Nrog rau kev txhim kho hauv zej zog thiab kev txhim kho qib kev kho mob, cov kev cai ntawm cov teb chaws thoob ntiaj teb rau cov tshuaj, cov cuab yeej kho mob, thiab APIs siv hauv cov tshuaj thiab cov cuab yeej siv tau nruj dua txhua xyoo, uas zoo heev lav kev nyab xeeb ntawm kev tsim tshuaj!
Cia peb saib cov kev cai ntawm API hauv Brazilian lag luam!
ANVISA yog dab tsi?
Anvisa yog ib qho luv luv los ntawm Portuguese Agência Nacional de Vigilância Sanitária, xa mus rau Lub Chaw Saib Xyuas Kev Noj Qab Haus Huv Brazilian.
Lub Chaw Haujlwm Saib Xyuas Kev Noj Qab Haus Huv Brazilian (Anvisa) yog ib lub koom haum tswj hwm muaj feem cuam tshuam nrog Ministry of Health, uas yog ib feem ntawm Brazilian National Health System (SUS) thiab lub koom haum koom tes ntawm Brazilian Health Regulatory System (SNVS), thiab ua haujlwm. thoob teb chaws.
Anvisa lub luag haujlwm yog los txhawb kev tiv thaiv thiab ciam teb ntawm tib neeg kev noj qab haus huv los ntawm kev tswj hwm kev tsim khoom, kev lag luam thiab kev siv cov khoom thiab cov kev pabcuam raug saib xyuas kev noj qab haus huv, suav nrog ib puag ncig cuam tshuam, txheej txheem, cov khoom xyaw thiab thev naus laus zis, nrog rau kev tswj cov chaw nres nkoj thiab tshav dav hlau.
Dab tsi yog qhov yuav tsum tau muaj ntawm Anvisa rau importing APIs rau Brazilian lag luam?
Raws li rau Active Pharmaceutical Ingredients (IFA) hauv kev lag luam Brazilian, muaj qee qhov kev hloov pauv hauv xyoo tas los no.Anvisa, Brazil, tau tshaj tawm peb txoj cai tshiab hais txog cov khoom xyaw tshuaj nquag.
●RDC 359/2020 qhia txog Master Document for Drug Substance Registration (DIFA) thiab Cov Txheej Txheem Kev Ntsuam Xyuas Hauv Nruab Nrab rau Kev Sau Npe Tshuaj Yeeb (CADIFA), thiab cov kev cai npog cov tshuaj uas xav tau rau cov tshuaj tshiab, tshuaj tshiab thiab tshuaj generic;
●RDC 361/2020, hloov kho cov ntsiab lus ntsig txog kev sau npe ntawm cov khoom siv raw hauv daim ntawv thov kev lag luam RDC 200/2017 thiab daim ntawv thov hloov pauv tom qab kev lag luam RDC 73/2016;
●RDC 362/2020 qhia txog cov kev cai ntawm GMP Certificate (CBPF) thiab cov kev cai ntawm cov txheej txheem soj ntsuam rau txawv teb chaws API cov chaw tsim khoom, suav nrog APIs tau los ntawm cov nroj tsuag extraction, tshuaj synthesis, fermentation thiab semi synthesis;
Kev sau npe API yav dhau los (RDC 57/2009) yuav siv tsis tau txij lub Peb Hlis 1, 2021, thiab yuav raug xa mus rau Cadifa hloov, yog li ua kom yooj yim rau qee cov txheej txheem rau kev sau npe API yav dhau los.
Tsis tas li ntawd, cov kev cai tshiab tau teev tseg tias API cov tuam txhab tuaj yeem xa cov ntaub ntawv ncaj qha (DIFA) rau Anvisa txawm tias lawv tsis muaj cov neeg sawv cev lossis cov ceg ntoo hauv Brazil.Anvisa kuj tau npaj cov ntaub ntawv Phau Ntawv Qhia CADIFA los coj cov tuam txhab thoob ntiaj teb xa cov ntawv thov.Qhia txhua tus. kauj ruam ntawm kev xa cov ntaub ntawv.
Los ntawm qhov kev pom no, Brazil Anvisa tau yooj yim heev rau cov txheej txheem ntawm API daim ntawv sau npe rau qee qhov, thiab tseem maj mam nce kev saib xyuas ntawm API ntshuam.Yog tias koj xav paub txog Brazilian cov ntaub ntawv sau npe, koj tuaj yeem xa mus rau cov tshiab no. kev cai.
Yunnan Hande Bio-Tech tsis tsuas yog muaj peev xwm ntawm cov khoom lag luam siab thiab cov khoom zoo hauvPaclitaxel API, tab sis kuj muaj qhov tshwj xeeb zoo hauv cov ntaub ntawv sau npe thiab ntawv pov thawj hauv lwm lub tebchaws! Yog tias koj xav tauPaclitaxel APIs uas tuaj yeem ua tau raws li cov kev xav tau ntawm Brazilian APIs, thov hu rau peb txhua lub sijhawm! (Whatsapp / Wechat: +86 18187887160)
Post lub sij hawm: Dec-30-2022