Ngomhla we-19 ka-Agasti, i-Beijing Innovata Biological Technology Co., Ltd. ("INNOVITA") ifumene isatifikethi se-MDSAP, ebandakanya i-United States, iJapan, iBrazil, iCanada, kunye ne-Australia, eya kunceda i-INNOVITA ivule ngakumbi imarike yamazwe ngamazwe.
Igama elipheleleyo le-MDSAP yiNkqubo yoPhicotho lweSixhobo soNyango esiNye, neyinkqubo yophicotho olunye lwezixhobo zonyango.Yiprojekthi eqalwe ngokudibeneyo ngamalungu eForam yoLawulo lweSixhobo sezoNyango saMazwe ngaMazwe (IMDRF).Injongo kukuba i-arhente yophicotho-zincwadi zenkampani yesithathu inokwenza uphicotho lwabavelisi bezixhobo zonyango ukuhlangabezana neemfuno ezahlukeneyo ze-QMS/GMP zamazwe athatha inxaxheba.
Le projekthi ivunyiwe ngamaqumrhu amahlanu alawulayo, i-US Food and Drug Administration, i-Arhente yezeMpilo yaseCanada, i-Australian Therapeutic Products Administration, i-Arhente yezeMpilo yaseBrazil kunye noMphathiswa wezeMpilo waseJapan, uMsebenzi kunye neNtlalontle.Kufanelekile ukukhankanya ukuba esi satifikethi sinokuthatha indawo yolunye uphicotho kunye nokuhlolwa kwesiqhelo kumazwe akhankanywe ngasentla, kwaye nokufumana ukufikelela kwimarike, ngoko ke iimfuno zesatifikethi ziphezulu kakhulu.Ngokomzekelo, i-Health Canada ibhengeze ukuba ukususela nge-1 kaJanuwari 2019, i-MDSAP iya kunyanzeliswa endaweni ye-CMDCAS njengenkqubo yokuphonononga ukufikelela kwisixhobo sonyango saseKhanada.
Ukufumana isiqinisekiso senkqubo ye-MDSAP yamazwe amahlanu ayikona nje ukuqondwa okuphezulu kwe-INNOVITA kunye neemveliso zayo yi-Australia, iBrazil, iCanada, iUnited States, kunye neJapan, kodwa ikwanceda i-INNOVITA ukuba iqhubeke nokwandisa isikali sobhaliso lwaphesheya kolwandle. ii-reagents zokuvavanya isithsaba.Okwangoku, uvavanyo lwe-INNOVITA lwe-Covid-19 lubhalisiwe kumazwe aphantse abe ngama-30, kubandakanya i-United States, iBrazil, iFransi, i-Itali, iRussia, iSpain, iPortugal, iNetherlands, iHungary, iOstriya, iSweden, iSingapore, iiPhilippines, iMalaysia, iThailand. , Argentina, Ecuador, Colombia, Peru, Chile, Mexico, njl.
Kuxelwe ukuba i-INNOVITA isakhawulezisa isicelo sobhaliso kunye namazwe amaninzi kunye namaziko, ukwandisa isikali sobhaliso lwaphesheya kovavanyo lwe-Covid-19, kubandakanya ukufaka isicelo sesiqinisekiso se-EU CE (ukuzivavanya) kunye ne-US FDA yovavanyo lwe-antigen entsha ye-Covid-19. ukubhaliswa kwekhithi.
Ubhubhani wehlabathi usaqhubeka ukusasazeka.Izixhobo zovavanyo ze-INNOVITA ze-Covid-19 zithengiswe kumazwe nakwimimandla engaphezulu kwama-70, kwaye baye baqhuba uphando oluchanekileyo, olukhawulezayo nolukhulu lwentsholongwane ye-SARS-CoV-2, bedlala indima ebalulekileyo kumlo wehlabathi ochasene ne-Covid-19. indyikitya yesifo esisulelayo.
Ixesha lokuposa: Oct-18-2021