Journal of Veterinary Clinics (한국임상수의학회지)

The Korean Society of Veterinary Clinics (한국임상수의학회)
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Trends of Market and Approval Management System for in vitro Diagnostic Veterinary Medical Reagents in Korea

  • Kang, Kyoung-Mook (Veterinary Pharmaceutical Management Division, Animal and Plant Quarantine Agency) ;
  • Kang, Min-Hee (Department of Veterinary Internal Medicine, College of Veterinary Medicine, Konkuk University) ;
  • Suh, Tae-Young (Veterinary Pharmaceutical Management Division, Animal and Plant Quarantine Agency) ;
  • Kang, Hwan-Goo (Veterinary Pharmaceutical Management Division, Animal and Plant Quarantine Agency) ;
  • Moon, Jin-San (Veterinary Pharmaceutical Management Division, Animal and Plant Quarantine Agency)
  • Received : 2018.07.17
  • Accepted : 2018.08.09
  • Published : 2018.08.31
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Abstract

In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicine by the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into class I-IV according to risks of individual and public health. However, good manufacturing practices requirements on IVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant Quarantine Agency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978 to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infection disease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug of abuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association was estimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales were approximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumption and 40.4% (CAGR) in export from 2011 to 2017.

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References

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