor.

However, this approach could create long-term problems. While developing innovative medicines is undoubtedly important, without the essential components (APIs) needed to manufacture those medicines, we cannot expect to receive fast and effective treatments. The development of new treatments must be accompanied by efforts to stabilize API production and ensure a reliable supply chain for these crucial ingredients.

Solutions that we need act to solve the medicine shortage problem

Then, what can we do to solve this problem? To solve this problem, we have to approach this problem in multiple ways. First, countries need to increase their domestic production capacity for API. If many countries work to increase their local production of API, they can ensure the stable supply of essential medicines regardless of external issues. Also, it can decrease API reliance on other countries, while losing government’s spending for customs duty.

Second, it is important to diversify the sources of API supply. Reducing dependence on just one or two countries and establishing multiple sources of API production will help to build a more resilient supply chain. Additionally, there is a need for policy changes to create long-term economic incentives for pharmaceutical companies to invest in API production.

Third, governments and pharmaceutical companies should collaborate to innovate and improve the efficiency of API production. For example, automation in the production process or the introduction of new technologies to reduce costs could help solve some of these issues. By doing so, production costs could be lowered, and more resources could be allocated toward API production, ensuring a stable supply.

Ultimately, to ensure the stable supply of medicines, it is crucial to restructure the entire supply chain. Just as the development of new medicines is important, stabilizing the production of APIs, which are essential for manufacturing those medicines, must be prioritized. By doing so, we can address the growing problem of medicine shortages and ensure more timely and effective treatments for patients.

Medicine shortage is a main issue we should be concerned about. That is because it is a matter of patient health and access to critical medications. The cause of the medicine shortage is API shortage, which is caused by manufacturing issues and reliance on a few countries. Therefore, urgent and proactive solutions must be sought to resolve this issue. To make it possible, we need to show more concern for the APIs so that the government and pharmaceutical companies take action. B

Yonsei Quantum Week 2025 and quantum computers

Journalist | Jeonghye Seol | jeonghye15@yonsei.ac.kr

Designer | Inhyeok Kim | inhyeok0802@yonsei.ac.kr

On November 20, 2024, Yonsei University installed South Korea’s first IBM quantum computer, IBM Quantum System One. This made South Korea the fifth country in the world- after the U.S., Germany, Japan, and Canada-to operate a quantum computer. Alongside the installation, Yonsei University established the Yonsei Quantum Complex on its International Campus in Songdo. The Quantum Complex includes two independent buildings-the Quantum Computing Center and Quantum Convergence Research Center-housing laboratory and educational spaces for quantum computing, and a collaborative space for convergence research. to mark this launch and promote broader understanding of quantum science and technology, the university hosted Yonsei Quantum Week 2025 from March 4 to 8. The event was held at both Seoul Campus and International Campus, and included an international conference, industrial session, special lectures on quantum computing, and cultural events, including a dedication ceremony. Professor Jaeho Jung, head of Yonsei Quantum Initiative, noted that quantum computing could push beyond existing limits in areas like biomedicine, drug development, cryptography, AI, and quantitative finance. He added that Yonsei University aims to contribute not only to academic research but also to industrial and societal advancement through the adoption of advanced quantum technologies. You can check the details about Yonsei Quantum Week on the official website-but here, we’ll explore the basic principles of quantum computers and their applications.

How Quantum Computers Work

Classical computers process information using bits, which are either 0 or 1. In contrast, quantum computers use quantum bits, or qubits. Thanks to a quantum phenomenon called superposition, qubits can be in a combination of 0 and 1 at the same time. A helpful way to imagine this is to think of a spinning coin-it’s not just heads or tails, but both at once until it lands. This allows quantum computers to explore many possible solutions in parallel.

Another important feature is entanglement, where qubits become linked in such a way that the state of one immediately affects the other, even if they are far apart. This property helps quantum systems perform computations that are difficult or impossible for classical systems.

Together, these properties enable quantum computers to solve certain problems much more efficiently than traditional computers. But it’s important to note that quantum computers don’t outperform classical ones at everything—they are useful for very specific types of problems.

Applications

One of the most widely discussed applications of quantum computing is in cryptography. Modern encryption methods, such as RSA, depend on the fact that factoring large numbers is extremely hard for classical computers. A quantum algorithm called Shor’s algorithm can solve this problem much faster, meaning that current cryptographic systems could one day become insecure if large quantum computers become available. This has led researchers and governments to begin working on post-quantum cryptography to prepare for that future.

Quantum computers are also promising in other areas that involve complex systems and large datasets. These include:

Molecular simulation: Accurately modeling how atoms and molecules behave is difficult for classical computers. Optimization: Quantum algorithms can explore large solution spaces more efficiently. This could be useful in logistics, traffic management, or financial modeling.

Artificial Intelligence: Some quantum techniques could improve the speed of training machine learning models or help analyze large datasets more efficiently.

These early applications are still being explored. Many of them require better hardware and more stable qubits before they can be used widely.

The IBM Quantum Eagle at Yonsei

The IBM Eagle processor installed at Yonsei has 127 qubits, making it one of the most advanced quantum processors publicly available. While more powerful devices like IBM’s Osprey (433 qubits) and Condor (1,121 qubits) exist, they remain internal prototypes and are not accessible for general use. Another processor, Heron (133 qubits), offers a similar qubit count but represents a new experimental architecture focused on improved fidelity, modular design, and long-term scalability for error-corrected systems. However, like all current quantum systems, it is part of the NISQ (Noisy Intermediate-Scale Quantum) era. NISQ devices are powerful but still have limitations. They are sensitive to noise, and their quantum states can’t be maintained for long periods. As a result, today’s quantum computers can only run relatively short and simple algorithms.

Despite these challenges, NISQ devices can already be used for experimental research and certain practical problems. The system at Yonsei allows students and researchers to run quantum circuits on real hardware, not just simulations. This makes it a valuable educational and research platform.

A Future-Focused Investment

Quantum computing is expected to evolve rapidly in the coming years. As error correction improves and more stable qubits are developed, future quantum systems could become powerful enough to handle much larger and more complex tasks. Experts believe that fault-tolerant quantum computers-devices capable of running long and accurate computationscould become available sometime in the 2030s.

Yonsei University’s quantum program is designed to prepare for that future. In addition to installing the IBM system, the university has launched a Quantum Computing Center to promote research, collaboration, and education. Early-stage partnerships, including some with companies in the biotech and pharmaceutical sectors, are underway to explore how quantum computing can be applied in areas like drug discovery.

But beyond specific collaborations, Yonsei’s larger goal is to help train a new generation of quantum-literate students. The university is encouraging students from mathematics, physics, engineering, and even non-STEM majors to learn about quantum information and explore what it means to compute in a quantum world.

Looking Ahead

Quantum computers today are still limited and experimental, much like classical computers were in the 1950s. But even now, they are being used to explore small-scale problems that classical systems find challenging. As the technology gradually improves, it may influence how we understand data, computation, and information.

Yonsei Quantum Week 2025 was not just a celebration of new hardware-it was a signal that quantum computing is becoming more visible and relevant, even outside of specialized research labs. For many students, including those without a background in computer science, this can be a starting point.

In my case, I became interested after reading IBM’s official website and educational materials. The fact that these kinds of resources are freely available online suggests that quantum computing is becoming more approachable for students from various backgrounds. While the long-term impact of this technology remains to be seen, learning the basic ideas can be a valuable first step. Here are some websites I found helpful when getting started. Feel free to check them out. B

MEMBERS

Editor in chief Design Manager

Journalist

Jiwoo Kang 15th
In Jeong 15th
Jeonghye Seol 15th
Yejoo Lee 15th
Hyemin Park 16th
Dakyung Baik 16th
Jungbin Shin 16th
Yeshin Eom 16th
Yunseo Lee 16th
Heejae Hwang 16th
Jeongyun Park 17th
Junseo Park 17th Bee Yoo 17th
Junghyun Yoon 17th

17th

17th

Designer

17th

Dawon Han 14th
Seonu Hong 14th
Inhyeok Kim 16th
Hyeokwon Kim 16th
Minseo Choi 16th
Yein Oh 17th
Jiyoon Lee 17th
Jongyun Jeong
Heonje Cho 17th
DongHyeon Lee
Junheon Lee
Seongjun Cho 17th
Jiyoon Lee 17th

T HE

B LU E VANGUARD

Yonsei Student Pharmacist Magazine THE

BLUE VANGUARD

YONSEI STUDENT PHARMACIST MAGAZINE

Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.