Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan

被引：1

作者：

Potockova, H. ^{[1
,2
]}

Dohnal, J. ^{[1
]}

Thome-Kromer, B. ^{[3
]}

机构：

[1] Masaryk Univ, Dept Appl Pharm, Palackeho Tr 1946-1, Brno 61200, Czech Republic

[2] Bioinova Sro, Videnska 1083, Prague 14200, Czech Republic

[3] Regulatory & Qual Management, Str Jugend 32, D-14532 Kleinmachnow, Germany

来源：

REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES | 2020年 / 39卷 / 03期

关键词：

European Union; Japan; Point-of-care testing; Regulation; United States of America; Veterinary diagnostics;

D O I：

10.20506/rst.39.3.3171

中图分类号：

S85 [动物医学（兽医学）];

学科分类号：

0906 ;

摘要：

Point-of-care testing (POCT) is used to detect diseases and other conditions or to monitor therapeutic procedures. In veterinary medicine, POCT not only helps during the prevention, diagnosis and treatment of animal diseases but it also has a direct impact on human health by safeguarding food supplies and preventing zoonoses. Despite its importance, the regulation of the quality, safety and effectiveness of POCT products is rarely discussed. This review reveals that the level of regulatory surveillance of veterinary POCT products in the European Union (EU), the United States of America and Japan is strikingly different, ranging from no regulation (EU) to comprehensive regulation, which is comparable to the procedures for the regulation of human in vitro medical devices (Japan). Details about the licensing procedures in these three locations, discussion of their strengths and weaknesses, and suggestions for possible future development of the regulation of these products are also provided.

引用

页码：699 / 709

页数：11

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