I-FDA ikhuphe isaziso esithi “ukubhaliswa kwezixhobo kunye nokufakwa kuluhlu” kwiwebhusayithi yayo esemthethweni ngomhla wama-23 kuJuni, esigxininise ukuba:
I-FDA ayizikhuphi iZatifikethi zoBhaliso kwiindawo zezixhobo zonyango. I-FDA ayiqinisekisi ubhaliso kunye noluhlu
ulwazi lweenkampani ezibhalisileyo nezibhalisiweyo. Ubhaliso kunye noLuhlu alubonisi ukuvunywa okanye ukuvunyelwa kwenkampani
okanye izixhobo zabo.
Imiba ekufuneka siyiqwalasele xa kubhaliselwa i-FDA yile ilandelayo:
Umbuzo 1: ngowuphi umbutho okhuphe isatifiketi se-FDA?
A: akukho satifiketi sobhaliso lwe-FDA. Ukuba imveliso ibhalisiwe kwi-FDA, inombolo yobhaliso iya kufumaneka. I-FDA iya kunika umfaki-sicelo ileta yempendulo (esayinwe ngumphathi oyintloko we-FDA), kodwa akukho satifiketi se-FDA.
Isibhengezo se-FDA sesaziso esinjalo ngeli xesha sisikhumbuzo esinamandla! Ngenxa yophuhliso lwakutshanje lwemeko yobhubhane eMelika, imfuno yeemveliso zokuthintela ubhubhane kwezonyango ezithunyelwa eMelika ikhule kakhulu, kwaye imfuno yokubhaliswa kokuthunyelwa kwamanye amazwe nayo inyukile.
Xa amanye amashishini ezenza i-FDA ukuze akhuphe izatifikethi kubavelisi, amanye amashishini okuhambisa anokufumana “izatifikethi ze-FDA” zobuxoki xa ecebisa abavelisi.
Umbuzo 2: ngaba i-FDA ifuna ilebhu eqinisekisiweyo?
A: I-FDA yiarhente yokunyanzelisa umthetho, ayiyoarhente yenkonzo. Ukuba umntu uthi yilabhoratri yesatifikethi se-FDA, ubuncinane ukhohlisa abathengi, kuba i-FDA ayinayo inkonzo karhulumente.
Iiarhente zeziqinisekiso zesondo kunye neelabhoratri, akukho nto ibizwa ngokuba "yilebhu ekhethiweyo". Njengearhente yokunyanzeliswa komthetho karhulumente, i-FDA akufuneki ibandakanyeke kwizinto ezinjengokuba ngumpempe kunye nomdlali wezemidlalo. I-FDA iya kuvavanya kuphela inkonzo.
Umgangatho we-GMP welebhu uza kuqatshelwa, kwaye lowo ufanelekileyo uza kunikwa isatifiketi, kodwa asiyi “kutyunjwa” okanye kucetyiswe uluntu.
Umbuzo 3: ngaba ubhaliso lwe-FDA lufuna iarhente yaseMelika?
A: Ewe, ishishini kufuneka liqeshe ummi waseMelika (inkampani/uMbutho) njengearhente yalo xa libhalisa kwi-FDA. Iarhente inoxanduva lweenkonzo zenkqubo ezikwi-United States, eziziindaba ezinxibelelana ne-FDA kunye nomfaki-sicelo.
Iimpazamo eziqhelekileyo kubhaliso lwe-FDA
1. Ubhaliso lwe-FDA lwahlukile kwisiqinisekiso se-CE. Indlela yalo yokuqinisekiswa yahlukile kwindlela yovavanyo lwemveliso yesiqinisekiso se-CE + indlela yesatifikethi sengxelo. Ubhaliso lwe-FDA lusebenzisa indlela yokubhengeza ukuthembeka, oko kukuthi, unendlela yokubhengeza ngokholo olukhulu kwiimveliso zakho.
Ngokuhambelana nemigangatho efanelekileyo kunye neemfuno zokhuseleko, kwaye ibhalisiwe kwiwebhusayithi ye-US Federal, ukuba kukho ingozi ngemveliso, kufuneka ithwale uxanduva olufanelekileyo. Ke ngoko, ubhaliso lwe-FDA kwiimveliso ezininzi, akukho vavanyo lokuthumela isampuli
Nengxelo yesatifikethi.
2. Ixesha lokusebenza lobhaliso lwe-FDA: Ubhaliso lwe-FDA lusebenza unyaka omnye. Ukuba lungaphezulu konyaka omnye, kufuneka luphinde lungeniswe ukuze lubhaliswe, kwaye umrhumo wonyaka obandakanyekayo nawo kufuneka uhlawulwe kwakhona.
3. Ingaba i-FDA ibhalisiwe inesatifikethi?
Enyanisweni, akukho satifiketi sobhaliso lwe-FDA. Ukuba imveliso ibhalisiwe kwi-FDA, inombolo yobhaliso iya kufumaneka. I-FDA iya kunika umfaki-sicelo ileta yempendulo (esayinwe ngumphathi oyintloko we-FDA), kodwa akukho satifiketi se-FDA.
Isatifikethi esihlala sisibona sikhutshwa yiarhente yomlamli (iarhente yobhaliso) kumenzi ukubonisa ukuba sincede umenzi ukuba agqibezele "ubhaliso lwendawo yokuvelisa kunye nobhaliso lohlobo lwemveliso" olufunekayo yi-FDA.
(ubhaliso lokusekwa kunye noluhlu lwezixhobo), uphawu olugqityiweyo lunceda umenzi ukuba afumane inombolo yobhaliso ye-FDA.
Ngokwemigangatho eyahlukeneyo yomngcipheko, i-FDA yahlula izixhobo zonyango zibe ziindidi ezintathu (I, II, III), kwaye iklasi yesi-III ineyona nqanaba liphezulu lomngcipheko.
I-FDA ichaze ngokucacileyo iimfuno zokuhlelwa kwemveliso kunye nolawulo lwesixhobo ngasinye sezonyango. Okwangoku, kukho iintlobo ezingaphezu kwe-1700 zekhathalogu yezixhobo zonyango. Ukuba nasiphi na isixhobo sezonyango sifuna ukungena kwimarike yase-US, kufuneka kuqala sicacise iimfuno zokuhlelwa kunye nolawulo lweemveliso ezifakelwe ukuthengisa.
Emva kokucacisa ulwazi olungasentla, ishishini linokuqalisa ukulungiselela izixhobo ezifanelekileyo zokufaka isicelo, kwaye linike ingxelo kwi-FDA ngokweenkqubo ezithile ukuze lifumane imvume. Kuyo nayiphi na imveliso, amashishini kufuneka abhalise kwaye adwelise iimveliso.
Kwimveliso zeklasi yoku-1 (ezimalunga nama-47%), ulawulo oluqhelekileyo luyasetyenziswa. Uninzi lweemveliso lufuna kuphela ukubhaliswa, ukubhalwa kunye nokusetyenziswa kwemigangatho ye-GMP, kwaye iimveliso zinokungena kwimarike yase-US (zimbalwa kakhulu kuzo ezidibene ne-GMP)
Inani elincinci kakhulu leemveliso ezigciniweyo kufuneka zingenise isicelo se-510 (k) kwi-FDA, oko kukuthi i-PMN (isaziso sangaphambi kwemarike));
Kwiimveliso zeklasi yesiBini (ezimalunga nama-46%), ulawulo olukhethekileyo luyasetyenziswa. Emva kobhaliso nokufakwa kuluhlu, amashishini kufuneka asebenzise i-GMP aze angenise isicelo se-510 (k) (iimveliso ezimbalwa zikhululekile kwi-510 (k);
Kwimveliso zeklasi yesi-III (malunga ne-7%), ilayisenisi yokuthengisa ngaphambi kokuthengisa iyasetyenziswa. Emva kokubhalisa nokudweliswa, amashishini kufuneka asebenzise i-GMP kwaye angenise isicelo se-PMA (isicelo se-premarket) kwi-FDA (iCandelo lesi-3)
PMN).
Kwiimveliso zeklasi yoku-1, emva kokuba ishishini lingenise ulwazi olufanelekileyo kwi-FDA, i-FDA yenza isaziso kuphela, kwaye akukho satifiketi sifanelekileyo sinikwa ishishini; kwizixhobo zeklasi yesi-2 neyesi-3, ishishini kufuneka lingenise i-PMN okanye i-PMA, kwaye i-FDA iya
Nika ishishini ileta esemthethweni yokuvuma ukufikelela kwimarike, oko kukuthi, vumela ishishini ukuba lithengise iimveliso zalo ngqo kwimarike yezixhobo zonyango yaseMelika ngegama lalo.
Ukuba kufuneka uye kwishishini ukuze kuhlolwe i-GMP kwinkqubo yesicelo kugqitywa yi-FDA ngokwenqanaba lomngcipheko wemveliso, iimfuno zolawulo kunye nengxelo yemarike kunye nezinye izinto ezibanzi.
Ukusuka koku kungasentla, sinokubona ukuba uninzi lweemveliso lungafumana isiqinisekiso se-FDA emva kokubhaliswa, uludwe lwemveliso kunye nokusetyenziswa kwe-GMP yezixhobo zonyango, okanye ukungeniswa kwesicelo se-510 (k).
Ungajonga njani ukuba imveliso idweliswe yi-FDA okanye ibhalisiwe kwi-510k?
Eyona ndlela isemthethweni: jonga kwiwebhusayithi ye-FDA
Ixesha lokuthumela: Jan-09-2021