Zonke izitifiketi zokubhalisa ze-FDA azikho emthethweni

Zonke izitifiketi zokubhalisa ze-FDA azikho emthethweni

I-FDA yakhipha isaziso esinesihloko esithi “ukubhaliswa nokufakwa kuhlu kwensiza” kuwebhusayithi yayo esemthethweni ngomhla ka-23 Juni, eyagcizelela ukuthi:

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I-FDA ayizikhiphi Izitifiketi Zokubhalisa ezikhungweni zedivayisi yezokwelapha. I-FDA ayiqinisekisi ukubhaliswa nokufakwa kuhlu 
imininingwane yamafemu abhalisile futhi abhalisiwe. Ukubhalisa nokufakwa kuhlu akusho ukwamukelwa noma ukuvunyelwa kwenkampani 
noma amadivayisi abo.

Izinkinga esidinga ukuzinaka ekubhalisweni kwe-FDA zimi ngale ndlela elandelayo:
Umbuzo 1: iyiphi inkampani ekhiphe isitifiketi se-FDA?

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

Ukumenyezelwa kwe-FDA kwesaziso esinje ngalesi sikhathi kuyisikhumbuzo esinamandla! Ngenxa yokuthuthuka kwakamuva kwesimo sobhadane e-United States, isidingo semikhiqizo yokuvikela ubhubhane lwezokwelapha ethunyelwa e-United States sikhule kakhulu, futhi nesidingo sokubhaliswa kokuthunyelwa kwamanye amazwe naso sikhuphukile

Lapho amanye amabhizinisi ezenza i-FDA ukukhipha izitifiketi kubakhiqizi, amanye amabhizinisi okusabalalisa angathola “izitifiketi ze-FDA” mbumbulu lapho ebonisana nabakhiqizi.
Umbuzo 2: ingabe i-FDA iyayidinga ilabhorethri eqinisekisiwe?

A: I-FDA iyinhlangano yokuphoqelela umthetho, hhayi i-ejensi yesevisi. Uma othile ethi bayilabhorethri yokuqinisekisa ye-FDA, okungenani badukisa abathengi, ngoba i-FDA ayinayo imisebenzi yomphakathi

Ama-ejensi wokuqinisekisa ubulili namalabhorethri, akukho okubizwa nge- "laboratory eqokiwe." Njengesikhungo sokuphoqelela umthetho, i-FDA akufanele ihlanganyele ezintweni ezinjengokuba ngunompempe nomsubathi. I-FDA izohlola kuphela insizakalo

Ikhwalithi ye-GMP yelabhorethri izokwamukelwa, bese kuthi lowo oqeqeshiwe anikezwe isitifiketi, kepha ngeke "sikhethwe" noma sinconywe emphakathini.
Umbuzo 3: ingabe ukubhaliswa kwe-FDA kudinga umenzeli wase-US?

IMP: Yebo, ibhizinisi kufanele liqoke isakhamuzi sase-US (inkampani / Inhlangano) njenge-ejenti yaso lapho sibhalisa ne-FDA. Umenzeli ubhekene nezinsizakalo zenqubo ezise-United States, okungabezindaba ukuxhumana ne-FDA kanye nomfakisicelo.

Amaphutha ajwayelekile ekubhalisweni kwe-FDA

1. Ukubhaliswa kwe-FDA kuhlukile kunesitifiketi se-CE. Imodi yesitifiketi sayo ihlukile kunqubo yokuhlola umkhiqizo we-CE + imodi yesitifiketi yokubika. Ukubhaliswa kwe-FDA empeleni kwamukela imodi yesimemezelo sobuqotho, okusho ukuthi, unemodi enhle yesimemezelo sokholo semikhiqizo yakho

Ngokuya ngamazinga afanele nezidingo zokuphepha, futhi kubhaliswe kuwebhusayithi ye-US Federal, uma kukhona ingozi ngalo mkhiqizo, khona-ke kufanele ithwale umthwalo ohambisanayo. Ngakho-ke, ukubhaliswa kwe-FDA kwemikhiqizo eminingi, akukho sivivinyo sokuthumela isampula

Futhi isitatimende sesitifiketi.

2. Isikhathi sokuba semthethweni kokubhaliswa kwe-FDA: Ukubhaliswa kwe-FDA kusebenza unyaka owodwa. Uma kungaphezu konyaka owodwa, idinga ukuhanjiswa kabusha ukuze ibhaliswe, futhi imali yonyaka ethintekayo nayo idinga ukukhokhwa futhi.

3. Ngabe i-FDA ibhaliswe ngesitifiketi?

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), kepha asikho isitifiketi se-FDA.

Isitifiketi esivame ukusibona sikhishwa yi-ejensi yokulamula (i-ejenti yokubhalisa) kumenzi wazo ukufakazela ukuthi sisizile umkhiqizi ukuqedela “ukubhaliswa kwendawo yokukhiqiza kanye nokubhaliswa kohlobo lomkhiqizo” okudingwa yi-FDA

(ukusungulwa kokubhaliswa nohlu lwedivayisi), uphawu oluqediwe ukusiza umenzi ukuthi athole inombolo yokubhalisa ye-FDA.

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Ngokwamazinga ahlukene engcuphe, i-FDA ihlukanisa amadivayisi wezokwelapha ngezigaba ezintathu (I, II, III), kanti isigaba III sinamazinga aphezulu engcuphe.

I-FDA ichaze ngokucacile ukuhlukaniswa komkhiqizo nezidingo zokuphatha zedivayisi ngayinye yezokwelapha. Njengamanje, kunezinhlobo ezingaphezu kuka-1700 zekhathalogi yedivayisi yezokwelapha. Uma noma iyiphi into yezokwelapha ifuna ukungena emakethe yase-US, kufanele iqale icacise ukuhlukaniswa kanye nezidingo zokuphathwa kwemikhiqizo esetshenziselwe ukumaketha.

Ngemuva kokucacisa imininingwane engenhla, ibhizinisi lingaqala ukulungisa izinto zokusebenza ezifanele, bese libika kwi-FDA ngokwezinqubo ezithile zokuthola imvume. Kunoma yimuphi umkhiqizo, amabhizinisi adinga ukubhalisa nokufaka kuhlu imikhiqizo.

Kwemikhiqizo yeklasi I (ebalwa cishe ngama-47%), ukulawula okujwayelekile kuyasetshenziswa. Iningi lemikhiqizo idinga ukubhaliswa, ukufakwa kuhlu nokuqaliswa kwamazinga we-GMP, futhi imikhiqizo ingangena emakethe yase-US (imbalwa kakhulu yayo exhunywe ne-GMP)

Inani elincane kakhulu lemikhiqizo ebekiwe lidinga ukuhambisa isicelo esingu-510 (k) ku-FDA, okuyi-PMN (isaziso sangaphambi kokuthengiswa);

Ngemikhiqizo yesigaba II (ebalwa cishe ngama-46%), kwenziwa ukulawula okukhethekile. Ngemuva kokubhaliswa nokufakwa kuhlu, amabhizinisi adinga ukusebenzisa i-GMP futhi athumele isicelo esingu-510 (k) (imikhiqizo embalwa ingu-510 (k) ukukhululwa);

Emikhiqizweni yekilasi III (cishe u-7%), ilayisense yangaphambi kokuthengisa iyasetshenziswa. Ngemuva kokubhalisa nokufakwa kuhlu, amabhizinisi kufanele asebenzise i-GMP futhi athumele isicelo se-PMA (premarket application) ku-FDA (Ingxenye III)

PMN).

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Emikhiqizweni yekilasi I, ngemuva kokuthi ibhizinisi lithumele imininingwane efanele ku-FDA, i-FDA yenza isimemezelo kuphela, futhi asikho isitifiketi esifanele esikhishelwa ibhizinisi; yamadivayisi wesigaba II no-III, ibhizinisi kufanele lithumele i-PMN noma i-PMA, ne-FDA izokwenza kanjalo

Nikeza ibhizinisi incwadi evunyelwe yokufinyelela emakethe ngokusemthethweni, okusho ukuthi, vumela ibhizinisi ukuthi lithengise ngqo imikhiqizo yalo emakethe yedivayisi yezokwelapha yase-US ngegama layo.

Ukuthi kuya yini ebhizinisini ukuze kuhlolwe i-GMP kunqubo yokufaka isicelo kunqunywa yi-FDA ngokwezinga lobungozi bomkhiqizo, izidingo zokuphatha kanye nempendulo yemakethe nezinye izinto ezibanzi.

Kulokhu okungenhla, siyabona ukuthi iningi lemikhiqizo lingathola isitifiketi se-FDA ngemuva kokubhaliswa, ukufakwa kuhlu komkhiqizo kanye nokuqaliswa kwe-GMP yamadivayisi wezokwelapha, noma ukuhanjiswa kwesicelo esingu-510 (k).

Ungahlola kanjani ukuthi ngabe umkhiqizo ubhalisiwe yi-FDA noma ubhaliswe ku-510k?

Ukuphela kwendlela egunyazayo: hlola kuwebhusayithi ye-FDA


Isikhathi Iposi: Jan-09-2021