Ua hoʻokipa ka 6th Innovation Week i nā malihini ʻike ma waho a ma waho e kaʻana like i nā ʻano o ka honua hou a me nā kulekele pili i waho.Ua mālama nā mea hoʻonohonoho i kahi seminar e pili ana i ka hana kūpono a me ke kūkulu ʻana i ke kahua o nā lāʻau lapaʻau e hele ana i waho, kahi i hoʻolauna ai nā malihini i ke kūlana o kēia manawa o ke komo ʻana i nā lāʻau lapaʻau o waho ma US, UK, Australia, Iapana a me nā ʻāina ʻē aʻe, a me ka makemake. nā kulekele o kēlā me kēia ʻāina no ke komo ʻana o nā lāʻau lapaʻau mai Kina e hōʻike i ko lākou manaʻo.
Ua wehewehe ʻo Kauka Kathrine Kumar, he loea hoʻoponopono FDA koʻikoʻi mai ka US, pehea e komo kūleʻa ai i ka mākeke US e pili ana i nā lula FDA a me nā ʻano hou loa.Ua ʻōlelo ʻo Kauka Kumar, ʻo ka hōʻano hou o ke alakaʻi a ka FDA e ʻōlelo nei e hiki i nā mea noi ke hilinaʻi wale i nā ʻikepili lapaʻau haole i ka wā e waiho ana i kahi noi.
Hiki i nā mea hana Kina ke hoʻohana i ka ʻikepili Kina e noi ai no ka ʻae ʻia ʻana o ka US FDA, akā pono e ʻae i ka FDA e komo i kāu kumu ʻikepili hoʻāʻo ma Kina.ʻOkoʻa ka GCP US (Good Clinical Practice for Medical Devices) ʻO ka GCP o Kina, akā ʻoi aku ka hapa nui o ia mea.Inā he keʻena nui ka mea hana Kina ma Kina a mālama i nā haʻawina ma Kina, ʻaʻole hoʻoponopono ka FDA i kāna mau haʻawina a pono ka mea hana e hoʻokō i nā kānāwai a me nā lula o Kina.Inā manaʻo ka mea hana Kina e hoʻohana i ka ʻikepili i ka US no ke kākoʻo ʻana i kahi mea hana a noi paha, pono ia e hoʻopiha i nā ʻāpana i nalowale e like me nā koi US GCP.
Inā loaʻa i kahi mea hana nā kūlana i ʻike ʻole ʻia e pale iā lākou mai ka hoʻokō ʻana i nā koi kūloko, hiki iā lākou ke noi no ka waiver e noi i kahi hālāwai me ka FDA.Pono e kākau ʻia kahi wehewehe o ka mea hana a me kahi hoʻolālā i ka FDA ma mua o ka hālāwai, a e pane ka FDA ma ke kākau ʻana i kahi lā ma hope.ʻO ka hālāwai, inā ʻoe e koho e hui kino a ma ke kelepona paha, ua palapala ʻia a ʻaʻohe uku no ka hālāwai.
E pili ana i nā noʻonoʻo noiʻi preclinical, ʻōlelo ʻo Dr Brad Hubbard, ka mea hoʻokumu o EastPoint (Hangzhou) Medical Technology Co., Ltd: "ʻO ka hoʻāʻo holoholona preclinical kahi hiʻohiʻona wānana e hiki ai iā mākou ke ʻike i ka pane ʻana o nā ʻiʻo holoholona i ka hoʻolālā ʻana o kahi huahana. ke aʻo ʻia nei kahi lāʻau lapaʻau i ka hoʻāʻo holoholona e hoʻomaopopo i ke ʻano o ka hana ʻana, a no ka manaʻo i ka hana ʻana o ka mea hana ke hoʻohana ʻia i loko o ke kanaka.
I ka noʻonoʻo ʻana i nā haʻawina hana preclinical, ʻelua mau ʻōlelo aʻoaʻo no ke alakaʻi ʻana e pili ana: ʻo ka US federal regulation CFR 21 standard, Part 58 Design GLP, hiki ke kuhikuhi ʻia inā pono e hoʻomaopopo i nā koi noiʻi GLP e like me ka holoholona. hānai, pehea e loiloi ai i nā mea ho'āʻo a me nā mea hoʻomalu, a pēlā aku.Aia kekahi mau alakaʻi kuhikuhi mai ka US Food and Drug Administration a me ka pūnaewele FDA e loaʻa nā ʻōlelo kikoʻī no nā haʻawina preclinical, e like me ka nui o nā puaʻa e pono ai no ka hoʻāʻo holoholona no nā haʻawina ʻoki ʻoki ʻoki ʻoki aortic mitral valve clot.
I ka hāʻawi ʻana i nā hōʻike kikoʻī no ka ʻae ʻana o FDA, ʻoi aku ka nui o nā hui lāʻau lapaʻau Kina i ka nānā ʻana a me nā nīnau, a ʻike pinepine ka FDA i ka hōʻoia maikaʻi ʻole, ʻike ʻole ʻia ka ʻike mālama holoholona, ka ʻikepili maka piha ʻole, a me ka papa inoa o nā limahana lab.Pono e hōʻike ʻia kēia mau mea i ka hōʻike kikoʻī no ka ʻae ʻia.
Ua wehewehe ʻo Raj Maan, Kāleka Kūʻai o ka British Consulate General ma Chongqing, i nā pono o ka mālama olakino UK a nānā i nā kulekele aloha o UK e pili ana i nā hui lāʻau lapaʻau ma ka haʻi ʻana i nā hiʻohiʻona o nā hui e like me Myriad Medical a me Shengxiang Biological i holo i UK.
Ma ke ʻano he helu ʻekahi o ʻEulopa no ka hoʻopukapuka ʻana i ka ʻepekema ola, ua lanakila nā mea hou ʻepekema ola UK ma mua o 80 mau makana Nobel, ʻelua wale nō i ka US.
He hale hoʻokolohua hoʻokolohua hoʻi ʻo UK, helu helu ʻekahi ma ʻEulopa no nā hoʻokolohua lapaʻau mua, me 20 mau hoʻokolohua lapaʻau i loaʻa i ka £ 2.7bn i hana ʻia i kēlā me kēia makahiki, e helu ana no 20 pākēneka o nā noi EU āpau.
ʻO ka hoʻomau ʻana i ke alakaʻi ʻana i nā ʻenehana hou, i hui pū ʻia me kahi moʻomeheu ʻoihana, ua hoʻoulu i ka hānau ʻana o kekahi mau unicorn hoʻomaka i UK ma mua o $ 1bn.
He 67 miliona ka nui o ka UK, a ma kahi o 20 pakeneka he mau lāhui liʻiliʻi, e hāʻawi ana i kahi heluna lehulehu no ka hana ʻana i nā hoʻokolohua lapaʻau.
R&D Expenditure Tax Credit (RDEC): ua hoʻonui mau ʻia ka ʻauhau ʻauhau no ka hoʻolilo R&D i 20 pākēneka, ʻo ia hoʻi ke hāʻawi aku nei ʻo UK i ka uku ʻauhau kiʻekiʻe loa no nā hui nui ma ka G7.
ʻO ka liʻiliʻi a me ka liʻiliʻi (SME) ʻauhau ʻauhau R&D: ʻae i nā hui e unuhi i kahi 86 pākēneka hou o kā lākou mau kumukūʻai kūpono mai kā lākou loaʻa kālā makahiki, a me ka unuhi maʻamau 100 pākēneka, ʻo 186 pākēneka.
Ka manawa hoʻouna: Oct-11-2023