IVeki ye-6 yeNphulelo itsaleleka eninzi phesheya kunye namava endwendwe kwindawo yokwabelana ngemigaqo-nkqubo yelizwe jikelele kunye nezaphene. Abaququzeleli babamba isemina esebenzayo kunye nolwakhiwo lweplatifomu yezixhobo zonyango eziphesheya, apho iindwendwe zazisa ngemeko yangoku e-US, e-UK, e-Australia, kunye namanye amazwe, kunye nolunye uhlobo Imigaqo-nkqubo yelizwe ngalinye lokungena kwezixhobo zonyango ukusuka e-China ukuya kwabelana ngeembono zabo.
UGqr. Kathrine Kumar, ingcali ye-FDA e-FDA e-US, wachaza ukuba ungangenisa ngempumelelo intengiso yaseMelika ngokwemigaqo ye-FDA kunye neendlela zakutshanje. UGqr. Kumar ukhankanywe ukuba uhlaziyo lwamva nje lwesikhokelo se-FDA uthi abenzi-sicelo banokuxhomekeka kwidatha yekliniki yangaphandle xa bengenisa isicelo.
Abavelisi baseTshayina banokusebenzisa idatha yaseTshayina ukufaka isicelo semvume ye-US ye-US, kodwa kufuneka ivumele i-FDA yokufikelela kwimithombo yedatha yakho kwi-China. I-GCP yase-US (isenzo esihle seklinikhi yezixhobo zonyango) i-GCP yase China yahlukile, kodwa inxenye enkulu yayo iyagqobhoza. Ukuba umenzi waseTshayina akazange ahlawulwe e-China kwaye enze izifundo eTshayina, i-FDA ingalawuli izifundo zayo kwaye umenzi kufuneka athobele imithetho nemigaqo yengingqi kuphela. Ukuba umvelisi waseTshayina unenjongo yokusebenzisa idatha kwi-US ukuba axhase isixhobo okanye isicelo, kuya kufuneka agcwalise iziqwenga ezingekhoyo ngokweemfuno ze-US ze-USGP.
Ukuba umenzi uneziimeko ezingalindelekanga ezibathintela ekuthobeleni iimfuno zengingqi, banokufaka isicelo se-waiver ukuba bacele intlanganiso kunye ne-FDA. Inkcazo yesixhobo kunye nesicwangciso esiya kufuneka sibhalwe kwaye singeniswe kwi-FDA ngaphambi kwentlanganiso, kwaye i-FDA iya kuphendula ngokubhala ngomhla olandelayo. Intlanganiso, nokuba ukhetha ukudibana ngokobuqu okanye nge-teleconferten, kubhalwe kwaye akukho ntlawulo kwintlanganiso.
Ibhekisa kwiNgqwalaselo yoPhando ngoPhando, uGqr Brad Hubbard, i-CO-OFFERPUPOUP (i-LTD, yathi: "Ukuvavanywa kwesilwanyana siyinto evumayo ukuba iphendule njani i-tissies yemveliso xa Isixhobo sonyango sifundwa kuvavanyo lwezilwanyana ukuze siqonde ukuba isebenza njani, kwaye silindele ukuba isebenza njani isixhobo xa isetyenziswa ebantwini.
Xa ujonga izifundo zomsebenzi omiselweyo, kukho izindululo ezibini zokukhokela ukubhekisa: Inye iMigaqo ye-US Formentation CFR 21, eSiyilo ye-GLP, enokuthi ifune ukuba kukho iimfuno zokufunda ze-GLP ezinje ngesilwanyana Ukondla, indlela yokuvavanya izixhobo zovavanyo kunye nezixhobo zolawulo, njalo njalo. There are also draft guidelines from the US Food and Drug Administration and the FDA website that will have specific instructions for preclinical studies, such as how many pigs are needed for animal testing for aortic mitral valve clot removal surgery studies.
Xa kufikwa ekuboneleleni ngeengxelo ezineenkcukacha zokuvunywa kwe-FDA, iinkampani zesixhobo sezonyango zaseTshayina zifumana ingqalelo enkulu kwaye i-FDA idla ngokubona ukuqinisekiswa komgangatho, ulwazi olulahlekileyo lwezilwanyana, idatha engaphelelanga i-lab. Ezi zinto kufuneka ziboniswe kwingxelo eneenkcukacha ukuze ivunywe.
URaj Maan, uRhwebo lweThombo yeBritane Generation, wachaza iingenelo zempilo ye-UK kwaye wahlalutya imiGaqo yeMifanekiso ye-UK kunye ne-Shengxiang Bindoging ehamba e-UK.
Inombolo yeYurophu ye-Europe yokuqala yoTyalo-mali yeSayensi yoBomi, iiSayensi zoBomi yase-UK ziye zaphumelela ngaphezulu kwe-80 UNobel PobS, Owesibini kuphela kwi-US.
I-UK ikwayindawo yokuvavanywa kweemvavanyo zeKliniki, indawo yokumakhisha enye eYurophu kwiimvavanyo zeklinikhi, ezinovavanyo lweklinikhi ezingama-20 ezixabisa £ 2.7bn eqhutywa pesenti ye-20 yazo zonke iinkqubo ze-EU.
Inkokheli eqhubekayo kwitekhnoloji entsha, edityaniswe nenkcubeko yeshishini, ithe kratya ukuzalwa kwenani le-Unicorn yokuqala kwi-UK ixabisa ngaphezulu kwe- $ 1bn.
I-UK inabemi abazizigidi ezingama-67, apho malunga neepesenti ezingama-20 ziintlanga ezincinci, zibonelela ngabemi abahlukeneyo bokuqhuba iimvavanyo zeklinikhi.
I-R & D Ityala leRhafu (i-RDEC): Ixabiso letyala lerhafu ye-R & D linyuke lingaphezulu kweepesenti ezingama-20, elithetha i-UK inikezela ngeyona nqanaba liphezulu lokukhululeka kwiinkampani ezinkulu kwi-G7.
Isibonelelo esincinci nesiphakathi (i-SEP) R & D RIDE: Ivumela iinkampani ukuba zikhuphe iindleko ze-86 ezongeziweyo ezivela kwiipesenti ezili-100 eziqhelekileyo, zizonke iipesenti ezili-186.
Ixesha leposi: I-Oct-11 ukuya kwi-1123