Hamwe niterambere ryumuryango no kuzamura urwego rwubuvuzi, ibisabwa mubihugu kwisi kwisi kubiyobyabwenge, ibikoresho byubuvuzi, na APIs zikoreshwa mubiyobyabwenge nibikoresho birakomeye uko umwaka utashye, ibyo bikaba byemeza cyane umutekano w’ibiyobyabwenge!
Reka turebe amabwiriza ya API ku isoko rya Berezile!
ANVISA ni iki?
Anvisa ni impfunyapfunyo yo mu Giporutugali Agência Nacional de Vigilância Sanitária, yerekeza ku kigo gishinzwe ubuzima muri Berezile.
Ikigo gishinzwe ubuzima muri Berezile (Anvisa) ni ikigo cy’ubutegetsi gifitanye isano na Minisiteri y’ubuzima, kikaba kiri muri gahunda y’ubuzima y’igihugu cya Berezile (SUS) n’ikigo gishinzwe guhuza ibikorwa by’ubuzima bwa Berezile (SNVS), kandi kigakora imirimo mu gihugu hose.
Uruhare rwa Anvisa ni uguteza imbere kurengera imipaka y’ubuzima bw’abantu mu kugenzura umusaruro, kwamamaza no gukoresha ibicuruzwa na serivisi bigenzurwa n’ubuzima, harimo ibidukikije, inzira, ibiyigize n’ikoranabuhanga, ndetse no kugenzura ibyambu n’ibibuga by’indege.
Nibihe bisabwa Anvisa mugutumiza API kumasoko ya Berezile?
Kubijyanye nibikoresho bifatika bya farumasi (IFA) kumasoko ya Berezile, habaye impinduka mumyaka yashize.Anvisa, Berezile, yagiye asohora amategeko mashya atatu ajyanye nibikoresho bya farumasi bikora.
● RDC 359/2020 iteganya inyandiko nkuru y’iyandikisha ry’ibiyobyabwenge (DIFA) hamwe n’uburyo bukuru bwo gusuzuma ibiyayuramutwe (CADIFA), kandi amabwiriza akubiyemo ibiyobyabwenge bikenerwa mu biyobyabwenge bishya, ibiyobyabwenge bishya n’ibiyobyabwenge rusange;
● RDC 361/2020, yavuguruye ibikubiyemo bijyanye no kwandikisha ibikoresho fatizo mubisabwa kwamamaza RDC 200/2017 hamwe na porogaramu yo guhindura ibicuruzwa RDC 73/2016;
● RDC 362/2020 igaragaza ibyangombwa bisabwa na GMP (CBPF) nibisabwa muburyo bwo kugenzura ibikorwa by’ibikorwa byo mu mahanga byo hanze ya API, harimo API ziva mu gukuramo ibihingwa, synthesis ya chimique, fermentation na synthesis;
Iyandikwa rya API ryabanje (RDC 57/2009) rizaba impfabusa guhera muri Werurwe 1,2021, kandi rizashyikirizwa Cadifa aho, bityo byoroshe inzira zimwe na zimwe zo kwiyandikisha kwa API.
Byongeye kandi, amabwiriza mashya ateganya ko abakora API bashobora kohereza Anvisa inyandiko (DIFA) mu buryo butaziguye kabone niyo baba badafite abakozi cyangwa amashami muri Berezile. intambwe yo gutanga inyandiko.
Dufatiye kuri iyi ngingo, Burezili Anvisa yoroshye cyane inzira yo kwandikisha inyandiko za API kurwego runaka, kandi iragenda yongera buhoro buhoro kugenzura ibicuruzwa bitumizwa muri API.Niba ushaka kumenya ibijyanye no kwandikisha inyandiko muri Berezile, urashobora kwifashisha ibi bishya amabwiriza.
Yunnan Hande Bio-Tech ntabwo ifite ubushobozi bwo gutanga umusaruro mwinshi kandi mwinshi muriYamazaki API, ariko kandi ifite ibyiza byihariye mukwiyandikisha no gutanga ibyemezo mubindi bihugu! Niba ukeneyeYamazaki APIs ishobora guhura nibisabwa na APIs yo muri Berezile, nyamuneka twandikire igihe icyo aricyo cyose! (Whatsapp / Wechat: +86 18187887160)
Igihe cyo kohereza: Ukuboza-30-2022