Ndi chitukuko cha anthu ndi kusintha kwa mlingo wa zamankhwala, zofunikira za mayiko padziko lonse lapansi pa mankhwala, zipangizo zamankhwala, ndi ma API omwe amagwiritsidwa ntchito pa mankhwala ndi zipangizo zimakhala zovuta chaka ndi chaka, zomwe zimatsimikizira kwambiri chitetezo cha mankhwala osokoneza bongo!
Tiyeni tiwone kuwongolera kwa API pamsika waku Brazil!
Kodi ANVISA ndi chiyani?
Anvisa ndi chidule cha Chipwitikizi Agência Nacional de Vigilância Sanitária, kutanthauza Brazilian Health Regulatory Agency.
Bungwe la Brazilian Health Regulatory Agency(Anvisa) ndi bungwe lovomerezeka logwirizana ndi Unduna wa Zaumoyo, lomwe ndi gawo la Brazilian National Health System(SUS)ndi bungwe logwirizanitsa la Brazilian Health Regulatory System(SNVS),ndipo limagwira ntchito. dziko lonse.
Udindo wa Anvisa ndikulimbikitsa chitetezo ndi malire a thanzi la anthu poyang'anira kupanga, kutsatsa ndi kugwiritsa ntchito zinthu ndi ntchito zomwe zimayang'aniridwa ndi thanzi, kuphatikiza malo oyenera, njira, zopangira ndi matekinoloje, komanso kuyang'anira madoko ndi ma eyapoti.
Kodi zofunikira za Anvisa ndi zotani polowetsa ma API kumsika waku Brazil?
Ponena za Active Pharmaceutical Ingredients(IFA) pamsika waku Brazil, pakhala zosintha zina m'zaka zaposachedwa.Anvisa,Brazil, motsatizana yalengeza malamulo atatu atsopano okhudzana ndi zosakaniza zogwira ntchito zamankhwala.
●RDC 359/2020 imanena za Master Document for Drug Substance Registration(DIFA)ndi Centralized Assessment Procedure for Drug Substance Registration(CADIFA),ndipo malamulowa amakhudza mankhwala ofunikira pa mankhwala opangidwa mwatsopano,mankhwala atsopano ndi mankhwala opangidwa ndi generic;
●RDC 361/2020, yasinthanso zinthu zokhudzana ndi kulembetsa kwazinthu zopangira zamalonda za RDC 200/2017 komanso ntchito yosintha malonda a RDC 73/2016;
●RDC 362/2020 imatchula zofunikira za GMP Certificate(CBPF)ndi zofunikira pa kawuniwunidwe kazinthu zopangira ma API kunja kwa nyanja, kuphatikiza ma API otengedwa kuchokera kumitengo, kaphatikizidwe ka mankhwala, kuwira ndi kaphatikizidwe kakang'ono;
Kulembetsa kwa API kwam'mbuyo (RDC 57/2009) kudzakhala kosavomerezeka kuyambira pa Marichi 1,2021, ndipo kudzaperekedwa ku Cadifa m'malo mwake, kufewetsa njira zina zolembetsa API yam'mbuyomu.
Kuphatikiza apo, malamulo atsopanowa amati opanga ma API atha kutumiza mwachindunji zikalata (DIFA) ku Anvisa ngakhale alibe othandizira kapena nthambi ku Brazil. sitepe yakutumiza zikalata.
Kuchokera pamalingaliro awa, Brazil Anvisa yafewetsa kwambiri njira yolembetsa zikalata za API mpaka pang'onopang'ono, ndipo ikuwonjezeranso kuyang'anira pa API import. malamulo.
Yunnan Hande Bio-Tech sikuti imakhala ndi zokolola zambiri komanso zapamwamba kwambiriPaclitaxel API,komanso ali ndi ubwino wapadera kulembetsa zikalata ndi certification m'mayiko ena!Ngati mukufunaPaclitaxel APIzomwe zingakwaniritse zofunikira zama API aku Brazil, chonde titumizireni nthawi iliyonse! (Whatsapp/Wechat:+86 18187887160)
Nthawi yotumiza: Dec-30-2022