Xa uthetha ngeFayile enguMphathi weDrugs, abavelisi abohlukeneyo banereactions.I-DMF ayinyanzelwanga ukuba abavelisi babhalise. Nangona kunjalo, inani elikhulu labenzi bamachiza basafaka isicelo kwaye babhalise iDMF kwiimveliso zabo. Ngoba?
Ukuhla kwishishini, masijonge imixholo yeFayile enguMphathi weziyobisi kuqala, emva koko sithethe ngento enokuyenza!
Iseti epheleleyo yamaxwebhu abonisa imveliso yeziyobisi kunye nolawulo lomgangatho ibizwa ngokuba yiFayile eyiNgqondo yeziyobisi (DMF), ebandakanya ukwaziswa kwendawo yokuvelisa (iplanti), imilinganiselo ethile yomgangatho kunye neendlela zokuhlola, inkqubo yokuvelisa kunye nenkcazelo yezixhobo, ulawulo lomgangatho kunye nomgangatho. ulawulo.
Zeziphi iinkampani ezinokufaka isicelo seDMF?
Kukho iintlobo EZINHLANU zeDMF ekhutshwe yi-FDA:
Uhlobo I:Isiza soVeliso, iZibonelelo, iiNkqubo zokuSebenza, kunye naBasebenzi
Uhlobo II: Iziyobisi, iChiza eliPhakathi, kunye nezinto ezisetyenziswa ekuzilungiseleleni, okanye imveliso yeziyobisi.
Uhlobo lwe-III: Izinto zokuPakisha
Uhlobo IV: Umxhasi, uMbala, iNcasa, iEssence, okanye izinto ezisetyenziswa kuLungiselelo lwazo
Uhlobo lwe-V: Ulwazi olwamkelweyo lwe-FDA lweNkomba
Ngokwezi ntlobo zintlanu zingentla, iindidi ezahlukeneyo zeenkampani zinokufaka izicelo kuzo ngokweemfuno zazo kumxholo wolwazi ofunwa ziintlobo ezahlukeneyo zeDMF.
Umzekelo, ukuba ungumntuAPI umenzi,i-DMF okufuneka uyifake kwi-FDA yeyodidi II.Izixhobo ozinikezelayo kufuneka zibandakanye:ukufakwa kwesicelo,ulwazi olufanelekileyo lolawulo,ingxelo yokuzibophelela kweshishini,inkcazo yezinto eziphathekayo kunye neekhemikhali zemveliso esetyenzisiweyo,inkcazo eneenkcukacha yeendlela zokuvelisa imveliso. ,Ulawulo lomgangatho wemveliso kunye nolawulo lwenkqubo yokuvelisa, uvavanyo lozinzo lwemveliso, ukupakishwa kunye nokuleyibheli, iinkqubo zokusebenza eziqhelekileyo Ukugcinwa kunye nokulawulwa kwezinto ezikrwada kunye neemveliso ezigqityiweyo, ulawulo lwamaxwebhu, ukuqinisekiswa, inkqubo yokulawula inombolo yebhetshi, ukubuyiswa kunye nokulahlwa, njl.
Kwiimeko ezininzi, i-DMF ibe yenye yezinto ezibalulekileyo kuhlobo oluthile lwechiza kunye ne-API ukuba inokuthunyelwa kwilizwe elithile.Xa ufuna ukungena kwimarike yokuthengisa yamanye amazwe, ukufumaneka kwale DMF kubalulekile. .
NjengakuLuluntu lwaseYurophu, iDMF yinxalenye yelayisenisi yokuthengisa. Ngamachiza, iseti yezinto ziya kungeniswa kuLuntu lwaseYurophu okanye kuLawulo lweLizwe lokuthengisa lweDrugs lelizwe elithengisayo, kwaye ilayisenisi yokuthengisa iya kuphathwa.Xa umthengisi yesithako esisebenzayo (ie API) esetyenziswa kutshintsho lwechiza, ezi nkqubo zingentla ziyakusebenza.I-DMF yinxalenye ebalulekileyo yemathiriyeli yesicelo.Ukuba i-DMF ayibonelelwanga njengoko kufuneka, iimveliso eziveliswayo azinakuthengiswa kwilizwe.
I-DMF idlala indima ephambili kubavelisi. Okwangoku, i-Hande yenza isiceloI-MelatoninI-DMF.Ngokubhekiselele kuxwebhu lobhaliso, i-Hande ineminyaka emininzi yamava esicelo kunye neqela leengcali.Iziko lokuPhendula ngokuKhawuleza esinalo libonelela ngezona ndlela zingcono zokuhlangabezana neemfuno zakho ngelona xesha lifutshane.Ukuba ufuna ukufaka isicelo samaxwebhu eDMF ngelixa ukuodolaI-Melatonin, Nceda uzive ukhululekile ukuqhagamshelana nathi!
Ixesha lokuposa: Sep-23-2022