Sabata yachisanu ndi chimodzi ya Innovation idakopa alendo ambiri akunja ndi kutsidya kwa nyanja kuti agawane zomwe zachitika posachedwa padziko lonse lapansi komanso mfundo zokhudzana ndi kutsidya kwa nyanja.Okonzawo adachita semina yokhudzana ndi ntchito yothandiza komanso yomanga nsanja ya zida zamankhwala kupita kunja, komwe alendowo adawonetsa momwe zinthu ziliri pano zopezera zida zamankhwala zakunja ku US, UK, Australia, Japan ndi mayiko ena, komanso zomwe amakonda. malamulo a dziko lililonse polowera zipangizo zachipatala kuchokera ku China kuti afotokoze maganizo awo.
Dr. Kathrine Kumar, katswiri wamkulu wa FDA wochokera ku US, adalongosola momwe angalowetse bwino msika wa US malinga ndi malamulo a FDA ndi zochitika zamakono.Dr. Kumar adanenanso kuti zosintha zaposachedwa za malangizo a FDA akuti ofunsira amatha kudalira chidziwitso chachipatala chakunja akamatumiza.
Opanga aku China atha kugwiritsa ntchito zidziwitso zaku China kuti apemphe chilolezo cha US FDA, koma alole FDA kuti ipeze magwero anu oyeserera ku China.US GCP (Good Clinical Practice for Medical Devices) GCP yaku China ndi yosiyana, koma gawo lalikulu limapitilira.Ngati wopanga waku China ali ku China ndipo amachita maphunziro ku China, a FDA sawongolera maphunziro ake ndipo wopanga amangofunika kutsatira malamulo ndi malamulo aku China.Ngati wopanga waku China akufuna kugwiritsa ntchito zomwe zili ku US kuthandizira chipangizo kapena pulogalamu, iyenera kudzaza zidutswa zomwe zikusowa malinga ndi zofunikira za US GCP.
Ngati wopanga ali ndi zochitika zosayembekezereka zomwe zimawalepheretsa kutsatira zofunikira zakumaloko, atha kupempha chiwongolero kuti apemphe msonkhano ndi a FDA.Kufotokozera kwa chipangizocho ndi ndondomeko zidzafunika kulembedwa ndikutumizidwa ku FDA msonkhano usanachitike, ndipo a FDA adzayankha molemba mtsogolo.Msonkhano, kaya mwasankha kukumana pamasom'pamaso kapena pa teleconference, walembedwa ndipo palibe malipiro a msonkhanowo.
Ponena za zofufuza zachipatala, Dr Brad Hubbard, woyambitsa mnzake wa EastPoint (Hangzhou) Medical Technology Co., Ltd, adati: "Kuyesa nyama zakutsogolo ndi njira yodziwikiratu yomwe imatilola kuwona momwe minofu ya nyama ingayankhire pakapangidwe kake. chipangizo chachipatala chikuphunziridwa poyezetsa nyama kuti amvetsetse momwe chimagwirira ntchito, komanso kudziwa momwe chipangizocho chidzagwirira ntchito chikagwiritsidwa ntchito mwa anthu.
Poganizira maphunziro a preclinical work, pali malingaliro awiri oti atsogolere ku: imodzi ndi ya US federal regulation CFR 21 standard, Part 58 Design GLP, yomwe ingatchulidwe ngati pakufunika kumvetsetsa zofunikira pa kafukufuku wa GLP monga nyama. kudyetsa, momwe angawunikire zida zoyesera ndi zida zowongolera, ndi zina zotero.Palinso malangizo okonzekera kuchokera ku US Food and Drug Administration ndi webusaiti ya FDA yomwe idzakhala ndi malangizo enieni a maphunziro a preclinical, monga nkhumba zingati zomwe zimafunika kuti ziyesedwe ndi zinyama pa maphunziro a opaleshoni yochotsa magazi a aortic mitral valve.
Zikafika popereka malipoti atsatanetsatane kuti avomerezedwe ndi FDA, makampani opanga zida zamankhwala aku China amapeza chidwi komanso mafunso ambiri, ndipo a FDA nthawi zambiri amawona kutsimikizika kopanda pake, zidziwitso zosowekera zanyama, zosakwanira zaiwisi, komanso mindandanda yazantchito yosakwanira.Zinthu izi ziyenera kuwonetsedwa mu lipoti latsatanetsatane kuti livomerezedwe.
Raj Maan, Commercial Consul of the British Consulate General ku Chongqing, adafotokoza za ubwino wa chithandizo chamankhwala ku UK ndikusanthula mfundo zaubwenzi za UK ku makampani a zida zamankhwala potchula zitsanzo zamakampani monga Myriad Medical ndi Shengxiang Biological omwe adapita ku UK.
Monga nambala yoyamba ku Europe pazachuma za sayansi ya moyo, akatswiri opanga sayansi ya moyo ku UK apambana Mphotho za Nobel zopitilira 80, wachiwiri ku US.
UK ilinso malo oyesera azachipatala, omwe ali nambala wani ku Europe pamayesero achipatala oyambilira, ndi mayeso 20 azachipatala okwana $ 2.7bn omwe amachitidwa chaka chilichonse, kuwerengera 20 peresenti yazinthu zonse za EU.
Utsogoleri wopitilira muukadaulo watsopano, komanso chikhalidwe chazamalonda, zalimbikitsa kubadwa kwa mayunivesite angapo ku UK okwera $ 1bn.
UK ili ndi anthu okwana 67 miliyoni, omwe pafupifupi 20 peresenti ndi mafuko ang'onoang'ono, omwe amapereka anthu osiyanasiyana kuti achite mayesero azachipatala.
Ngongole Yamsonkho Yogwiritsa Ntchito R&D (RDEC): Ngongole yamisonkho ya ndalama za R&D yakwezedwa mpaka 20 peresenti, kutanthauza kuti UK ikupereka chiwongola dzanja chambiri chamakampani akuluakulu ku G7.
Thandizo lamisonkho la Small and Medium Enterprise (SME) R&D: limalola makampani kuchotsera 86 peresenti ya ndalama zawo zowayenereza ku phindu lawo lapachaka, komanso kuchotsera 100 peresenti, zomwe zimakwana 186 peresenti.
Nthawi yotumiza: Oct-11-2023