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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: 20 September 2012

DOI: https://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 18 August 2012       Accepted 30 August 2012

Copyright © 2012 Korean Medical Association

(open-access):

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.

Keywords: Adverse drug reaction, Safety management, Drug utilization review

Figures and Tables

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.
jkma-55-827-g001
Table 1
The cancelled and/or suspended pharmaceuticals associated with safety or effectiveness problems since 2000 in Korea
jkma-55-827-i001

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.

Table 2
The 20 regional pharmacovigilance monitoring centers designated by Korea Food and Drug Administration in 2012
jkma-55-827-i002
Table 3
The number of drug utilization review informations provided by Korea Food and Drug Administration since 2004
jkma-55-827-i003

Total: 2,315 substances.

Table 4
The list of drug utilization review information books (or leaflets) provided by Korea Food and Drug Administration since 2008
jkma-55-827-i004

References

1. Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85 (Sep 27, 2007).
2. European Commission. Volume 9A of the rules governing medicinal products in the European Union: guidelines on pharmacovigilance for medicinal products for human use. 2008. Bruxelles: European Commission.
3. Levinthal CF. Drugs, behavior, and modern society. 2005. 4th ed. Boston: Pearson Education.
4. The standard of toxicity test of pharmaceutical products: notification of Korea Food and Drug Administration under the title of 2009-116. (amendment in Aug 24, 2009).
5. Korea Food and Drug Administration. Guideline for non-clinical trial for performance of clinical trial and marketing authorization of pharmaceutical products. 2012. Cheongwon: Korea Food and Drug Administration.
6. The regulation about post-market review of new drug, etc.: notification of Korea Food and Drug Administration under the title of 2011-60. (amendment in Oct 10, 2011).
7. The regulation about implementation of drug re-evaluation: notification of Korea Food and Drug Administration under the title of 2012-4. (amendment in Feb 23, 2012).
8. The regulation of safety information management of drug, etc.: notification of Korea Food and Drug Administration under the title of 2012-18. (amendment in May 15, 2012).
9. World Health Organization. Drug and therapeutics committees: a practical guide. 2003. Geneva: World Health Organization.
10. The regulation of adverse drug reaction committee: regulation of Korea Food and Drug Administration under the title of 2012-239.
11. US Pharmacopeia Drug Utilization Review Advisory Panel. Drug utilization review: mechanisms to improve its effectiveness and broaden its scope. J Am Pharm Assoc (Wash). 2000. 40:538–545.
12. Choi KE, Oh OH. Drug information development for drug utilization review system in USA. J Korean Acad Manag Care Pharm. 2005. 1:28–32.
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