Current status of pharmaceutical safety management in Korea

Donwoong Choi; Miseop Choi; Ara Ko

doi:10.5124/jkma.2012.55.9.827

J Korean Med Assoc > Volume 55(9); 2012 > Article

Choi, Choi, and Ko: Current status of pharmaceutical safety management in Korea

Focused Issue of This Month

Drug Safety and Risk Management

Journal of the Korean Medical Association

Journal of the Korean Medical Association 2012; 55(9): 827-834.

Published online: September 20, 2012

DOI: http://doi.org/10.5124/jkma.2012.55.9.827

Current status of pharmaceutical safety management in Korea

Donwoong Choi, PhD, Miseop Choi, MS, Ara Ko, MS

Pharmaceutical Safety Information Team, Pharmaceutical Safety Bureau, Korea Food and Drug Administration, Cheongwon, Korea.

Corresponding author: Donwoong Choi, donwoong@korea.kr

Received August 18, 2012 Accepted August 30, 2012

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

찾아보기말: Adverse drug reaction; Safety management; Drug utilization review

References

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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.

Table 1

The cancelled and/or suspended pharmaceuticals associated with safety or effectiveness problems since 2000 in Korea

KFDA, Korea Food and Drug Administration; US FDA, US Food and Drug Administration; EMA, European Medicines Agency; PMDA, Pharmaceuticals and Medical Devices Agency.

^a)Prohibit the sales of pharmaceuticals on the marketing place.

^b)Withdrawal of approval on pharmaceutical manufacture or import.