Current status of pharmaceutical safety management in Korea.
10.5124/jkma.2012.55.9.827
- Author:
Donwoong CHOI
1
;
Miseop CHOI
;
Ara KO
Author Information
1. Pharmaceutical Safety Information Team, Pharmaceutical Safety Bureau, Korea Food and Drug Administration, Cheongwon, Korea. donwoong@korea.kr
- Publication Type:Original Article
- Keywords:
Adverse drug reaction;
Safety management;
Drug utilization review
- MeSH:
Drug Toxicity;
Drug Utilization Review;
Jurisprudence;
Korea;
Reinforcement (Psychology);
Safety Management;
Social Control, Formal;
United States Food and Drug Administration
- From:Journal of the Korean Medical Association
2012;55(9):827-834
- CountryRepublic of Korea
- Language:Korean
-
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.
