Performance assessment of registration, sales and the regulatory management system of in vitro diagnostic veterinary medical reagents in Korea

• 발행기관: 한국예방수의학회
• 저자명: Hyang-Jin Yoon Hyo-Jin An Chung-Hyun Kim Yeon-Hwa Kim Sung-Hwan Wee Jin-San Moon
• 간행물 정보: 『Journal of Preventive Veterinary Medicine』Vol.39, No.3, 119~125쪽, 전체 7쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2015.09.30

영문 초록

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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In vitro diagnostic veterinary medical reagents registration sales regulatory management system