J Korean Med Assoc.  2012 Sep;55(9):827-834. 10.5124/jkma.2012.55.9.827.

Current status of pharmaceutical safety management in Korea

• Choi D
• Choi M
• Ko A

• KMID: 1787245
• DOI: http://doi.org/10.5124/jkma.2012.55.9.827

Abstract

The reinforcement of regulation on of post-market safety management including adverse drug reactions (ADRs) has received significant emphasiszed significantly over the last several years in Korea. Not only has there been an increase in the number of spontaneous reports on ADRs, but an amendment of to the pharmaceutical law has been passed and notifications have noticeably been accelerated noticeably. However, compared with advanced countries, the efficiency of the system and people's satisfaction withon post-market safety management was has been as low as ever. This article focuses on the state of the regulations with regard to reporting of ADRs information. In addition, the status and kinds of drug utilization review informations offered by the Korea Food and Drug Administration were are illustrated in detail.

Keyword

Adverse drug reaction; Safety management; Drug utilization review

MeSH Terms

Drug Toxicity
Drug Utilization Review
Jurisprudence
Korea
Reinforcement (Psychology)
Safety Management
Social Control, Formal
United States Food and Drug Administration

Figure

• 

  Figure 1 This figure illustrates the number of reports entered into Korea Food and Drug Administration Database of Adverse Drug Reaction since 2002 until the middle of 2012. The dotted line (red) represents the number of reports estimated in 2012.

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