Current Status of Spontaneous Adverse Reactions Reporting System on Herbal
Medicine in China, Japan, Korea and WHO

Woo, Yeon-ju; Chung, Soo-youn; Park, Byung-joo

The Journal of Internal Korean Medicine > Volume 35(2); 2014 > Article

Original Article

The Journal of Internal Korean Medicine 2014;35(2): 111-118.

중국, 일본, 한국, WHO의 한약 자발적부작용보고체계 현황

우연주¹, 정수연¹, 박병주^1,2

¹한국의약품안전관리원
²서울대학교 의과대학 예방의학교실

Current Status of Spontaneous Adverse Reactions Reporting System on Herbal Medicine in China, Japan, Korea and WHO

Yeon-ju Woo¹, Soo-youn Chung¹, Byung-joo Park^1,2

¹Korea Institute of Drug Safety and Risk Management
²Seoul National University, College of Medicine, Department of Preventive Medicine

Correspondence

Byung-joo Park ,Tel: 02-2172-6700, Fax: 02-2172-6701, Email: bjpark@drugsafe.or.kr

Published online: June 30, 2014.

ABSTRACT

Drugs may cause adverse effects, and spontaneous adverse drug reaction (ADR) reports have been used as the main method of drug safety evaluation after drugs have been released. The World Health Organization (WHO) collects ADR data reported from pharmacovigilance organizations in each nations. In China, pharmacovigilance centers operate with hierarchical structure at local, provincial and national levels. Also, Japan and Korea each operate their own respective independent pharmacovigilance organizations. WHO is collecting ADR reports for herbal medicine and 15~20% of all ADRs was related to herbal medicine in China. There are status reports of ADRs for herbal medicine in Japan as well. However, in Korea, there is no ADR reporting system regarding herbal medicine. In light of these overseas cases, a spontaneous ADR reporting system for herbal medicine in Korea should be necessary as well.

Key words: herbal medicine, adverse drug reactions, China, Japan, Korea, WHO