Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan
Identifikátory výsledku
Kód výsledku v 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>
Výsledek na webu
<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>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan
Popis výsledku v původním jazyce
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.
Název v anglickém jazyce
Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan
Popis výsledku anglicky
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.
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
—
OECD FORD obor
30104 - Pharmacology and pharmacy
Návaznosti výsledku
Projekt
—
Návaznosti
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Ostatní
Rok uplatnění
2020
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES
ISSN
0253-1933
e-ISSN
1608-0637
Svazek periodika
39
Číslo periodika v rámci svazku
3
Stát vydavatele periodika
FR - Francouzská republika
Počet stran výsledku
11
Strana od-do
699-709
Kód UT WoS článku
000770919000004
EID výsledku v databázi Scopus
2-s2.0-85126389190