Yintoni Le Ngcaciso Ecacileyo?
I-DMF iyadingeka ukubonelela izinto ezininzi kwiUnited States, kodwa i-FDA ayifuni ukuba bonke abakhiqizi bangenise iDMF. Nangona kunjalo, ulwazi oluqulethwe kwi-DMF lungasetyenziselwa ukuxhasa isicelo soPhando olutsha lweDrug (I-IND), iSicelo seNtsha seDrug (i-NDA), iSicelo esitsha esiPhezulu seDrug (ANDA), esinye i-DMF, isicelo se-Export, okanye amaxwebhu ahlobene.
I-FDA ithi i-DMF ayikwazi ukutshintshwa kwi-IND, i-NDA, i-ANDA okanye i-Export Application. "Ayivunywanga okanye ayivumelekanga," ngokutsho kwe-FDA. Okuqukethwe kobugcisa be-DMF kuhlaziywa kuphela malunga nokuhlaziywa kwe-IND, i-NDA, i-ANDA, okanye i-Application Export. "
Abenzi be-API abaneenombolo ezininzi ze-DMF bahlala becinga ukuba banokwethenjelwa ngokubhekiselele kumgangatho, ukuma komthetho, kunye nokukwazi ukuhlangabezana neemfuno ezikhoyo ze-Current Good Manufacturing Process (cGMP).
Ngaphambi kokuba i-DMF ihlaziywe, umenzi kufuneka angenise ifom yefom yefayile ebonisa iDMF. Azikho zonke ii-DMF ezihlaziywa yi-FDA, kwaye i-DMF yemveliso ayiqinisekisi ukuba umenzi uvelisa loo mveliso okanye unokukwazi ukunikezela kwi-United States.
Kwixesha elidlulileyo, ukufakela i-DMF yayiyindlela eya kufakwa amafemu angancinci ukuba athathe i-degree of trust xa ezama ukuthengisa kwimakethi yase-US nakwezinye iimarike ezilawulwayo.
Nangona kunjalo, ekubeni i-DMF ihlaziywa kuphela xa i-ANDA okanye i-NDA ibhekisela kuyo, i-DMF engakhange ibhekiswe kuyo ixabiso lokungabaza nokuba ngaba umnini we-DMF ucinga ukuba ne-DMF yenza ukuba bajonge ngokusemthethweni. Ukufakela i-DMF ngaphandle kwanamaphi amakhasimende ase-US sele ephantsi kakhulu, ngoko ke ii-DMF zakutshanje zibonakaliso olungcono kunenjongo yokuvelisa kune-DMF endala.
Iintlobo ezintlanu zeDMF
Uhlobo I: Indawo yokuvelisa, izibonelelo, iinkqubo zokusebenza kunye nabasebenzi abangabalulekanga kwiziyobisi. Uhlobo lwam I-DMF alwamkelekanga yi-FDA, kodwa abadala bahlala kwifayile.
Uhlobo II: Izinto zokusetyenziswa kweziyobisi, izidibanisi zezinto eziphathekayo kunye nezinto ezisetyenziselwa ukulungiselela, okanye imveliso yeziyobisi. Ifom ye-II i-DMF, ifomu eqhelekileyo, inokufakela ifom yefayili yefayili eyenziwe phantsi kwekhontrakthi kwenye inkampani leyo eya kufaka i-ANDA.
Uhlobo lwe-III: Izixhobo zokupakisha, kwiibhotile kunye neefowuni kwi-resin ye-PVC esetyenziswe ekuvelweni kwayo kufuneka ikhutshwe kwi-DMF okanye enye i-FDA njengokwi-NDA.
Uhlobo IV: I- excipient, i-colorant, i-flavour, i-essence okanye i-DMF yezinto. Izinto ezithandayo zizinto ezingasebenziyo ezinjengomzimba okanye i-cellulose esetyenziselwa ukubopha i-powder yezilwanyana ndawonye ukuze ixinzeke kwi-tablet. Eminye imizekelo ibandakanya ukunambitheka kweziyobisi zamanzi, utywala kotywala, njl njl.
Uhlobo lwe-V: I- FDA yamkela ulwazi lwenkcukacha engabandakanywa kwezinye iindidi.
I-FDA idinga ukuba i-DMF ibe yangoku ngexesha lokuhlaziywa. Imimiselo ye-FDA ephathelene ne-DMF ithi: "Nayiphi na isongezelelo, utshintsho okanye ukususwa kolwazi kwifayili yomphathi weziyobisi (ngaphandle kweluhlu olufunekayo phantsi komhlathi (d) kweli candelo) kufuneka ukuba lithunyelwe kwiikopi ezimbini kwaye zichazwe ngamagama, inombolo yereferensi, umthamo, kunye nenombolo yekhasi ulwazi oluchaphazelekayo kwifayile yefayili. "
I-FDA iqinisekisa ukuba ii-DMF zikhoyo. Ukuba inkampani ingazange ingenise ingxelo yonyaka kwiminyaka emithathu, i-arhente ithumela "Iincwadi zokuLawulwa kweeNkcitho" kwi-DMF. Umnini unemihla engama-90 ekuphenduleni kwaye angenise ingxelo yayo yonyaka. Ukuba abahluleki ukuphendula, i-DMF yabo ingavalwa.
Isikhokelo se-FDA yeeFayili zeMadakamizwa zifumaneka kwiwebhusayithi yayo.