IVeki yesi-6 yokuTshintsha yatsala uninzi lwabakhenkethi baphesheya naphesheya bamava ukuya kwindawo ukuze babelane ngeentsingiselo zamva nje zamazwe ngamazwe kunye nemigaqo-nkqubo enxulumene naphesheya kweelwandle.Abaququzeleli babambe isemina malunga nokusebenza okusebenzayo kunye nokwakhiwa kweqonga lezixhobo zonyango eziya phesheya, apho iindwendwe zazisa imeko yangoku yokufikelela kwizixhobo zonyango zaphesheya e-US, UK, Australia, Japan kunye nakwamanye amazwe, kunye neyona nto ikhethekileyo. imigaqo-nkqubo yelizwe ngalinye yokungena kwezixhobo zonyango ezivela e-China ukwabelana ngezimvo zabo.
UDkt Kathrine Kumar, ingcali ephezulu yokulawula i-FDA evela e-US, ichaze indlela yokungena ngempumelelo kwimarike yase-US ngokwemigaqo ye-FDA kunye neendlela zamva nje.UDkt. Kumar ukhankanye ukuba uhlaziyo lwamva nje lwesikhokelo se-FDA sithi abafaki-zicelo banokuthembela kuphela kwidatha yeklinikhi yangaphandle xa befaka isicelo.
Abavelisi baseTshayina banokusebenzisa idatha yaseTshayina ukufaka isicelo semvume ye-FDA yase-US, kodwa kufuneka bavumele i-FDA ifikelele kwimithombo yedatha yolingo lwakho eTshayina.I-US GCP (Uqheliselo oluLungileyo lweKlinikhi kwiZixhobo zoNyango) I-GCP yaseTshayina yahlukile, kodwa inxalenye enkulu yayo iyangenana.Ukuba umenzi waseTshayina ukomkhulu e-China kwaye uqhuba izifundo e-China, i-FDA ayilawuli izifundo zayo kwaye umenzi kufuneka athobele kuphela imithetho nemimiselo yaseTshayina.Ukuba umenzi waseTshayina uzimisele ukusebenzisa idatha e-US ukuxhasa isixhobo okanye isicelo, kuya kufuneka ukuba agcwalise iziqwenga ezilahlekileyo ngokweemfuno ze-GCP zase-US.
Ukuba umenzi uneemeko ezingalindelekanga ezibathintela ekuthobeleni iimfuno zendawo, banokufaka isicelo sokurhoxisa ukucela intlanganiso kunye ne-FDA.Inkcazo yesixhobo kunye nesicwangciso siya kufuneka sibhalwe kwaye singeniswe kwi-FDA ngaphambi kwentlanganiso, kwaye i-FDA iya kuphendula ngokubhaliweyo emva kwexesha.Intlanganiso, nokuba ukhetha ukudibana buqu okanye nge-teleconference, ibhaliwe kwaye akukho ntlawulo yentlanganiso.
Ebhekisa kwingqwalaselo yophando lwangaphambili, uGqr Brad Hubbard, umseki we-EastPoint (Hangzhou) Medical Technology Co., Ltd, uthe: “Uvavanyo lwezilwanyana lwangaphambi kweklinikhi ngumzekelo osivumelayo ukuba sibone ukuba izihlunu zezilwanyana ziya kusabela njani kuyilo lwemveliso xa. isixhobo sonyango siyaphononongwa kuvavanyo lwezilwanyana ukuqonda indlela esisebenza ngayo, kunye nokuqikelela ukuba isixhobo siya kusebenza njani na xa sisetyenziswa ebantwini.
Xa kuqwalaselwa izifundo zangaphambi kweklinikhi, kukho izindululo ezibini zesikhokelo ekubhekiselelwe kuzo: enye ngumgaqo womanyano wase-US CFR 21 umgangatho, iCandelo 58 loYilo lwe-GLP, ekunokuthiwa kubhekiswa kulo ukuba kukho imfuneko yokuqonda iimfuno zophononongo lwe-GLP ezifana nesilwanyana. ukondla, indlela yokuvavanya izixhobo zovavanyo kunye nezixhobo zokulawula, njalo njalo.Kukwakho nezikhokelo eziyidrafti ezivela kwi-US Food and Drug Administration kunye newebhusayithi ye-FDA eya kuba nemiyalelo ethile yezifundo zangaphambi kweklinikhi, ezifana nokuba zingaphi iihagu ezifunekayo kuvavanyo lwezilwanyana kwizifundo zotyando lokususa ihlwili le-aortic mitral valve.
Xa kuziwa ekuboneleleni ngeengxelo ezineenkcukacha zokuvunywa kwe-FDA, iinkampani zezixhobo zonyango zaseTshayina zifumana ingqalelo engakumbi kunye nemibuzo, kwaye i-FDA ihlala ibona uqinisekiso lomgangatho ophantsi, ulwazi olulahlekileyo lokhathalelo lwezilwanyana, idatha engaphelelanga ekrwada, kunye noluhlu lwabasebenzi baselebhu olungaphelelanga.Ezi zinto maziboniswe kwingxelo eneenkcukacha ezininzi ukuze yamkelwe.
U-Raj Maan, uMmeli wezoRhwebo we-Consulate General yase-Bhritane e-Chongqing, uchaze iingenelo zenkathalo yezempilo yase-UK kwaye wahlalutya imigaqo-nkqubo enobubele yase-UK malunga neenkampani zezixhobo zonyango ngokucaphula imizekelo yeenkampani ezifana neMyriad Medical kunye ne-Shengxiang Biological eziye zaya e-UK.
Njengenombolo yokuqala yaseYurophu kutyalo-mali lwezenzululwazi zobomi, abavelisi bezenzululwazi zobomi base-UK baphumelele amaBhaso eNobel angaphezu kwama-80, okwesibini kuphela kwi-US.
I-UK ikwayindawo yovavanyo lweklinikhi, ebeka inani lokuqala eYurophu kwiimvavanyo zeklinikhi zenqanaba lokuqala, kunye nezilingo zeklinikhi ezingama-20 ezixabisa i-£ 2.7bn ezenziwa ngonyaka, zibalelwa kwi-20 yeepesenti yazo zonke izicelo ze-EU.
Ubunkokheli obuqhubekayo kubuchwephesha obutsha, buhamba nenkcubeko yorhwebo, buqhubele phambili ukuzalwa kwenani le-unicorn yokuqala e-UK exabisa ngaphezulu kwe-1bn yeedola.
I-UK inabemi abazizigidi ezingama-67, apho malunga neepesenti ezingama-20 ngabantu beentlanga ezincinci, ezibonelela ngabantu abohlukeneyo ukuze benze ulingo lwezonyango.
I-R&D Expenditure Tax Credit (RDEC): izinga letyala lerhafu kwinkcitho yeR&D linyuswe ngokusisigxina laya kutsho kuma-20 ekhulwini, oku kuthetha ukuba i-UK ibonelela ngelona zinga liphezulu lokukhululwa kwerhafu kwiinkampani ezinkulu kwi-G7.
AmaShishini amaNcinci naPhakathi (i-SME) umnyinyiva werhafu ye-R&D: ivumela iinkampani ukuba zitsale umyinge wama-86 eepesenti ezongezelelweyo zeendleko zabo ezifanelekileyo kwiingeniso zabo zonyaka, kunye nokutsalwa kwesiqhelo kwe-100 lepesenti, iyonke i-186 yeepesenti.
Ixesha lokuposa: Oct-11-2023