Thaum Lub Xya Hli 1, 2024, US Food and Drug Administration (FDA) tau tso cai tsis raug cai rau lub sijhawm muaj txiaj ntsig rau kev sau npe cov tuam txhab tshuaj pleev ib ce thiab cov npe khoom raws li Modernization of Cosmetic Regulations Act of 2022 (MoCRA). Cov tuam txhab uas tsis tau ua tiavFDA tso npetej zaum yuav muaj kev pheej hmoo ntawm kev raug kaw lossis tsis kam nkag mus rau Tebchaws Meskas.
1. FDA tshuaj pleev ib ce tub ceev xwm officially siv
Thaum Lub Kaum Ob Hlis 29, 2022, US Thawj Tswj Hwm Biden tau kos npe thiab dhau Txoj Cai Kev Cai Kho Kom Zoo Nkauj Niaj Hnub Nyoog 2022 (MoCRA), uas yog ib qho kev hloov pauv tseem ceeb ntawm US cov kev cai tshuaj pleev ib ce nyob rau yav dhau los 80 xyoo txij li xyoo 1938. Cov kev cai tshiab xav kom txhua lub tuam txhab tshuaj pleev ib ce xa tawm mus rau lub tuam txhab. Tebchaws Asmeskas lossis hauv tebchaws kom ua tiav FDA tso npe.
Thaum Lub Kaum Ib Hlis 8, 2023, FDA tau tshaj tawm cov lus qhia tias txhawm rau kom ntseeg tau tias cov tuam txhab muaj sijhawm txaus los xa lawv cov ntawv sau npe, ntxiv 6-hli lub sijhawm pub dawb tau tso cai rau FDA kom ua tiav tag nrho cov kev cai ua raws li lub Kaum Ob Hlis 31, 2023. Thaum Lub Xya Hli 1, 2024, cov tuam txhab uas tsis tau ua tiav lub sijhawm kawg yuav raug nplua los ntawm FDA.
Lub sijhawm kawg rau Lub Xya Hli 1, 2024 tau tas sijhawm, thiab FDA txoj cai tswjfwm ntawm cov tshuaj pleev ib ce tau pib siv. Txhua lub tuam txhab tshuaj pleev ib ce uas xa tawm mus rau Tebchaws Meskas yuav tsum tau them nyiaj tshwj xeeb rau kev ua tiav cov npe lag luam thiab cov npe khoom ua ntej xa tawm, txwv tsis pub lawv yuav ntsib kev pheej hmoo xws li tsis kam nkag thiab txeeb cov khoom.
2. FDA Cosmetic Registration Requirements
Cov chaw tsim tshuaj pleev ib ce koom nrog hauv kev tsim, ua, thiab muag khoom hauv Tebchaws Meskas yuav tsum tau sau npe ua lag luam. Ib lub chaw tsim khoom cog lus, tsis hais txog pes tsawg lub npe lawv cog lus rau, tsuas yog yuav tsum tau sau npe ib zaug. Cov tuam txhab uas tsis yog Asmeskas yuav tsum tau xaiv ib tus neeg sawv cev hauv Asmeskas los sawv cev rau lub tuam txhab hauv kev sib txuas lus thiab kev sib tham nrog US FDA. Cov neeg ua haujlwm hauv Asmeskas yuav tsum nyob hauv lub cev hauv Tebchaws Meskas thiab tuaj yeem teb cov lus nug FDA ntawm 7/24.
Tus neeg saib xyuas yuav tsum tau sau npe rau cov khoom. Cov neeg tsim khoom, cov ntim khoom, cov xa tawm, lossis cov tswv lag luam uas nws cov npe tshwm rau ntawm cov ntawv sau tshuaj pleev ib ce yuav tsum sau cov khoom lag luam thiab tshaj tawm cov qauv tshwj xeeb rau FDA. Tsis tas li ntawd, "tus neeg muaj lub luag haujlwm" tseem yuav yog lub luag haujlwm rau cov xwm txheej tsis zoo, daim ntawv pov thawj kev nyab xeeb, daim ntawv lo, thiab nthuav tawm thiab sau cov tshuaj tsis haum rau hauv cov txuj lom.
Cov tuam txhab sau npe saum toj no thiab cov khoom lag luam tau teev npe hauv khw yuav tsum ua kom tiav ua ntej Lub Xya Hli 1, 2024!
Yuav tsum ua raws li Txoj Cai Zoo Ntim thiab Sau Npe (FPLA) thiab lwm yam kev cai siv.
Ua ntej Lub Kaum Ob Hlis 29, 2024, txhua daim ntawv tshuaj pleev ib ce yuav tsum qhia cov ntaub ntawv tus neeg sib cuag rau kev ceeb toom tsis zoo, uas yog siv los txais cov ntawv ceeb toom tsis zoo.
3. FDA Cosmetic Update Requirements
Enterprise Registration Update Requirements:
· Kev sau npe ua lag luam yuav tsum tau hloov kho txhua ob xyoos
· Txhua yam kev hloov pauv hauv cov ntaub ntawv yuav tsum tau tshaj tawm rau FDA hauv 60 hnub, xws li:
Cov ntaub ntawv tiv tauj
yam khoom
Hom, thiab lwm yam
· Txhua lub tuam txhab uas tsis yog US yuav tsum xaiv ib tus neeg sawv cev hauv Asmeskas, thiab hloov kho rau lub sijhawm ua haujlwm hauv Asmeskas tus neeg sawv cev kuj yuav tsum tau lees paub nrog tus neeg sawv cev
✔ Cov npe khoom hloov tshiab yuav tsum muaj:
· Tus neeg saib xyuas cov npe khoom yuav tsum hloov kho cov npe khoom txhua xyoo, suav nrog kev hloov pauv
· Tus neeg saib xyuas yuav tsum xa daim ntawv teev npe ntawm txhua yam khoom kom zoo nkauj ua ntej sau npe, thiab tuaj yeem hloov pauv ntau cov npe khoom lag luam hauv ib zaug
· De-Sau cov khoom uas tau txiav tawm, uas yog, tshem tawm cov npe khoom npe
Lub sij hawm xa tuaj: Plaub Hlis-09-2024
