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KMID : 0380420150390030119
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Journal of Prventive Veterinary Medicine
2015 Volume.39 No. 3 p.119 ~ p.125
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Performance assessment of registration, sales and the regulatory management system of in vitro diagnostic veterinary medical reagents in Korea
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Yoon Hyang-Jin
An Hyo-Jin
Kim Chung-Hyun
Kim Yeon-Hwa
Wee Sung-Hwan
Moon Jin-San
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Abstract
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In this study, we investigated and analyzed the registration, sales and regulatory management system of in vitro diagnostic veterinary medical reagents (IVDVMRs) in Korea. The registration of IVDVMRs has gradually increased since 2000, and total of 233 products from 58 companies were registered from 1975 to 2014. The market size of IVDVMRs is estimated to be approximately 12 billion Won per year from 2011 to 2013: the export sales and proportion was estimated to be 36.8% as 4.4 billion Won in 2013. Of these products, the ranking of the sales were canine heartworm, bovine tuberculosis, swine fever, porcine reproductive and respiratory syndrome, canine distemper+adenovirus+parvovirus disease, foot and mouth disease, etc. In vitro diagnostic human medical reagents were diverted biological medicine from the medical devices by the revision of the Pharmaceutical Affairs Law Enforcement Regulations in 2014 in Korea. In contrast, in vitro diagnostic devices for animal were still managed as medical devices and biological medicines, respectively. The diagnostic reagents for infectious diseases have neither classification nor grade systems. Good manufacturing practices (GMP) requirements on IVDVMRs were also exempted from the current system. This study suggested that the registration of the IVDVMRs has increased since 2005, and regulations of these devices should be improved for the effective operating system.
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KEYWORD
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In vitro diagnostic veterinary medical reagents, registration, sales, regulatory management system
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