Korean Journal of Clinical Pharmacy (한국임상약학회지)
- Volume 16 Issue 2
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- Pages.123-130
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- 2006
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- 1226-6051(pISSN)
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- 2508-786X(eISSN)
Regulatory System of Quasi-drugs in Korea
우리나라 의약외품 허가심사제도 고찰 및 개선 방안
- Sohn, Hyun-Soon (College of Pharmacy, Sookmyung Women's University) ;
- Shin, Hyun-Taek (College of Pharmacy, Sookmyung Women's University) ;
- Song, In-Sook (Drug Information Research Institute, Sookmyung Women's University) ;
- Jun, Hyo-Jung (College of Pharmacy, Sookmyung Women's University)
- Published : 2006.12.30
Abstract
The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.