1. Ibikorwa bigezweho:
Kumenyekanisha kugenga paclitaxel karemano:
CD Ubushinwa CDE:
Ku ya 13 Ukuboza 2021, porogaramu y'inyongera ya CDE yararangiye (imiterere ya CDE iheruka kugaragara ku ifoto).na Hande bemeye igenzura rya GMP ku rubuga rw’ubuyobozi bushinzwe ibiryo n'ibiyobyabwenge mu Ntara ya Yunnan ku ya 18-20 Mutarama 2022. Kubera ko CDE itazongera gutanga ibyangombwa byemewe byo kwiyandikisha kwa API no gusuzuma impinduka, ntabwo izatanga ibyangombwa byemeza kuri igihe kiri, ariko birashobora kwerekanwa nimyiteguro nibikoresho.Ukurikije ibyemezo bya CDE, nyamuneka reba imeri imenyesha impinduka kubikorwa bijyanye nimpinduka zisanzwe..
Nyuma yo kugenzura aho, Yunnan Hande azakomeza kugurisha ku isoko ku isoko ry’Ubushinwa.Isosiyete yawe irashobora gukoresha ibicuruzwa bya Hande mubushakashatsi niterambere, ikizamini gito, ikizamini cyikigereranyo no gukoresha amavuriro ukurikije ibyo ukeneye.Ibikoresho byo gusaba birashobora gusubiramo mu buryo butaziguye ibikoresho bya CDE.
ED EU EDQM:
Hande yabonye icyemezo cya CEP n '“Icyemezo cyo kohereza APIs mu bihugu by’Uburayi” (“WC”), kandi isoko ry’Uburayi ryongeye kugurisha ku mugaragaro.Niba isosiyete yawe ikeneye icyemezo cya CEP nibaruwa yemewe cyangwa ibicuruzwa, nyamuneka twandikire mugihe.
● US FDA:
Amakuru yo guhindura DMF yatanzwe.
● Ibindi bihugu cyangwa uturere:
Uburusiya: Abakiriya bariho batangiye gukora kwiyandikisha;
Ubuhinde: Amakuru ya DMF yatanzwe;
Burezili: Gutegura amakuru ya DMF;
Ubuyapani: Ibikoresho byo kwiyandikisha byatanzwe;
TGA yo muri Ositaraliya: Mu kwitegura;
EU GMP: mu myiteguro;
Ibihugu bisigaye bizasaba icyarimwe.Mu bihe biri imbere, Hande azafasha isosiyete yawe kwagura isoko mpuzamahanga.
2. 10-DAB igice cya sintetike ya paclitaxel yumurongo:
Umusaruro windege urarangiye kandi ibizamini birarangiye.Noneho kora ubushakashatsi bufite ireme no kugenzura ituze.Gahunda yo kugenzura ibyiciro 3 yo gutangira bizatangira muri Mutarama 2022 nyuma yo gushyira no gutangiza ibikoresho birangiye.
10-DAB igice-cyogukora paclitaxel gahunda yo kwiyandikisha:
CD Ubushinwa CDE: Inyandiko No.: Y20210000685, hateganijwe gutangira gusaba mu gihembwe cya kabiri cya 2022;
● EDQM na FDA: Teganya gutanga dosiye mu gihembwe cya kane cya 2022.
3. Umurongo wibanze wo gutunganya:
Binyuze mu mibare ikorerwa hamwe no gupima icyitegererezo cy’ibiti byinshi byatewe, gahunda y’amasoko ngarukamwaka yashyizwe mu bikorwa hamwe n’ibiti 3 binini byo gutera kugira ngo habeho ibikoresho bihagije bya paclitaxel.Umusaruro wumwaka wa 10-DAB ni 2000kg / mwaka, hamwe nubwiza buhamye hamwe nigihe kirekire.
● 10-DAB III gutanga amabwiriza:
DMF: Umubare DMF wabonetse.
2. Andi makuru
1. Yibasiwe nicyorezo, Hande ntazongera kwitabira imurikagurisha rya CPHI.Kugirango turusheho gukorera uruganda rwawe, tuzakomeza gukora gusura abakiriya no gufatanya nakazi ka sosiyete yawe guteza imbere isoko hamwe na serivisi nziza.
Igihe cyo kohereza: Gashyantare-18-2022