Ibipimo ngenderwaho

Mu 1965, Umuryango w’ubumwe bw’ibihugu by’i Burayi washyizeho amabwiriza y’imiti (65 / EEC) hagamijwe guhuza amategeko n’amabwiriza ajyanye n’imiti y’ibimera mu bihugu.Mu 1988, Umuryango w’ubumwe bw’ibihugu by’i Burayi washyizeho Amabwiriza agenga imicungire y’ibicuruzwa by’ibimera, wagize neza ugira uti: “Ubuvuzi bw’ibimera ni ubwoko bw’imiti, kandi ibiyigize bikora birimo ibimera cyangwa imyiteguro y’imiti y’ibimera.Imiti y'ibyatsi igomba kuba ifite uruhushya rwo kugurisha.Ibipimo by’ubuziranenge, umutekano n’ingirakamaro bigomba kubahirizwa mbere yuko ibicuruzwa bigurishwa ku isoko. ”Gusaba uruhushya birasabwa gutanga amakuru akurikira: 1. Amakuru yujuje ubuziranenge ninshi yibigize;2. Ibisobanuro byuburyo bwo gukora;3. Kugenzura ibikoresho byambere;4. Kugenzura ubuziranenge no kumenyekanisha bigomba gukorwa buri gihe;5. Kugenzura ubuziranenge no gusuzuma ibicuruzwa byarangiye;6. Kumenya umutekano.Mu 1990, Umuryango w’ubumwe bw’ibihugu by’i Burayi wasabye GMP yo gukora imiti y’ibimera.
Ukuboza 2005, ubuvuzi gakondo KlosterfrauMelisana bwanditswe neza mu Budage.Iki gicuruzwa kigizwe ahanini nubwatsi bwa balsam, impumuro nziza yabaturage, angelica, ginger, karungu, galangal, Eurogentian, kuvura impagarara zo mumutwe no guhangayika, kubabara umutwe, dysmenorrhea, kubura ubushake bwo kurya, dyspepsia, imbeho nibindi.Mu Bwongereza, hari amagana asaba kwandikisha imiti gakondo, ariko kugeza ubu nta nimwe mu buvuzi gakondo bw'Abashinwa.

Igitekerezo cyibanze cyibiyobyabwenge muri Reta zunzubumwe zamerika nuko imiterere yimiti igomba kuba isobanutse, kandi mugihe habaye imyiteguro y’imyororokere, imiti ya farumasi ya buri kintu kigizwe n’imiti n'ingaruka z’imikoranire yabo ku mikorere n'uburozi bigomba kuba bisobanutse.Bitewe nicyo bita orthodoxe yubuvuzi, FDA yo muri Amerika ntabwo isobanukiwe cyane nubuvuzi bwibimera, harimo nubuvuzi gakondo bwabashinwa, bityo ntibwemera ko imiti y’ibimera ari imiti.Icyakora, kubera igitutu cy’amafaranga menshi yo kwivuza n’ibitekerezo rusange by’abaturage, Kongere y’Amerika yemeje itegeko ryita ku buzima bw’imirire (DSHEA) mu 1994 binyuze mu mbaraga zidatezuka no guharanira ibikorwa bimwe na bimwe bito n'ibiciriritse, byashyize ku rutonde imiti y’ibihingwa bisanzwe harimo ubuvuzi gakondo bwabashinwa nkibiryo byokurya.Birashobora kuvugwa ko inyongera yimirire nigicuruzwa kidasanzwe hagati yibiribwa nubuvuzi.Nubwo ibimenyetso byihariye bidashobora kugaragazwa, imikorere yubuvuzi irashobora kugaragazwa.

Imiti y'ibyatsi isanzwe ikorwa kandi igurishwa muri Amerika ifite ubuzima gatozi, ni ukuvuga ko izwiho gukoreshwa mu gukumira no kuvura indwara.Mu 2000, mu rwego rwo gusubiza icyifuzo cya rubanda, Perezida wa Leta zunze ubumwe z’Amerika yafashe icyemezo cyo gushyiraho “****** Politiki y’inama y’ubuvuzi bwuzuzanya n’ubundi buryo”, abanyamuryango 20 bashyirwaho na Perezida kugira ngo baganire ku murongo ngenderwaho wa politiki yo kuzuzanya. nubundi buryo bwo kuvura no gucukumbura agaciro kayo.Muri raporo yayo yagejeje kuri Perezida na Kongere mu 2002, ****** yashyizemo “ubuvuzi gakondo bw'Abashinwa” muri gahunda y'ubuvuzi bwuzuzanya n'ubundi buryo.

Mu myaka yashize, FDA yashimangiye imicungire y’imiti y’ibimera bisanzwe.Mu 2003, yatangiye gushyira mu bikorwa imiyoborere ya GMP ku byongera ibiryo kandi ishyiraho amahame akomeye yo gukora no gushyiramo ibirango byongera ibiryo.FDA yasohoye umurongo ngenderwaho mugutezimbere ibiyobyabwenge byibimera kumurongo kandi isaba ibisobanuro kwisi yose.Amahame ngenderwaho yerekana neza ko imiti y’ibimera itandukanye n’imiti y’imiti, bityo rero ibyo basabwa mu bya tekiniki na byo bigomba kuba bitandukanye n’ibya nyuma, kandi bikagaragaza bimwe mu biranga imiti y’ibimera: imiterere y’imiti y’imiti y’ibimera ikunze kuvangwa n’ibice byinshi, aho kuruta uruganda rumwe;Ntabwo imiti yose iri mumiti y'ibyatsi ****** isobanutse;Mubihe byinshi, ibintu bifatika byimiti y'ibyatsi ntabwo bigenwa ******;Rimwe na rimwe, ibikorwa byibinyabuzima byubuvuzi bwibimera ntabwo ****** bisobanutse kandi bisobanutse;Uburyo bwinshi bwo gutegura no gutunganya imiti y'ibyatsi ahanini ni ibyingenzi;Ibimera bifite uburambe burambuye kandi burambye mubikorwa byabantu.Nta ngaruka mbi z'uburozi zabonetse mu gihe kirekire kandi kinini cyo gukoresha imiti y'ibyatsi mu mubiri w'umuntu.Imiti y'ibyatsi imwe yagurishijwe nkibicuruzwa byubuzima cyangwa inyongera zimirire.

Hashingiwe ku myumvire ya FDA ku biyobyabwenge by’ibimera, ibisabwa bya tekiniki ku biyobyabwenge by’ibimera mu mahame ngenderwaho bitandukanye n’ibiyobyabwenge by’imiti, harimo: ibisabwa bya tekiniki mu bushakashatsi bw’ibanze birarekuwe;Ikizamini cya farumasi gishobora gukemurwa byoroshye.Ubuvuzi bwihariye bwo gutegura ibyatsi bivanze;Ubuhanga mu bya farumasi busaba gutunganya byoroshye;Ibisabwa tekinike ya farumasi nuburozi byagabanutse.Amabwiriza yerekana gusimbuka kwiza muburyo FDA ikoresha imiti gakondo, harimo nubuvuzi gakondo bwabashinwa.Impinduka nini ya politiki ya guverinoma y’Amerika ku buvuzi bw’ibimera yashyizeho uburyo bw’ibanze bw’imiti y’ibimera yinjira ku isoko ry’Amerika.
Usibye Veregen, imaze kwemezwa, ibimera bigera kuri 60 kugeza kuri 70 biri mu nzira kugeza ubu.