1. Inqubekelaphambili yomsebenzi yakamuva:
Isimemezelo esilawulayo se-paclitaxel yemvelo:
● I-China CDE:
Ngomhla ziyi-13 kuZibandlela, 2021, isicelo sokuchibiyela se-CDE sesiqediwe (isimo sakamuva se-CDE sikhonjisiwe esithombeni).futhi u-Hande wamukele ukuhlolwa kokuthobela kwe-GMP esizeni kwe-Yunnan Provincial Food and Drug Administration ngoJanuwari 18-20, 2022. Njengoba i-CDE ngeke isakhipha noma yimaphi amadokhumenti okugunyaza ukubhaliswa kwe-API noshintsho lokubuyekezwa, ngeke ikhiphe noma yimaphi amadokhumenti asekelayo isikhathi esikhona, kodwa singase sivele sibhekiselwe ngamalungiselelo namadivayisi.Ngokuvumelana nemvume ye-CDE, sicela ubhekisele ku-imeyili yesaziso soshintsho ukuze uthole inqubo ehlobene nezinguquko ezijwayelekile..
Ngemuva kokuhlolwa kwendawo, u-Yunnan Hande uzoqala kabusha ngokusemthethweni ukuthengisa emakethe yaseShayina.Inkampani yakho ingasebenzisa imikhiqizo ye-Hande ukwenza ucwaningo nokuthuthuka, ukuhlolwa okuncane, ukuhlolwa komshayeli kanye nokusetshenziswa komtholampilo ngokwezidingo zakho.Izinto zokufaka isicelo zingacaphuna ngokuqondile izinto ze-Hande CDE.
● EU EDQM:
U-Hande uthole isitifiketi se-CEP kanye “Nedokhumenti Yesitifiketi Sokuthunyelwa kwama-API e-EU” (“WC”), futhi imakethe ye-EU isiqalise kabusha ukuthengisa okusemthethweni kwezentengiso.Uma inkampani yakho idinga isitifiketi se-CEP kanye nencwadi yokugunyazwa noma imikhiqizo, sicela usithinte kusenesikhathi.
● I-US FDA:
Ulwazi loshintsho lwe-DMF luthunyelwe.
● Amanye amazwe noma izifunda:
I-Russia: Amakhasimende akhona aseqalile ukwenza ukubhaliswa kusebenze;
I-India: Idatha ye-DMF ithunyelwe;
IBrazil: Ukulungiswa kwedatha ye-DMF;
EJapane: Izinto zokubhalisa sezithunyelwe;
I-TGA yase-Australia: Ilungiselela;
I-EU GMP: ilungiselela;
Amanye amazwe azosebenza kanyekanye.Ngokuzayo, i-Hande izosiza inkampani yakho ukuthi yandise imakethe yesu lamazwe ngamazwe.
2. Umugqa wokukhiqiza we-paclitaxel we-10-DAB semi-synthetic:
Ukukhiqizwa komshayeli kuphelile futhi ukuhlolwa kuqediwe.Manje yenza ucwaningo lwekhwalithi nokuhlola ukuzinza.Uhlelo lokukhiqiza iqoqo lokuqinisekiswa kwenqwaba engu-3 luzoqala ngoJanuwari 2022 ngemva kokuqedwa kokufakwa nokusetshenziswa kwezisetshenziswa.
Uhlelo lokubhalisa lokulawula i-10-DAB semi-synthetic paclitaxel:
● I-China CDE: Inombolo Yedokhumenti: Y20210000685, kuhlelwe ukuqala isicelo engxenyeni yesibili ye-2022;
● I-EDQM ne-FDA: Hlela ukufayela ngekota yesine ka-2022.
3. Ulayini wokucubungula oyinhloko:
Ngezibalo ezikhona lapho kanye nokuhlolwa kwesampula kwezisekelo zokutshala i-yew eminingi, uhlelo lonyaka lokuthengwa kwempahla selusetshenziswe ngezisekelo zokutshala ezinkulu ezi-3 ukuze kuqinisekiswe ukutholakala kwempahla eluhlaza eyanele enani elisebenzayo le-paclitaxel.Ukukhishwa kwaminyaka yonke kwe-10-DAB kungu-2000kg/ngonyaka, enekhwalithi ezinzile kanye nokunikezwa isikhathi eside.
● Ukugcwalisa kwe-10-DAB III kokulawula:
I-DMF: Inombolo ye-DMF itholiwe.
2. Olunye ulwazi
1. Ethintwe yilolu bhubhane, i-Hande ngeke isahlanganyela embukisweni we-CPHI.Ukuze sinikeze usizo kangcono inkampani yakho, sizoqhubeka nokuvakashela amakhasimende futhi sibambisane nomsebenzi wokuthuthukisa imakethe wenkampani yakho ngezinsizakalo ezingcono.
Isikhathi sokuthumela: Feb-18-2022