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KMID : 0941820060160020123
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Korean Journal of Clinical Pharmacy
2006 Volume.16 No. 2 p.123 ~ p.130
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Regulatory System of Quasi-drugs in Korea
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Sohn Hyun-Soon
Shin Hyun-Taek
Song In-Sook
Jun Hyo-Jung
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Abstract
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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 heath 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 uasi-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-drugs monographs, 4) re-evauate 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.
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KEYWORD
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Quasi-drugs, Regulatory review system, Regulatory process, Regulations
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