Other formats:
BibTeX
LaTeX
RIS
@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.
|