Muva nje, i-State Food and Drug Administration ikhiphe Isimemezelo ngeSigaba Sokuphatha semikhiqizo ye-Medical sodium hyaluronate (No. 103 ngo-2022, ngemuva kwalokhu okubizwa ngokuthi Isimemezelo se-No. 103).Isizinda nokuqukethwe okuyinhloko kokubuyekezwa kwesiMemezelo No. 103 kumi kanje:
I. Isendlalelo sokubukeza
Ngo-2009, i-State Food and Drug Administration yangaphambili yakhipha Isaziso Esigabeni Sokuphatha Semikhiqizo ye-Medical Sodium hyaluronate (No. 81 ka-2009, kamuva ebizwa ngokuthi Isaziso No. sodium hyaluronate) imikhiqizo ehlobene.Ngokuthuthuka okusheshayo kobuchwepheshe nezimboni kanye nokuvela kwemikhiqizo emisha, iSimemezelo 81 asisakwazi ukuhlangabezana ngokugcwele nezidingo zemboni kanye nemithethonqubo.Ngakho-ke, i-State Food and Drug Administration ihlele ukubuyekezwa kwesimemezelo esingu-81.
Ii.Ukubuyekezwa kokuqukethwe okuyinhloko
(a) Njengamanje, imikhiqizo ye-sodium hyaluronate (i-sodium hyaluronate) ayisetshenziswa nje kuphela ezidakamizweni nasezinsizeni zezokwelapha, kodwa futhi ivame ukusetshenziselwa izimonyo, ukudla neminye imikhakha, kanti eminye imikhiqizo isetshenziswa emaphethelweni ezidakamizwa, amadivaysi ezokwelapha nezimonyo. .Ukuze kuqondiswe kangcono ukunqunywa kwezimfanelo zokuphatha kanye nezigaba zemikhiqizo ehlobene, Isaziso No. 103 sengeze isimiso sencazelo yesibaluli sokuphatha semikhiqizo esemaphethelweni kanye nenhlanganisela yemikhiqizo yedivayisi yezemithi ehlanganisa i-sodium hyaluronate (i-sodium hyaluronate) kanye nomgomo wokuhlukaniswa komkhiqizo wedivayisi yezokwelapha ehlobene. , futhi yachaza isibaluli sokuphatha nesigaba semikhiqizo ehlobene.
(2) Imikhiqizo yezokwelapha ye-sodium hyaluronate yokwelapha ukukhubazeka kwesendlalelo sokuvikela sesinye se-urinary epithelial glucosamine igunyazelwe ukumakethwa njengamadivayisi ezokwelapha eSigaba III.Lolu hlobo lomkhiqizo aluvunyelwe ngokuvumelana nesimo sokumakethwa kwezidakamizwa, ukuze kugcinwe ukuqhubeka kokuphatha, ukuqhubeka nokugcina izimfanelo zokuphatha zangempela.
(3) Lapho umkhiqizo wezokwelapha we-sodium hyaluronate usetshenziselwa umjovo ku-dermis nangaphansi, futhi usetshenziswa njengomkhiqizo wokugcwalisa umjovo ukwandisa umthamo wezicubu, uma umkhiqizo ungenazo izithako zemithi ezidlala imiphumela yemithi, i-metabolic noma i-immunological, izophathwa njengedivaysi yezokwelapha ye-Class III;Uma umkhiqizo uqukethe izibulala-zinzwa zasendaweni nezinye izidakamizwa (ezifana ne-lidocaine hydrochloride, ama-amino acid, amavithamini), kubhekwa njengomkhiqizo oyinhlanganisela osuselwe ensizeni yezokwelapha.
(4) Lapho imikhiqizo yezokwelapha ye-sodium hyaluronate ijova ku-dermis ukuze kuthuthukiswe isimo sesikhumba ikakhulukazi ngemiphumela yokuthambisa kanye ne-hydrating ye-sodium hyaluronate, uma imikhiqizo ingenazo izithako zemithi ezidlala imiphumela ye-pharmacological, metabolic noma immunological, kufanele ilawulwa ngokohlobo lwesithathu lwemishini yezokwelapha;Uma umkhiqizo uqukethe izibulala-zinzwa zendawo nezinye izidakamizwa (ezifana ne-lidocaine hydrochloride, ama-amino acid, amavithamini, njll.), kuthathwa njengomkhiqizo oyinhlanganisela osuselwe ensizeni yezokwelapha.
(5) Isaziso No. 81 sibeka ukuthi “ekwelapheni… Imikhiqizo enemiphumela eqondile yezemithi efana nezilonda esikhumbeni izophathwa ngokulawulwa kwezidakamizwa”.Kodwa-ke, ngokuthuthukiswa kwesayensi nobuchwepheshe kanye nokuqonda okujulile kwe-sodium hyaluronate, ngokuvamile kukholelwa emphakathini wocwaningo lwesayensi ukuthi lapho i-hyaluronate ye-sodium isetshenziselwa ukugqoka kwezokwelapha, i-hyaluronate ye-molecular weight high esetshenziswa ezilonda zesikhumba inganamathela phezulu. amanxeba esikhumba futhi amunce inani elikhulu lama-molecule amanzi.Ukuhlinzeka ngendawo yokuphulukisa emanzi endaweni yesilonda, ukuze kube lula ukuphulukiswa kwesilonda, isimiso sesenzo saso singokomzimba.Le mikhiqizo ilawulwa njengamadivayisi ezokwelapha e-United States nase-European Union.Ngakho-ke, ukugqoka kwezokwelapha okuchazwe ku-Bulletin 103 equkethe i-hyaluronate ye-sodium ilawulwa njengemishini yezokwelapha uma ingenayo izithako zemithi ezinemiphumela ye-pharmacological, metabolic noma immunological;Uma ingamuncwa umzimba kancane noma iphelele noma isetshenziselwe izilonda ezingapheli, kufanele ilawulwe ngokohlobo lwesithathu lwensiza yezokwelapha.Uma ingakwazi ukumuncwa umzimba futhi isetshenziselwa izilonda ezingalapheki, kufanele ilawulwe ngokohlobo lwesibili lwedivayisi yezokwelapha.
(6) Njengoba izinto zokulungisa izibazi ezisiza ekuthuthukiseni nasekuvimbeleni ukwakheka kwezibazi ezinengqondo zesikhumba zifakwe ohlwini “Ukuhlelwa Kwamadivayisi Ezokwelapha” 14-12-02 Izinto zokulungisa izibazi, zizophathwa ngokuvumelana neSigaba II semishini yezokwelapha.Uma imikhiqizo enjalo iqukethe i-hyaluronate ye-sodium, izakhiwo zabo zokuphatha kanye nezigaba zokuphatha azishintshi.
(7) I-sodium hyaluronate (i-sodium hyaluronate) ngokuvamile ikhishwa ezicutshini zezilwane noma ikhiqizwe ukuvutshelwa kwe-microbial, okunezingozi ezithile ezingase zibe khona.Ukuphepha nokusebenza ngempumelelo kwemishini yezokwelapha Yesigaba I akukwazi ukuqinisekiswa ngezinyathelo zokulawula.Ngakho-ke, isigaba sokuphatha semikhiqizo ye-sodium hyaluronate yezokwelapha (sodium hyaluronate) ngaphansi kokuphathwa kwemishini yezokwelapha akufanele ibe ngaphansi kweSigaba II.
(8) I-sodium hyaluronate, njengesithako esithambisayo nesifaka amanzi, isetshenziswe ezimonyoni.Imikhiqizo equkethe i-sodium hyaluronateezisetshenziswa esikhunjeni, izinwele, izinzipho, izindebe nezinye izindawo zabantu ngokuhlikihla, ukufafaza noma ezinye izindlela ezifanayo ngenjongo yokuhlanza, ukuvikela, ukulungisa noma ukwenza zibe zinhle, futhi akusetshenziswa njengezidakamizwa noma izinto zokwelashwa.Imikhiqizo enjalo akufanele ifunelwe ukusetshenziswa kwezokwelapha.
(9) izinto zokuthambisa, izibulala magciwane kanyeamaphedi kakotiniequkethe izibulala-magciwane ezisetshenziswa kuphela ekubulaleni amagciwane esikhumbeni esilimele kanye namanxeba ngeke inikezwe njengezidakamizwa noma izinto zokwelashwa.
(10) Uma izinto ezibonakalayo, zamakhemikhali nezebhayoloji ze-hyaluronate ye-sodium eguquliwe zihambisana nalezo ze-sodium hyaluronate ngemva kokuqinisekiswa, izibaluli zokuphatha nezigaba zokuphatha zingasetshenziswa ngokubhekisela kulesi Simemezelo.
(11) Ukuze kucaciswe izidingo zokusetshenziswa, izindaba ezifanele zesicelo sokubhalisa ngaphansi kwezimo ezihlukene ziyabalulwa.Ezimweni ezibandakanya ukuguqulwa kwezibaluli zokuphathwa komkhiqizo noma izigaba, isikhathi soshintsho sokuqalisa esicishe sibe yiminyaka emi-2 sinikezwa ukuze kuqinisekiswe inguquko eshelelayo.
HEALTHSMILEizohlukaniswa ngokuqinile ngokuhambisana nemithetho kazwelonke.Ngokuvumelana nomgomo wokuba nesibopho kumakhasimende, iHyaluronate izoqhubeka nokuthuthukisa imikhiqizo emisha ukukhuthaza impilo yesikhumba.
Isikhathi sokuthumela: Nov-23-2022