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

J 2020

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

POTOČKOVÁ, Hana, Jiří DOHNAL and B. THOME-KROMER

Basic information

Original name

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

Authors

POTOČKOVÁ, Hana (203 Czech Republic, guarantor, belonging to the institution), Jiří DOHNAL (203 Czech Republic, belonging to the institution) and B. THOME-KROMER

Edition

REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES, Paris, OFFICE INT EPIZOOTIES, 2020, 0253-1933

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30104 Pharmacology and pharmacy

Country of publisher

France

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 1.181

RIV identification code

RIV/00216224:14160/20:00129819

Organization unit

Faculty of Pharmacy

DOI

http://dx.doi.org/10.20506/rst.39.3.3171

UT WoS

000770919000004

Keywords in English

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

Abstract

V originále

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.

Citovat

POTOČKOVÁ, Hana, Jiří DOHNAL and B. THOME-KROMER. Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan. REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES. Paris: OFFICE INT EPIZOOTIES, 2020, vol. 39, No 3, p. 699-709. ISSN 0253-1933. Available from: https://dx.doi.org/10.20506/rst.39.3.3171.

@article{1846921,
   author = {Potočková, Hana and Dohnal, Jiří and ThomeandKromer, B.},
   article_location = {Paris},
   article_number = {3},
   doi = {http://dx.doi.org/10.20506/rst.39.3.3171},
   keywords = {European Union; Japan; Point-of-care testing; Regulation; United States of America; Veterinary diagnostics},
   language = {eng},
   issn = {0253-1933},
   journal = {REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES},
   title = {Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan},
   url = {https://doc.oie.int/dyn/portal/index.xhtml?page=alo&aloId=42232},
   volume = {39},
   year = {2020}
}

TY  - JOUR
ID  - 1846921
AU  - Potočková, Hana - Dohnal, Jiří - Thome-Kromer, B.
PY  - 2020
TI  - Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan
JF  - REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES
VL  - 39
IS  - 3
SP  - 699-709
EP  - 699-709
PB  - OFFICE INT EPIZOOTIES
SN  - 02531933
KW  - European Union
KW  - Japan
KW  - Point-of-care testing
KW  - Regulation
KW  - United States of America
KW  - Veterinary diagnostics
UR  - https://doc.oie.int/dyn/portal/index.xhtml?page=alo&aloId=42232
N2  - 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.
ER  -

POTOČKOVÁ, Hana, Jiří DOHNAL and B. THOME-KROMER. Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan. \textit{REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES}. Paris: OFFICE INT EPIZOOTIES, 2020, vol.~39, No~3, p.~699-709. ISSN~0253-1933. Available from: https://dx.doi.org/10.20506/rst.39.3.3171.

Detailed Information on Publication Record