Uma ukhuluma ngefayela le-Drug Master, abakhiqizi abahlukene banokusabela okuhlukile. I-DMF ayiphoqelekile ukuthi abakhiqizi babhalise. Nokho, inani elikhulu labakhiqizi bezidakamizwa lisafaka isicelo futhi libhalise i-DMF ngemikhiqizo yabo. Kungani?
Ukuze singene kwezamabhizinisi, ake sibheke okuqukethwe yi-Drug Master File kuqala, bese sikhuluma ngalokho elingakwenza!
Iqoqo eliphelele lamadokhumenti abonisa ukukhiqizwa kwezidakamizwa nokuphathwa kwekhwalithi libizwa ngokuthi I-Drug Master File(DMF), okuhlanganisa ukwethulwa kwendawo yokukhiqiza(isitshalo), ukucaciswa kwekhwalithi ethile nezindlela zokuhlola, inqubo yokukhiqiza nencazelo yemishini, ukulawulwa kwekhwalithi kanye nekhwalithi. abaphathi.
Yiziphi izinkampani ezingafaka isicelo se-DMF?
Kunezinhlobo EZINHLANU ze-DMF ezikhishwe yi-FDA:
Uhlobo I:Isizinda Sokukhiqiza, Izinsiza, Izinqubo Zokusebenza, Nabasebenzi
Uhlobo II:Isidakamizwa,Isidakamizwa Esimaphakathi, kanye Nezinto Ezisetshenziswa Ekulungiseni Kwazo, noma Umkhiqizo Wezidakamizwa
Uhlobo III:Into yokupakisha
Uhlobo IV: I-excipient, Colorant, Flavour, Essence, noma Izinto Ezisetshenziswa Ekulungiseleleni
Thayipha i-V: Ulwazi Oluyisethenjwa olwamukelwe yi-FDA
Ngokwalezi zinhlobo ezinhlanu ezingenhla, izinhlobo ezahlukene zezinkampani zingazifaka izicelo kuye ngokwezidingo zazo zokuqukethwe kolwazi oludingwa izinhlobo ezahlukene ze-DMF.
Isibonelo, uma uyi-Umkhiqizi we-API,i-DMF odinga ukufaka isicelo sayo ku-FDA ingeyohlobo II.Izinto ozihlinzekayo kufanele zihlanganise:ukuthunyelwa kwesicelo,ulwazi olufanelekile lokuphatha,isitatimende sokuzibophezela kwebhizinisi,incazelo yezakhiwo zomzimba namakhemikhali zomkhiqizo osetshenzisiwe,incazelo enemininingwane yezindlela zokukhiqiza umkhiqizo. ,ukulawulwa kwekhwalithi yomkhiqizo kanye nokulawula inqubo yokukhiqiza,ukuhlolwa kokuzinza komkhiqizo,ukupakishwa nokulebula,izinqubo ezijwayelekile zokusebenza Ukugcinwa nokuphathwa kwezinto ezingavuthiwe nemikhiqizo eqediwe,ukuphathwa kwemibhalo,ukuqinisekisa,uhlelo lokuphatha inombolo yenqwaba,ukubuyisela nokulahlwa,njll.
Ezimweni eziningi, i-DMF isiphenduke enye yezinto ezibalulekile zohlobo oluthile lomuthi kanye ne-API ukuthi ingathunyelwa yini ezweni elithile.Uma ufuna ukungena emakethe yokuthengisa yamanye amazwe, ukutholakala kwale DMF kubalulekile. .
Njengase-European Community, i-DMF iyingxenye yelayisensi yokumaketha.Ngezidakamizwa, iqoqo lezinto ezisetshenziswayo kufanele zihanjiswe ku-European Community noma i-National Drug Administration yezwe elidayisayo, futhi ilayisensi yokumaketha izophathwa.Lapho umphakeli yesithako esisebenzayo(ieAPI)esisetshenziswa ezinguqukweni zomuthi,izinqubo ezingenhla zizosebenza.I-DMF iyingxenye ebalulekile yezinto ezisetshenziswayo.Uma i-DMF inganikezwanga njengoba kudingekile, imikhiqizo ekhiqizwayo ayikwazi ukudayiselwa izwe.
I-DMF idlala indima ebalulekile kubakhiqizi.Okwamanje, i-Hande ifaka isiceloI-MelatoninI-DMF.Mayelana nokubhaliswa kwemibhalo, i-Hande inesipiliyoni seminyaka eminingi yokufaka isicelo kanye nethimba eliqeqeshiwe.I-Rapid Response Center esinayo ikunikeza izinketho ezingcono kakhulu zokuhlangabezana nezidingo zakho ngesikhathi esifushane.Uma udinga ukufaka isicelo semibhalo ye-DMF ngenkathi iyalaI-Melatonin, sicela ukhululeke ukuxhumana nathi!
Isikhathi sokuthumela: Sep-23-2022