Shin Ju-Young, Jung Sun-Young, Ahn So-Hyeon, Lee Shin Haeng, Kim Su-Jin, Seong Jong-Mi, Chung Soo-Youn, Park Byung-Joo
Korea Institute of Drug Safety and Risk Management, Seoul, Korea.
Pharmacoepidemiol Drug Saf. 2014 Nov;23(11):1115-22. doi: 10.1002/pds.3715. Epub 2014 Sep 24.
Pharmacovigilance plays a vital role in ensuring that patients receive appropriate medical products that are safe and effective. This paper aims to describe the history of pharmacovigilance in Korea and introduce the establishment and goal of the KIDS.
In Korea, the adverse drug reactions (ADR) reporting system was launched in 1988 by the Korea Ministry of Food and Drug Safety (MFDS) and spontaneous ADR reports have been collected from health care professionals and the general public. Although the ADR reporting system has begun, the reporting rate was very low in the first 10 years, and safety actions were done passively in response to the US Food and Drug Administration (FDA) or European Medicines Agency (EMA)'s safety alert and communications.
Therefore, the Korea Institute of Drug Safety and Risk Management (KIDS) was established in April 2012 as a new initiative for pharmacovigilance.
The KIDS will continue to contribute to the improvement of Korean pharmacovigilance by collecting, managing, and analyzing consumer-centered drug safety information.
药物警戒在确保患者获得安全有效的适当医疗产品方面发挥着至关重要的作用。本文旨在描述韩国药物警戒的历史，并介绍韩国药物安全与风险管理研究所（KIDS）的成立及目标。
在韩国，药品不良反应（ADR）报告系统于1988年由韩国食品药品安全部（MFDS）启动，已从医疗保健专业人员和公众那里收集自发的药品不良反应报告。尽管药品不良反应报告系统已经启动，但在最初的10年里报告率非常低，并且是被动地针对美国食品药品监督管理局（FDA）或欧洲药品管理局（EMA）的安全警报和通报采取安全行动。
因此，韩国药物安全与风险管理研究所（KIDS）于2012年4月成立，作为药物警戒的一项新举措。
韩国药物安全与风险管理研究所（KIDS）将通过收集、管理和分析以消费者为中心的药物安全信息，继续为韩国药物警戒的改进做出贡献。
