Iviki Lesithupha Lokusungula lihehe izihambeli eziningi zaphesheya kwezilwandle zokuhlangenwe nakho ukuze zabelane ngokuthrendayo kwakamuva kwamazwe ngamazwe kanye nezinqubomgomo ezihlobene phesheya kwezilwandle.Abahleli babe nesemina mayelana nokusebenza okungokoqobo kanye nokwakhiwa kweplatifomu yemishini yezokwelapha eya phesheya kwezilwandle, lapho izihambeli zethule khona isimo samanje sokufinyelela ezinsizakalweni zokwelapha zaphesheya e-US, UK, Australia, Japan nakwamanye amazwe, kanye nokukhethekile. izinqubomgomo zezwe ngalinye zokungena kwemishini yezokwelapha evela e-China ukuze babelane ngemibono yabo.
UDkt. Kathrine Kumar, uchwepheshe ophezulu we-FDA ovela e-US, uchaze ukuthi ungangena kanjani ngempumelelo emakethe yase-US ngokwemithetho ye-FDA kanye namathrendi akamuva.UDkt. Kumar uveze ukuthi isibuyekezo sakamuva somhlahlandlela we-FDA sithi abafake izicelo bangathembela kuphela kudatha yomtholampilo yangaphandle lapho bethumela isicelo.
Abakhiqizi baseShayina bangasebenzisa idatha yesiShayina ukuze bafake isicelo sokugunyazwa yi-US FDA, kodwa kufanele bavumele i-FDA ukuthi ifinyelele emithonjeni yakho yedatha yesilingo e-China.I-US GCP (Umkhuba Omuhle Womtholampilo Wamadivayisi Ezokwelapha) I-GCP yase-China ihlukile, kodwa ingxenye enkulu yayo iyagqagqana.Uma umkhiqizi wase-China ekomkhulu e-China futhi enza izifundo e-China, i-FDA ayilawuli izifundo zayo futhi umkhiqizi kudingeka kuphela athobele imithetho neziqondiso zendawo zase-China.Uma umkhiqizi wase-China ehlose ukusebenzisa idatha e-US ukuze asekele idivayisi noma uhlelo lokusebenza, uzodinga ukugcwalisa izingcezu ezingekho ngokuvumelana nezimfuneko ze-US GCP.
Uma umkhiqizi enezimo ezingalindelekile ezimvimbela ekuthobeleni izimfuneko zendawo, angafaka isicelo sokuyekwa ukuze acele umhlangano ne-FDA.Incazelo yedivayisi nohlelo kuzodingeka ukuthi kubhalwe futhi kuhanjiswe ku-FDA ngaphambi komhlangano, futhi i-FDA izophendula ngokubhala kamuva.Umhlangano, kungakhathaliseki ukuthi ukhetha ukuhlangana mathupha noma nge-teleconference, ubhaliwe futhi akukho nkokhelo yomhlangano.
Ebhekisela ekucatshangelweni kocwaningo lwangaphambi komtholampilo, uDkt Brad Hubbard, umsunguli we-EastPoint (Hangzhou) Medical Technology Co., Ltd, uthe: “Ukuhlolwa kwezilwane ngaphambi komtholampilo kuyimodeli ebikezelayo esivumela ukuthi sibone ukuthi izicubu zezilwane zizosabela kanjani ekwakhiweni komkhiqizo lapho. umshini wezokwelapha uyacwaningwa ekuhlolweni kwezilwane ukuze kuqondwe ukuthi usebenza kanjani, kanye nokubikezela ukuthi idivayisi izosebenza kanjani uma isetshenziswa kubantu.
Lapho kucutshungulwa izifundo zomsebenzi wangaphambi komtholampilo, kunezincomo ezimbili zokuqondiswa okufanele kubhekiselwe kuzo: esinye yisimiso sombuso wase-US CFR 21 indinganiso, Ingxenye 58 Design GLP, okungabhekiselwa kuyo uma kunesidingo sokuqonda izidingo zocwaningo lwe-GLP njengesilwane. ukuphakela, indlela yokuhlola okokusebenza kokuhlola kanye nemishini yokulawula, nokunye.Kukhona neziqondiso ezisalungiswa ezivela ku-US Food and Drug Administration kanye nesizindalwazi se-FDA esizoba neziqondiso eziqondile zocwaningo lwangaphambi komtholampilo, njengokuthi zingaki izingulube ezidingekayo ukuze kuhlolwe izilwane ukuze kuhlolwe ukuhlinzwa kokukhipha ihlule le-aortic mitral valve.
Uma kuziwa ekunikezeni imibiko enemininingwane yokugunyazwa kwe-FDA, izinkampani zemishini yezokwelapha zaseShayina zithola ukunakwa okwengeziwe nemibuzo, futhi i-FDA ivamise ukubona ukuqinisekiswa kwekhwalithi ephansi, ulwazi olulahlekile lokunakekelwa kwezilwane, idatha eluhlaza engaphelele, kanye nohlu lwezisebenzi zelebhu olungaphelele.Lezi zakhi kufanele ziboniswe embikweni onemininingwane ukuze ugunyazwe.
U-Raj Maan, u-Commercial Consul we-British Consulate General e-Chongqing, uchaze izinzuzo zokunakekelwa kwezempilo kwase-UK futhi wahlaziya izinqubomgomo zobungane zase-UK eziphathelene nezinkampani zemishini yezokwelapha ngokucaphuna izibonelo zezinkampani ezifana ne-Myriad Medical kanye ne-Shengxiang Biological eziye zaya e-UK.
Njengenombolo yokuqala yaseYurophu ekutshalweni kwezimali kwesayensi yezempilo, abasunguli besayensi yezempilo base-UK bawine imiklomelo kaNobel engaphezu kuka-80, isibili ngemuva kwe-US.
I-UK futhi iyisikhungo esinamandla esivivinyweni somtholampilo, ikleliswe endaweni yokuqala eYurophu ezivivinyweni zomtholampilo zasesiteji sokuqala, nezivivinyo zemitholampilo ezingama-20 ezibiza u-£2.7bn ezenziwa unyaka ngamunye, zibalelwa kumaphesenti angama-20 azo zonke izicelo ze-EU.
Ukuqhubeka kobuholi kubuchwepheshe obusha, kuhambisana nesiko lezamabhizinisi, kugqugquzele ukuzalwa kwenani lezinkampani eziqala i-unicorn e-UK ezibiza ngaphezu kuka-$1bn.
I-UK inabantu abayizigidi ezingama-67, cishe amaphesenti angama-20 kubo bezinhlanga ezincane, okuhlinzeka ngenani labantu abahlukahlukene ukuze benze izivivinyo zemitholampilo.
I-R&D Expenditure Tax Credit (RDEC): izinga lesikweletu lentela lezindleko ze-R&D linyuswe unomphela laya kumaphesenti angama-20, okusho ukuthi i-UK ihlinzeka ngezinga eliphakeme kakhulu elingabanjwanga lokukhululeka kwentela ezinkampanini ezinkulu ku-G7.
Impumuzo yentela ye-R&D Yamabhizinisi Amancane Naphakathi (ama-SME): kuvumela izinkampani ukuthi zidonse enye ingxenye engamaphesenti angama-86 ezindleko zazo ezifanelekile enzuzweni yazo yonyaka, kanye nesilinganiso esivamile sokubanjwa ngamaphesenti ayi-100, okuyisamba esingamaphesenti ayi-186.
Isikhathi sokuthumela: Oct-11-2023