Zonke izatifikethi zobhaliso ze-FDA azisemthethweni

I-FDA ikhuphe isaziso esithi "ubhaliso lwesixhobo kunye noluhlu" kwiwebhusayithi ye-23 esemthethweni nge-23 kaJuni, egxininisa loo nto:

I-FDA ayikhupheli izatifikethi zobhaliso kwiziseko zezonyango. I-FDA ayiqinisekisi zobhaliso kunye noluhlu
ulwazi lweefemu ezibhalisiweyo kwaye zidwelisiwe. Ubhaliso kunye noluhlu alubonakali imvume okanye imvume yenkampani eqinileyo
okanye izixhobo zabo.

Imiba esiyifunayo ukuze sinikele ingqalelo kubhaliso lwe-FDA ngolu hlobo lulandelayo:
Umbuzo 1: Yeyiphi i-arhente ekhuphe isiqinisekiso se-FDA?

A: Akukho siqinisekiso sobhaliso lwe-FDA. Ukuba imveliso ibhalisiwe kwi-FDA, inombolo yobhaliso iya kufumaneka. I-FDA iya kunika umenzi-sicelo ileta yokuphendula (isayinwe nguMphathi oyintloko we-FDA), kodwa akukho satifiketi se-FDA.

Isibhengezo se-FDA sesaziso esinjalo ngeli xesha sisikhumbuzo esomeleleyo! Ngenxa yokuphuhliswa kwakutshanje kwemeko yesifo eUnited States, imfuno yeemveliso zokuthintela ezonyango ezithunyelwa kwelinye ilizwe e-United States yonyuke kakhulu, kwaye imfuno yobhaliso lokuthumela ngaphandle ikhule

Xa amanye amashishini elinza i-FDA ukukhupha izatifikethi kubavelisi, amanye amashishini asasazwayo anokufumana izatifikethi "ze-FDA"
Umbuzo 2: Ngaba i-FDA ifuna ilabhoratri eqinisekisiweyo?

A: I-FDA yi-Arhente yokunyanzeliswa komthetho, hayi iarhente yenkonzo. Ukuba umntu uthi zii-FDA isiqinisekiso se-FDA, zilahlekisa abathengi, kuba i-FDA ayinayo inkonzo yoluntu

I-arhente yokuqinisekisa ngesondo kunye neelebhu, akukho zibizwa ngokuba "labhoratri etyunjiweyo.". Njenge-Arhente yokunyanzeliswa komthetho, i-FDA akufuneki ukuba ibandakanyeke kwizinto ezinjalo njengokungasompempe kunye nembaleki. I-FDA iya kuvavanya kuphela inkonzo

Umgangatho we-GMP osemgangathweni uyakuqatshelwa, kwaye umntu ofanelekileyo uya kunikwa isatifikethi, kodwa asiyi kuba "sonyulelwa" okanye esicetyiswayo eluntwini.
Umbuzo 3: Ngaba ubhaliso lwe-FDA lufuna iarhente yaseMelika?

A: Ewe, ishishini kufuneka inyule i-US (inkampani / umbutho) njengearhente yayo xa kubhaliswa nge-FDA. Iarhente inoxanduva lweenkonzo zenkqubo ezikwi-United States, ezingumajelo osasazo ukunxibelelana ne-FDA kunye nomenzi-sicelo.

Iimpazamo eziqhelekileyo kubhaliso lwe-FDA

1. Ubhaliso lwe-FDA lwahlukile ku-CE. Imowudi yayo yokuqinisekisa yahlukile kwimowudi yokuvavanya imveliso yokuvavanya imveliso ye-CE. Ubhaliso lwe-FDA lumkela indlela yokuvakalisa ingqibelelo, oko kukuthi, unemodi yokubhengeza yenkolo yeemveliso zakho

Ngokungqinelana nemigangatho efanelekileyo kunye neemfuno zokhuseleko, kwaye babhalisiwe kwiwebhusayithi ye-US federal, ukuba kukho ingozi ngemveliso, kuya kufuneka ithwale uxanduva oluhambelana nayo. Ke ngoko, ukubhaliswa kwe-FDA uninzi lweemveliso, akukho luvavanyo lwesampulu

Kunye nengxelo yesatifikethi.

2. Ixesha lokuqinisekiswa kobhaliso lwe-FDA: Ubhaliso lwe-FDA lusebenza unyaka omnye. Ukuba ingaphezulu konyaka, kufuneka ingeniswe ukuze ihlawulwe, kwaye umrhumo wonyaka ubandakanyekayo kufuneka uhlawulwe.

3. Ngaba i-FDA ibhaliswe ngesatifikethi?

Ngapha koko, akukho siqinisekiso sobhaliso lwe-FDA. Ukuba imveliso ibhalisiwe kwi-FDA, inombolo yobhaliso iya kufumaneka. I-FDA iya kunika umenzi-sicelo ileta yokuphendula (isayinwe nguMphathi oyintloko we-FDA), kodwa akukho satifiketi se-FDA.

Isatifikethi esihlala sisibona sikhutshwa yi-Arhente yoMsebenzi (iArhente yoBhaliso) kumenzi ukubonisa ukuba uncede umenzi ukuba agqibe "ukubhaliswa kwemveliso yemveliso kunye ne-FDA

.

Ngokwenqanaba lomngcipheko olwahlukileyo, i-FDA yahlulahlula izixhobo zonyango zamanani amathathu (i, II, ii), kwaye iklasi III inelona nqanaba liphezulu lomngcipheko.

I-FDA ichaze ngokucacileyo ukuhlelwa kwemveliso kunye neemfuno zolawulo kwisixhobo ngasinye sezonyango. Okwangoku, zingaphezulu kwe-1700 iintlobo zekhathalogu ye-phalog yeOpa. Ukuba kukho nasiphi na isixhobo esifuna ukufaka imarike yaseMelika, kufuneka icacisa kuqala ukuhlelwa kunye neemfuno zolawulo lweemveliso ezifakwe kwintengiso.

Emva kokucacisa le ngcaciso ingentla, ishishini linokuqala ukulungisa izixhobo ezifanelekileyo zesicelo, kwaye linike ingxelo kwi-FDA ngokweenkqubo ezithile zokufumana imvume. Kuyo nayiphi na imveliso, amashishini kufuneka abhalise kwaye adwelise iimveliso.

Kwiklasi ye-ITS (Accounting malunga ne-47%), ulawulo ngokubanzi luphunyezwa. Uninzi lweemveliso kufuneka zibhalise, zidweliswe kwaye zaphunyezwa imigangatho ye-GP, kwaye iimveliso zinokungena kwimakethi yase-US (ezimbalwa kakhulu ezinxulumene ne-GMP)

Inani elincinci kakhulu leemveliso ezigciniweyo kufuneka zingenise isicelo se-510 (k) i-FDA, i-PMN TMN (ISAZISO SOLWAZI);

Kwimveliso yeklasi yeklasi (inika ingxelo malunga ne-46%), ulawulo olukhethekileyo luphunyezwa. Emva kobhaliso kunye noluhlu, amashishini kufuneka asebenzise i-GMP kwaye angenise isicelo se-510 (k) (k) i-510 (k) Ukuxolelwa);

Kwimveliso yeklasi ye-III (malunga ne-7%), iphepha-mvume lokuthengisa laphambi kokuthengisa liphunyezwa. Emva kobhaliso kunye noluhlu, amashishini kufuneka asebenzise i-GMP kwaye angenise i-PMA (isicelo se-PARRET) isicelo kwi-FDA (i-III)

I-PMN).

Kwiimveliso zeklasi, emva kokuba ishishini lingenisa ulwazi olufanelekileyo kwi-FDA, i-FDA kuphela yenza isaziso, kwaye akukho satifikethi sinikezelwa kwishishini; Kwisixhobo seklasi ye-II ne-III, ishishini kufuneka lingenise i-PMN okanye i-PMA, kunye ne-FDA

Nika ishishini ileta ekwaziyo ileta esesikweni yemakethi, oko kukuthi, vumela ishishini ukuba lithengise ngokuthe ngqo iimveliso zalo zentengiso ye-US kwigama lakhe.

Nokuba uye kwishishini lovavanyo lwe-GPP kwinkqubo yokufaka isicelo kugqitywa yi-FDA ngokomngcipheko wemveliso, iimfuno zolawulo kunye nengxelo yentengiso kunye nezinye izinto eziqinisekileyo.

Koku kungasentla, sinokubona ukuba uninzi lweemveliso zinokufumana isiqinisekiso se-FDA emva kobhaliso, uluhlu lwemveliso kunye nokuphunyezwa kwe-GMP yezixhobo zonyango, okanye ukungeniswa kwe-510 (k) yesicelo se-510 (k) isicelo.

Ungayijonga njani ukuba imveliso idweliswe yi-FDA okanye ibhaliswe kwi-510k?

Eyona ndlela igunyazisiweyo: Jonga kwiwebhusayithi ye-FDA