Ngophuhliso loluntu kunye nokuphuculwa kwenqanaba lezonyango, iimfuno zamazwe kwihlabathi jikelele ngamachiza, izixhobo zonyango, kunye nee-API ezisetyenziswa kumachiza kunye nezixhobo zingqongqo unyaka nonyaka, nto leyo iqinisekisa kakhulu ukhuseleko lwemveliso yamachiza!
Makhe sijonge kulawulo lwe-API kwimarike yaseBrazil!
Yintoni i-ANVISA?
I-Anvisa sisishunqulelo se-Portuguese Agência Nacional de Vigilância Sanitária, sibhekisa kwi-Arhente yoLawulo lwezeMpilo yaseBrazil.
I-Arhente yoLawulo lwezeMpilo yaseBrazil (i-Anvisa) yi-arhente enegunya enxulumene noMphathiswa wezeMpilo, oyinxalenye yeNkqubo yezeMpilo yeSizwe yaseBrazil (SUS) kunye ne-arhente eququzelelayo yeNkqubo yoLawulo lwezeMpilo yaseBrazil (i-SNVS), kwaye yenza umsebenzi. kwilizwe lonke.
Indima ye-Anvisa kukukhuthaza ukhuseleko kunye nomda wempilo yabantu ngokulawula imveliso, ukuthengisa kunye nokusetyenziswa kweemveliso kunye neenkonzo eziphantsi kolawulo lwezempilo, kubandakanywa nokusingqongileyo okufanelekileyo, iinkqubo, izithako kunye nobuchwepheshe, kunye nokulawulwa kwamazibuko kunye nezikhululo zeenqwelomoya.
Ziziphi iimfuno ze-Anvisa zokungenisa ii-APIs kwimarike yaseBrazil?
Ngokuphathelele kwiZithako eziSebenzayo zoNyango (IFA) kwimarike yaseBrazil, kubekho utshintsho oluthile kwiminyaka yakutshanje.U-Anvisa, eBrazil, uye wabhengeza ngokulandelelana imimiselo emithathu emitsha enxulumene nezithako ezisebenzayo zoxubo mayeza.
●I-RDC 359/2020 imisela uXwebhu oluPhambili loBhaliso lweziyobisi (DIFA) kunye neNkqubo yoVavanyo olusembindini yoBhaliso lweziyobisi (CADIFA), kwaye imimiselo ibandakanya amachiza afunekayo kumachiza amatsha, amachiza amatsha kunye namachiza enziwe afana nalawo aveliswe ngabenzi;
●I-RDC 361/2020, ihlaziywe umxholo onxulumene nokubhaliswa kwempahla ekrwada kwisicelo sentengiso ye-RDC 200/2017 kunye nesicelo sokutshintsha isithuba sentengiso ye-RDC 73/2016;
●I-RDC 362/2020 ichaza iimfuno zeSatifikethi se-GMP(CBPF) kunye neemfuno zenkqubo yophicotho-zincwadi kumaziko emveliso ye-API yaphesheya kweelwandle, kubandakanywa nee-APIs eziphuma kwi-extraction yeplanti, i-chemical synthesis, i-fermentation kunye ne-semi synthesis;
Ubhaliso lwangaphambili lwe-API(RDC 57/2009) aluyi kuba semthethweni ukususela ngoMatshi 1,2021, kwaye endaweni yoko luya kufakwa kwiCadifa, ngaloo ndlela kwenziwe lula ezinye iinkqubo zobhaliso lwangaphambili lwe-API.
Ukongeza, imimiselo emitsha imisela ukuba abavelisi be-API banokungenisa ngokuthe ngqo amaxwebhu (DIFA) kwi-Anvisa nokuba abanazo iiarhente okanye amasebe eBrazil. U-Anvisa uphinde walungiselela incwadi yencwadana Manual CADIFA ukukhokela iinkampani zamazwe ngamazwe ukuba zingenise izicelo. inyathelo lokungeniswa koxwebhu.
Ngokwale mbono, iBrazil Anvisa yenze lula kakhulu inkqubo yobhaliso lwe-API ukusa kwinqanaba elithile, kwaye ngokuthe ngcembe ikhulisa ulongamelo kwi-API yokungenisa. Ukuba ufuna ukwazi malunga nokubhaliswa koxwebhu lwaseBrazil, ungabhekisa kwezi zintsha. imimiselo.
I-Yunnan Hande Bio-Tech ayinayo kuphela amandla okuvelisa isivuno esiphezulu kunye nomgangatho ophezulu kwiPaclitaxel API,kodwa ukwaneenzuzo ezizodwa kubhaliso loxwebhu kunye nesiqinisekiso kwamanye amazwe!Ukuba uyafunaPaclitaxel APIs ezinokuhlangabezana neemfuno zolawulo lwe-APIs yaseBrazil, nceda uqhagamshelane nathi nangaliphi na ixesha!(Whatsapp/Wechat:+86 18187887160)
Ixesha lokuposa: Dec-30-2022