Earticle

Regulatory science plays a vital role in ensuring the safety, efficacy, and quality of products in the food, pharmaceutical, and medical device industries while supporting their efficient commercialization. Major regulatory agencies in the United States, Europe, and Japan have implemented early-stage collaboration frameworks to facilitate the market entry of innovative products. In Korea, the amendment of the「ACT ON REGULATORY SCIENCE INNOVATION FOR SUPPORTING FOOD AND DRUG SAFETY AND COMMERCIALIZATION」 and the introduction of the Examination of Regulatory Coherence have established a legal foundation for strengthening commercialization support programs. This study compares and analyzes product commercialization support systems in Korea and other leading countries while assessing researchers awareness of regulatory coherence. The findings highlight the need for regulatory agencies to provide tailored guidance, develop proactive regulatory frameworks, and enhance communication with researchers. Expanding regulatory education, ensuring policy sustainability, and strengthening interagency collaboration are essential for improving Korea’s commercialization support system. Through these improvements, Korea can enhance the effectiveness of its regulatory science initiatives, ultimately accelerating the market entry of innovative research and development outcomes.

This study conducts a comparative analysis of the medical device talent development education systems of major regulatory agencies, including the FDA (USA), PMDA (Japan), Health Canada, and MFDS (Korea), and proposes improvements for Korea’s system based on the current workforce status and demand in the domestic bio-health industry. The analysis reveals that each country’s education system differs in terms of operating bodies, tailored programs for trainees, industry-academia-research collaboration, and approaches to international regulatory harmonization. The United States and Japan operate systematic, dedicated educational organizations with continuous online learning platforms and provide long-term programs closely linked to practical experience. In contrast, Korea’s education is dispersed across multiple departments and relies mainly on in-person training, limiting accessibility and practical, hands-on learning. Additionally, domestic programs lack direct education on international regulatory harmonization and global standards, focusing primarily on theory-based short- and mid-term courses. Based on these findings, this study recommends: establishing a continuous and autonomous online education platform, creating a dedicated educational department for systematic management, introducing practice-oriented programs in collaboration with regulatory agencies, and expanding education on international regulatory harmonization and global standards. These improvements are expected to foster highly skilled professionals with regulatory science expertise and practical capabilities, particularly as the industry shifts toward digital healthcare and AI medical devices.

This study analyzes and compares the major GMP violations and patterns observed in South Korea and Japan based on FDA inspection data from 2009 to 2023. Rather than simply examining the frequency of violations, this research introduces keyword network analysis—a method rarely applied in regulatory science to explore the interrelations and structural characteristics among violation categories in greater depth. The results indicate that in South Korea, violations related to laboratory control and documentation were prominent, with labeling issues and the absence of laboratory systems closely linked to other quality concerns. These findings highlight the need for strengthened data integrity and quality systems. In contrast, Japan showed a higher prevalence of violations in production processes, storage, and equipment management, with significant associations observed particularly in sterilization processes and approval procedures. By visualizing the results through keyword network mapping, this study clarifies regulatory vulnerabilities in each country and offers a novel analytical framework for understanding complex violation patterns. These insights can serve as foundational data for developing proactive strategies in response to FDA inspections and may contribute to the establishment of quality management systems aligned with global regulatory standards.

The accelerated vaccine development during the COVID-19 pandemic underscored the importance of robust post-approval change management systems. This study examines such systems for vaccines across major regulatory authorities, including the EMA, FDA, WHO, and Korea’s MFDS. We conducted a comparative analysis of risk-based classification systems for post-approval changes by reviewing relevant guidelines and quantifying differences in change management items. The MFDS adopts a three-tier risk classification system with uniform regulatory actions, whereas other agencies implement four-tier systems with differentiated regulatory responses. Furthermore, the MFDS covers a narrower range of post-approval change items and classifies fewer changes as “Important” compared to its counterparts. Notable discrepancies were observed in areas such as the container closure system of APIs (64.3%) and the risk classification of changes in drug product composition and manufacturing processes. MFDS and WHO exhibited the highest proportions of “Minor” classifications at 45.9% and 51.1%, respectively, and the lowest proportions of “Important” classifications at 12.8% and 9.1%, respectively. In contrast, the EMA and FDA reported the highest proportions of “Important” classifications at 38.2% and 46.3%, and the lowest “Moderate” proportions at 25.4% and 16.6%, respectively. To enhance global harmonization, the study suggests that the MFDS develop more detailed guidelines in alignment with ICH Q12 principles, implement risk-based differentiated regulatory actions, broaden the scope of managed items, and increase the proportion of changes classified as “Important.” While the MFDS system shows alignment with WHO, further harmonization with EMA and FDA standards is essential to strengthen the global competitiveness of Korea’s vaccine industry.

Analyzing clinical trial success rates is crucial for informing strategic investment and decision-making in drug development. While numerous studies have explored clinical trial outcomes and the associated costs of drug development, research on preclinical success rates, particularly for biologics, remains limited. In this study, we analyzed the preclinical success rates and key success factors of 540 biopharmaceutical candidates that completed private-sector investment agreements—including licensing, acquisition, and financing—from 2016 to 2020. Success rates were evaluated across therapeutic categories and technological platforms. Among the total biopharmaceutical candidates that are subjected to this study, oncology emerged as the most common therapeutic category, while monoclonal antibodies dominated the technological category. The calculated success rate of all biopharmaceutical candidates was 29.8%. Success rates were varied by therapeutic category and technology. The therapeutic categories with the highest success rates were sensory organ and oncology, and the technologies with the highest success rates were Gene-Modified Cell Therapy and Monoclonal antibody. The results of this study are expected to provide strategic investment guidelines for private sector investment in the pharmaceutical industry.

Polymeric aggregates formed during the manufacturing process of intravenous immunoglobulin (IVIG), as a result of protein interactions and further promoted by external factors such as pH shifts, temperature changes, or mechanical agitation can activate the complement system, potentially leading to severe adverse reactions. To mitigate such risks, the anticomplementary activity (ACA) test is employed to evaluate the safety of IVIG by measuring complement consumption following exposure to guinea pig complement. However, the ACA test described in the Korean Minimum Requirements for Biological Products differs from internationally recognized regulatory methods, highlighting the need for harmonization. This study aimed to validate the ACA test based on the European Pharmacopoeia and to establish an internationally harmonized protocol. Method validation confirmed that all analytical parameters met the required criteria. Following validation, the method was applied to assess ACA levels in five IVIG products, with testing conducted across three laboratories. The ACA levels ranged from 7.10% to 29.08%, all within the specified limits. This study provides a foundation for adopting the European Pharmacopoeia-based ACA test for national lot release and quality control of IVIG products. Moreover, it demonstrates the method’s applicability across various IVIG products and supports the global harmonization of testing practices, thereby enhancing international competitiveness.

Phthalates, or phthalate esters, are widely used as solvents and plasticizers across various industrial sectors, particularly to impart flexibility to polyvinyl chloride (PVC) products. However, due to concerns over their potential environmental and human health hazards, such as endocrine-disrupting effects, global regulatory scrutiny of phthalates has increased. In Korea, the Ministry of Food and Drug Safety (MFDS) has set safety limits for seven regulated phthalates (DEHP, DBP, BBP, DINP, DIDP, DNOP, DIBP) under the Hygiene Products Control Act, restricting their concentration to below 0.1% in hygiene products intended for infants and children, such as diapers and cotton swabs. In this study, a gas chromatography-mass spectrometry (GC-MS) method was developed to simultaneously analyze 15 phthalates, including the seven regulated by MFDS and eight additional substances (DEP, DMP, DMEP, DIPP, PIPP, DNPP, DNHP, DCHP) which are regulated due to toxicity concerns by the European Chemicals Agency (ECHA) or have raised potential health concerns in toxicological studies. Hygiene product samples were cryogenically ground and extracted using ultrasonic extraction with n-hexane. Analysis was performed using both full-scan and selected ion monitoring (SIM) modes with a DB-5MS column. The developed method was validated following AOAC Appendix K guidelines and demonstrated excellent linearity (R2 ≥ 0.99), accuracy (recoveries of 90.52-114.06%), and precision (RSD 0.99-16.73%) for all target analytes. Limits of detection (LOD) ranged from 0.03 to 0.15 mg/L, and limits of quantification (LOQ) from 0.09-0.46 mg/L. These results confirm that the proposed method is suitable for the quality control and safety assessment of phthalates in hygiene products.

The global cosmetics industry is expanding rapidly, and compliance with internationally recognized Good Manufacturing Practices (GMP) has become essential for market competitiveness. Korea’s cosmetic manufacturers must adhere to both Korea’s GMP (KGMP) and international standards such as ISO 22716, as required by major export markets like the United States, the European Union (EU), China, and ASEAN countries. This dual compliance places a significant burden on businesses, highlighting the need for regulatory harmonization. To address this, the Ministry of Food and Drug Safety (MFDS) revised Korea’s GMP in August 2024, aligning key elements—such as terminology, facility standards, and reprocessing criteria—with ISO 22716 and global GMP frameworks. While this revision strengthens Korea’s global competitiveness, challenges remain in regulatory effectiveness, integration with existing certification systems, and reducing compliance burdens on businesses. This study analyzes the key differences between Korea’s GMP and international standards (ISO 22716, EU, U.S., Japan, China, and ASEAN countries) to propose policy improvements for enhanced compliance. By aligning Korea’s GMP framework with global standards, this research seeks to reduce regulatory redundancy, alleviate compliance burdens on manufacturers, and improve market accessibility. These findings contribute to the longterm competitiveness and sustainable growth of Korea’s cosmetic industry.

In Korea, Usability evaluation is being applied in phases to all medical devices. Accordingly, medical device manufacturers are required to identify potential use errors during the design and development process and improve them to ensure the safety and effectiveness of their devices. While international standards such as IEC 62366-1,2 as well as certain guidelines from the Ministry of Food and Drug Safety (MFDS), provide references, further research is necessary to derive evaluation items that reflect the characteristics of each product. Therefore, this study proposes a usability evaluation method for portable electrocardiogram (ECG) analysis software, which is increasingly used due to the rise in aging populations and chronic disease patients. Based on the usage procedures of domestically approved products, Perception, Cognition, and Action (PCA) analysis was conducted, and heuristic evaluation items were derived using Jakob Nielsen’s ten usability heuristics. Subsequently, risk assessment was carried out based on the software safety classification criteria of IEC 62304, and final heuristic evaluation items were selected. The proposed heuristic evaluation items are expected to serve as a useful formative evaluation reference for manufacturers in designing and refining user interfaces of their products.