Icyumweru cya 6 cyo guhanga udushya cyakuruye abashyitsi benshi mu mahanga ndetse no mu mahanga kugira ngo basangire ibyerekezo mpuzamahanga biherutse ndetse na politiki ijyanye n’amahanga.Abateguye amahugurwa bakoze amahugurwa ku mikorere ifatika no kubaka urubuga rw’ibikoresho by’ubuvuzi bijya mu mahanga, aho abashyitsi berekanye uko ibintu byifashe muri iki gihe cyo kubona ibikoresho by’ubuvuzi byo hanze muri Amerika, Ubwongereza, Ositaraliya, Ubuyapani ndetse n’ibindi bihugu, ndetse n’ibikenewe. politiki ya buri gihugu cyo kwinjiza ibikoresho byubuvuzi biva mubushinwa kugirango basangire ibitekerezo byabo.
Dr. Kathrine Kumar, impuguke mu bijyanye n’ubuyobozi bukuru bwa FDA ukomoka muri Amerika, yasobanuye uburyo bwo kwinjira neza ku isoko ry’Amerika mu bijyanye n’amabwiriza ya FDA ndetse n’ibigezweho.Dr. Kumar yavuze ko ivugururwa rigezweho ry’amabwiriza ya FDA rivuga ko abasaba bashobora kwishingikiriza gusa ku makuru y’amavuriro yo hanze iyo batanze icyifuzo.
Inganda zUbushinwa zirashobora gukoresha amakuru yubushinwa kugirango zisabe kwemererwa na FDA muri Amerika, ariko zigomba kwemerera FDA kugera kumasoko yawe yikigereranyo mubushinwa.GCP yo muri Amerika (Ubuvuzi bwiza bwibikoresho byubuvuzi) GCP yUbushinwa iratandukanye, ariko igice kinini cyayo kirahuzagurika.Niba uruganda rukora Ubushinwa rufite icyicaro gikuru mu Bushinwa kandi rukora ubushakashatsi mu Bushinwa, FDA ntigenga ubushakashatsi bwayo kandi uwabikoze asabwa gusa kubahiriza amategeko n'amabwiriza y'Ubushinwa.Niba uruganda rwabashinwa rufite intego yo gukoresha amakuru muri Amerika kugirango rushyigikire igikoresho cyangwa porogaramu, bizakenera kuzuza ibice byabuze ukurikije ibisabwa muri Amerika GCP.
Niba uruganda rufite ibihe bitunguranye bibabuza kubahiriza ibisabwa byaho, barashobora gusaba kureka gusaba inama na FDA.Ibisobanuro by'igikoresho na gahunda bizakenera kwandikwa no gushyikirizwa FDA mbere yinama, kandi FDA izasubiza mu nyandiko nyuma.Inama, waba uhisemo guhura imbonankubone cyangwa kuri terefone, byanditswe kandi nta nama yishyurwa.
Avuga ku bitekerezo by’ubushakashatsi bwibanze, Dr Brad Hubbard, washinze ikigo cy’ubuvuzi cy’ubuvuzi cya EastPoint (Hangzhou), yagize ati: “Kwipimisha inyamaswa mbere y’icyitegererezo ni uburyo bwo guhanura budufasha kureba uko inyama z’inyamaswa zizitabira igishushanyo mbonera cy’ibicuruzwa igihe igikoresho cyubuvuzi kirimo kwigwa mugupima inyamaswa kugirango yumve uko ikora, no kumenya uko igikoresho kizakora mugihe kizakoreshwa mubantu.
Iyo usuzumye ubushakashatsi bwibanze bwakazi, hari ibyifuzo bibiri byubuyobozi bwerekezaho: kimwe ni amategeko agenga leta zunzubumwe za Amerika CFR 21, Igice cya 58 Igishushanyo cya GLP, gishobora koherezwa niba hakenewe gusobanukirwa ibyifuzo bya GLP nkinyamaswa kugaburira, uburyo bwo gusuzuma ibikoresho byo gupima nibikoresho byo kugenzura, nibindi.Hariho kandi umushinga w’amabwiriza yatanzwe n’ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge n’urubuga rwa FDA ruzaba rufite amabwiriza yihariye y’ubushakashatsi bwibanze, nk’ingurube zingahe zikenewe mu gupima inyamaswa kugira ngo hakorwe ubushakashatsi bwo kubaga aortic mitral valve.
Ku bijyanye no gutanga raporo zirambuye kugira ngo FDA yemerwe, amasosiyete y’ibikoresho by’ubuvuzi by’Ubushinwa yitabwaho cyane n’ibibazo, kandi FDA ikunze kubona ibyiringiro bidafite ireme, kubura amakuru y’inyamaswa, amakuru y’ibanze atuzuye, hamwe n’urutonde rw’abakozi ba laboratoire.Ibi bintu bigomba kugaragara muri raporo irambuye kugirango iyemeze.
Raj Maan, Umujyanama w’Ubucuruzi w’Ambasade Nkuru y’Ubwongereza i Chongqing, yasobanuye ibyiza by’ubuvuzi bw’Ubwongereza anasesengura politiki y’ubucuti y’Ubwongereza ku masosiyete y’ibikoresho by’ubuvuzi atanga ingero z’amasosiyete nka Myriad Medical na Shengxiang Biological yagiye mu Bwongereza.
Nk’Uburayi bwa mbere mu ishoramari ry'ubumenyi bw’ubuzima, abashakashatsi mu bumenyi bw’ubuzima mu Bwongereza batsindiye ibihembo birenga 80 bya Nobel, bikurikira Amerika.
Ubwongereza nabwo ni imbaraga z’ibizamini by’amavuriro, biza ku mwanya wa mbere mu Burayi mu bigeragezo by’amavuriro hakiri kare, hakorwa ibizamini 20 by’amavuriro bifite agaciro ka miliyoni 2.7 z'amapound buri mwaka, bingana na 20 ku ijana by’ibihugu by’Uburayi.
Ubuyobozi bukomeje mu ikoranabuhanga rishya, bufatanije n’umuco wo kwihangira imirimo, byatumye havuka umubare w’abantu benshi batangiriye mu Bwongereza bafite agaciro ka miliyoni imwe y'amadolari.
Ubwongereza butuwe na miliyoni 67, muri bo abagera kuri 20 ku ijana ni bake mu moko, batanga abaturage batandukanye kugira ngo bakore ibizamini by’amavuriro.
Inguzanyo y’imisoro ya R&D (RDEC): igipimo cy’inguzanyo y’imisoro ku ikoreshwa rya R&D cyiyongereye burundu kugera kuri 20%, bivuze ko Ubwongereza butanga igipimo ntarengwa cy’imisoro ku misoro minini muri G7.
Ibigo bito n'ibiciriritse (SME) R&D yorohereza imisoro: yemerera ibigo gukuramo andi 86 ku ijana y’amafaranga yujuje ibyangombwa bivuye mu nyungu zabo za buri mwaka, ndetse no kugabanywa bisanzwe 100 ku ijana, byose hamwe bikaba 186%.
Igihe cyo kohereza: Ukwakira-11-2023