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Iyo ichangobva kuvandudzwa "Mitemo pamusoro peKutarisira uye Kutungamirirwa kweMidziyo Yekurapa" (inozonzi "Mitemo" mitsva yakapihwa, zvichiratidza nhanho nyowani mukuongororwa kwemidziyo yezvokurapa yenyika yangu nekuvandudzwa kwemvumo. I "Regulations on the Supervision and Administration of Medical Devices" yakagadzirwa muna 2000, yakanyatsogadziridzwa muna 2014, uye yakadzokororwa zvishoma muna 2017. Kudzokorora uku kuri pamberi pekukurumidza kukura kweindasitiri mumakore achangopfuura uye mamiriro matsva e kudzamisa shanduko. Kunyanya, Bato reCentral Committee uye State Council vakaita sarudzo dzakakura uye kutumirwa pakuvandudzwa kweiyo mushonga uye yezvokurapa mudziyo wongororo uye hurongwa hwekubvumidza, uye kubatanidza mhedzisiro yekuvandudza kuburikidza nemitemo nemirairo. Kubva padanho remasangano, tichaenderera mberi nekusimudzira kuvandudzwa kwemidziyo yekurapa, kusimudzira kusimudzira kweindasitiri, kumutsa simba remusika, uye kusangana nezvinodiwa nevanhu zvemhando yepamusoro michina yekurapa.
Zvakanakisa zve "Mitemo" mitsva zvinonyanya kuratidzwa mune zvinotevera zvinhu:
1. Ramba uchikurudzira hutsva uye kusimudzira budiriro yemhando yepamusoro yeindasitiri yemidziyo yekurapa
Innovation ndiyo yekutanga kufambisa simba inotungamira budiriro. Kubva paNational Congress yechigumi nesere yeBato reCommunist yeChina, Bato reCentral Committee neState Council vakakoshesa hunyanzvi hwekuvandudza tekinoroji, vakashandisa hurongwa hwebudiriro hunofambiswa nehutsva, uye nekukasira kukwidziridza hunyanzvi hwakazara nehunyanzvi hwekuvandudza tekinoroji semusimboti. Kubva 2014, National Food and Drug Administration yakabatsira zvinopfuura zana zvigadzirwa zvekurapa uye zvekurapa zvinodikanwa nekukurumidza kuti zvibvumidzwe kuti zvinyorwe kuburikidza nematanho akadai sekuvaka chiteshi chegirini chekuongorora uye kubvumidzwa kwezvishandiso zvekurapa zvitsva. Kufarira kwekuvandudza kwemabhizinesi kwakakwira, uye indasitiri iri kukura nekukurumidza. Kuti uenderere mberi nekuita zvinodiwa neParty Central Committee uye State Council kusimudzira kugadziridzwa uye tekinoroji yeindasitiri yemidziyo yekurapa uye kuwedzera kukwikwidza kweindasitiri, ongororo iyi inoratidza mweya wekuenderera mberi nekukurudzira hunyanzvi uye kusimudzira budiriro yemaindasitiri. pahwaro hwekuona kuchengetedzwa nekubudirira kwekushandiswa kweruzhinji kwemichina. "Mitemo" mitsva inotara kuti nyika igadzire zvirongwa zveindasitiri yezvishandiso zvekurapa, inobatanidza hunyanzvi hwemidziyo yekurapa mune zvekutanga zvekusimudzira, inotsigira kusimudzirwa kwekiriniki uye kushandiswa kwezvishandiso zvekurapa zvehunyanzvi, inovandudza hunyanzvi hwekuzvimiririra, inosimudzira budiriro yemhando yepamusoro yekurapa. indasitiri yemidziyo, uye ichagadzira uye nekuvandudza chaiyo Shandisa iyo maindasitiri kuronga uye kutungamira marongero ekambani; kunatsiridza iyo yekurapa mudziyo innovation system, tsigira yekutanga kutsvagisa uye kushandiswa kutsvagisa, uye kupa rutsigiro mumapurojekiti esainzi uye tekinoroji, mari, kiredhiti, kubhidha uye kutenga, inishuwarenzi yekurapa, nezvimwe; tsigira kugadzwa kwemabhizinesi kana kumisikidzwa kwakabatana kwemasangano ekutsvagisa, uye kukurudzira Bhizinesi rinoshanda pamwe nemayunivhesiti uye masangano ekurapa kuita hunyanzvi; inorumbidza uye inopa mibairo mayuniti uye vanhu vakapa mupiro wakatanhamara mukutsvagisa nekuvandudzwa kwemidziyo yekurapa. Chinangwa chemirau iri pamusoro apa ndechekusimudzira simba rekuvandudza magariro nenzira yakatenderedza, uye kusimudzira kusvetuka kwenyika yangu kubva kunyika huru yekugadzira michina yekurapa kuenda kune simba rekugadzira.
2. Batanidza mhedzisiro yekuvandudza uye kuvandudza mwero wekutariswa kwemidziyo yekurapa
Muna 2015, Dare reHurumende rakapa "Maonero ekugadzirisa Ongororo uye Kubvumirwa System yeDrugs uye Medical Devices", iyo yakanzwika kudanidzira kwakajeka kwekugadzirisa. Muna 2017, Central Office uye State Council yakabudisa "Maonero eKudzamisa Kuvandudzwa kweKudzokorora uye Kubvumira System uye Kukurudzira Kuvandudzwa Kwezvinodhaka uye Zvishandiso Zvekurapa". Iyo State Food and Drug Administration yakaunza nhevedzano yematanho ekugadzirisa. Ongororo iyi ichave chikamu cheyakakura uye inoshanda yekudzora matanho masisitimu. Chiyero chakakosha kubatanidza zvakabudirira zviripo, kuita mabasa ekutonga, kuvandudza zvimiro zvemitemo, uye kushandira hutano hweveruzhinji. Zvakadai sekushandisa iyo yekurapa mudziyo wekushambadzira rezinesi rezinesi, kugadzirisa uye kubatanidza kugoverwa kwezviwanikwa zveindasitiri; kushandisa iyo yakasarudzika yekuzivikanwa sisitimu yezvishandiso zvekurapa nhanho nhanho kuti uwedzere kunatsiridza kuwanikwa kwechigadzirwa; kuwedzera mitemo yekubvumira kushandiswa kwekiriniki yakawedzerwa kuratidza huchenjeri hwekutonga.
3. Gadzirisa maitiro ekubvumirwa uye uvandudze kuongorora uye kubvumirwa hurongwa
Iyo yakanaka system ndiyo vimbiso yemhando yepamusoro yekusimudzira. Mukuita kudzokorora "Mitemo" mitsva, takanyatsoongorora matambudziko ehurongwa hwakadzama hwakafumurwa mubasa rekutarisa zuva nezuva izvo zvaive zvakaoma kuenderana nezvinodiwa nemamiriro ezvinhu matsva, akadzidza zvizere kubva kune ruzivo rwepamusoro penyika dzepasirese, akakurudzira kutarisa kwakanaka, uye yakagadzirisa bvunzo uye nzira dzekubvumidza uye yakavandudza ongororo uye hurongwa hwekubvumidza. Kuvandudza mwero wekuongororwa kwemidziyo yekurapa yenyika yangu uye hurongwa hwemvumo, uye kuvandudza kunaka uye kugona kwekuongorora, kuongorora uye kubvumidzwa. Semuenzaniso, kujekesa hukama pakati pekuongororwa kwekiriniki uye miedzo yekiriniki, uye kuratidza kuchengetedzwa nekubudirira kwechigadzirwa kuburikidza nenzira dzakasiyana-siyana dzekuongorora maererano nekukura, njodzi uye kwete yekliniki tsvakurudzo yemigumisiro yechigadzirwa, kuderedza zvisingakoshi kliniki yekuedza mutoro; kushandura mvumo yekuedzwa kwekiriniki kuti iite mvumo, kupfupisa Nguva yemvumo; kunyoresa vanyoreri vanobvumidzwa kuendesa chigadzirwa chega-yekuongorora mishumo kuti vawedzere kudzikisa mutengo weR&D; kubvumirwa kwemamiriro ezvinhu kunobvumirwa kune zvigadzirwa zvekurapa zvinodiwa nokukurumidza zvakadai sekurapa zvirwere zvisingawanzoitiki, zvakanyanya kutyisa upenyu uye kupindura kune zviitiko zvehutano hwevanhu. Kusangana nezvinodiwa nevarwere pasi pemamiriro akatemerwa; batanidza ruzivo rwekudzivirira uye kutonga kwekorona itsva pneumonia denda kuti uwedzere kushandiswa kwekukurumidzira kwemichina yezvokurapa uye kuvandudza kukwanisa kupindura kune hukuru hwehutano hwehutano.
Chechina, mhanyisa kuvaka kwekuzivisa, uye kuwedzera kusimba kwe "kutumwa, manejimendi, uye sevhisi"
Kuenzaniswa nekutarisa kwechinyakare, kutarisisa kweruzivo kune zvakanakira kumhanya, kureruka uye kufukidzwa kwakafara. Informatization kuvaka nderimwe remabasa akakosha ekuvandudza kugona kwekutarisa uye masevhisi masevhisi. Iyo "Mitemo" mitsva yakaratidza kuti nyika ichasimbisa kuvakwa kwekutarisirwa kwemidziyo yekurapa uye ruzivo, kuvandudza mwero wemasevhisi ehurumende yepamhepo, uye kupa mukana wekupihwa marezenisi ekutonga uye kufaira kwemidziyo yekurapa. Ruzivo pamusoro pemidziyo yekurapa yakafayerwa kana kunyoreswa ichapfuudzwa kuburikidza nehurumende yepamhepo nyaya dzedhipatimendi rekuona nezvezvinodhaka reState Council. Chikuva chinoziviswa kuvanhu. Kuitwa kwematanho ari pamusoro apa kuchawedzera kuvandudza kushanda kwekutarisa uye kuderedza mutengo wekuongorora uye kubvumidzwa kwevakanyoresa kunyorera. Panguva imwecheteyo, veruzhinji vachaziviswa nezveruzivo rwezvigadzirwa zvakanyorwa nenzira yakazara, yakarurama uye nenguva, kutungamira veruzhinji kushandisa zvombo, kugamuchira kutariswa kwevanhu, uye kuvandudza hutongi hwehurumende.
5. Kutevedzera kutariswa kwesainzi uye kukurudzira kuvandudzwa kwehurongwa hwekutarisa uye kugona kwekutarisa
Iyo "Mitemo" mitsva yakataura zvakajeka kuti kutariswa uye manejimendi emidziyo yekurapa kunofanirwa kutevedzera misimboti yekutariswa kwesainzi. Iyo State Food and Drug Administration yakatanga chirongwa chekutonga chemishonga yesainzi muna 2019, ichivimba nemayunivhesiti anozivikanwa epamba uye masangano ekutsvagisa sainzi kuti amise mabhesi akawanda ekutsvagisa esainzi, vachishandisa zvizere masimba emagariro kugadzirisa nyaya uye nyaya mubasa rekutonga. pasi penguva itsva uye mamiriro matsva. Zvinetso, maturusi ekutsvaga maturusi, zviyero, uye nzira dzekusimudzira basa rekutarisa resainzi, remberi uye rinochinjika. Boka rekutanga remapurojekiti akakosha ekutsvagisa mudziyo wekurapa akaitwa akawana zvibereko, uye chikamu chechipiri chezvirongwa zvakakosha zvekutsvagisa zvichakurumidza kutangwa. Nekusimbisa tsvakiridzo yesainzi yekutarisisa uye manejimendi, ticharamba tichiisa pfungwa yekutarisisa yesainzi muhurongwa nemuchina, uye nekuwedzera kuvandudza mwero wesainzi, wemutemo, wepasirese uye wemazuva ano wekutariswa kwemidziyo yekurapa.

Chinyorwa chinyorwa: Ministry of Justice