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“IMimiselo yoLawulo noLawulo lweZixhobo zoNyango” (emva koku ebizwa ngokuba “yiMimiselo” emitsha) iye yakhutshwa, iphawula inqanaba elitsha kuphononongo lwezixhobo zonyango lwelizwe lam kunye nohlaziyo lolwamkelo. I-"Regulations on Supervision and Administration of Medical Devices" yaqulunqwa kwi-2000, yahlaziywa ngokubanzi ngo-2014, kwaye yahlaziywa ngokuyinxenye ngo-2017. Olu hlaziyo lujongene nophuhliso olukhawulezayo lweshishini kwiminyaka yamuva kunye nemeko entsha uhlaziyo olunzulu. Ngokukodwa, i-Party Central Committee kunye ne-State Council yenze uluhlu lwezigqibo eziphambili kunye nokuthunyelwa kwi-reform yokuhlaziywa kweyeza kunye nesixhobo sonyango kunye nenkqubo yokuvunywa, kwaye idibanise iziphumo zohlaziyo ngokusebenzisa imithetho nemimiselo. Ukusuka kwinqanaba leziko, siya kuqhubela phambili ukukhuthaza ukusungulwa kwezixhobo zonyango, ukukhuthaza uphuhliso olukumgangatho ophezulu weshishini, ukuvuselela amandla emarike, kunye nokuhlangabezana nemfuno yabantu yezixhobo zonyango ezikumgangatho ophezulu.
Amagqabantshintshi “eMigaqo” emitsha abonakaliswa ikakhulu kule miba ilandelayo:
1. Qhubeka nokukhuthaza ukwenziwa kwezinto ezintsha kunye nokukhuthaza uphuhliso olukumgangatho ophezulu kushishino lwezixhobo zonyango
Ukwenziwa kwezinto ezintsha ngamandla okuqala aqhuba uphuhliso. Ukusukela kwiNkongolo yeSizwe ye-18 yeQela lamaKomanisi laseTshayina, iKomiti ePhakathi yeQela kunye neBhunga leSizwe baye bancamathisela ukubaluleka okukhulu kubuchule obutsha bobugcisa, baphumeza isicwangciso sophuhliso esiqhutywa zizinto ezintsha, kwaye bakhawulezisa ukukhuthazwa kokutsha okubanzi kunye nokutsha kobuchwepheshe njengondoqo. Ukususela kwi-2014, i-National Food and Drug Administration iye yanceda ngaphezu kwe-100 izixhobo zonyango ezitsha kunye nezixhobo zonyango ezifunekayo ngokukhawuleza ukuba zivunywe ngokukhawuleza ukuba zidweliswe ngamanyathelo afana nokwakha umjelo oluhlaza wokuphononongwa okuphambili kunye nokuvunywa kwezixhobo zonyango ezitsha. Umdla wokusungula amashishini uphezulu, kwaye ishishini likhula ngokukhawuleza. Ukuze kuphunyezwe ngakumbi iimfuno zeKomiti ePhakathi yeQela kunye neBhunga leSizwe ukukhuthaza uhlengahlengiso kunye nokuveliswa kwezinto ezintsha kwezobuchwepheshe kushishino lwezixhobo zonyango kunye nokuphucula ukukhuphisana kolu shishino, olu hlaziyo lubonisa umoya wokuqhubeka nokukhuthaza ukutsha kunye nokukhuthaza uphuhliso lwamashishini. ngesiseko sokuqinisekisa ukhuseleko nokusebenza koluntu lwezixhobo zokusebenza. "Imimiselo" emitsha ichaza ukuba urhulumente uqulunqa izicwangciso kunye nemigaqo-nkqubo yoshishino lwezixhobo zonyango, udibanisa izixhobo zonyango kwizinto eziphambili zophuhliso, uxhasa ukukhuthazwa kweklinikhi kunye nokusetyenziswa kwezixhobo zonyango ezitsha, ukuphucula amandla okuvelisa okuzimeleyo, ukukhuthaza uphuhliso oluphezulu lwezonyango. ishishini lezixhobo, kwaye liza kuqulunqa kwaye liphucule uPhumezo oluthile lwesicwangciso soshishino kunye nemigaqo-nkqubo yesikhokhelo yenkampani; ukuphucula inkqubo yokuveliswa kwezixhobo zonyango, ukuxhasa uphando olusisiseko kunye nophando olusetyenzisiweyo, kunye nokubonelela ngenkxaso kwiiprojekthi zenzululwazi nezobuchwepheshe, ukuxhaswa ngemali, ikhredithi, ukubhida kunye nokuthengwa kwempahla, i-inshurensi yezonyango, njl.; ukuxhasa ukusekwa kwamashishini okanye ukusekwa ngokubambisana kwamaziko ophando, kunye nokukhuthaza Ishishini lisebenzisana neeyunivesithi kunye namaziko ezonyango ukwenza izinto ezintsha; incoma kwaye ivuze iiyunithi kunye nabantu ngabanye abenze igalelo elibalaseleyo kuphando kunye nokuveliswa kwezinto ezintsha zonyango. Injongo yale mimiselo ingasentla kukuvuselela ngakumbi amandla okwenziwa kwezinto ezintsha kwezentlalo ngendlela ejikelezayo, kunye nokukhuthaza ukutsiba kwelizwe lam ukusuka kwilizwe lokwenziwa kwezixhobo zonyango ukuya kumandla okuvelisa.
2. Ukuhlanganisa iziphumo zohlaziyo kunye nokuphucula umgangatho wolongamelo lwezixhobo zonyango
Kwi-2015, iBhunga likaRhulumente likhuphe "Iimbono malunga nokuHlaziywa kweNkqubo yokuPhonononga kunye nokuVunywa kweMichiza kunye neZixhobo zezoNyango", ezavakala ikhwelo elicacileyo lokuguqulwa. Kwi-2017, i-Ofisi ePhakathi kunye neBhunga likaRhulumente likhuphe "Iimbono malunga nokuNxibisa uHlaziyo lweNkqubo yokuHlola kunye nokuVunywa kunye nokuKhuthaza ukuTshintsha kweZidiza kunye neZixhobo zoNyango". I-State Food and Drug Administration yazisa uluhlu lwamanyathelo ohlaziyo. Olu hlaziyo luya kuba yinxalenye yenkqubo yolawulo esele ikhulile nesebenzayo. Linyathelo elibalulekileyo lokuhlanganisa impumelelo esele ikho, ukwenza uxanduva lolawulo, ukuphucula imigangatho yolawulo, kunye nokusebenzela impilo yoluntu. Okufana nokumilisela inkqubo yomnini welayisenisi yokuthengisa isixhobo sonyango, ukukhulisa nokudibanisa ulwabiwo lwezibonelelo zoshishino; ukuphumeza inkqubo yokuchonga eyodwa yezixhobo zonyango inyathelo ngenyathelo ukuphucula ngakumbi ukulandeleka kwemveliso; Ukongeza imimiselo ukuvumela ukusetyenziswa kweklinikhi okwandisiweyo ukubonisa ubulumko bokulawula.
3. Ukuphucula iinkqubo zokuvunywa nokuphucula inkqubo yokuphonononga nokuvunywa
Inkqubo elungileyo sisiqinisekiso sophuhliso olukumgangatho ophezulu. Kwinkqubo yokuhlaziya "iMithetho" emitsha, sihlalutye ngononophelo iingxaki zenkqubo enzulu evezwe kumsebenzi wokulawula wemihla ngemihla ekwakunzima ukuziqhelanisa neemfuno zemeko entsha, efundwe ngokupheleleyo kumava olawulo oluphezulu lwamazwe ngamazwe, ukukhuthaza ukongamela ngobuchule, kunye nokuphucula iinkqubo zoviwo kunye nokuvunywa kunye nokuphucula inkqubo yokuphonononga kunye nokuvunywa. Ukuphucula umgangatho wophononongo lwesixhobo sonyango selizwe lam kunye nenkqubo yokuvunywa, kwaye uphucule umgangatho kunye nokusebenza kakuhle kophononongo, uphononongo kunye nolwamkelo. Umzekelo, ukucacisa ubudlelwane phakathi kovavanyo lweklinikhi kunye nezilingo zeklinikhi, kunye nokuqinisekisa ukhuseleko kunye nokusebenza kwemveliso ngeendlela ezahlukeneyo zokuvavanya ngokukhula, umngcipheko kunye neziphumo zophando ezingezizo zeklinikhi zemveliso, ukunciphisa umthwalo ongeyomfuneko wovavanyo lweklinikhi; ukutshintsha ukuvunywa kovavanyo lweklinikhi kwimvume echaziweyo, ukunciphisa ixesha lokuVuma; abafaki-zicelo zobhaliso bavumelekile ukuba bangenise iingxelo zokuzihlola kwemveliso ukunciphisa ngakumbi iindleko ze-R&D; imvume enemiqathango ivunyelwe kwizixhobo zonyango ezifuneka ngokungxamisekileyo ezifana nonyango lwezifo ezinqabileyo, ezibeka ubomi esichengeni kakhulu kunye nokusabela kwiziganeko zempilo yoluntu. Ukuhlangabezana neemfuno zezigulane phantsi kweemeko ezimiselweyo; ukudibanisa amava okuthintela kunye nokulawulwa kwesifo esitsha sesithsaba se-pneumonia ukwandisa ukusetyenziswa ngokukhawuleza kwezixhobo zonyango kunye nokuphucula ukukwazi ukuphendula kwiimeko ezingxamisekileyo zempilo yoluntu.
Okwesine, ukukhawulezisa ulwakhiwo lolwazi, kunye nokwandisa ubunzulu "bogunyaziso, ulawulo kunye nenkonzo"
Xa kuthelekiswa nolongamelo lwemveli, ukongamela ulwazi kuneengenelo zesantya, lula kunye nokhuseleko olubanzi. Ulwakhiwo lolwazi ngomnye wemisebenzi ebalulekileyo yokuphucula amandla olongamelo kunye namanqanaba eenkonzo. I-"Regulations" emitsha ibonise ukuba urhulumente uya kuqinisa ukwakhiwa kokulawulwa kwezixhobo zonyango kunye nolwazi, ukuphucula inqanaba leenkonzo zikarhulumente kwi-intanethi, kunye nokubonelela ngokulula kwilayisenisi yolawulo kunye nokufakwa kwezixhobo zonyango. Ulwazi malunga nezixhobo zonyango ezifakwe efayilini okanye ezibhalisiweyo ziya kudluliselwa kwimicimbi karhulumente we-intanethi yesebe elilawula iziyobisi leBhunga leSizwe. Iqonga libhengezwa eluntwini. Ukuphunyezwa kwala manyathelo angasentla kuya kuphucula ngakumbi ukusebenza kakuhle kolongamelo nokunciphisa iindleko zokuphonononga nokuvunywa kwabafaki-zicelo ababhalisiweyo. Kwangaxeshanye, uluntu luya kwaziswa ngolwazi lweemveliso ezidwelisiweyo ngendlela ebanzi, echanekileyo nangexesha, lukhokele uluntu ukuba lusebenzise izixhobo, lwamkele ukonganyelwa luluntu, nokuphucula ukwenziwa elubala kolongamelo lukarhulumente.
5. Ukubambelela kulawulo lwezenzululwazi nokukhuthaza ukwenziwa kwenkqubo yokongamela yala maxesha nesakhono sokulawula
“IMimiselo” emitsha yachaza ngokucacileyo ukuba ukubeka iliso nokulawulwa kwezixhobo zonyango kufuneka kulandele imigaqo yolawulo lwenzululwazi. I-State Food and Drug Administration isungule isicwangciso sokusebenza kwesayensi yokulawula iziyobisi ngo-2019, sixhomekeke kwiiyunivesithi ezaziwayo zasekhaya kunye namaziko ophando lwesayensi ukuseka iziseko zophando lwezenzululwazi ezininzi ezilawulayo, ukusebenzisa ngokupheleleyo amandla entlalo ukujongana nemiba kunye nemiba kumsebenzi wolawulo. phantsi kwexesha elitsha kunye nemeko entsha. Imiceli mngeni, izixhobo zophando, imigangatho, kunye neendlela zokuphucula umsebenzi wenzululwazi, ojonge phambili kunye noguquguqukayo wokongamela. Ibhetshi yokuqala yeeprojekthi zophando zezixhobo zonyango eziye zaqhutywa zifumene iziphumo ezineziqhamo, kwaye ibhetshi yesibini yeeprojekthi zophando eziphambili iza kusungulwa kungekudala. Ngokomeleza uphando lwezenzululwazi lokongamela kunye nolawulo, siya kuthi gqolo siphumeza ingqikelelo yokongamela yezenzululwazi kwinkqubo nakwindlela yokusebenza, kwaye siphucule ngakumbi inqanaba lenzululwazi, elisemthethweni, lamazwe ngamazwe kunye nelanamhlanje lokongamela izixhobo zonyango.

Umthombo wenqaku: UMphathiswa wezoBulungisa