I-FDA ikhiphe isaziso esinesihloko esithi “ukubhaliswa kwedivayisi nokufakwa kuhlu” kuwebhusayithi yayo esemthethweni ngomhlaka-23 Juni, esigcizelela ukuthi:

I-FDA ayizikhiphi Izitifiketi Zokubhalisa ezikhungweni zemishini yezokwelapha.I-FDA ayikuqinisekisi ukubhaliswa nokufakwa kuhlu
ulwazi lwamafemu abhalisiwe futhi afakwe ohlwini.Ukubhaliswa nokufakwa ohlwini akusho ukugunyazwa noma ukugunyazwa kwenkampani
noma amathuluzi abo.

Izinkinga okudingeka sizinake ekubhaliseni kwe-FDA zimi kanje:
Umbuzo 1: iyiphi i-ejensi ekhiphe isitifiketi se-FDA?

A: asikho isitifiketi sokubhaliswa kwe-FDA.Uma umkhiqizo ubhaliswe ne-FDA, inombolo yokubhalisa izotholakala.I-FDA izonikeza umfakisicelo incwadi yokuphendula (esayinwe yisikhulu esiphezulu se-FDA), kodwa asikho isitifiketi se-FDA.

Isimemezelo se-FDA sesaziso esinjalo ngalesi sikhathi siyisikhumbuzo esinamandla!Ngenxa yokuthuthuka kwakamuva kwesimo sobhubhane e-United States, isidingo semikhiqizo yokuvimbela ubhubhane lwezokwelapha ethunyelwa e-United States sikhule kakhulu, futhi isidingo sokubhaliswa kokuthunyelwa kwamanye amazwe sikhule kakhulu.

Lapho amanye amabhizinisi elingisa i-FDA ukuze akhiphe izitifiketi kubakhiqizi, amanye amabhizinisi asabalalisa angathola “izitifiketi ze-FDA” zomgunyathi lapho ethintana nabakhiqizi.
Umbuzo 2: ingabe i-FDA idinga ilabhorethri eqinisekisiwe?

IMP: I-FDA iyisikhungo somthetho, hhayi i-ejensi yesevisi.Uma othile ethi uyilabhorethri yesitifiketi se-FDA, okungenani ukhohlisa abathengi, ngoba i-FDA ayinawo umsebenzi womphakathi.

Ama-ejensi wokuqinisekisa ubulili namalabhorethri, akukho okuthiwa “ilabhorethri eqokiwe.”.Njengesikhungo somthetho sikahulumeni, i-FDA akufanele izibandakanye ezintweni ezinjengokuba onompempe kanye nomsubathi.I-FDA izohlola isevisi kuphela

Izinga le-GMP lelabhorethri lizoqashelwa, futhi oqeqeshiwe uzonikezwa isitifiketi, kodwa ngeke “siqokwe” noma sinconyelwe umphakathi.
Umbuzo 3: ingabe ukubhaliswa kwe-FDA kudinga i-ejenti yase-US?

IMP: Yebo, ibhizinisi kufanele liqoke isakhamuzi sase-US (inkampani/Inhlangano) njengomenzeli walo lapho libhalisa ne-FDA.Umenzeli unesibopho samasevisi enqubo atholakala e-United States, okuyimithombo yezindaba yokuxhumana ne-FDA nomfakisicelo.

Amaphutha ajwayelekile ekubhaliseni kwe-FDA

1. Ukubhaliswa kwe-FDA kwehlukile kusitifiketi se-CE.Imodi yayo yesitifiketi ihlukile ekuhlolweni komkhiqizo wesitifiketi se-CE + nemodi yesitifiketi sokubika.Ukubhaliswa kwe-FDA empeleni kwamukela imodi yesimemezelo sobuqotho, okungukuthi, unemodi yesimemezelo sokholo esihle ngemikhiqizo yakho.

Ngokuhambisana namazinga afanelekile kanye nezidingo zokuphepha, futhi kubhaliswe kuwebhusayithi ye-US Federal, uma kuba nengozi ngomkhiqizo, kufanele ube nesibopho esihambisanayo.Ngakho-ke, ukubhaliswa kwe-FDA kwemikhiqizo eminingi, akukho ukuhlolwa kwesampula kokuthumela

Nesitatimende sesitifiketi.

2. Isikhathi sokuqinisekisa sokubhaliswa kwe-FDA: Ukubhaliswa kwe-FDA kusebenza unyaka owodwa.Uma ingaphezu konyaka owodwa, idinga ukuthunyelwa kabusha ukuze ibhaliswe, futhi imali yonyaka ehilelekile nayo idinga ukukhokhwa futhi.

3. Ingabe i-FDA ibhalisiwe nesitifiketi?

Eqinisweni, asikho isitifiketi sokubhaliswa kwe-FDA.Uma umkhiqizo ubhaliswe ne-FDA, inombolo yokubhalisa izotholakala.I-FDA izonikeza umfakisicelo incwadi yokuphendula (esayinwe yisikhulu esiphezulu se-FDA), kodwa asikho isitifiketi se-FDA.

Isitifiketi esivame ukusibona sikhishwa i-ejensi ebambeleyo (i-ejenti yokubhalisa) kumkhiqizi ukuze afakazele ukuthi sisize umenzi ukuthi aqedele “ukubhaliswa kwesikhungo sokukhiqiza nokubhaliswa kohlobo lomkhiqizo” oludingwa yi-FDA.

(ukubhaliswa kwesikhungo nokufakwa kuhlu kwedivayisi), umaki ogcwalisiwe wukusiza umenzi athole inombolo yokubhalisa ye-FDA.

Ngokwamazinga ahlukene ezingozi, i-FDA ihlukanisa amathuluzi ezokwelapha abe yizigaba ezintathu (I, II, III), futhi isigaba III sinezinga eliphezulu kakhulu lengozi.

I-FDA ichaze ngokucacile ukuhlukaniswa komkhiqizo kanye nezidingo zokuphatha kudivayisi ngayinye yezokwelapha.Njengamanje, kunezinhlobo ezingaphezu kuka-1700 zekhathalogi yemishini yezokwelapha.Uma noma iyiphi idivayisi yezokwelapha ifuna ukungena emakethe yase-US, kufanele iqale icacise izidingo zokuhlukaniswa nokuphathwa kwemikhiqizo efakwe isicelo sokumakethwa.

Ngemva kokucacisa ulwazi olungenhla, ibhizinisi lingaqala ukulungisa izinto zokufaka isicelo ezifanele, futhi libike ku-FDA ngokwezinqubo ezithile zokuthola imvume.Kunoma yimuphi umkhiqizo, amabhizinisi adinga ukubhalisa futhi aklelise imikhiqizo.

Ngemikhiqizo yekilasi I (ibalwa cishe ngama-47%), ukulawula okujwayelekile kuyasetshenziswa.Iningi lemikhiqizo idinga kuphela ukubhaliswa, ukufakwa ohlwini kanye nokusetshenziswa kwamazinga e-GMP, futhi imikhiqizo ingangena emakethe yase-US (imbalwa kakhulu kuyo exhunywe ne-GMP)

Inombolo encane kakhulu yemikhiqizo egodliwe idinga ukuhambisa isicelo esingu-510 (k) ku-FDA, okuyi-PMN (isaziso semakethe));

Ngemikhiqizo yeklasi II (ibalwa cishe ngama-46%), ukulawula okukhethekile kuyasetshenziswa.Ngemva kokubhaliswa nokufakwa kuhlu, amabhizinisi adinga ukusebenzisa i-GMP futhi athumele isicelo esingu-510 (k) (imikhiqizo embalwa ekhululiwe engama-510 (k));

Emikhiqizweni yekilasi lesi-III (cishe u-7%), ilayisense yokumaketha kwangaphambili iyasetshenziswa.Ngemuva kokubhaliswa nokufakwa kuhlu, amabhizinisi kufanele asebenzise i-GMP futhi athumele isicelo se-PMA (isicelo semakethe) ku-FDA (Ingxenye III)

PMN).

Ngemikhiqizo yekilasi I, ngemva kokuba ibhizinisi lithumele ulwazi olufanele kwa-FDA, i-FDA yenza isimemezelo kuphela, futhi asikho isitifiketi esifanelekile esikhishelwa ibhizinisi;kumadivayisi ekilasi II kanye nele-III, inkampani kufanele ilethe i-PMN noma i-PMA, futhi i-FDA izoletha

Nikeza ibhizinisi incwadi esemthethweni yemvume yokufinyelela emakethe, okungukuthi, vumela ibhizinisi ukuthi lidayise ngokuqondile imikhiqizo yalo emakethe yemishini yezokwelapha yase-US egameni layo.

Ukuthi uya ebhizinisini ukuze uhlolwe i-GMP ohlelweni lokufaka isicelo kunqunywa yi-FDA ngokwezinga lobungozi bomkhiqizo, izidingo zokuphatha kanye nempendulo yemakethe nezinye izici eziphelele.

Kulokhu okungenhla, singabona ukuthi iningi lemikhiqizo lingathola isitifiketi se-FDA ngemva kokubhaliswa, ukufakwa kuhlu kwemikhiqizo kanye nokuqaliswa kwe-GMP yemishini yezokwelapha, noma ukuhanjiswa kwesicelo esingu-510 (k).

Ungahlola kanjani ukuthi umkhiqizo ufakwe ohlwini yi-FDA noma ubhaliswe ku-510k?

Okuwukuphela kwendlela egunyaziwe: hlola kuwebhusayithi ye-FDA