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- 2026-06-09 12:55:35
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- Policy
- OTC Formulation changes to become easier in KOR
- by Lee, Tak-Sun Jun 09, 2026 10:01am
- Going forward, companies seeking approval for over-the-counter (OTC) drugs that use the same route of administration as an already approved or notified product but differ only in formulation will be required to submit significantly fewer review documents. By establishing specific criteria for what constitutes a ‘minor formulation difference,’ a concept that had previously remained ambiguous, the revision is expected to substantially reduce the burden associated with product development and approval changes for pharmaceutical companies.The Ministry of Food and Drug Safety (MFDS) announced on the 5th that it had issued a public notice of a proposed amendment to the ‘Regulations on the Approval, Notification, and Review of Pharmaceutical Products.’ The revision was introduced to address shortcomings in the current pharmaceutical approval, notification, and review system while rationalizing existing regulations.The core objective of the amendment is to streamline the administrative procedure by clearly specifying which supporting documents are required when changing the formulation of OTC drugs.Previously, if a company sought approval for a new product that had the same route of administration as an already approved or notified drug but differed in formulation, it was required to submit extensive review materials, such as head-to-head trial data or bioequivalence study data.However, under the revised proposal (Appendix 1), if the difference between the proposed OTC formulation and the existing formulation is considered ‘minor’ and falls within the same specified category, existing data for the drug may be used in place of the required review data.According to examples provided by the MFDS, eligible formulation changes include: Changes among tablets (plain tablets, sugar-coated tablets, and non-enteric film-coated tablets); capsule formulations; granules and powders; Changes among ointments, creams, gels, topical solutions, and topical powders; Changes among oral liquid formulations (excluding emulsions and suspensions) and syrups; Changes between cataplasms and adhesive patches.The pharmaceutical industry expects the measure to significantly reduce both development time and costs when diversifying OTC formulations to better align with consumer preferences and improve dosing convenience.In addition to simplifying formulation-change procedures, the amendment includes a number of broader regulatory rationalization measures.For medical high-pressure gases such as oxygen, a new exemption provision has been established, allowing safety validation data (long-term stability and accelerated stability study results) to be replaced by prior use cases for already approved or registered products. For orphan drug products whose active pharmaceutical ingredient quality data have already been submitted, multiple specifications for the active ingredient may be listed if it can be demonstrated that they do not affect the quality of the finished pharmaceutical product.In addition, a new provision stipulates that when only the name of a general test method in an official compendium has changed without any modification to the test procedure itself, the approval or notification will be deemed automatically updated without requiring a separate amendment procedure. In addition, efforts to refine legal terminology into easy-to-understand Korean, such as replacing Japanese-style Chinese characters like ' sujaedoen (recorded)’ with 'sillin(included)’ and ' jeokbu (judgment of suitability)’ with 'judgment of conformity/non-conformity’ were also includedThe MFDS will accept public comments on the proposed amendment until August 4, 2026. The revised regulation will take effect immediately upon promulgation and will apply to pharmaceutical products for which manufacturing, marketing, or import approval and notification applications (including amendments) are first submitted after the effective date.
- Policy
- GLP-1 obesity drugs may receive 'concern for misuse and abuse' designation
- by Lee, Tak-Sun Jun 09, 2026 10:01am
- AI-generated imageAs the Ministry of Food and Drug Safety (MFDS) pursues the designation of GLP-1 obesity treatments as 'drugs of concern for misuse and abuse,' it has released an analysis showing that the public interest benefits of protecting citizens' rights to know and to health are significant.Consequently, GLP-1 obesity treatments containing liraglutide, semaglutide, and tirzepatide are highly likely to be designated as drugs subject to concern for misuse and abuse following a collection of industry opinions. Once designated as a drug subject to concern for misuse and abuse, warning phrases will become mandatory on packaging, and sales without a prescription will be prohibited even in areas exempt from the separation of prescribing and dispensing.The MFDS issued an administrative notice on the 5th regarding a partial amendment to the "Regulations on the Designation of Drugs Subject to Concern for Misuse and Abuse," which features these primary measures. The MFDS has also concluded its economic and social feasibility review through a regulatory impact assessment report.6.3-fold increase in supply...severe safety insensitivity including inappropriate prescribing for pediatrics and pregnant womenThe background of the MFDS is to tighten regulatory oversight, which lies in the recent explosive growth of the obesity treatment market and the resulting indiscriminate misuse and abuse.According to the regulatory impact assessment report, the volume of GLP-1 receptor agonist obesity treatments (liraglutide, semaglutide, and tirzepatide) imported and supplied domestically increased by 6.3-fold (approximately KRW 901.0 billion) in just one year, skyrocketing from around KRW 169.9 billion in 2024 to approximately KRW 1.0709 trillion in 2025.The problem is that instances where these medicines are abused for simple cosmetic weight loss by individuals with normal body weights or are illegally distributed are surfacing consecutively. In fact, it was verified that 69 cases of inappropriate prescribing occurred for pediatric patients under the age of 12 and 194 cases for pregnant women. At the same time, crackdowns by relevant authorities revealed a sharp increase in the detection of online false or exaggerated advertisements and illegal distribution.Notably, pharmacy supply volumes in 'areas exempt from the separation of prescribing and dispensing', such as remote islands and mountainous regions lacking physicians, have also experienced a steep spike. For the flagship product 'Wegovy', supply volume to pharmacies in these exempt regions increased by 975.7% year-over-year.History of Designations for 'Drugs Subject to Concern for Misuse and Abuse'There are two core measures newly established through the introduction of this regulation. First, it restricts the sale of these obesity treatments so that they can be dispensed only upon a physician's prescription at pharmacies nationwide, including those located in areas exempt from the separation of prescribing and dispensing. The intent is to block indiscriminate acquisition channels that bypass prescriptions fundamentally.Second, pharmaceutical manufacturers and importers must clearly print the phrase "Drug Subject to Concern for Misuse and Abuse" on product containers, packaging, and package inserts. Through this, the agency plans to heighten awareness regarding drug misuse and abuse among both medical professionals and consumers.Direct costs to the pharmaceutical industry estimated at KRW 24 Million... "Public interest benefits overwhelmingly outweigh compliance costs"The MFDS found that the economic burden imposed on the pharmaceutical industry by this regulation remains marginal. Currently, there are a total of 24 authorized obesity treatment products containing the relevant active ingredients in South Korea. Upon calculating the costs of modifying labeling materials, such as replacing printing ink and copper plates, for the 12 items currently launched and actively selling in the market, it was estimated that a one-time direct cost of approximately KRW 2 million per product, totaling KRW 24 million (equivalent to an annualized net cost of KRW 2.9 million), would be incurred. Six products that have not yet been launched were excluded from the cost-incurring factors.The MFDS emphasized, "Compared to private losses such as material modification expenses for certain regulated entities or revenue declines for pharmacies, the public interest benefits of preventing side effects from inappropriate drug administration and protecting the citizens' right to know and right to health are significant."The MFDS plans to gather both positive and negative opinions on this administrative notice through June 26, 2026, and to implement the policy immediately. Consumers and the industry will be granted a one-year transitional grace period to use pre-manufactured packaging materials produced before the implementation date.
- Company
- Dupixent indication expanded to bullous pemphigoid and CSU
- by Son, Hyung Min Jun 09, 2026 10:01am
- Dupixent pre-filled penSanofi announced that its Type 2 inflammation-targeting therapy ‘Dupixent (dupilumab)’ has been approved for two new indications -- bullous pemphigoid (BP) and chronic spontaneous urticaria (CSU).With this approval, Dupixent has become the first and only targeted therapy approved in Korea for the treatment of BP. It also provides an additional treatment option for patients with CSU whose symptoms are not adequately controlled with H1-antihistamine therapy.With the approval, Dupixent pre-filled syringe and pre-filled pen 300 mg may be used for the treatment of bullous pemphigoid in adults aged 18 years and older, and Dupixent pre-filled syringe and pre-filled pen 200 mg and 300 mg formulations may be used for the treatment of CSU in adults aged 18 years and older and adolescents aged 12–17 years whose symptoms are inadequately controlled with H1-antihistamines.Dupixent demonstrated clinical efficacy in adults with moderate-to-severe bullous pemphigoid in the ADEPT Phase II/III clinical trial, which served as the basis for the approval.Patients received Dupixent 300 mg in combination with standard systemic corticosteroid therapy, followed by gradual tapering according to disease status. At Week 36, the proportion of patients who achieved sustained disease control without oral corticosteroids (OCS) was higher in the Dupixent group than in the placebo group.The recently published 2025 Canadian Dermatology Association (CDA) Guidelines included Dupixent as a first-line treatment option for extensive bullous pemphigoid. In addition, the 2022 S2K International Expert Consensus Guidelines issued by the European Academy of Dermatology and Venereology (EADV) recommend Dupixent as a biologic treatment option for treatment-resistant bullous pemphigoid.Dupixent’s indication expansion to chronic spontaneous urticaria was based on results from the Phase III CUPID trial, which enrolled biologic-naïve patients aged 6 years and older whose symptoms persisted despite H1-antihistamine therapy.The primary endpoint was the change from baseline in the Weekly Itch Severity Score (ISS7) at Week 24. Key secondary endpoints included changes in the Urticaria Activity Score over 7 Days (UAS7), achievement of symptom control (UAS7 ≤ 6), and complete remission (UAS7 = 0). In the study, patients treated with Dupixent experienced a statistically significant reduction in itch severity (ISS7) compared with placebo, and the reduction in UAS7 from baseline was 66% in the Dupixent group and 48% in the placebo group, respectively.Previously, first-line treatment for chronic spontaneous urticaria consisted of second-generation H1-antihistamines, which could be increased to as much as four times the standard dose. However, a substantial unmet need persists because nearly half of patients fail to achieve adequate symptom control with H1-antihistamines alone. To address this, the 2026 international guideline update formally included Dupixent alongside omalizumab as a targeted second-line therapy for H1-antihistamine-refractory chronic spontaneous urticaria.Kyung-eun Bae, General Manager of Sanofi Korea, said, “Through these two indication expansions, we hope that patients suffering from poor quality of life associated with bullous pemphigoid and chronic spontaneous urticaria will receive the best possible treatments, improve their quality of life, and receive a higher standard of care. We will continue our efforts to improve the treatment environment for these patients.”
- Company
- Is this the end of the era of animal testing?
- by Cha, Ji-Hyun Jun 09, 2026 10:01am
- After the US government unveiled its roadmap to systematically decrease reliance on animal testing in drug development, Europe has officially announced measures to reduce animal use in pharmaceutical safety assessments. This shift aims to address the ethical controversies surrounding animal experimentation while significantly enhancing the predictive accuracy of human physiological responses. As global regulatory transitions begin, South Korean domestic companies possessing non-animal testing technologies, such as organoids, are gaining attention.EU joins systemic elimination of animal testing…accelerating safety assessment transformationsAccording to sources in the pharmaceutical biotech industry, the European Commission (EC) selected a roadmap on June 1st to systematically eliminate animal use in safety assessments for chemicals, including pharmaceuticals. This roadmap includes 15 distinct regulatory domains, including industrial and consumer chemicals, biocides and pesticides, human medicinal products, food and feed additives, and biocompatibility assessments for medical devices.The EC stated, "This roadmap proposes clear and concrete steps for transitioning toward innovative, non-animal approaches. We plan to maintain the absolute reliability of safety assessments to ensure a high level of protection for human and animal health, as well as the environment."The strategic framework presented by the EU rests on three primary pillars. ▲Accelerating the development and validation of non-animal testing methodologies ▲Expanding the utilization of research alongside artificial intelligence (AI) and data-driven analytics ▲Strengthening collaboration between EU member states and the international community.To support the development of alternative methods, the EC intends to grant developers access to the European Reference laboratories (EURLs) at the Joint Research Center (JRC) and to introduce a structured framework to map non-animal testing methods required in real-world regulatory settings. The EC will also incentivize the development of both EU and international standards to ensure these non-animal approaches can be effectively integrated into routine safety evaluations.Within the pharmaceutical sector, the roadmap outlines strategies to reduce the need for repeat-dose toxicity (RDT) studies for advanced cancers and severe or life-threatening conditions. The blueprint envisions substituting animal models with in vitro assays and computational simulations, and using virtual control groups to minimize the number of control animals deployed in RDT research.The EC plans to immediately implement this roadmap along with member states, EU agencies, and relevant stakeholders. It will convene a high-level meeting in 2029 to evaluate operational progress and audit the implementation status of non-animal approaches across applicable legislative frameworks, including the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.FDA animal testing policy timeline for new drug development (source: KOREABIO) The EU's latest initiative aligns seamlessly with the ongoing policy directives driven by the United States government to reduce animal experimentation. Through the enactment of the FDA Modernization Act 2.0 in December 2022, the US Congress removed the statutory mandate requiring animal testing in the new drug approval pipeline, establishing a robust legal foundation for the use of non-animal methods such as cell-based assays, organoids, organ-on-a-chip technologies, and computational modeling.Accordingly, in April last year, the US Food and Drug Administration (FDA) announced a systemic transition plan to reduce, refine, and replace animal testing, beginning with monoclonal antibodies and certain medicinal products. The FDA aims to reduce, refine, and replace animal testing using New Approach Methodologies (NAMs), such as organoid toxicity testing, organs-on-chips, and AI-based computational models, and to leverage relevant datasets in Investigational New Drug (IND) applications or Biologics License Applications (BLAs) for biosimilars.In the same month, the US National Institutes of Health (NIH) also unveiled plans to establish a new organization to expand the use of human-based research technologies. The NIH intends to support the development, validation, and expanded use of non-animal approaches, including organoids, tissue chips, computational models, and real-world data—centered around the Office of Research Innovation, Validation, and Application (ORIVA).On March 18th of this year, the FDA released a draft guidance document allowing the submission of NAMs data for novel drug approval reviews. This guidance states that testing methods not previously approved as animal testing alternatives may be submitted. That validation or qualification evaluations need not be completed in advance for non-clinical toxicity and safety assessments. Furthermore, the NIH plans to invest more than $150 million to support the development and validation of NAMs.4.59 million laboratory animals in South Korea…Ethical lontroversies and limitations in replicating human responsesThe background behind the United States and Europe starting on reducing animal testing stem from ethical concerns and the limitations of replicating human physiological responses.First, demands to resolve the ethical problems associated with animal testing have been continuously raised, primarily by animal protection organizations, civil society, and academia. According to the EU, the number of animals used in regulatory testing from 2015 to 2023 exceeded 15 million. Among these, approximately 40% were deployed in chemical safety assessments.The scale of laboratory animal use is also substantial in South Korea. According to the 2024 Institutional Animal Care and Use Committee (IACUC) Operational Performance Survey by the Animal and Plant Quarantine Agency, the number of laboratory animals used domestically last year totaled 4.59 million. Relevant organizations and experts argue that, since numerous animals are used in experiments worldwide each year, unnecessary animal sacrifice must be reduced and the use of alternative testing methods expanded.Number of animals used in EU toxicity and other safety tests (Source: KOREABIO)The limitations in connecting animal test results to actual human responses during the new drug development process are another factor accelerating the regulatory transition. Conventional non-clinical trials have served as an essential gateway to assess the toxicity and efficacy of candidate substances. However, criticisms persist that accurately predicting human drug responses solely from animal results has clear limitations. In particular, with the emergence of novel types of medicines, such as antibodies and cell/gene therapies, the problem that animal models alone cannot fully replicate human immune responses and disease characteristics has been highlighted.Announcing its plan to expand the utilization of human-based research technologies in April last year, the NIH said, "Some research institutions have failed to draw sufficient conclusions when applying animal model results to human diseases, such as Alzheimer's disease and cancer. These limitations may stem from differences in anatomy, physiology, lifespan, and disease characteristics between humans and animals. Even if humans and animals share genes, there can be differences in the functions of organs and bodily systems, which can create constraints in applying animal model results to human diseases."Even if a candidate substance confirms efficacy and safety in animal testing, its development can be discontinued if the expected effects do not manifest or unexpected toxicities are identified in human clinical trials. In such cases, years of research and development expenses, and the manpower invested in candidate discovery, non-clinical trials, and production process development, cannot be recovered, leading to the burden of delaying subsequent pipeline schedules. This is why regulatory bodies in various countries are rushing to introduce alternative testing methods.South Korea also accelerates alternative testing implementation…Korean organoid companies riseAlong with the global regulatory shift, the institutionalization and serialization of alternative testing methods are gathering full momentum in South Korea. Following the establishment of a foundational research base, the government is refortifying the legal basis for applications within the pharmaceutical sector and taking steps to preempt international standards for advanced alternative testing methods, such as organoids.In South Korea, the Ministry of Food and Drug Safety (MFDS) established the foundation for the development and validation of alternative testing methods by establishing the Korean Center for the Validation of Alternative Methods (KoCVAM) in 2009. In 2011, the MFDS joined the International Cooperation on Alternative Test Methods (ICATM) and has since participated in the development of international testing guidelines alongside regulatory agencies of major countries, including the United States and Europe.The MFDS has also officially begun to establish international standards. Last year, the MFDS launched the Committee for the International Standardization of Organoid Testing Methods and partnered with the Organisation for Economic Co-operation and Development (OECD) to develop international guidelines for organoid-based toxicity testing. The government plans to leverage the 14th World Congress on Alternatives and Animal Use in the Life Sciences (WC14), which will be held in Seoul in 2027, as an opportunity to enhance the regulatory utility of domestic technologies on the international stage.Collaboration between industry and research institutes has also begun. Last August, the 'K-Organoid Consortium' was launched, involving 27 corporations, including Samsung Biologics, Daewoong Pharmaceutical, and JW Pharmaceutical, as well as 18 research institutions. The consortium promotes standardization of testing methods, the development of industrial support infrastructure, and international cooperation, thereby supporting the global regulatory acceptance and market entry of domestic organoid technologies.Korean Companies Developing Organoids: JW Pharmaceutical, Kangstem Biotech, Gradient Bioconvergence, Next&Bio, Daewoong Pharmaceutical, ROKIT Healthcare, Samsung Biologics, MBD, OrganoidSciences, Ipsell, and T&R Biofab.As the reduction of animal testing and the adoption of non-animal testing methodologies spread globally, Korean companies with relevant technologies are garnering significant attention. Anticipation is growing that if global regulatory bodies expand the scope of utilizing non-animal testing datasets, such as organoids, organs-on-chips, and AI-based predictive models, it will lead to increased opportunities for technical validation and collaboration with global pharmaceutical companies for domestic firms.OrganoidSciences is regarded as one of the most active companies in the organoid field. Through its organoid-based drug evaluation platform 'ODISEI', the company replicates actual human organ architecture and disease microenvironments to evaluate the efficacy and toxicity of candidate compounds. It is also developing an organoid-based regenerative medicine pipeline called 'ATORM'; its lead asset, ATORM-C, recently secured Phase I IND approval from the MFDS for patients with Crohn's disease, successfully entering the clinical phase.MBD is developing patient-tailored workflows for predicting anticancer drug response using 3D cell culture technology. The company has proprietary automation technologies to uniformly mass-produce tumoroids (cancer mimics) from minimal patient specimens, alongside 'OncoCensi', a tumoroid-based assay evaluating chemosensitivity to anticancer therapies. Following a successful technical evaluation in November 2024, MBD filed a preliminary KOSDAQ listing review application with the Korea Exchange this past April, officially initiating its initial public offering (IPO) process.Samsung Biologics launched 'Samsung Organoid', an anticancer drug-screening service based on cancer-patient-derived organoids, in June last year. JW Pharmaceutical utilized human skin organoids to evaluate the hair follicle-generating efficacy of its alopecia drug candidate 'JW0061', and the candidate molecule is currently advancing toward entry into Phase I clinical trials. Daewoong is developing mass-production bioprocess technologies for organoid-based regenerative therapeutics with support from the Ministry of Trade, Industry and Energy (MOTIE). Its objective is to establish manufacturing protocols for therapeutics designed to assist in the regeneration of damaged organs and tissues, such as the heart, liver, and kidneys, and to expand its scope into treatments for intractable diseases.Lastly, Gradient Bioconvergence is operating oncology target discovery and drug response prediction businesses that pair AI and gene-editing technologies with a repository of approximately 1,000 patient-derived organoids and genomic datasets. Kangstem Biotech is engineering skin disease models based on skin organoids. Next&Bio is developing platforms for efficacy evaluation powered by patient-derived cancer organoids and microphysiological systems. Ipsell is advancing the commercialization of 'POLAR', an alternative testing platform leveraging induced pluripotent stem cells (iPSCs) and organoids. Concurrently, T&R Biofab is developing 3D bioprinting and vascularized tissue technologies, while ROKIT Healthcare is developing a patient-centric, personalized regenerative medicine platform.
- InterView
- [Desk’s View] Futile efforts to improve the rare disease drug system
- by Eo, Yun-Ho Jun 08, 2026 08:52am
- Calls for institutional reform to expand access to reimbursement for rare disease treatments have been raised so often that the annual requests have now become quarterly. The reimbursement listing process for orphan drugs remains difficult due to the difficulty of proving cost-effectiveness and the lack of financial predictability, either because the number of patients is too small or because the number of patients is slightly higher than the baseline during pharmacoeconomic evaluations.As of 2026, the National Assembly has been holding discussions roughly twice a month on expanding coverage for specific rare diseases. The Ministry of Health and Welfare and the Health Insurance Review and Assessment Service (HIRA) have also proposed improvement measures, but the dire need among healthcare professionals and patients persists.Why does it feel as though nothing has really changed? Within the current pharmacoeconomic evaluation calculation framework, the longer a chronic disease patient survives, the longer they must continue taking medications, which leads to an increase in the cost of medications that arise with the improvement in survival and quality of life.This creates a structure in which proving cost-effectiveness becomes increasingly difficult. In extreme cases, a paradox can arise in which a patient must become more severely ill before a treatment is judged to be cost-effective.In addition, most breakthrough therapies that are innovative enough to be considered for fast-track reimbursement listing do not have therapeutically equivalent alternatives available. In such cases, the comparator drug inevitably ends up being an inexpensive “old drug,” which naturally delays the reimbursement listing process.This is why growing voices argue that, if reimbursement rates for rare disease drugs are to genuinely improve, the evaluation system itself must undergo a fundamental change. Rare diseases are defined as conditions affecting fewer than 20,000 people, or diseases for which the number of patients is difficult to determine because the diagnosis itself is challenging. In many cases, the limited patient population makes conducting clinical trials difficult.Due to the small number of patients, profitability is difficult to achieve, making active new drug development less likely. Even when a company succeeds in developing a new treatment against all odds, it then needs to overcome the difficulty of proving cost-effectiveness through pharmacoeconomic evaluation. And the vicious cycle continues to repeat itself.Earlier this year, the government announced plans to strengthen support for rare, severe, and intractable diseases, stating that it would reduce the reimbursement listing period for rare disease treatments from more than one year to 100 days by simplifying reimbursement adequacy assessments and negotiation procedures.However, shortening the evaluation period does not guarantee rapid reimbursement listing. It merely shortens the period during which someone (a pharmaceutical company) submits an application and the authorities review it. The repeated excuse that “We have also made efforts” and “We will review the matter” holds no meaning. The time has come for the fundamental reconsideration of the evaluation framework itself, one that reflects current realities, and for concrete results to emerge from that effort.
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