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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14160%2F20%3A00129819" target="_blank" >RIV/00216224:14160/20:00129819 - isvavai.cz</a>

Result on the web

<a href="https://doc.oie.int/dyn/portal/index.xhtml?page=alo&aloId=42232" target="_blank" >https://doc.oie.int/dyn/portal/index.xhtml?page=alo&aloId=42232</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.20506/rst.39.3.3171" target="_blank" >10.20506/rst.39.3.3171</a>

Result language

angličtina

Original language name

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

Original language description

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.

Czech name

—

Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30104 - Pharmacology and pharmacy

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2020

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES

ISSN

0253-1933

e-ISSN

1608-0637

Volume of the periodical

39

Issue of the periodical within the volume

3

Country of publishing house

FR - FRANCE

Number of pages

11

Pages from-to

699-709

UT code for WoS article

000770919000004

EID of the result in the Scopus database

2-s2.0-85126389190