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

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>

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2020

Kód důvěrnosti údajů

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

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