The 6th Innovation Vhiki yakakwezva vazhinji vekumhiri kwemakungwa nevemhiri kwemakungwa vane ruzivo vaenzi kunzvimbo yechiitiko kuti vagovane zvichangobva kuitika zvepasirese uye mitemo ine chekuita nemhiri kwemakungwa.Varongi vakaita semina pamusoro pekushanda kunoshanda uye kuvaka kwepuratifomu yemidziyo yekurapa inoenda mhiri kwemakungwa, umo vashanyi vakaunza mamiriro aripo ekuwanikwa kwemidziyo yekurapa mhiri kwemakungwa muUS, UK, Australia, Japan nedzimwe nyika, pamwe nezvinodiwa. mitemo yenyika imwe neimwe yekupinda kwemidziyo yekurapa kubva kuChina kugovera maonero avo.
Dr. Kathrine Kumar, nyanzvi yepamusoro yeFDA inodzora kubva kuUS, yakatsanangura nzira yekubudirira kupinda mumusika weUS maererano nemirairo yeFDA uye yazvino maitiro.Dr. Kumar akataura kuti yazvino kuvandudzwa kwegwaro reFDA rinoti vanyoreri vanogona kuvimba chete nedata rekiriniki yekunze kana vachiendesa chikumbiro.
Vagadziri veChinese vanogona kushandisa dhata yeChinese kunyorera kubvumidzwa kweUS FDA, asi vanofanirwa kubvumidza iyo FDA kuwana kune yako yekuyedza data masosi muChina.Iyo US GCP (Yakanaka Clinical Practice for Medical Devices) yeChina GCP yakasiyana, asi chikamu chikuru chayo chinopindirana.Kana mugadziri weChinese ane muzinda kuChina uye achiitisa zvidzidzo muChina, iyo FDA haidzore zvidzidzo zvayo uye mugadziri anongodiwa chete kutevedzera mitemo nemirairo yemuno yeChinese.Kana mugadziri weChinese achifunga kushandisa iyo data muUS kutsigira mudziyo kana application, inozoda kuzadza zvidimbu zvisipo zvinoenderana neUS GCP zvinodiwa.
Kana mugadziri aine mamiriro asingatarisirwe anovatadzisa kutevedzera zvinodiwa munharaunda, vanogona kunyorera kuregererwa kukumbira musangano neFDA.Tsanangudzo yemudziyo uye chirongwa chinozoda kunyorwa uye kuendeswa kune FDA musangano usati waitwa, uye FDA ichapindura nekunyora pane imwe nguva inotevera.Musangano, ungave wasarudza kusangana wega kana netereconference, wakanyorwa uye hapana muripo wemusangano.
Vachitaura nezvemafungidziro ekutsvagisa, Dr Brad Hubbard, mubatsiri weEastPoint (Hangzhou) Medical Technology Co., Ltd, vakati: “Kuongororwa kwemhuka kwepamberi inzira yekufungidzira inotibvumira kuona kuti nyama dzemhuka dzinozopindura sei magadzirirwo echigadzirwa. mudziyo wekurapa uri kudzidzwa mukuedzwa kwemhuka kuti unzwisise kuti unoshanda sei, uye kutarisira kuti mudziyo uchashanda sei kana uchinge washandiswa muvanhu.
Kana uchifunga nezvezvidzidzo zvebasa repamberi, pane kurudziro mbiri dzekutungamira kunongedzera kune: imwe ndeye US federal regulation CFR 21 standard, Chikamu 58 Dhizaini GLP, iyo inogona kutaurwa kwairi kana paine chikonzero chekunzwisisa zvinodiwa pakudzidza GLP senge mhuka. kudyisa, maitiro ekuongorora midziyo yekuyedza nekudzora michina, zvichingodaro.Kune zvakare dhizaini nhungamiro kubva kuUS Food and Drug Administration uye iyo FDA webhusaiti iyo ichava nemirairo chaiyo yezvidzidzo zvepamberi, sekuti inguruve ngani dzinodiwa pakuongororwa kwemhuka kune aortic mitral valve clot yekuvhiya zvidzidzo.
Kana zvasvika pakupa mishumo yakadzama yemvumo yeFDA, makambani ekuChina emidziyo yekurapa anowana kutariswa kwakawanda uye mibvunzo, uye iyo FDA inowanzoona isina kunaka simbisiro, kushaya ruzivo rwekuchengeta mhuka, isina kukwana data mbishi, uye rondedzero isina kukwana yevashandi vemurabhoritari.Zvinhu izvi zvinofanirwa kuratidzwa mumushumo wakadzama kuti utenderwe.
Raj Maan, Commercial Consul weBritish Consulate General muChongqing, akatsanangura zvakanakira hutano hweUK uye akaongorora hushamwari hweUK kumakambani emidziyo yekurapa nekutaura mienzaniso yemakambani akaita seMyriad Medical uye Shengxiang Biological akaenda kuUK.
Sezvo muEurope nhamba yekutanga yekudyara sainzi yehupenyu, vagadziri vesainzi veUK vakahwina anopfuura makumi masere eNobel Prize, yechipiri chete kuUS.
Iyo UK zvakare inzvimbo yekiriniki yekuedza simba, iri nhamba yekutanga muEurope kune yekutanga-nhanho miedzo yekiriniki, ine makumi maviri ekiriniki miedzo inokosha £2.7bn inoitwa gore rega rega, inoverengera makumi maviri muzana yezvese zvikumbiro zveEU.
Kuenderera mberi kwehutungamiriri mumatekinoroji matsva, pamwe netsika yebhizinesi, kwakurudzira kuzvarwa kwehuwandu hwekutanga unicorn muUK hunokosha kupfuura $ 1bn.
Iyo UK ine huwandu hwevanhu vanosvika mamirioni makumi matanhatu nenomwe, avo vanosvika makumi maviri muzana vemarudzi madiki, vachipa huwandu hwakasiyana hwekuita ongororo dzekiriniki.
R&D Expenditure Tax Credit (RDEC): mutero wechikwereti chekushandisa kweR&D wawedzerwa zvachose kusvika pamakumi maviri muzana, zvichireva kuti UK inopa mwero wepamusoro usina kuvharwa wekubvisa mutero kumakambani makuru muG7.
Diki neMedium Enterprise (SME) R&D mutero wekubvisa: inobvumira makambani kubvisa imwe 86 muzana yemitengo inokodzera kubva kune yavo purofiti yegore, pamwe neyakajairwa 100 muzana kubviswa, inokwana 186 muzana.
Nguva yekutumira: Oct-11-2023