Niki Idosiye Yibiyobyabwenge?

Iyo uvuze kuri File Master File, abayikora batandukanye bafite reaction zitandukanye. DMF ntabwo ari itegeko kubayikora kwiyandikisha.Nyamara, umubare munini wabakora ibiyobyabwenge baracyasaba kandi bakandikisha DMF kubicuruzwa byabo.Kuki?

Kugirango umanuke mubucuruzi, reka turebe ibiri muri File Master File File, hanyuma tuvuge kubyo ishobora gukora!

Urutonde rwuzuye rwerekana umusaruro wibiyobyabwenge nubuyobozi bwiza byitwa Drug Master File File (DMF), bikubiyemo kumenyekanisha ahakorerwa uruganda (uruganda), ibisobanuro byihariye byuburyo bwubugenzuzi, uburyo bwo gukora nibisobanuro byibikoresho, kugenzura ubuziranenge nubuziranenge imiyoborere.

Ni ayahe masosiyete ashobora gusaba DMF?

Hariho ubwoko butanu bwa DMF bwatanzwe na FDA:

Ubwoko bwa I: Urubuga rukora, ibikoresho, uburyo bukoreshwa, nabakozi

Ubwoko bwa II: Ibiyobyabwenge, Ibiyobyabwenge Hagati, nibikoresho bikoreshwa mugutegura, cyangwa ibicuruzwa byibiyobyabwenge

Ubwoko bwa III: Ibikoresho byo gupakira

Ubwoko bwa IV: Bishimishije, Ibara, Ibiryo, Ibyingenzi, cyangwa Ibikoresho Byakoreshejwe Mubitegura

Ubwoko V: FDA Yemewe Ibisobanuro

Ukurikije ubwoko butanu bwavuzwe haruguru, ubwoko butandukanye bwibigo bushobora kubisaba ukurikije ibyo bakeneye kubikenewe byamakuru asabwa nubwoko butandukanye bwa DMF.

Kurugero, niba uri anUruganda rwa API. , kugenzura ubuziranenge bwibicuruzwa no kugenzura ibikorwa, kugenzura ibicuruzwa bihamye, gupakira no kuranga, uburyo busanzwe bwo gukora Kubika no gucunga ibikoresho fatizo nibicuruzwa byarangiye, gucunga inyandiko, kugenzura, sisitemu yo gucunga umubare, kugaruka no kujugunya, nibindi.

Mu bihe byinshi, DMF yabaye kimwe mubintu byingenzi byubwoko runaka bwibiyobyabwenge na API niba bishobora koherezwa mu gihugu runaka.Iyo ushaka kwinjira ku isoko ry’igurisha ry’ibindi bihugu, kuboneka kwa DMF ni ngombwa .

Nko mu Muryango w’ubumwe bw’ibihugu by’i Burayi, DMF iri mu ruhushya rwo kwamamaza. Ku biyobyabwenge, urutonde rw’ibikoresho ruzashyikirizwa Umuryango w’ubumwe bw’ibihugu by’Uburayi cyangwa Ikigo cy’igihugu gishinzwe ibiyobyabwenge, kandi uruhushya rwo kwamamaza ruzakorwa.Iyo utanga isoko y'ibikoresho bifatika (ieAPI) bikoreshwa muguhindura ibiyobyabwenge, inzira zavuzwe haruguru zirakurikizwa.DMF nigice cyingenzi mubikoresho bisabwa.Niba DMF idatanzwe nkuko bisabwa, ibicuruzwa byakozwe ntibishobora kugurishwa mugihugu.

DMF ifite uruhare runini kubayikora. Kugeza ubu, Hande arasabaMelatoninFM gutumizaMelatonin, nyamuneka twumve neza!