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KMID : 0614720120550090827
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Journal of Korean Medical Association
2012 Volume.55 No. 9 p.827 ~ p.834
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Current status of pharmaceutical safety management in Korea
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Choi Don-Woong
Choi Mi-Seop
Ko A-Ra
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Abstract
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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.
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KEYWORD
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Adverse drug reaction, Safety management, Drug utilization review
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