JWEI Inozivisa Kuendeswa kwePremarket Fodya Chigadzirwa Chikumbiro (PMTA) cheNew Technology Platform Chigadzirwa kuUS Chikafu neDrug Administration Inokumbira Mvumo Yekushambadzira.

SHENZHEN, China, July 21, 2022 - JWEI, mutungamiri wepasi rose muindasitiri yefodya yemagetsi, anozivisa nhasi kuti vakabudirira kuendesa Pre-Market Fodya Chikumbiro kuUS Food and Drug Administration yemudziyo wakagadzirwa nehunyanzvi hwavo hutsva hwehunyanzvi, huri kutarisa nezvekuchengetedza, kuderedza kukuvadza uye kugadzirwa. kumisa kushandiswa kwevadiki.

Semumwe wevagadziri vemidziyo inotungamira pasi rose uye vanogadzira e-fodya uye zvigadzirwa zvehuputi, zvine mazana matatu nemazana matanhatu akapihwa patents uye akawanda anozivikanwa pasi rese ekugadzira uye emhando zvitupa (GMP, HACCP, ISO3,600, ISO9001, EHS, uye ERP), JWEI yakazvipira. kubatsira mukusimudzira hutano hweveruzhinji nezvitsva zvine musoro uye zvine hungwaru.

Kusvuta fodya ndeimwe yenjodzi huru dzehutano hweveruzhinji, ichiuraya vanhu vanopfuura mamirioni manomwe pasi rose gore rega rega. ¹. Inenge imwe chete pavashanu vanofa muUS inokonzerwa nekuputa fodya gore negore ². Iyo litany yezvirwere zvine chekuita nefodya yakareba. Zvinosuruvarisa, ruzhinji rwekufa uye kurwara zvinodzivirirwa.

Fodya inopindwa muropa, zvikurukuru nemhaka yokuvapo kwechikakananda, kunyange zvazvo chikakananda pachacho chisiri chikonzero chakananga chezvirwere zvakawanda zvine chokuita nokusvuta. ³. Vakawanda vanosvuta vanoedza kurega, vangave vari voga kana kuti nebetsero yezvirongwa zvokurega, vanokundikana mukuedza kwavo. ^4 5 6.

Pane kuenderera mberi kwenjodzi kune zvigadzirwa zvinounza nicotine, kubva kune zvinonyanya kupiswa zvigadzirwa (semidzanga) kusvika pazvino zvinokuvadza zvisingakuvadzi mishonga yechikakananda senge nicotine replacement therapy (NRT). Mumakore achangopfuura, kutarisisa kwakatendeukira kune mukana wekukurudzira avo vasingakwanisi kana vasingadi kurega kuti vaderedze kuputa kwavo fodya kana kushandura kune imwe nzira isingakuvadzi senge e-fodya sechinangwa chinogona kuitika. ^6 7.

Zvinoda nzira yakazara, ine mativi mazhinji uye kuedza kubata denda rekuputa fodya kubva kune vanodzora, vagadziri, mabhizinesi, vanoongorora muzvidzidzo kana zvikamu zvakazvimiririra, mapoka evamiriri, uye vagovani asi zvisiri kugadzira imwe denda rinoputika muvechidiki uye vanhu vari munjodzi.

Chekutanga, JWEI yakagadzira seti yemisimboti yekutungamira kuburikidza nenhanho yega yega yekugadzirwa kwechigadzirwa chitsva, ichitungamirwa nechengetedzo nekubudirira zvidzidzo mukutanga kwa2019. Uzivi hwekugadzira ndiyo hwaro uye njanji yekugadzira, kugadzira, kuongorora, kusimbisa, uye kuenderera mberi nekuvandudza. zvigadzirwa zvitsva, zvine mutoro, zvakavimbika, uye zvemhando yepamusoro. Uzivi hwekugadzira hwakagadzwa zvakajeka pakutanga kwechigadzirwa chitsva chepuratifomu: Kushandura dambudziko rekuputa dambudziko kuti rivandudze mikana yehutano hweveruzhinji nehunyanzvi uye hune mutoro.

Kechipiri, JWEI yakaumba boka rakazvitsaurira rakasiyana-siyana rinosanganisira aerosol chemist, zvinhu zvesainzi, toxicologists, epidemiologists, varapi, masayendisiti ehunhu, uye dzimwe nyanzvi dzechidzidzo chekushandisa hunyanzvi uye hunyanzvi mukuzadzikiswa kwechigadzirwa chine musoro uye chinoshanda.

Chechitatu, JWEI yakabata chiyero chepamusoro kubva pakutanga kwechigadzirwa chitsva chepuratifomu uye mukati mese maitiro. Vakaunza nyanzvi dzemadomasi, kusanganisira mainjiniya ebiomedical uye nyanzvi dzekiriniki nekudzora vane makumi emakore 'ruzivo rwakakura muClass III michina yekurapa. Ivo vakakoshesa kuchengetedzwa nekudzikisira kwakanyanya kukuvadza kwevashandisi uye zvirambidzo-zvinobva mumudziyo kudzivirira kutangwa kwevechidiki.

Chechina, JWEI yakadzamisa iyo yakazara PMTA gwara kuita seti yemaitiro anowirirana ekuvandudza chigadzirwa uye zvinangwa zvekudzidza. Iyo yakakwana uye yakarongeka kuyedzwa uye zvidzidzo zvakaitwa mumakondinendi matatu (Asia, Europe, uye North America) ine akawanda akasimirirwa echitatu-bato maLab uye vane mukurumbira vanoongorora uye vaongorori kubva kuindasitiri nedzidzo, kusanganisira kuongororwa kweaerosol, kuyedza kugadzikana, kuyedza E&L, ezvokunambira kunze kwomuviri waamai toxicology kuongororwa, biomarker zvidzidzo, in vivo pharmacokinetics, zvidzidzo zvekiriniki, maonero echigadzirwa uye maitiro ezvidzidzo, zvidzidzo zvevanhu, kuongororwa kwehutano hwemunhu, zvidzidzo zvemashandisirwo chaiwo, kuenzanisira kwehutano hwevanhu, uye ongororo yezvakatipoteredza. Iyo ruoko-mu-ruoko inodyidzana maitiro pakati pechigadzirwa chitsva chepuratifomu kusimudzira uye kuita PMTA kudzidza modules yaburitsa zvinokatyamadza mhedzisiro nemazvo uye nemazvo. Semuenzaniso, chigadzirwa chitsva chakaratidzwa kuderedza> 99.9% zvinokuvadza uye zvingangokuvadza zvinoumba (HPHC) zvichienzaniswa nefodya inobvira. Iyi nicotine kutamisa kushanda kwayo kunogona kugonesa kugona kweiyo yakadzikira nicotine kushandiswa kusangana nezvinodiwa nevashandisi kudzika pasi, hunyanzvi uye pragmatic deterrence zvinhu zvinoodza moyo zvakanyanya vasiri vashandisi, uye kugona kuchengetedza switch seyokutanga sosi yechikakana mukushandisa chaiko. pakati pevashandisi.

Chekupedzisira asi chisiri chidiki, timu inofambiswa nemishoni mumakondinendi matatu (Asia, Europe, uye North America) kushanda nesimba pabasa racho siku nesikati.

Iyo diki yechigadzirwa debut muUK yakagamuchira kucherechedzwa kukuru kubva kune vashandisi uye vekutengesa vadyidzani mushure memwedzi mishoma yekushandiswa chaiko. Hunhu hwepamusoro-soro uye hutsva hunoenderana nevashandisi. Kuwanda kwehuwandu hwekugovera kwezera rekushandisa kwakaratidzawo ruzhinji rwevashandisi varipo nicotine chigadzirwa vashandisi vakapfuura kare. diki kukura. Huwandu hwehumbowo hunovaka hwaro hwakasimba hunoratidza chigadzirwa chitsva uye zvigadzirwa zvepapuratifomu zvine mukana wepamusoro wekushandisa zvakanyanya paAPPH (yakakodzera kuchengetedzwa kwehutano hweveruzhinji).

Kupfuura magwaro e1,500, mazana emishumo yekudzidza, uye makumi ezviuru emapeji mukutumira kwekupedzisira kwePMTA akaendeswa kuFDA. Chikumbiro ichi chazoongororwa neFDA pasati paitwa tsinhiro nesangano kuti rigamuchire chikumbiro chekuisa padanho ripi rinobva raitwa ongororo yekutanga yesainzi kuti ive nechokwadi chekuti chikumbiro chine zvinhu zvese zvinodiwa kuti zvibvumidze kuongororwa kwakadzama neFDA. .

"JWEI yanga iri mutungamiri muindasitiri iyi kubva pakutanga uye chiitiko ichi chinosimbisa zvakare kuzvipira kwedu kune indasitiri uye hutano hweveruzhinji: kuona kuti vatengi vedu vakura vanoramba vachiwana dzimwe nzira dzisina kukuvadza kune zvigadzirwa zvefodya yechinyakare, tichiisa mwero mutsva unodzivirira kupinda kwevechidiki vasati vabva zera. .” akadaro Jason Yao, VP weJWEI Group.

References:

1. WHO. Fodya,https://www.who.int/news-room/fact-sheets/detail/tobacco#:~:text=Key%20facts,exposed%20to%20second%2Dhand%20smoke.> (2022).
2. CDC. Kusvuta & Kushandisa Fodya,https://www.cdc.gov/tobacco/data_statistics/fact_sheets/economics/econ_facts/index.htm> (2022).
3. Apelberg, BJ and unto. Zvinogona Kuitika Hutano Hweveruzhinji Kuderedza Mazinga eNicotine muMidzanga mu United States. N Engl J Med 378, 1725-1733, doi:10.1056/NEJMsr1714617 (2018).
4. Giovino, GA Epidemiology yekushandiswa kwefodya mukati United States. oncogene 21, 7326-7340, doi:10.1038/sj.onc.1205808 (2002).
5. Messer, K. and unto. The California Tobacco Control Programme pesvedzero pavasvuti vakura: (1) Kurega kusvuta. Kubata Kweturu 16, 85-90, doi:10.1136/tc.2006.016873 (2007).
6. Yong, HH, Borland, R., Hyland, A. & Siahpush, M. Kuedza kurega kukundikana pakati pevasvuta nguva dzose kunotapura sei kusvuta kwavo mudzanga? Zvakawanikwa kubva kuInternational Tobacco Control Four-Country Survey (ITC-4). Nicotine Tob Res 10, 897-905, doi:10.1080/14622200802023841 (2008).
7. Smith, TT and unto. Kusundidzira kana kudhonza? Nicotine kuderedza uye dzimwe nzira dzisina kupisa - Nzira mbiri dzekuderedza kusvuta nekuvandudza hutano hwevanhu. Prev Med 117, 8-14, doi:10.1016/j.ypmed.2018.03.021 (2018).

BATA: Fany Guo, [email inodzivirirwa]

SOURCE Shenzhen JWEI Electronics Co., LTD.