Me ka hoʻomohala ʻana o ke kaiāulu a me ka hoʻomaikaʻi ʻana i ka pae olakino, ʻoi aku ka ikaika o nā koi o nā ʻāina a puni ka honua no nā lāʻau lapaʻau, nā lāʻau lapaʻau, a me nā API i hoʻohana ʻia i nā lāʻau lapaʻau a me nā mea hana i ʻoi aku ka paʻakikī i kēlā me kēia makahiki, kahi e hōʻoiaʻiʻo nui ai i ka palekana o ka hana lāʻau!
E nānā kākou i ka hoʻoponopono ʻana o ka API ma ka mākeke Palakila!
He aha ka ANVISA?
He pōkole ʻo Anvisa mai Portuguese Agência Nacional de Vigilância Sanitária, e pili ana i ka Brazilian Health Regulatory Agency.
ʻO ka Brazilian Health Regulatory Agency (Anvisa) he hui mana e pili ana i ka Ministry of Health, he ʻāpana ia o ka Brazilian National Health System (SUS) a me ka hui hoʻonohonoho o ka Brazilian Health Regulatory System (SNVS), a ke hana nei i ka hana. a puni ka ʻāina.
ʻO ka hana a Anvisa ka hoʻolaha ʻana i ka pale a me ka palena o ke olakino o ka poʻe ma o ka hoʻomalu ʻana i ka hana, kūʻai aku a me ka hoʻohana ʻana i nā huahana a me nā lawelawe e pili ana i ka nānā ʻana i ke olakino, me ke kaiapuni kūpono, nā kaʻina hana, nā mea hana a me nā ʻenehana, a me ka mana o nā awa a me nā mokulele.
He aha nā koi o Anvisa no ka lawe ʻana i nā API i ka mākeke Brazil?
No ka Active Pharmaceutical Ingredients (IFA) ma ka mākeke ʻo Brazil, aia kekahi mau loli i nā makahiki i hala.
●RDC 359/2020 i ka Master Document for Drug Substance Registration (DIFA) a me ke Centralized Assessment Procedure for Drug Substance Registration (CADIFA), a ua uhi nā lula i nā mea lāʻau i koi ʻia no nā lāʻau lapaʻau hou, nā lāʻau lapaʻau hou a me nā lāʻau maʻamau;
●RDC 361/2020, hoʻoponopono hou i ka ʻike e pili ana i ka hoʻopaʻa inoa maka i loko o ka noi kūʻai RDC 200/2017 a me ka noi hoʻololi post marketing RDC 73/2016;
●RDC 362/2020 i nā koi o ka GMP Certificate(CBPF) a me nā koi o ke kaʻina hana loiloi no nā hale hana API ma waho, me nā API i loaʻa mai ka unuhi ʻana i nā mea kanu, ka synthesis kemika, ka fermentation a me ka semi synthesis;
ʻAʻole kūpono ka hoʻopaʻa inoa API mua (RDC 57/2009) mai Malaki 1,2021, a e waiho ʻia iā Cadifa, no laila e hoʻomaʻamaʻa i kekahi mau kaʻina hana no ka hoʻopaʻa inoa API mua.
Eia kekahi, ua ʻōlelo nā lula hou e hiki i nā mea hana API ke hoʻouna pololei i nā palapala (DIFA) iā Anvisa inā ʻaʻohe o lākou mau ʻelele a i ʻole nā lālā ma Brazil. kaʻina o ka hoʻouna palapala.
Mai kēia manaʻo, ua hoʻomaʻamaʻa nui ʻo Brazil Anvisa i ke kaʻina o ka hoʻopaʻa inoa palapala API i kekahi ʻano, a ke hoʻonui mālie nei hoʻi i ka nānā ʻana i ka lawe ʻana mai API. nā hoʻoponopono.
ʻAʻole ʻo Yunnan Hande Bio-Tech wale nō ka mana hana o nā hua kiʻekiʻe a me ke ʻano kiʻekiʻe i lokoAPI Paclitaxel,akā, loaʻa nō hoʻi nā pono kūʻokoʻa i ka hoʻopaʻa inoa palapala a me ka hōʻoia ma nā ʻāina ʻē aʻe! Inā pono ʻoeAPI Paclitaxels hiki ke hoʻokō i nā pono hoʻoponopono o Brazilian API, e ʻoluʻolu e kelepona mai iā mākou i kēlā me kēia manawa! (Whatsapp/Wechat: +86 18187887160)
Ka manawa hoʻouna: Dec-30-2022