Drug Master File yog dab tsi?

Thaum tham txog Drug Master File, cov tuam txhab lag luam sib txawv muaj cov tshuaj tiv thaiv sib txawv.Lub DMF tsis yog qhov yuav tsum tau rau cov tuam txhab sau npe.Txawm li cas los xij, cov tuam txhab tshuaj ntau tseem thov thiab sau npe DMF rau lawv cov khoom.Vim li cas?

Drug Master File yog dab tsi?

Txhawm rau nqis mus ua lag luam, cia peb saib cov ntsiab lus ntawm Cov Ntawv Pov Thawj Tshuaj Ua Ntej, thiab tom qab ntawd tham txog qhov nws tuaj yeem ua tau!

Cov txheej txheem ua tiav ntawm cov ntaub ntawv qhia txog kev tsim tshuaj thiab kev tswj xyuas zoo yog hu ua Drug Master File (DMF), uas suav nrog kev taw qhia ntawm qhov chaw tsim khoom (cog), cov kev qhia tshwj xeeb thiab kev tshuaj xyuas, cov txheej txheem tsim khoom thiab cov lus piav qhia, kev tswj xyuas thiab kev ua haujlwm zoo. kev tswj hwm.

Cov tuam txhab twg tuaj yeem thov rau DMF?

Muaj tsib hom DMF muab los ntawm FDA:

Hom I: Chaw Tsim Khoom, Chaw Ua Haujlwm, Cov Txheej Txheem Ua Haujlwm, thiab Cov Neeg Ua Haujlwm

Hom II: Cov Khoom Siv Tshuaj, Tshuaj Siv Tshuaj Nruab Nrab, thiab cov khoom siv hauv lawv cov kev npaj, lossis cov khoom siv tshuaj

Hom III: Ntim Khoom

Hom IV: Excipient, Colorant, Flavor, Essence, lossis Khoom siv hauv lawv Kev Npaj

Hom V: FDA lees txais cov ntaub ntawv siv

Raws li tsib hom saum toj no, ntau hom tuam txhab tuaj yeem thov rau lawv raws li lawv tus kheej xav tau rau cov ntaub ntawv cov ntsiab lus xav tau los ntawm ntau hom DMF.

Piv txwv li, yog tias koj yog ib tugAPI chaw tsim tshuaj paus, DMF koj yuav tsum tau thov los ntawm FDA yog hom II.Cov ntaub ntawv uas koj muab yuav tsum muaj xws li: daim ntawv thov, cov ntaub ntawv tseem ceeb, kev cog lus kev lag luam, kev piav qhia ntawm lub cev thiab tshuaj lom neeg ntawm cov khoom siv, cov lus piav qhia ntxaws txog cov txheej txheem tsim khoom. , kev tswj cov khoom zoo thiab kev tswj cov txheej txheem tsim khoom, cov khoom ruaj khov kuaj, ntim thiab sau npe, cov txheej txheem kev khiav haujlwm Cia thiab tswj cov khoom siv raw thiab cov khoom tiav, tswj cov ntaub ntawv, pov thawj, batch tooj tswj qhov system, rov qab thiab pov tseg, thiab lwm yam.

Feem ntau, DMF tau dhau los ua ib qho tseem ceeb rau qee yam tshuaj thiab API seb lawv puas tuaj yeem xa tawm mus rau qee lub tebchaws.Thaum koj xav nkag mus rau kev muag khoom ntawm lwm lub teb chaws, qhov muaj ntawm DMF no tseem ceeb heev. .

Ib yam li hauv European Community, DMF yog ib feem ntawm daim ntawv tso cai ua lag luam.Rau tshuaj, cov khoom siv yuav tsum raug xa mus rau European Community lossis National Drug Administration ntawm lub teb chaws muag, thiab daim ntawv tso cai ua lag luam yuav tsum tau ua.Thaum tus neeg muag khoom ntawm cov khoom xyaw nquag (ieAPI) siv hauv cov tshuaj hloov pauv, cov txheej txheem saum toj no yuav tsum siv.DMF yog ib feem tseem ceeb ntawm cov ntaub ntawv thov.Yog tias DMF tsis muab raws li qhov xav tau, cov khoom tsim tawm tsis tuaj yeem muag rau lub tebchaws.

DMF plays lub luag haujlwm tseem ceeb rau cov tuam txhab.Tam sim no, Hande tab tom thov rauMelatoninDMF.Nyob rau hauv cov ntaub ntawv sau npe, Hande muaj ntau xyoo ntawm daim ntawv thov kev paub thiab ib pab neeg ua hauj lwm.The Rapid Response Center peb tau muab koj nrog cov kev xaiv zoo tshaj plaws kom tau raws li koj xav tau nyob rau hauv luv luv lub sij hawm.Yog hais tias koj yuav tsum tau thov rau DMF cov ntaub ntawv thaum lub sij hawm. xajMelatonin, thov koj xav tiv tauj peb!


Post lub sij hawm: Sep-23-2022