INNOVITA yabonye icyemezo cya MDSAP, kizakomeza gufungura isoko mpuzamahanga

Ku ya 19 Kanama, Beijing Innovita Biological Technology Co., Ltd. (“INNOVITA”) yabonye impamyabumenyi ya MDSAP, irimo Amerika, Ubuyapani, Burezili, Kanada, na Ositaraliya, bizafasha INNOVITA kurushaho gufungura isoko mpuzamahanga.

Izina ryuzuye rya MDSAP nigikoresho cyubuvuzi Porogaramu imwe yo kugenzura, ni gahunda imwe yo kugenzura ibikoresho byubuvuzi.Numushinga watangijwe nabagize ihuriro mpuzamahanga rishinzwe kugenzura ibikoresho byubuvuzi (IMDRF).Ikigamijwe ni uko ikigo cy’ubugenzuzi cyujuje ibyangombwa gishobora gukora igenzura ryabakora ibikoresho byubuvuzi kugirango bahuze QMS / GMP zitandukanye mubihugu byitabiriye.

Uyu mushinga wemejwe n’inzego eshanu zishinzwe kugenzura, Ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge, Ikigo cy’ubuzima cya Kanada, Ikigo gishinzwe ubuvuzi bwa Ositarariya, Ikigo cy’ubuzima cya Berezile na Minisiteri y’ubuzima y’Ubuyapani, umurimo n’imibereho myiza.Twabibutsa ko iki cyemezo gishobora gusimbuza bimwe mubigenzuzi nubugenzuzi busanzwe mubihugu byavuzwe haruguru, kandi bikabona isoko, bityo ibyangombwa bisabwa bikaba biri hejuru.Kurugero, Ubuzima bwa Canada bwatangaje ko guhera ku ya 1 Mutarama 2019, MDSAP izasimbuza ku gahato CMDCAS nka porogaramu yo gusuzuma ibikoresho by’ubuvuzi bya Kanada.

Kubona impamyabumenyi ya MDSAP y'ibihugu bitanu ntabwo byemewe cyane na INNOVITA n'ibicuruzwa byayo na Ositaraliya, Burezili, Kanada, Amerika, n'Ubuyapani, ariko kandi bifasha INNOVITA gukomeza kwagura umubare w’abiyandikisha mu mahanga. kwipimisha ikamba.Kugeza ubu, ibizamini bya Covid-19 bya INNOVITA byanditswe mu bihugu bigera kuri 30, birimo Amerika, Burezili, Ubufaransa, Ubutaliyani, Uburusiya, Espagne, Porutugali, Ubuholandi, Hongiriya, Otirishiya, Suwede, Singapore, Filipine, Maleziya, Tayilande. , Arijantine, Ecuador, Kolombiya, Peru, Chili, Mexico, nibindi

Biravugwa ko INNOVITA ikomeje kwihutisha gusaba kwiyandikisha mu bihugu byinshi ndetse n’ibigo, ikagura umubare w’ibizamini bya Covid-19 mu mahanga, harimo no gusaba icyemezo cya EU CE (kwipimisha) hamwe n’ikizamini gishya cya Covid-19 cyo muri Amerika FDA. Kwiyandikisha.
Icyorezo ku isi gikomeje gukwirakwira.Ibikoresho bya Covid-19 bya INNOVITA byagurishijwe mu bihugu no mu turere dusaga 70, kandi bakoze iperereza ryuzuye, ryihuse kandi rinini kuri virusi ya SARS-CoV-2, bigira uruhare runini mu kurwanya isi yose kurwanya Covid-19 icyorezo.