Ngokuthuthuka komphakathi kanye nokwenza ngcono izinga lezokwelapha, izidingo zamazwe emhlabeni jikelele zezidakamizwa, izinsiza zezokwelapha, nama-API asetshenziswa ezidakamizweni nakumadivaysi ziba namandla unyaka nonyaka, okuqinisekisa kakhulu ukuphepha kokukhiqizwa kwezidakamizwa!
Ake sibheke ukulawulwa kwe-API emakethe yaseBrazil!
Iyini i-ANVISA?
I-Anvisa isifinyezo esivela ku-Portuguese Agência Nacional de Vigilância Sanitária, sibhekisela ku-Brazilian Health Regulatory Agency.
I-Brazilian Health Regulatory Agency(Anvisa) yisikhungo esinegunya esihlobene Nomnyango Wezempilo, oyingxenye ye-Brazilian National Health System(SUS) kanye ne-ejensi exhumanisayo ye-Brazilian Health Regulatory System(SNVS),futhi yenza umsebenzi. ezweni lonke.
Iqhaza le-Anvisa ukukhuthaza ukuvikelwa kanye nomngcele wempilo yabantu ngokulawula ukukhiqizwa, ukumaketha nokusetshenziswa kwemikhiqizo nezinsizakalo ezingaphansi kokuqondisa kwezempilo, okuhlanganisa indawo efanele, izinqubo, izithako nobuchwepheshe, kanye nokulawula amachweba nezikhumulo zezindiza.
Yiziphi izidingo ze-Anvisa zokungenisa ama-API emakethe yaseBrazil?
Mayelana Nezithako Zemithi Ezisebenzayo(IFA)emakethe yaseBrazil, kube khona izinguquko ezithile eminyakeni yamuva nje.I-Anvisa,Brazil,imemezele ngokulandelanayo imithethonqubo emisha emithathu ehlobene nezithako zemithi esebenzayo.
●I-RDC 359/2020 ibeka Idokhumenti Eyinhloko Yokubhaliswa Kwezidakamizwa(DIFA)kanye Nenqubo Yokuhlola Okumaphakathi Yokubhaliswa Kwezidakamizwa(CADIFA), kanye nemithethonqubo ihlanganisa izinto zomuthi ezidingekayo emithini emisha, imithi emisha nemithi ejwayelekile;
●I-RDC 361/2020, ibuyekeze okuqukethwe okuhlobene nokubhaliswa kwezinto ezingavuthiwe kuhlelo lokusebenza lokumaketha i-RDC 200/2017 kanye nesicelo sokushintsha ukumaketha kwe-RDC 73/2016;
●I-RDC 362/2020 icacisa izidingo zesitifiketi se-GMP(CBPF)kanye nezimfuneko zenqubo yokucwaninga yezindawo zokukhiqiza ze-API yaphesheya kwezilwandle, okuhlanganisa nama-API asuselwe ekukhishweni kwezitshalo, ukuhlanganiswa kwamakhemikhali, ukuvutshelwa kanye nokuhlanganisa okuncane;
Ukubhaliswa kwangaphambilini kwe-API(RDC 57/2009) ngeke kusebenze kusukela ngoMashi 1,2021, futhi kuzothunyelwa ku-Cadifa esikhundleni salokho, ngaleyo ndlela kube lula ezinye izinqubo zokubhaliswa kwe-API kwangaphambilini.
Ngaphezu kwalokho, imithetho emisha ibeka ukuthi abakhiqizi be-API bangathumela ngokuqondile imibhalo(DIFA) ku-Anvisa ngisho noma bengenawo ama-ejenti noma amagatsha e-Brazil. I-Anvisa iphinde yalungiselela incwadi eyimanuwali ye-CADIFA ukuze iqondise izinkampani zamazwe ngamazwe ukuthi zithumele izicelo. isinyathelo sokuhambisa idokhumenti.
Ngokwaleli phuzu, i-Brazil Anvisa yenze yaba lula kakhulu inqubo yokubhaliswa kwedokhumenti ye-API ngokwezinga elithile, futhi ikhulisa kancane kancane ukugadwa kokungeniswa kwe-API. Uma ufuna ukwazi ngokubhaliswa kwedokhumenti yase-Brazilian, ungabheka lezi ezintsha. imithethonqubo.
I-Yunnan Hande Bio-Tech ayinawo amandla okukhiqiza wesivuno esikhulu nekhwalithi ephezuluI-Paclitaxel API,kodwa futhi kunezinzuzo eziyingqayizivele ekubhaliseni imibhalo kanye nesitifiketi kwamanye amazwe!Uma udingaI-Paclitaxel APIezingahlangabezana nezidingo zokulawula zama-API aseBrazil, sicela usithinte nganoma yisiphi isikhathi!(Whatsapp/Wechat:+86 18187887160)
Isikhathi sokuthumela: Dec-30-2022