Asmeskas cov kws tshaj lij kev ua raws cai txhais qhov '1022 hluav taws xob haus luam yeeb qhov xwm txheej': yog tias koj xav nyob hauv Asmeskas kev lag luam, koj yuav tsum xa daim ntawv thov PMTA

Asmeskas cov kws tshaj lij kev ua raws cai txhais qhov '1022 hluav taws xob haus luam yeeb qhov xwm txheej': yog tias koj xav nyob hauv Asmeskas kev lag luam, koj yuav tsum xa daim ntawv thov PMTA

Tom qab kev sib koom ua kev cai lij choj los ntawm ntau lub tuam tsev hauv Tebchaws Meskas tau ntes kwv yees li 3 lab luam yeeb tsis raug cai, 2Firsts hu Tom Beaudet, CEO ntawm American ua raws li lub tuam txhab Accor. Nws txhais cov keeb kwm yav dhau los ntawm kev tswj hwm no, kwv yees yav tom ntej tiam sis, thiab muab cov tswv yim teb rau cov tuam txhab ua raws li Teb Chaws Asmeskas. Ntawm lub rooj sib tham txog kev ua raws cai los ntawm 2Firsts thaum Lub Yim Hli, Tom tau kwv yees tias Tebchaws Meskas yuav nce nws cov kev siv zog tiv thaiv cov luam yeeb tsis raug cai. Qhov tshwm sim ntawm qhov xwm txheej no lees paub qhov kev twv ua ntej no.

Lub US Food and Drug Administration (FDA) tsis ntev los no tau tshaj tawm txog kev ntes ntawm kwv yees li 3 lab cov khoom lag luam luam yeeb tsis raug cai nrog kwv yees tus nqi muag khoom ntawm $ 76 lab, ua rau nws yog ib qho kev tswj hwm loj tshaj plaws los ntawm FDA rau hnub tim. Qhov kev ua haujlwm no, tau ua los ntawm kev sib koom tes ntawm FDA thiab Asmeskas Kev lis kev cai thiab Kev Tiv Thaiv Ciam Teb (CBP), qhia txog kev nce ntxiv ntawm Asmeskas kev siv zog los tiv thaiv cov khoom lag luam luam yeeb tsis raug cai nkag hauv lub tebchaws. Muab qhov kev ntsuas tseem ceeb no, 2Firsts xam phaj Tom Beaudet, CEO ntawm Accor, kom nkag siab txog kev ua raws li cov kev sib tw thiab kev hloov pauv kev lag luam uas ntsib kev lag luam e-luam yeeb.

Hauv kev xam phaj thiab ntau qhov kev sib tham ntawm "Txoj Cai Tswj Kev Cai Luam Yeeb Tshiab thiab Kev Txhim Kho Kev Ua Raws Cai rau Asmeskas Kev Lag Luam" tuav los ntawm 2Firsts hauv Shenzhen thaum Lub Yim Hli xyoo no, Beaudet tau ceeb toom tias FDA cov kev cai ntawm cov khoom siv luam yeeb, tshwj xeeb tshaj yog cov uas muaj tsw, yog tas li nruj. . Nws kwv yees tias cov tuam txhab uas tsis ua raws li PMTA nruj (Pre Market Application for Tobacco Products) cov qauv yuav ntsib cov teeb meem tseem ceeb, uas kuj txhais tau tias cov khoom tsis ua raws cai yuav raug rho tawm ntawm lub khw. FDA qhov kev ntes loj ntawm cov khoom lag luam luam yeeb tsis raug cai lees paub nws qhov kev kwv yees.

Hauv kev xam phaj no, Tom Beaudet tau tsom mus rau kev txhais cov kev ua tsis ntev los no ntawm FDA thiab lawv cov kev cuam tshuam dav rau kev lag luam, suav nrog:

Kev Tiv Thaiv Kev Ruaj Ntseg: Kev sib koom tes ntawm FDA thiab CBP tau tsim cov qauv tshiab rau kev taug qab thiab tshem tawm cov khoom tsis raug cai.
Qhov tseem ceeb ntawm kev ua raws li PMTA: Raws li kev tswj hwm yuav ntxiv dag zog ntxiv, yog tias lub tuam txhab xav nyob hauv kev ua lag luam, nws yuav tsum xa daim ntawv thov ua raws PMTA.

Txo cov nqi ua raws cai los ntawm "bridging": Cov lag luam tuaj yeem txo tus nqi PMTA ua raws li "bridging" daim ntawv thov rau cov khoom pom zoo, yog li txo qhov xav tau rau kev tshawb fawb ntev ntev xws li kev tshawb fawb pharmacokinetic thiab kev sim ntsuas kev hloov pauv.

Kev sib tw hla ciam teb kev ua raws cai: Cov kev cai tshiab ntawm FDA thiab CBP ua rau muaj teeb meem loj rau cov tuam txhab thoob ntiaj teb kom tsis txhob ua raws li qhov xwm txheej, xav kom lawv khaws cov ntaub ntawv tshiab thiab hloov kho sai.

PMTA ua raws li qhov tseem ceeb: cov txheej txheem tseem ceeb suav nrog kev tshuaj xyuas tshuaj, tshuaj ntsuam xyuas kev pheej hmoo toxicological, kev ntsuas kev ruaj ntseg mus ntev, thiab kev ntsuas kev pheej hmoo mob qog noj ntshav.

Txhawm rau tiv thaiv kev txhim kho txuas ntxiv ntawm kev tswj hwm kev cai lij choj: Nrog rau kev nce ntxiv ntawm kev tswj hwm, txhawm rau kom tsis txhob muaj kev pheej hmoo ntawm kev nplua nyiaj siab thiab txwv kev nkag mus rau kev ua lag luam, cov lag luam yuav tsum tsim kom muaj kev tswj hwm kev ua raws cai.

2 Thawj zaug xam phaj peb tus kws paub txog kev ua raws cai ntawm lub rooj sib tham hauv Shenzhen hauv lub Yim Hli xyoo no, nrog Tom Beaudet ntawm sab xis|Duab Source: 2Firsts

Thaum Lub Yim Hli 26, 2024, "Kev Tshawb Fawb Txog Kev Cai Luam Yeeb Tshiab thiab Kev Txhim Kho Kev Ua Raws Cai hauv Teb Chaws Asmeskas Kev Lag Luam" tuav los ntawm Ob Tus Thawj Coj tau ua tiav hauv Shenzhen| Duab Source: 2Firsts