earticle

영어

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.