Nkhani

“Malamulo a Kuyang’anira ndi Kuwongolera Zida Zachipatala” (omwe tsopano akutchedwa “Malamulo” atsopano) anaperekedwa, kusonyeza gawo latsopano m’kuwunikanso kwa zipangizo zachipatala m’dziko langa ndi kukonzanso zovomereza. The "Regulations on the Supervision and Administration of Medical Devices" adapangidwa mu 2000, adasinthidwa mozama mu 2014, ndipo adasinthidwa pang'ono mu 2017. kusintha kozama. Makamaka, Komiti Yaikulu Yachipani ndi Bungwe la State Council yapanga zisankho zazikulu zambiri ndikutumiza pakusintha kwa mankhwala ndi zida zamankhwala kuwunika ndi kuvomereza dongosolo, ndikuphatikiza zotsatira za kusinthaku kudzera mu malamulo ndi malamulo. Kuchokera m'mabungwe, tidzapititsa patsogolo luso la zipangizo zamankhwala, kulimbikitsa chitukuko chapamwamba cha makampani, kulimbikitsa mphamvu za msika, ndi kukwaniritsa zofuna za anthu za zipangizo zamakono zamakono.
Mfundo zazikuluzikulu za "Malamulo" atsopano zimawonekera makamaka m'mbali izi:
1. Pitirizani kulimbikitsa zatsopano ndikulimbikitsa chitukuko chapamwamba cha makampani opanga zipangizo zamankhwala
Innovation ndiye mphamvu yoyamba yotsogolera chitukuko. Kuyambira pa 18 National Congress of the Communist Party of China, Komiti Yaikulu Yachipani ndi State Council awona kufunika kwakukulu pazaluso zaukadaulo, akhazikitsa njira yachitukuko yoyendetsedwa ndiukadaulo, ndikufulumizitsa kupititsa patsogolo luso lazopangapanga ndi luso laukadaulo monga pachimake. Kuyambira 2014, National Food and Drug Administration yathandiza zida zopitilira 100 zamankhwala komanso zida zamankhwala zomwe zimafunikira mwachangu kuti zivomerezedwe mwachangu kuti zilembetsedwe pogwiritsa ntchito njira monga kupanga njira yobiriwira kuti iwunikenso patsogolo ndikuvomereza zida zachipatala zatsopano. Chidwi chofuna kuyambitsa mabizinesi ndichokwera, ndipo bizinesi ikukula mwachangu. Pofuna kukwaniritsa zofunikira za Komiti Yaikulu ya Party ndi State Council kuti apititse patsogolo kusintha ndi luso lamakono la mafakitale a zida zachipatala ndikupititsa patsogolo mpikisano wamakampani, kukonzanso uku kukuwonetsa mzimu wopitiriza kulimbikitsa zatsopano ndi kulimbikitsa chitukuko cha mafakitale. pamaziko owonetsetsa chitetezo ndi mphamvu zogwiritsa ntchito zida za anthu. "Malamulo" atsopanowa akuwonetsa kuti boma limapanga mapulani ndi mfundo zamakampani azachipatala, kuphatikiza luso lazida zamankhwala kukhala zofunika kwambiri pachitukuko, kuthandizira kukwezedwa kwachipatala ndi kugwiritsa ntchito zida zachipatala zatsopano, kupititsa patsogolo luso lodzipangira okha, kulimbikitsa chitukuko chapamwamba chachipatala. makampani opanga zida, ndipo adzakonza ndikuwongolera Kukhazikitsa ndondomeko zamakampani ndi kalozera wamakampani; kukonza njira zatsopano zopangira zida zachipatala, kuthandizira kafukufuku woyambira ndi kafukufuku wogwiritsa ntchito, ndikupereka chithandizo pama projekiti asayansi ndiukadaulo, ndalama, ngongole, kubitsa ndi kugula, inshuwaransi yachipatala, ndi zina zotero; kuthandizira kukhazikitsidwa kwa mabizinesi kapena kukhazikitsidwa pamodzi kwa mabungwe ofufuza, ndikulimbikitsa Bizinesiyo ikugwirizana ndi mayunivesite ndi mabungwe azachipatala kuti achite zatsopano; amayamikira ndi kupereka mphoto mayunitsi ndi anthu amene apereka zambiri pa kafukufuku ndi luso la zipangizo zachipatala. Cholinga cha malamulo omwe ali pamwambawa ndikulimbikitsanso nyonga yazinthu zatsopano za anthu m'njira zonse, ndikulimbikitsa dziko langa kuti lichoke kudziko lalikulu lopanga zipangizo zachipatala kupita ku mphamvu zopangira.
2. Kuphatikizira zotsatira za kusintha ndikuwongolera kawonedwe ka zida zachipatala
Mu 2015, Bungwe la State Council linapereka "Maganizo pa Kukonzanso Kubwereza ndi Kuvomerezeka kwa Mankhwala Osokoneza Bongo ndi Zida Zachipatala", zomwe zinamveka kuti zikufunika kusintha. Mu 2017, Central Office ndi State Council inapereka "Maganizo pa Kukulitsa Kusintha kwa Kubwereza ndi Kuvomereza System ndi Kulimbikitsa Kukonzekera kwa Mankhwala Osokoneza Bongo ndi Zida Zachipatala". Boma la State Food and Drug Administration lidayambitsa njira zingapo zosinthira. Kuwunikiridwaku kudzakhala gawo limodzi la machitidwe okhwima komanso ogwira mtima. Ndilo gawo lofunikira kuphatikiza zomwe zidachitika kale, kuchita ntchito zowongolera, kukonza zowongolera, ndikuthandizira thanzi la anthu. Monga kukhazikitsa njira yogulitsira zida zachipatala, kukhathamiritsa ndikuphatikiza kugawa kwazinthu zamafakitale; kukhazikitsa njira yapadera yozindikiritsira zida zachipatala pang'onopang'ono kuti apititse patsogolo kufufuza kwazinthu; kuwonjezera malamulo kuti alole kugwiritsidwa ntchito kwachipatala kuti awonetse nzeru zamalamulo.
3. Konzani ndondomeko zovomerezeka ndikuwongolera kubwereza ndi kuvomereza dongosolo
Dongosolo labwino ndi chitsimikizo cha chitukuko chapamwamba. Pokonzanso "Malamulo" atsopano, tidasanthula mosamalitsa zovuta zadongosolo lakuya zomwe zimawululidwa muntchito yoyang'anira tsiku ndi tsiku zomwe zinali zovuta kuti zigwirizane ndi zomwe zidachitika zatsopanozi, zomwe zidaphunzira kwathunthu kuchokera kuzomwe zidachitika padziko lonse lapansi kuyang'anira, kulimbikitsa kuyang'anira mwanzeru, ndikuwongolera njira zowunikira ndi kuvomereza ndikuwongolera njira yowunikira ndi kuvomereza. Limbikitsani mulingo wa kuwunika kwa zida zachipatala za dziko langa ndi kuvomera, ndikuwongolera kuwongolera bwino, kuwunikira ndi kuvomereza. Mwachitsanzo, kufotokozera mgwirizano pakati pa kuunika kwachipatala ndi mayesero a zachipatala, ndi kutsimikizira chitetezo ndi mphamvu ya mankhwala pogwiritsa ntchito njira zosiyana zowunikira malinga ndi kukhwima, chiopsezo ndi zotsatira zosawerengeka za kafukufuku wa mankhwala, kuchepetsa zosafunika zoyezetsa zachipatala; kusintha chivomerezo chachipatala kuti chikhale chilolezo, kuchepetsa nthawi yovomerezeka; olembetsa amaloledwa kupereka malipoti odziwonera okha kuti achepetse ndalama za R&D; kuvomerezedwa kovomerezeka kumaloledwa pazida zamankhwala zomwe zikufunika mwachangu monga kuchiza matenda osowa, kuyika moyo pachiwopsezo komanso kuyankha pazochitika zaumoyo wa anthu. Kukwaniritsa zosowa za odwala pansi pamikhalidwe yolembedwa; phatikizani chidziwitso cha kupewa ndi kuwongolera mliri watsopano wa chibayo cha korona kuti muwonjezere kugwiritsa ntchito mwadzidzidzi kwa zida zamankhwala ndikuwongolera kuthekera kochitapo kanthu pazadzidzidzi zazikulu zapagulu.
Chachinayi, kufulumizitsa ntchito yomanga chidziwitso, ndikuwonjezera mphamvu ya "kugawa, kasamalidwe, ndi ntchito"
Poyerekeza ndi kuyang'anira kwachikhalidwe, kuyang'anira chidziwitso kuli ndi ubwino wa liwiro, kumasuka komanso kufalikira kwakukulu. Kupanga chidziwitso ndi chimodzi mwazinthu zofunika kwambiri pakuwongolera luso la kuyang'anira ndi kuchuluka kwa ntchito. "Malamulo" atsopanowa adawonetsa kuti boma lidzalimbitsa ntchito yomanga kasamalidwe ka zida zachipatala ndi chidziwitso, kupititsa patsogolo ntchito za boma pa intaneti, komanso kupereka mwayi wopereka zilolezo zoyang'anira ndikusunga zida zamankhwala. Zambiri pazida zamankhwala zomwe zasungidwa kapena zolembetsedwa zidzaperekedwa kudzera muzochitika za boma pa intaneti za dipatimenti yoyang'anira mankhwala ku State Council. Pulatifomu imalengezedwa kwa anthu. Kukhazikitsidwa kwa njira zomwe zili pamwambazi kupititsa patsogolo kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe kake Panthawi imodzimodziyo, anthu adzadziwitsidwa zambiri za zinthu zomwe zalembedwa mwatsatanetsatane, molondola komanso panthawi yake, kutsogolera anthu kugwiritsa ntchito zida, kuvomereza kuyang'aniridwa ndi anthu, komanso kuwonetsetsa kuti boma liziyang'anira.
5. Kutsatira kuyang'anira kwasayansi ndikulimbikitsa kutsogola kwa kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe kake
"Malamulo" atsopanowa adanena momveka bwino kuti kuyang'anira ndi kuyang'anira zipangizo zamankhwala ziyenera kutsata mfundo zoyendetsera sayansi. State Food and Drug Administration yakhazikitsa dongosolo lasayansi lowongolera mankhwala mu 2019, kudalira mayunivesite odziwika bwino apakhomo ndi mabungwe ofufuza asayansi kuti akhazikitse maziko angapo ofufuza asayansi, kugwiritsa ntchito mokwanira mphamvu zamagulu kuthana ndi zovuta komanso zovuta pantchito yoyang'anira. pansi pa nyengo yatsopano ndi mkhalidwe watsopano. Zovuta, zida zofufuzira zatsopano, miyezo, ndi njira zopititsira patsogolo ntchito yasayansi, yoyang'anira kutsogolo komanso yosinthika. Gulu loyamba la mapulojekiti ofufuza a zida zachipatala omwe achitika apeza zotsatira zabwino, ndipo gulu lachiwiri la mapulojekiti ofunikira ofufuza lidzakhazikitsidwa posachedwa. Mwa kulimbikitsa kafukufuku wasayansi wa kuyang'anira ndi kasamalidwe, tidzapitirizabe kugwiritsa ntchito lingaliro la kuyang'anira sayansi mu dongosolo ndi makina, ndi kupititsa patsogolo sayansi, zamalamulo, zapadziko lonse ndi zamakono za kuyang'anira zipangizo zachipatala.

Gwero la nkhani: Unduna wa Zachilungamo