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This study was conducted to analyze the current status of Good Manufacturing Practice(GMP) implementation in the Korean pharmaceutical industry and to propose directions for future system improvement. To this end, relevant domestic and international GMP literature and guidelines were reviewed and compared, and a survey was conducted targeting GMP practitioners. The results indicate that while the domestic GMP system is generally aligned with international standards, shortcomings remain in areas such as ensuring data integrity, digitalization and automation of manufacturing processes, and the application of risk-based quality management. In addition, practitioners commonly recognized the need to enhance the effectiveness of GMP education, strengthen communication systems with regulatory authorities, clarify inspection standards, and provide field-oriented technical support. Based on these findings, the study proposes policy measures such as the introduction of digital quality management systems, reinforcement of job-specific GMP training, improvement of inspectors' professional capabilities, and the establishment of tailored support systems for the industry. The results of this study are expected to serve as a foundational reference for enhancing the effectiveness of the domestic GMP system and strengthening the global competitiveness of the Korean pharmaceutical industry.

To ensure the reliability of research data in clinical trials, this study analyzed findings from FDA inspections conducted over 18 years, from 2007 (October 2006) to 2024 (December 2024), under the Bioresearch Monitoring (BIMO) Program. This study analyzed trends in findings related to clinical trials, targeting the ‘Institutional Review Board (IRB), Sponsor and Contract Research Organization (CRO), and Clinical Investigators (CI)’, and studied the correlation between type of findings by each center and Data Integrity. A total of 4,410 FDA Form 483 were issued, showing a significant decreasing trend over the years, the violation was Protocol compliance of 37%, followed by Inadequate management of case history records of 22% in findings of 6,277. This was also linked with the total Warning Letter issued of 336, with a distribution of Protocol compliance of 22% and Inadequate management of history records of 15%. Through the analysis of Warning Letters highlights the Protocol compliance, History records, Complying with approved documents(such as informed consent, meeting minutes, and procedures, etc.), and Reporting and Oversight. Furthermore, when analyzed in Data Integrity, the finding types of issued by each institution aligned with shared standards and oversight methods for inspection, and interventions to reduce violations(e.g., enhanced training, improved record management systems) were emphasized as effective strategies. Through this study, domestic/foreign companies or research institutes preparing for BIMO will recognize the importance of Data Integrity with violation type, and this study can serve as a reference for further improvement research.

Advancements in 3D printing technology have facilitated the development of implantable medical devices capable of replacing damaged human tissues. These devices are primarily fabricated from synthetic polymers with biocompatible and biodegradable properties. In particular, biodegradable polymers require appropriate degradation rates that match the pace of tissue regeneration, making performance evaluation under conditions similar to the human body essential. In this study, we developed a testing method to assess the performance of 3D-printed absorbable barrier membrane fabricated from polycaprolactone. Human biomimetic conditions were simulated using artificial saliva and phosphate-buffered saline, and the changes in performance before and after exposure were evaluated. Domestic and international standards and guidelines were analyzed to determine relevant test items and procedures, and the reliability of the proposed evaluation method was verified through validation tests. The results showed no observable changes in appearance, while the changes in dimensional and porosity characteristics were not statistically significant. In contrast, decreases in mass and molecular weight were observed, and tensile strength showed a substantial reduction, with all three parameters exhibiting statistically significant changes. These findings indicate that performance degradation is more closely associated with the reduction in molecular weight and the resulting decrease in mechanical strength than with changes in appearance. Based on these results, the study highlights the necessity of evaluating biodegradable implantable medical devices under conditions that simulate the implantation environment, and it is expected to contribute to enhancing the reliability of performance evaluation for future devices.

Background: Drugs are essential to cure diseases and it is crucial to maintain the safety and stability of drugs during the supply chain process. Therefore, the Korean government manages drug distribution in accordance with the Pharmaceutical Affairs Act, even if the efficacy of drugs is guaranteed through manufacturing. The drug wholesale distribution market continues to grow and the types of wholesalers are diversifying. This study aims to identify issues related to drug distribution and to draw improvement measures. Methods: In order to explore a plurality of perspectives, data were obtained from five focus groups composed of employees from pharmaceutical companies, wholesalers, hospitals, pharmacies, and public health center. A semi-structured guide was applied in obtaining the participants’ opinions. Common themes were extracted by authors, which were used to gather results and draw conclusion. Results: Participants acknowledged that as the number of wholesale transactions increases, the drug supply chain becomes complicated, making it difficult to check the transparent distribution flow. Participants concerned about low barrier to market entry by wholesalers, soft regulation of distribution management, and conflict of interest among players in drug market. Conclusions: This study suggest that solid regulations on wholesalers and a fair pharmaceutical trading environment should be effective strategies to enhancing the transparency of pharmaceutical drug structures.

This study aimed to re-evaluate the robustness of the current testing method for determining the potency of aprotinin, one of the quality control for fibrin sealant kits, by applying Analytical Quality by Design (AQbD). A processing map and an Ishikawa diagram were used to identify potential test variables. The critical method attributes (CMAs) were defined as the coefficient of determination of the calibration curve, the relative standard deviation of system suitability solution measurements, and the relative range of test sample measurements. Through preliminary experiments and risk assessment, column oven temperature, flow rate, and mobile phase buffer composition were identified as critical method parameters. A design of experiment established the design space satisfying CMA requirements: 10–20oC for column oven temperature, 0.5–1.5 mL/min for flow rate, and 80–100% for mobile phase buffer composition. Robustness within this space was verified through an inter-laboratory collaborative study at low, medium, and high conditions, with all conditions satisfying CMA requirements. These results confirm that the current testing method falls within the validated design space and possesses adequate robustness. This study demonstrates that AQbD can be applied to ensure consistency and re-validation of plasmaderived medicinal product testing, contributing to enhanced reliability in national lot release outcomes.

Phthalates could be unintentionally added into plastic materials-containing cosmetics or raw materials during manufacture and storage. Hence, the maximum permissible detection limit to phthalates has been regulated by the sum of dibutylphthalate (DBP), butylbenzylphthalate (BBP) and diethylhexylphthalate (DEHP) of 100 ppm in Korea. From the monitoring, it is found that relatively high level of phthalates was detected in eye make-up products, rinse-off products and perfumes among the 160 kinds of cosmetics. The risk assessment was carried out with two scenarios; one for harsh conditions, assuming the 97.5 percentile concentration level of phthalates to expose, and one for mild conditions, assuming the averaged concentration level of phthalates to expose. The margin of safety (MOS) of DBP, BBP and DEHP were 11742, 129482 and 14320 when 97.5 percentile concentration level was applied, respectively. Also, the aggregated risk assessment was carried out and the result was 6145 of MOS, assuming that three phthalates were exposed simultaneously. All MOS values from the assessments were larger than 100, which is not considered to be of concern to the human health.

This study proposes an integrated multi-task learning model that performs both lesion segmentation and lesion-type classification simultaneously in breast ultrasound images. Conventional single-task approaches handle segmentation and classification independently, often leading to information isolation and a failure to leverage complementary features between the tasks. To overcome these limitations, we adopt a two-stage U-Net architecture with a ResNet-101 backbone and introduce the Hierarchical Gating Module (HGM) as the core component of our framework. HGM hierarchically reuses the coarse segmentation probability map generated in Stage 1 to modulate multi-scale encoder features in Stage 2, thereby maximizing the synergistic interaction between segmentation and classification. Experiments conducted on the BUSI breast ultrasound dataset demonstrate that the proposed HGMNet achieves superior performance compared to existing models, recording a Dice coefficient of 0.7431 for segmentation and an accuracy of 0.8500 for classification. These results indicate that the proposed model can effectively integrate the two tasks within a single unified network, thereby enhancing both the accuracy and reliability of breast ultrasound–based diagnosis.

Drugs are directly related to disease treatment and differ from general consumer goods. Biological products, which are high-cost and high-risk, are highly sensitive to temperature fluctuations; exceeding recommended storage conditions can compromise both efficacy and safety. The International Council for Harmonisation (ICH) provides stability test guidelines that define scientifically justified storage conditions and expiration criteria to ensure drug quality, safety, and effectiveness. Based on these guidelines, national regulatory authorities establish their own standards for drug storage and distribution. However, temperature excursions still occur during distribution, and especially at the patient storage stage. Self-Injectable Drugs which have increased in use, have system limitations. Patients themselves are directly responsible for storage and administration at home, so they cannot check the state of a drug’s condition. Studies have shown that patients frequently fail to maintain proper conditions. To address these challenges, this study aims to develop a regulatory science-based temperature monitoring system. The Time-Temperature Indicator, a color-changing label that irreversibly reacts when exposed to excessive temperature, is proposed as a simple, user-friendly and cost-effective solution. By analyzing domestic and international temperature monitoring regulations and identifying blind spots in current cold chain systems, this study seeks to enhance patient safety, strengthen public trust, and minimize economic losses.

The in vitro diagnostic reagents have become increasingly important for rapid diagnosis since the pandemic of the novel coronavirus (COVID-19). However, development status analysis based on Ministry of Food and Drug Safety approval information is insufficient. In this study, we analyze the domestic in vitro diagnostic (IVD) reagents based on all the approval information for pathogen diagnostics, classified the product group that require national research and development promotion. In addition, we provide the reference information for domestic IVD companies to develop and invest in new products. Through the approval information, it was organized and an based on imported and domestic products, single target and complex target , diagnostic methods, target pathogens, etc., and shows changes in the number of in vitro diagnostic product approvals for each infectious disease. From the results of this analysis, IVD-related domestic companies can improve their international competitiveness by innovating products based on new technologies and expanding investment in diagnostic products for novel infectious diseases. In addition, by identifying the approval information of diagnostic products targeting pathogens such as fungi, protozoa, Nematoda, and flatworms that are underdeveloped by domestic companies due to economic reasons or competition with giants foreign companies. It is possible to provide information on diagnostic products that require expanded development support at the national level and improve public health by increasing self-sufficiency of in vitro diagnostic reagents.

As the association between the gut microbiota and human health has become well established, interest in functional ingredients for gut health has continued to grow. Although the domestic health functional food market has expanded rapidly, conventional probiotics have inherent limitations, including issues related to the stability of live microorganisms and the potential risk of infection in immunocompromised individuals. Parabiotics, defined as inactivated probiotic cells, do not contain viable microorganisms and have therefore attracted attention as an alternative that may overcome the safety and stability limitations of existing probiotic products. This study comprehensively examined the health-promoting effects of parabiotics and explored their potential as functional food ingredients, along with related regulatory implications. A synthesis of the studies included in the metaanalysis indicated that parabiotics generally exhibited favorable effects on immune modulation, inflammation reduction, and metabolic improvement. The pooled effect size was estimated to be in the moderate-to-large range; however, statistical significance was not achieved due to substantial heterogeneity across studies. Nevertheless, several individual studies demonstrated pronounced effects under specific conditions, suggesting that parabiotics may exert clinically meaningful benefits in certain strains or specific target populations. The high degree of heterogeneity among studies indicates that the effects of parabiotics may vary according to strain characteristics, intervention methods, and the immune status of the target population, highlighting the need for a more personalized approach rather than a uniform evaluation framework. In particular, effects appeared to be limited in healthy adult populations, whereas more pronounced improvements were observed in populations with immune imbalance or inflammatory conditions. A comprehensive review of domestic and international regulatory environments suggests that the characteristics of parabiotics are not adequately reflected within existing probioticcentered evaluation systems. For their inclusion as health functional food ingredients in Korea, improvements to current evaluation criteria, accumulation of large-scale human studies, and establishment of standardized manufacturing and quality control guidelines are required. This study provides scientific evidence supporting the potential public health applicability of parabiotics as next-generation functional ingredients that combine safety and efficacy. In the context of increasing public health burdens associated with population aging and the growing prevalence of chronic diseases, parabiotics may represent a valuable preventive health management option that can be used relatively safely even by immunocompromised individuals.

Digital wellness products delivered via smartphones and wearable devices increasingly collect, analyze, and provide health-related information, including lifestyle patterns and physiological signals. Even without explicit diagnostic or therapeutic claims, some products can influence risk perceptions, care-seeking, and the timing of screening, testing, or clinical visits. This creates a regulatory “grey zone” at the boundary of medical device definitions, where intended use is formally non-medical but real-world effects may still raise public health and consumer protection concerns. This study compares how Korea, the United States, the European Union (EU), and Japan regulate such boundary products. We conducted a document-based comparative legal and policy analysis of statutes, regulations, and official guidance. The analytical framework comprised three domains: (1) regulatory scope and definitions, (2) market entry pathways, and (3) quality/performance assurance mechanisms. The United States clarifies boundaries through statutory exclusions for certain software functions and enforcement discretion for low-risk wellness products. The EU regulates software with a medical intended purpose under the Medical Device Regulation (MDR) via qualification, risk-based classification, and conformity assessment, while non-medical wellness products are primarily governed by horizontal regimes such as product safety and data protection. Japan improves predictability by delineating the SaMD–wellness boundary through guidance and publicly available interpretation examples. Korea establishes a distinct legal category—digital medical and health support devices—combining notification with optional performance certification, thereby institutionalizing a managed middle ground between full medical device authorization and market autonomy. This design aims to reduce regulatory blind spots by enabling administrative traceability while offering a public signal of performance through voluntary certification. Because Korea’s key provisions for this category are scheduled to take effect from January 24, 2026, its real-world impact should be assessed after implementation, including certification uptake, market adoption by key purchasers, disclosure effectiveness, and the practical functioning of postmarket oversight and corrective actions.