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KMID : 1011320120050030103
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Journal of Pharmacoepidemiology and Risk Management
2012 Volume.5 No. 3 p.103 ~ p.112
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An Overview of the Drug Safety Surveillance System in China
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Jin Xue-Mei
Lee Joong-Yub
Choi Nam-Kyong
Park Byung-Joo
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Abstract
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China’s National Center for Adverse Drug Reaction (ADR) Monitoring was established both for western and Traditional Chinese Medicine (TCM) in 1988. In 1998, nearly a decade later, China joined the World Health Organization’s (WHO) Program for International Drug Monitoring. During 2011, China formally promulgated the upgrade version of the “Adverse Drug Reaction Reporting and Monitoring Provision”. This publication clarified the local and provincial level of ADR monitoring bodies, thus, four-level monitoring system has been established. The ADR reporting in China is growing at a rapid rate. Total 852,799 ADRs reported to National ADR monitoring center in 2011, much higher than 692,904 in 2010. By the end of 2011, 46 issues of ADR information bulletin had been published listing 85 ADR Alerts. There also have several big safety issues like Longdan Xiegan (Guanmutong) had withdrawn, Yu Xing Cao injection and clindamycin suspended for the major causes of the serious ADRs. These procedures for decision making did not take long time. The Twelfth Five-Year Plan for drug safety that the first national special plan of drug safety also had been announced in 2012. While postmarketing surveillance guidelines are not yet available in China, the system shows considerable progress and promising future, especially in ADR reporting procedure awareness continues to grow among China’s Healthcare professionals and public.
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KEYWORD
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China, Adverse drug reaction, Drug safety, Surveillance, Adverse drug reaction monitoring
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