Nekuvandudzwa kwenharaunda nekuvandudzwa kwedanho rekurapa, zvinodiwa nenyika dzepasirese zvemishonga, midziyo yekurapa, uye maAPI anoshandiswa mumishonga nemidziyo zvakaomesesa gore negore, izvo zvinovimbisa zvakanyanya kuchengetedzwa kwekugadzirwa kwezvinodhaka!
Ngatitarisei kudzorwa kweAPI mumusika weBrazil!
Chii chinonzi ANVISA?
Anvisa chidimbu chinobva kuPortugal Agência Nacional de Vigilância Sanitária, zvichireva iyo Brazilian Health Regulatory Agency.
Brazilian Health Regulatory Agency (Anvisa) isangano rine chiremera rine hukama neBazi rezvehutano, rinova chikamu cheBrazilian National Health System (SUS) uye sangano rinoronga reBrazilian Health Regulatory System (SNVS), uye rinoita basa. munyika yose.
Basa reAnvisa nderekusimudzira kuchengetedzwa uye muganho wehutano hwevanhu nekudzora kugadzirwa, kushambadzira uye kushandiswa kwezvigadzirwa nemasevhisi pasi pekutariswa kwehutano, kusanganisira nharaunda yakakodzera, maitiro, zvigadzirwa uye matekinoroji, pamwe nekutonga kwezviteshi nendege.
Ndezvipi zvinodikanwa zveAnvisa zvekupinza maAPIs kumusika weBrazil?
Kana iri Active Pharmaceutical Ingredients(IFA)mumusika wekuBrazil,pave neshanduko dzakati wandei mumakore achangopfuura.Anvisa,Brazil,yakatevedzana yazivisa mitemo mitsva mitatu ine chekuita nemishonga inoshanda.
●RDC 359/2020 inotaura Master Document yeDrug Substance Registration(DIFA)uye Centralized Assessment Procedure for Drug Substance Registration(CADIFA),uye mitemo inovhara zvinhu zvemushonga zvinodikanwa pamishonga itsva,mishonga mitsva nemishonga inogadzirwa negeneric;
●RDC 361/2020, yakagadziridza zvirimo zvine chekuita nekunyoreswa kwezvinhu muchirongwa chekushambadzira RDC 200/2017 uye post marketing change application RDC 73/2016;
●RDC 362/2020 inotsanangura zvinodikanwa zveGMP Certificate(CBPF) uye zvinodikanwa zvemaitiro ekuongorora kune mhiri kwemakungwa maAPI ekugadzira zvivakwa,kusanganisira maAPI anobva mukutorwa kwechirimwa,chemical synthesis,fermentation uye semi synthesis;
Iyo yapfuura API kunyoreswa (RDC 57/2009) ichave isiri iyo kubva munaKurume 1,2021, uye ichaendeswa kuCadifa panzvimbo, nekudaro kurerutsa mamwe maitiro ekunyoreswa kweAPI yapfuura.
Pamusoro pezvo, mitemo mitsva inoti vagadziri veAPI vanokwanisa kutumira magwaro zvakananga (DIFA) kuAnvisa kunyangwe vasina vamiririri kana mapazi muBrazil. danho rekutumira magwaro.
Kubva pamaonero aya, Brazil Anvisa yakarerutsa zvakanyanya maitirwo ekunyoreswa kwegwaro reAPI kusvika padanho rakati, uye iri kuwedzerawo zvishoma nezvishoma kutariswa kweAPI import.Kana uchida kuziva nezve kunyoreswa kwegwaro reBrazil, unogona kutarisa kune izvi zvitsva mitemo.
Yunnan Hande Bio-Tech haingori nehunyanzvi hwekugadzira goho repamusoro uye mhando yepamusoro mukatiPurogiramu inonzi Paclitaxel,asi zvakare ine yakasarudzika mabhenefiti mukunyoresa magwaro uye certification mune dzimwe nyika!Kana uchidaPurogiramu inonzi Paclitaxels iyo inogona kusangana nezvinodiwa zveBrazilian APIs, ndapota taura nesu chero nguva!(Whatsapp/Wechat:+86 18187887160)
Nguva yekutumira: Zvita-30-2022