P219: Regional Pharmacovigilance Centers: A Cornerstone of Drug Safety Information Development in Korea
Poster Presenter
HYUN JOO JUNG
Department of Drug Safety Information
Korea Institute of Drug Safety & Risk Management Korea, Republic of
Objectives
The purpose is to introduce the role of Regional Pharmacovigilance Centers (RPVCs), which play an important role in the decentralized pharmacovigilance system in Korea.
Method
We analyzed annual Individual Case Safety Reports (ICSRs) from the Korea Adverse Event Reporting System (KAERS) (2014–2024) to compare RPVCs' report quantity and quality with other sources. Additionally, we examined annual data on RPVCs' educational, promotional, and counseling activities.
Results
The decentralized pharmacovigilance system has been in operation in the Republic of Korea to encourage the spontaneous reporting of adverse drug events (AEs). Regional Pharmacovigilance Centers (RPVCs) have played a crucial role in this system since 2006, and as of 2025, 28 RPVCs are in operation. These centers serve as the primary point of contact for local hospitals, clinics, pharmacies, and patients. They collect AE reports and conduct causality assessments. Additionally, they monitor drugs with safety issues and carry out important region-specific projects.
From the early stages of RPVC operation (2006–2013), the number of RPVCs increased, leading to a proportional rise in the total number of ICSRs collected in the Republic of Korea. Since 2014, RPVCs have accounted for approximately 70% of the total annually collected ICSRs (Number of ICSRs: RPVCs vs. MAHs – 170,433 vs. 75,241). Moreover, RPVCs demonstrate higher completeness for each AE reporting item compared to Marketing Authorization Holders (MAHs) using the same reporting format (Completeness Score: RPVCs vs. MAHs – 95.4 vs. 70.4).
Additionally, RPVCs continuously promote safe drug use and enhance AE reporting awareness through education, promotional activities, and consultation services. In 2024, they conducted approximately 2,700 educational and promotional activities and about 37,600 AE consultations.
Conclusion
ICSRs collected from RPVCs have accounted for approximately 70% of all ICSRs in Korea. Given that RPVCs are evenly distributed across regions and that medical experts in tertiary hospitals conduct causality assessments of adverse reactions, the ADR reports they collect are significant for pharmacovigilance. RPVCs enhance the objectivity and reliability of ICSR collection through high-quality reporting in the Republic of Korea, making them essential for deriving drug safety information. Additionally, as local hub institutions, RPVCs carry out various activities to increase awareness of AE reporting. They are a crucial component of Korea’s voluntary pharmacovigilance system and will continue to play a vital role in advancing the country’s rapidly evolving pharmacovigilance landscape. Furthermore, it is time to explore the role and future direction of RPVCs in pharmacovigilance in Korea.
