Umahluko phakathi kwe-CGMP yaseMelika kunye ne-Old Chinese GMP (Icandelo I)

I-GMP (Uqheliselo oluLungileyo lokuVelisa) sisikhokelo esijolise ekulawuleni nasekubekeni iliso kwimisebenzi yokwenziwa kwamayeza kwihlabathi liphela.Kukwayimvume eyimfuneko yokuba abavelisi bamayeza bangene kwintsimi yorhwebo lwamazwe ngamazwe.

I-GMP ibandakanya: indawo, abantu, indawo, ucoceko, ukuqinisekiswa, uxwebhu, imveliso, umgangatho, ukuthengiswa, ukusetyenziswa kwakhona kunye nokuhlola njl. Inemithetho engqongqo yethekhnoloji, inkqubo yokulawula kunye nokulawula ukuqinisekiswa ukukhusela: ukudideka phakathi kwezithako, ukusuleleka kunye nokusuleleka amanye amayeza, ukuguquguquka kunye nokutenxa kumxube wamacandelo ahlukeneyo, iingozi zamanyathelo alahlekileyo okuhlola, ukusebenza okungalunganga kunye nenye inkqubo engafanelekanga.

Umbono we-GMP wakhuliswa kwi-80s yaseTshayina kwaye yabhengezwa ngokusemthethweni njengommiselo obanzi kunye nonyanzelekileyo ngoJulayi 1.^st, 1999. E-USA, i-cGMP (ifutshane kwiiNdlela zokuSebenza eziLungileyo zangoku) yakhululwa kwi-CFR inxalenye ye-210 kunye nenxalenye ye-211 kwi-90s.

Lilonke, injongo, umgaqo, isifundo kunye nemfuno ye-GMP yaseTshayina iphantse yafana naleyo ye-cGMP yaseMelika kodwa ngenene kukho iyantlukwano emininzi ngolu hlobo lulandelayo.

Inkqubo yokuVunywa

Isiqinisekiso se-GMP yaseTshayina sisiqinisekiso kuphela semvume yokuvelisa amayeza, ngaphandle kokubhaliswa kwemveliso.Emva kokuba umenzi evunyiwe kwimveliso entsha kunye nenombolo yobhaliso, uyakwazi ukuqhubeka nesicelo sesiqinisekiso se-GMP.Ngaphezu koko, idatha yeebhetshi ezintathu zemveliso kunye nedatha yovavanyo lozinzo ubuncinane kwiinyanga ezintandathu ziyafuneka ukuba zingeniswe kubhaliso lwemveliso okanye isatifikethi se-GMP.

Isiqinisekiso se-American cGMP siqukethe iinxalenye ezimbini: uPhuhliso lweMveliso kunye noLawulo lweMichiza yoMveliso.Oko kuthetha ukuba ukubhaliswa kwemveliso kunye nemvume yokuvelisa kuqhubeka ngexesha elinye.Kukho iintlobo ezimbini zokubhaliswa kwemveliso e-USA: Isicelo esitsha seChiza (i-NDA) kunye neSifinyezo seSicelo esitsha seChiza (i-ANDA).I-NDA idinga idatha yeebhetshi ezintathu zemveliso kunye nedatha yokuvavanya ukuzinza kwiinyanga ezintandathu.I-ANDA idinga idatha yebhetshi yemveliso kunye nedatha yokuvavanya ukuzinza kwiinyanga ezintathu.Idatha yovavanyo oluqhubekayo kunye nokuqinisekiswa iya kugcinwa ngumenzi kwaye ibhengezwe kwingxelo yonyaka kwi-FDA.

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