Isimiso Esingokomthetho Nesokuqondisa Sombuso

Iminyango yoMbuso ingobameli abaphambili bempilo yomphakathi uma kuziwa ekuqondiseni imikhakha yokwelapha nabezokwelapha. Umsebenzi wabo uqinisekisa ukuthi iziguli ezisebenzisa imithi kanye nezisetshenziswa yimishini ziphephile, ziyasebenza, futhi zenziwe ngokwezindinganiso eziqinile. Nakuba izinhlangano zikahulumeni njenge .S. Food and Drug Administration (FDA)[FLT) [FOLT] [1] umqondisi wokungena kwezezokwelapha nokuhlola ukuphepha kwesizwe, iminyango kahulumeni iphatha iziyalezo zezinsuku zonke, izikhutha, nokuzimela imicimbi yendawo okuthinta ngokuqondile imiphakathi. Lengxenye yemithwalo yemithwalo yemfanelo idala inqubo ebekwe ndawonye lapho izikhulu zikahulumeni zingakhuluma khona ngezindaba ezikhethekile zezwe lapho izinhlangano zesizwe zilondoloza khona isisekelo sokhuseleko lwezwe lonke izwe.

Isisekelo somthetho wokuthaka imithi kahulumeni sisemkhankasweni wezemithi wesigungu ngasinye nemithetho yezempilo yomphakathi. Lemithetho inikeza iminyango kahulumeni − ngokuvamile ifakwe phakathi kwamabhodi ekhemisi, iminyango yempilo, noma izinhlangano ezingochwepheshe zokumisa izinhlangano .(igunya lokudala imithetho edlula isilinganiso esincane kakhulu sikahulumeni. Ngokwesibonelo, uhulumeni ungadinga umthetho oqinile wokulawula izinga lokushisa kwemithi egciniwe edayisayo noma umyale ukuba zonke izimboni zezokwelapha zikhiphe itsheyina le-tikene le-tike. Ngenxa yokuthi lemithetho ingahluka kakhulu kuhulumeni, izinhlangano ezisebenza ezigabeni eziningi kumelwe zihambe ngezindlela eziyinkimbinkimbi zezimfuneko.

Ukubambisana Nezimo Eziphuthumayo

Iminyango kahulumeni ayisebenzi ngokungenalutho. Isebenzisana eduze ne-FDA ngezivumelwano, ngezimiso zokwaziswa, nangezenzo zokuqinisekisa ukugcinwa kwamalungu. I-FDA ithembele kubahloli bakahulumeni ukuba iqhube ukuhlolwa kwezimiso eziningi ezindaweni zokwakha nakwezobuchwepheshe. Futhi, iminyango kahulumeni isebenzisa izimpawu ze-FDA futhi ikhumbule ukwaziswa kokuvusa ukuhlola kwendawo. Lobu buhlobo buqinisekisa ukuthi umkhiqizo oyingozi ophawulwe engxenyeni eyodwa yezwe ngokushesha uholela ekuthatheleni isinyathelo ezindaweni zonke kuyo yonke indawo. Izinhlangano zikahulumeni zifaka imibiko emibi kuhlelo lwe-FDA [FLT:] [FLD] [FLD]]

Imithetho Ekhethekile Yezinga likahulumeni

Ngaphandle kwemithetho ye-baseline kahulumeni, isho ukuthi ishaya imithetho esingatha izifo eziwumshayabhuqe zendawo noma izinto eziza kuqala. Ngokwesibonelo, lapho isabela enkathazweni ye-opioid, iminyango eminingi kahulumeni yasebenzisa izinhlelo zokuhlola imilaliso ezigunyaziwe (PDMPs) ezilawula imitapo elawula izinto ezisetshenziswayo. Lemitapo yosizo isiza odokotela nabezokwelapha ukuba baphawule izindlela zokuxhaphaza ezingase ziholele ekuluthekeni. Ngokufanayo, amanye amazwe adinga umshini wezokwelapha (imishini yokulungisa i-operacroscope (iiacileties) ehlanzekile nesetshenziswa yimishini ekhethekile yokusebenzisa i-activessss (*) ukuze ikwazi ukuthatha imvume ekhethekile yokuhlola imishini ekhethekile. Lezi zimfuneko zikahulumeni ziveza izimo zezokuhlala abantu bendawo, izimo zempilo, izinto ezingoko zezempilo, kanye nezinqumbiso ezingoko ngokomthetho zemithetho kahulumeni ezingenakuzinza ngokugcwele.

Ukuphonsa Amasimu Nokuqinisekisa Ngobuchwepheshe

Enye yemithwalo yemfanelo ebonakalayo kakhulu yeminyango kahulumeni ukunikeza amalayisense ama-pharmac, ama-accompars, abakhiqizi, amathuluzi ezokwelapha, abadlulisi bemishini, kanye nochwepheshe abawasebenzisayo. Inqubo yokulungisa inqubo ingowokuqala wesango ovimbela imikhiqizo engaphephile ekufinyeleleni iziguli. Isicelo selayisensi ngasinye sibangela ukuhlola isizinda, ukubukezwa kwezinqubo zokusebenza, futhi ngokuvamile ekuhlolweni ngaphambi kokuba kuvunyelwe. Imijikelezo emisha, ewunyaka nonyaka noma onyaka, izinhlangano ezisebenza ngokuqhubekayo ukubonakalisa ukuhambisana nemikhuba emihle yamanje yokukhiqiza (CGMP) kanye nokugcinwa kwezindinganiso zikahulumeni.

Ukuphonsa Ilacens Nebhodi Ye - Pharmake

Umbuso ngamunye unebhodi lekhemisi elinamapesenti omphakathi, amapharmacy, nezindawo zeposi ezidayiswayo. Lamabhodi aqinisekisa ukuthi izindawo zekhemisi zihlangabezana nezimfuneko ezikhethekile zokuvikela nokukhucululwa kwendle, ukuthi umekhemisi uphethe ilayisensi esebenzayo, engalinganisi, nokuthi ikhemisi liphethe umshuwalense ofanele. Ngaphezu kwalokho, amabhodi amaningi adinga amakhambi ahlanganisa izinqubo zokuvimbela ukuvala imvume ekhethekile yokuhlanganisa indleko nokuhlola imvelo (EM). Lezi zinyathelo zabekwa ziqinile ngemva kokuqubuka kwe-methemicry exubevayo ngo-Massachusetts.

Umsakazi Wemishini Yezokwelapha Nomshini Wokukhiqiza

Nakuba i-FDA iphatha ukuvunyelwa kwemishini yezokwelapha, iminyango kahulumeni igunyaza izinkampani ezisakaza futhi zisebenzise lezo zisetshenziswa. Umkhangisi wamathuluzi okuhlinza, imishini yokuxilonga, noma imishini efakwayo ngokuvamile kufanele athole i-alctive directive ekhululayo ye-operactive layisensi evela kuhulumeni ngamunye lapho iqhuba khona. Isicelo sicela imininingwane ngezigaba zomshini eziphathwayo, iziqu zochwepheshe bezobuchwepheshe, kanye necebo lokukhumbula. Amanye awena awena i-alptudiotation ehlukile “edivregister". i-layisensective" yemishini ehlanganisa noma ehlela amathuluzi asebenza ngeqophelo ngalinye lapho ibhizinisi lisebenza khona. /an olight digievesssss shorters 3-s shorters short

I - Prictor Nesiqinisekiso Sokungagculisi

Iminyango yezempilo iqinisekisa futhi ukuthi odokotela abanakekela impilo bafanelekela ukugunyaza noma ukusebenzisa imishini ethile yezokwelapha. Ngokwesibonelo, izifundazwe eziningi zidinga odokotela abanikeza iBotox (umuthi kadokotela osetshenziswa njengethuluzi lezokwelapha kwezinye izimo) ukuba babambe isitifiketi sokuqeqesha. Ngokufanayo, imithola-khaya esebenzisa imishini ye-laser elawula i-sclectalology noma i-ophphlyology i-actalology ihlola njalo ukuvikela izingo zomsebe, isheke ukutholakala kwamehlo, kanye nokulahlwa okufanelekile. Lo dokotela we-crector clacy wamanje usiza ukuqinisekisa ukuthi imishini eyinkimbinkimbi isetshenziswa kuphela yilabo abane-activective.

Ukuhlolwa, Ukuphishekelwa Nokuhlolwa Kwenhlangano

Lapho ilayisense ikhishwa, iminyango kahulumeni ishintsha ifeza indima yokuhlola. Ukuhlola kuyithuluzi eliyinhloko lokuqinisekisa ukuthi imishini yezemithi neyezokwelapha isasebenza. Abahloli bezokwelapha ,... ngokuvamile osokhemisi, onjiniyela, noma ochwepheshe bezempilo bomphakathi . Ikhompuyutha yomibili emenyezelwayo nengashiwonga ukuthi i-i-injini. Bahlola amarekhodi, amathuluzi okuxoxa, nokuqoqa amasampula okuhlola. Ubuninzi bokuhlola kuxhomeke esicini esiyingozi salento: ikhemisi exubile, onjini yokupheka yemithi engahlolwa njalo ngemva kwezinyanga eziyisithupha, kuyilapho indawo yokugcina impahla ephansi egcina impahla ye-riski ingahlolwa njalo ngemva kweminyaka emibili.

Ukuhlolwa Kwezindawo Zokuhlolela Imisebenzi

Izindawo zokwakha imishini ekhipha amagciwane, ikakhulukazi lezo ezikhiqiza amabhathithi aphezulu angenayo igciwane, zithola ukucubungula kakhulu kubaphathi bezwe. Phakathi nokuhlolwa okuvamile, iqembu lihlola izimiso zeHVAC zokuphatha umoya ngendlela efanele, liqinisekisa ukuthi izimiso zokuhlanza amanzi zihlangana nezindinganiso ze-pharmacopetic, futhi zihlola ukuthi amarekhodi eqoqo ahambelanayo nezinyathelo ezingokoqobo zokukhiqiza. Imishini yezokwelapha, abahloli bagxila ekwazinininini kokulawula umklamo, amarekhodi entengiselwano, nenqubo yokulungisa (CAPA). Noma iziphi izindlela zokuzimela amanzi zihlangabezana novivinyo lokuzinza noma ukuhlolwa okungatholangatholangatholi mvume okumelwe kubhalwe njengokushiwo phakathi nesikhathi esishiwoyo.

Ukusabela Ezicingweni Nezehlakalo Ezibi

Ngaphezu kokuhlola okuhleliwe, iminyango kahulumeni ihlola izikhalo zeziguli, abagcini bezempilo, nabafuyi bempetha. Ucingo lomhlengikazi olubika ukuthi i-al yemithi ibonakala ingenambala ingabangela ukuhlolwa okusheshayo kwezimo zokugcina imoto. Ngokufanayo, ukuvalwa kwezenzakalo ezihlangene nemishini ethile elungisa ijubane kuholela abacwaningi bemishini yezokwelapha ukuba bacele ukusungula amarekhodi nokuhlola impande. Le zenzo zokukhononda zivame ukuveza izimo zesimiso sokuhlola inqubo ezingase ziphuthe, njengokuhamba okungafanele kokuthumela amagesi phakathi nemishini yokuthumela noma ukukhwaba amaxwebhu.

Izenzo Nezimvume Zokuphoqelelwa

Lapho ukuhlolwa kwembula ukuphulwa okukhulu, iminyango kahulumeni inamathuluzi okuqinisekisa. Ingakhipha izincwadi ezixwayisayo ezifuna icebo lokulungisa, ukuphoqa izihlawukiso, ukumisa noma ukukhipha ilayisense, futhi ezimweni ezidlule kakhulu zicela ukuvala inqubo yenkantolo. Kuleyo zinhlangano zezokwelapha, ukukhishwa kwelayisensi kusho ukuthi isakhiwo asinakukhipha noma yimiphi imithi mayelana nokucindezela okusheshayo ukulungisa ukuswela. Ukuphoqesha kwemithetho yomthetho kubhalwe obala futhi ngokuvamile kuvela kuyi-movidual Association of Boards of Phamacy (NABP), leyo i-websiteji ehlo abathengi abaningi nezinhlangano zezempilo abahlola ngayo ngaphambi kokuba benze ibhizinisi nomthengikazi wemali. Ukusongela kwemali kuthathwe kwe-racracter.

Imfundo Yomphakathi Yempilo Nemikhankaso Yokuphepha

Iminyango yoMbuso yenza okungaphezu kwemithetho ephoqelelwe; futhi ifundisa abaqashi bomphakathi nabezempilo ngokusetshenziswa okuphephile kwemithi nemishini yezokwelapha. Lemizamo yemfundo isiza ekuvimbeleni amaphutha emithi, ukunciphisa izenzakalo zezidakamizwa ezingezinhle, futhi iqinisekise ukuthi imishini yezokwelapha isetshenziswa ngokunembile. Imikhankaso ngokuvamile ihlotshaniswa nezibalo zempilo eziqondene nombuso onezinga eliphakeme lesifo sikashukela ingagxila ekukhuselekeni kwe-insulin nasekusebenziseni okufanele kwemishini yokuhlola i-glucose.

Ukukhulumisana Kwezidakamizwa Okukhumbulayo

Lapho kumenyezelwa ukukhumbula izidakamizwa, iminyango kahulumeni ihola ekutholeni amakhemikhali, izibhedlela, nemithola-mpilo esendaweni yayo. Ikhipha izixwayiso ngama-imeyili aqondile, izikhangiso zempilo yomphakathi kumawebhusayithi abo, futhi phakathi nemihlangano yehholo ledolobha. Iminyango yoMbuso ihlanganisa nababhula ngezindlela zokudayisa izinto ezikhumbulekayo ezindleleni zokudayisa izibhedlela, iqinisekisa ukuthi imithi ikhishwa emashalofini ngaphambi kokuba ifinyelele iziguli. Kwezinye izizwe, ibhodi yekhemisi isebenzisa ithelikhi yokuda ithengisa izimpawu zayo zokudayisa kuyo yonke ikhemisi ebalini ebalini elibaliwe elibaliwe futhi elikhona ngokushesha, indlela ephumelelayo ehambisana nokukhiqiniswa kwe-Flatem edayo.

Izinhlelo Eziphephile Nemithi Ezibuya Ngemuva

Ukulahlwa kabi kwemithi engasetshenziswayo .Izinhlelo zibalulekile ekunciphiseni ukutholakala kwamaopioid okusetshenziswa kabi kwendlu yangasese noma ukuwalahla emfucumfucwini. Iminyango kahulumeni ihlela izinhlelo ezibuyisela emuva ezivumela abathengi ukuba balahle imithi engekho ezingosini ezimisiwe, ngokuvamile eziteshini zamaphoyisa noma ezindaweni zendawo. Lezinhlelo zibalulekile ekunciphiseni ukutholakala kwama-opioid okusebenzisa kabi nokuvimbela imithi ekungcoliseni imithombo yamanzi. Imishini isebenza futhi ne-National Precrigic Da Take Back Day ukuze ifinyelele. Eminye imishini yezokwelapha, eminye ikhipha izinhlelo zokubuyisela izinto ezisetshenziswayo zokusetshenziswa kwemishini enjenge-insulin kanye nemishini yokulungisa i-glucose, ivimbela izingozi ze-gluss.

Isixwayiso Sezisetshenziswa Zezokwelapha

Iminyango yoMbuso futhi ixwayisa ngezindaba zokuphepha zemishini yezokwelapha. Uma umhloli wezwe ethola ukuthi iqoqo lamaglove okuhlinza linezinga eliphakeme ngokungavamile phakathi nokuhlola indawo, ukuqapha kuya kuzo zonke izibhedlela nezikhungo zokuhlinza kuhulumeni eziyala ukuba zihlole izinombolo zezimo. Ngokufanayo, phakathi nobhadane lwe-COVID-19, iminyango kahulumeni isakaza iziqondiso eziqondiswe ngokushesha kuma-N95 a Respirator ukuze alondoloze ukulinganiselwa okulinganiselwe. Lezi zixwayiso ngokuvamile zisebenza kakhulu kunezixwayiso ezivamile zika-FDA ngoba zihlanganisa isiqondiso esiqondile sokulungisa izinto zendawo ebhaliwe futhi zihambisa izimo ze-kethenjiwe.

Izinselele Neziyalezo Zesikhathi Esizayo

Izindawo zokulawula amakhemikhali nemishini yezokwelapha zishintsha ngokushesha. Imithi engokomuntu siqu, ukukhula kwe-software njengethuluzi lezokwelapha (SAMD), kanye nokwanda kwe-website yama-pharmacy kwakha izinselele ezintsha eminyangweni kahulumeni. Ngesikhathi esifanayo, ukuqina kobunkimbinkimbi bezindawo zokuphatha kwembulunga yonke kulingana namandla amaqembu ahlolayo kahulumeni. Ukubhekana nalezi zinselele, iminyango yombuso ifaka izimali, ubuchwepheshe bokuhlola isayensi ekude, kanye namaqoqo ahlukene avumela ukuhlangana kolwazi ngokushesha.

Imikhiqizo Yobugunya Neminye Engathandeki

Imithi yokunyanga nemishini yezokwelapha iyazimelela kabi isiqalo sayo noma izimpawu. Ngokungenhloso emakethe ye-Internet kanye nokuthengwa okungekho emthethweni. Iminyango yoMbuso isebenza ngamasiko kahulumeni nesivikelo somngcele ukuze ibone lemikhiqizo esendaweni kahulumeni, kodwa i-pane ivame ukuba ikhemisi noma umthola mpilo. Ekuphenduleni, amazwe amaningi adinga inqubo eqinisekile yenqubo ye-padigree ethola yonke imithi, ibhala ikethenjana lelungelo lokugcina imfuno embonini. Imishini, iphawula ukuthi ayamukela imishini ekhethekile ekhethekile evumela abahloli ukuba baqiniseke ngokushesha phakathi nokuhlola.

Imithi Nemishini Ephambili Yomuntu Siqu

Intuthuko ekwakheni imisebe ye-genenomics kanye nemisebenzi yezinto eziphilayo yenza izigaba ezintsha zezidakamizwa nemishini ezihlolwa isiguli ngasinye. Ngokwesibonelo, isiko i-3D-ishicilelwe izitsha nezidakamizwa ezilula ezilula ezifakwayo ze-octensins zehlela endaweni empunga phakathi kokukhiqizwa kwemishini kanye nokunakekelwa kwemikhakha. Iminyango kahulumeni iphazamisana nendlela yokuhlola le mikhiqizo: Ingabe kufanele iziphathe njengemishini ebekwe ngaphansi kwelayisense yokusungula i-crective, noma kufanele umkhiqizo ngamunye wesiko utholwe endaweni ehlukile ye-cregister? Ezinye izisholo ziye zaqala ukuqondisa “ihele elinolwazi”, lapho ukuklama kanye nokukhiqisa imingcele yemiklano ebukelwe kude ngaphambi kokuba kukhishwe. Lokhu kukhiqizwe kungase kuqale ukusetshenziswa njengendlela ejwayelekileyo yobuchwepheshe.

Isiphetho

Imithwalo yemfanelo yeminyango kahulumeni eqondisa imithi nemishini yezokwelapha inamandla futhi inezici eziningi. Ngokuhlola, ukuqinisekisa, ukuphoqelela, nemfundo yomphakathi, bakha inetha lokuphepha elivikela iziguli emikhiqizweni engaphephile futhi linike ochwepheshe bezempilo ulwazi oludingekayo ukuze lusetshenziswe ngendlela ephephile. Nakuba uhulumeni umisa izindinganiso zesizwe, izindlela ezihlelwa ngokushesha zezokwelapha zezwe ziyokwenza ukuba ukusabela okusheshayo ezinkingeni zempilo yendawo nokuzivumelanisa nokuvela kwezimo zezemboni. Ukutshala izimali ezisemkhakheni eziqhubekayo zezentengiselwano zikahulumeni ezivikela imikhiqizo engaphephile (izisebenzi ezikakhulu, izinhlelo zokuqeqesha ukwaziswa, nezokusebenza kwezezobuchwepheshe zezokwelapha, kanye nezisetshenziswa kwezezokwelapha. Izinkampani zezempilo, ukuqonda nokulandelana kwemithetho yezombuso kungenza kungesona imfuneko esingokomthetho esingokomthetho somthetho; ukusekela esimweni somthetho esingokwempilo esimweni somphakathini sempilo.