Raws li cov ntaub ntawv cuam tshuam los ntawm US Food and Drug Administration, generic tshuaj uas tuaj yeem tau txais kev pom zoo los ntawm US Food and Drug Administration yuav tsum ua raws li cov xwm txheej hauv qab no: lawv muaj cov khoom xyaw tib yam li cov khoom siv coj los ua, nrog rau cov khoom xyaw uas tsis muaj zog sib txawv; Ua raws li cov lus qhia, daim ntawv ntau npaum, cov lus qhia tshwj xeeb, thiab kev tswj hwm ntawm cov khoom siv coj los ua; Bioequivalence; Qhov zoo ua tau raws li qhov yuav tsum tau ua; Cov qauv tsim muaj sib npaug nruj raws li cov khoom siv coj los ua.
Kev ntsuam xyuas qhov zoo thiab kev ua tau zoo ntawm cov tshuaj generic xav kom qhov zoo thiab kev ua tau zoo ntawm cov tshuaj generic pom zoo raws li cov tshuaj tshawb fawb qub, thiab lawv tuaj yeem hloov tau rau ib leeg hauv kev kho mob, uas yog qhov zoo rau kev txuag nqi kho mob. hauv zej zog.
Dab tsi yog cov tshuaj generic?
Ua ntej yuav kawm txog cov tshuaj generic, cia peb xub saib cov tshuaj tshawb fawb thawj zaug. Txhawm rau kom tsis txhob muaj kev tsis sib haum xeeb patent thiab tiv thaiv tib neeg txoj kev pib, cov tshuaj patented tau teev tseg nyob rau theem kev cai lij choj, feem ntau nrog lub sijhawm tiv thaiv ntawm 17 txog 20 xyoo. Thaum lub sijhawm tiv thaiv, lwm lub tuam txhab tsis tuaj yeem luam tawm thiab muag yam tsis tau tso cai. Lub tswv yim sib raug zoo yog cov tshuaj thawj zaug, uas yog tawm ntawm lub sijhawm tiv thaiv patent thiab tuaj yeem coj los ntawm lwm lub lag luam.
Generic tshuaj yog cov tshuaj uas muaj tib yam khoom xyaw, ntau npaum li cas, kev xa khoom, thiab kev kho mob raws li cov tshuaj qub. Cov tshuaj generic uas tau dhau qhov kev ntsuam xyuas qhov sib xws yog cov tshuaj sib npaug thiab bioequivalent rau cov tshuaj tshawb fawb qub (piv txwv li, nrog kev ua tau zoo thiab kev ua tau zoo), tab sis nrog cov nqi qis dua cov tshuaj tshawb fawb qub, uas tuaj yeem ua tiav kev sib hloov nrog cov tshuaj tshawb fawb qub hauv kev kho mob. Cov tshuaj tsis tas yuav tsum muaj cov khoom xyaw uas tsis muaj zog ib yam li cov khoom lag luam.
Txawm li cas los xij, cov tshuaj muaj peev xwm tsuas yog tsim tawm tom qab patent ntawm thawj cov tshuaj tas sij hawm, uas yuav siv sij hawm txog 20 xyoo tom qab tus neeg tuav ntaub ntawv cov tshuaj thawj zaug xa daim ntawv thov mus rau US Food and Drug Administration (FDA). Raws li Doha Daim Ntawv Pom Zoo, Qee lub tebchaws (xws li Bangladesh, Nplog, thiab lwm yam) tuaj yeem txaus siab rau lub sijhawm zam tshuaj patent txog xyoo 2033, thaum lub sijhawm lawv tuaj yeem hloov cov tshuaj raws cai hauv lub sijhawm patent. Tsis tas li ntawd, Is Nrias teb tau tshaj tawm cov cai yuav tsum tau tso cai rau cov tshuaj siv tshuaj, tso cai rau cov tshuaj uas pej xeem tsis tuaj yeem yuav ntawm tus nqi tsim nyog, hu ua cov tshuaj skyrocketing. Rau cov tshuaj no, tsoomfwv Indian tau hais tias cov tuam txhab tuaj yeem hloov pauv lawv.
Vim li cas cov tshuaj generic pheej yig dua?
Txawm hais tias cov khoom xyaw nquag ntawm cov tshuaj nquag muaj tshuaj zoo ib yam rau lawv cov khoom lag luam, lawv feem ntau muag ntawm tus nqi qis dua li cov tshuaj qub.
Yog vim li cas cov tshuaj generic muaj cov nqi qis dua, vim tias cov tuam txhab tshuaj tsis tas yuav rov ua qhov kev sim tshuaj thawj zaug rau kev ua tau zoo thiab kev nyab xeeb, yog li txo tus nqi nqa tshuaj mus rau lub khw. Nyob rau tib lub sijhawm, tsis tas yuav them tus nqi patent rau tus neeg tsim khoom, uas yog qhov kev siv nyiaj ntau heev. Qhov no tsis yog tsuas yog tsim nyog rau kev txhim kho cov tshuaj tshiab, tab sis kuj yog qhov tsim nyog rau kev rov qab kho tus nqi lag luam qub ntawm cov tshuaj qub.
Vim li cas cov tshuaj generic thiab cov tshuaj qub zoo li txawv? Puas muaj kev nyab xeeb?
Hauv Tebchaws Meskas, kev cai lij choj kev lag luam tsis tso cai rau cov tshuaj generic zoo li cov tshuaj qub. Txawm li cas los xij, generic tshuaj yuav tsum muaj tib yam khoom xyaw. Cov xim, saj, thiab lwm yam khoom xyaw uas tsis muaj zog yuav txawv, tab sis nws yog qhov tsim nyog rau kev ua haujlwm ntawm cov tshuaj kom tsis txhob hloov pauv. Cov tshuaj nquag siv tib yam khoom xyaw ua cov tshuaj qub thiab ua tib yam. Lawv sib koom tib yam kev pheej hmoo thiab cov txiaj ntsig zoo li cov tshuaj tshawb fawb qub. Nyob rau tib lub sijhawm, nyob rau theem kev cai lij choj, cov tshuaj generic yuav tsum xub tau txais kev pom zoo ua ntej lawv tuaj yeem tsim tawm. Yog li, generic tshuaj, zoo li thawj cov tshuaj tshawb fawb, muaj cov yam ntxwv ntawm kev ua tau zoo, muaj zog ua tau zoo, purity, thiab ruaj khov.
Puas yog txhua yam tshuaj tseem ceeb muaj cov tshuaj generic?
Lub tuam txhab kws kho mob tsim cov tshuaj tshiab raws li cov tshuaj patented thawj. Qhov no tiv thaiv cov tuam txhab tshuaj kev nqis peev hauv kev tshawb fawb tshuaj los ntawm kev tso cai rau lawv ib leeg los tsim thiab muag cov tshuaj qub thaum lub sijhawm patent.
Thaum lub sijhawm patent lossis lwm lub sijhawm tshwj xeeb tas sijhawm, lwm cov tuam txhab tuaj yeem xa daim ntawv luv luv New Drug Application (ANDA) rau FDA rau kev pom zoo muag cov tshuaj generic ntawm cov tshuaj thawj. Thaum nkag mus rau hauv kev ua lag luam, cov tshuaj generic feem ntau pheej yig dua li cov tshuaj tshawb fawb qub. Yog li kev ua lag luam yog tib yam uas txiav txim siab txoj sia nyob ntawm cov tshuaj generic. Qee cov tshuaj yuav tsis muaj cov tshuaj generic, vim cov tuam txhab lag luam yuav pom cov khoom no tsis muaj txiaj ntsig lossis tus nqi ntawm kev rov ua dua siab dhau.
Cov ntaub ntawv hauv kab lus no yog los ntawm Is Taws Nem thiab tsis siv los ua cov lus qhia txog kev kho mob lossis cov lus qhia peev. Yog tias tsab xov xwm no muaj kev cuam tshuam rau koj txoj cai thiab kev txaus siab lossis xav paub txog cov khoom no, thov hu rau peb raws sijhawm kom peb tuaj yeem muab kev pab ntxiv rau koj