Poyankhulana chaposachedwa ndi Cindy Pelosiu, Mutu wa Komiti Yaukadaulo ya Securiyati Yapadera ya Utumiki wa Indonesia chifukwa cha chipangizo cha ku Indosystem zachilengedwe.
A: Pafupifupi, adilesi yakale imasinthidwa malinga ndi kampani yomwe ikuvomereza ili ndi satifiketi yoyenera ndipo imatha kuwonetsa kuti kubwezeretsa (nthawi zambiri kumapangitsa chitetezo, chabwino komanso magwiridwe antchito a zamankhwala chida.
Q: Ndi dipatimenti iti yautumiki waku Indonesia akuwunika maselo ndi kulembetsa kwa Gene?
Yankho: Maselo a Incyrapy mankhwala amawunikiridwa ndi chakudya cha Indonesia ndi mankhwala osokoneza bongo (bpom) komanso zida zamankhwala.
Q: Makamaka makampani omwe akufunika kulembetsa zinthu zawo, gulu liti loti likhale pachiwopsezo cha zida zamankhwala? Kodi nthawi yomwe idalili yovomerezeka ya kulembetsa?
Yankho: Kuwunika kwa chidziwitsochi ndiko udindo wa FDA Indonesia (BPpom).
Q: Kodi zosintha zazing'ono zomwe zingasinthe
Yankho: Pakadali pano, kusintha kumaloledwa ngati zikugwira ntchito kwa onse kapena ambiri. Komabe, ngati itagwira ntchito imodzi yokha kapena iwiri yokha, chidziwitso cha kusintha chimafunikira.
Q: pakati pa Meyi 2021, tinali ndi zokambirana ndi utumiki wa zaumoyo (Moh) zokhudzana ndi kalata yochokera ku GuslaB yokhala ndi malingaliro a Ruo (kafukufuku wogwiritsa ntchito ku Indonesia. Chimodzi mwazomwe zimayenera kuti muchepetse kapena kusinthira ruro kulembetsa (msika woyamba ndi msika) ku Indonesia. Kulembetsa kwa Ruro kumathandiza kulimbikitsa malo ofufuza ndi kuthandizira Indonesia posintha chipilala chake chathanzi. Tikamapitilizabe kuchirikiza kafukufuku ku Indonesia, kodi tingatsatire ndiutumiki wathanzi ku Ruo?
A: Utumiki wa thanzi wa Indonesia wakambirana za ruo ndikuzindikira momwe amayendetsera ndi a Canshuls azaumoyo (HSA) ku Singapore. Tinaphunzira kuti HSA sawongolera ma roos koma amayambitsa malonda ogulitsa post. Pali zitsamba zowopsa ngati zinthu za RUO zimagwiritsidwa ntchito pochizira. Komabe, atapatsidwa msika waukulu waku Indonesia wokhala ndi laboratories, sitingathe kutengera izi. Indonesia ikugwira ntchito molimbika malamulo ndipo ndife otseguka pokambirana ndi omwe ali ndi chidwi ndi omwe amakhudzidwa ndi machitidwe abwino.
Q: Kodi Indonesia amalola kulembedwa pambuyo potumiza kutumiza? (mwachitsanzo, boma lokhala ndi chilolezo cha miyambo kapena kusinthasintha)
A: Kulembanso kumaloledwa mutatha kutsimikizira ndikutsimikizira kuti palibe vuto pa chinthucho komanso chitetezo chazogulitsa.
Q: Kodi ndi ngozi ziti zomwe zimayambitsa katundu ndi zilembo zosakanikirana? Mwachitsanzo, bokosi la bokosilo limakhala ndi dzina la kampani yatsopano koma mkati, bungwe (malangizo ogwiritsira ntchito zida zamankhwala) ili ndi dzina lakale la kampani. Kodi utumiki waku Indonesia umaloleza nthawi yosintha kuti kusintha kwa kulembedwa / IFU sikuonedwa kokakamizidwa?
Yankho: Ngati pali chisokonezo pakati pa IFU ndi zilembo, zimakanidwa chifukwa ndizofunikira kwambiri kuti muzisasintha. Ngakhale kuti zochitika zina za Gylay zimaperekedwa, zimakonda kukondweretsedwa pagululi zikufunikabe. Chifukwa chake amalimbikitsidwa kuti zinthu zonse zakale zalembedwa zisanapereke zosintha kuti zithetse kutumizanso kotheratu. Kutengera ndi zochitika, mutha kulembetsanso malonda pogwiritsa ntchito chilolezo cholondola.
Q: Kodi wophedwa akulimbikitsa pulogalamu yolamulira yodalirika, kodi utumiki waku Indonesia ndi uti wa malingaliro a chipatala pa pulogalamuyi? Monga momwe mfundo zomwe zilili ndikupanga zinthu zina zakomweko, Indonesia zitha kupindula ndi mtundu wodalirika ndikulola kuti ntchito ifane ndi misika ina ya Asean.
Yankho: Utumiki waku Indonesia umakhala ndi chidwi chokhazikitsa mtundu wokhulupirira ndipo akufuna kugwirizanitsa ndi a Cateapore a Sukulu ya Indiapore (HSA) of Singapore ndi oyang'anira Australia. Gawolo lidakali utali, ngakhale kudalirika kukuyembekezeka chaka chamawa. Pomaliza, Indonesia amasangalala kuphunzira ndi kutenga nawo mbali mokhulupirika ndipo akuyembekezera kugwira ntchito yotsatira ntchitoyi.
Q: Ponena za malamulo a Halal (malamulo a Halal), zinthu zopangidwa ndi zida zosakhala za Halal zikufunika kuwonetsa chidziwitso choyenera pazolemba zomwe zisanathe kutumizidwa ndikugawidwa ku Indonesia. Kodi pali malangizo oti mudziwe ngati katundu wathu ndi Halal kapena Solal?
A: Zokambirana pakupereka malangizo olemba polemba 2024 akupitirirabe. Tikugwirabe ntchito momveka bwino momveka bwino, kuyesera kuti musankhe njira yoyambayo. Unduna wa zaumoyo waku Indonesia amalandila malingaliro panjira yabwino kwambiri yokulitsa malangizo.
Q: Kodi boma la boma lili ndi chiani pomwe malonda / malonda omwe amapangidwa ndi komweko amafikira kuchuluka kwa zomwe akufuna? (Zinkatchulidwa pamwambapa kuti chinthu ichi chidzaundana mu e-catalog, chotsatira chotsatira?)
A: Zogulitsa zokha zomwe zimapangidwa ndi zomwe zimapanga kwanu zimaloledwa kulowa pamsika wapamtunda. Ndondomeko iyi ipitilira mpaka chaka chamawa ndipo mutha kusintha zisankho 2024. Tipitiliza kuwunika ziyembekezo za chida chazidachiriki.
Q: Ndikufuna kudziwa ngati zipatala zapadera zithandiza kuti pulogalamuyi ilimbikitse kugwiritsa ntchito zinthu zakumaloko (P3Dn)? Ngati ndi choncho, kodi nthawi yomwe nthawi ikuyembekezeredwa ndi iti? Kodi izi zikutanthauza kuti zipatala zapamwamba zimatha kugula zinthu zakomweko?
Yankho: Palibe pulogalamu inayake pamsika wachinsinsi ndi zipatala panthawiyi. Chifukwa chake, muli ndi ufulu kutenga nawo mbali pakugulitsa kwaulere ndi kugula. Kugwiritsa ntchito misika yachinsinsi pogulitsa ndikugula.
Q: Kodi Indonesia akuchita chiyani?
A: Tinaphatikiza malamulo autumiki ochita malonda komanso utumiki wa mafakitale omwe amaletsa katundu wopangidwanso kuti alowe pamsika waku Indonesia. Malamulowa adakwaniritsidwa poyankha zovuta zomwe Indonesia adakumana nawo m'mbuyomu pomwe katundu wokonzanso adalowa pamsika. Cholinga cha mauthengawa ndikupewa kuchuluka kwa katundu wokonzanso kwambiri. Tidzayang'ana kupezeka kwa zinthu ndipo tidzatsimikizira nthawi zonse.
Q: Pakadali pano utumiki waku Indonesia wa gulu lazaumoyo umakhazikitsidwa pa zida za chida, monga mawonekedwe osiyanasiyana (kumanzere kwa Catheter, Catheter kumanja), zomwe zingafunike kulembetsa kwamayisensi angapo. Kodi ntchito yathanzi ili ndi mapulani ena osintha gulu lotengera chida cha Asean Chipatala cha Asean)?
Yankho: Mutha kuwona chikalata chowongolera patsamba la patsamba la patsamba la Indonesia. Zipangizo zachipatala zitha kugawidwa m'njira zosiyanasiyana monga banja, kachitidwe ndi gulu. Palibe mtengo wowonjezera wolembetsa ndi gulu kapena payekha.
Q: Kodi pali cholinga chogwiritsa ntchito gulu lomwelo la matenda omwe amapezeka mu matenda a Vitro (IVD)?
A: Zinthu za IVD zimapezeka m'magulu otsekeka ndi otseguka. Pali zambiri zomwe zikupezeka mu chikalata chotsogolera ku Indonesia chazauzimu Webssite. Magulu azogulitsa IVD amatsatira mawonekedwe ofanana ndi a Amd. Zokambirana zikugwirizanabe momwe mungagwiritsire ntchito gulu lomwe lili ndi pulogalamu ya e-catalog.
Q: Kodi zinthu zopanda pake zimatengera zinthu zomwe zili ndi zida zanyama koma kodi sizikuyenera kutsimikizika, kapena zimangotanthauza zinthu zomwe sizili ndi zida za nyama?
Yankho: Zogulitsa zomwe sizinthu zanyama sizimafunikira kutsimikizika kwa Halal. Zogulitsa zokha zomwe zimakhala ndi zinyama zimafunikira. Ngati malondawo satsatira dongosolo la chitsimikizo cha Halal, kulemba zoyenera kumafunikira.
Q: Kodi padzakhala malangizo osiyana ndi zinthu za IVD pankhani ya malamulo a Halal?
Yankho: Malangizo apano amagwira ntchito ku zida zamankhwala zopangidwa ndi nyama. Komabe, poganizira kuti ma IVD amalumikizana mwachindunji ndi thupi la wodwalayo, ndizotheka kuti malangizowo azikhala olunjika nawo. Komabe, sipanatenge zokambirana pa malangizo a IVD panthawiyi.
Q: Chimachitika ndi chiani ngati chogulitsa cha DASPE cha Class ndichachikulire kuposa nthawi yomwe zimatenga kuti zitsimikizidwe kuti kutsimikizika kwa Hala) koma kumachokera ku nyama?
Yankho: Uwu ndi mkhalidwe womwe cholinga chowonjezera chingafunikire kukwaniritsidwa. Pano tikukambirana pakadali pano pokambirana kuti tidziwe mtundu womwe walembedwa. Cholinga chathu ndikuwonetsetsa kuti malamulowo ndi oyenera kuti atsimikizire chitetezo chodzitchinjiriza ndi kupewa kapena kuposerapo. Ndikofunikira kudziwa kuti izi sizoletsedwa pazopanga zomwe zimalowa pamsika waku Indonesia, zokhazo zomwe zimafunikira zimafunikira kuti zilowe mumsika.
Q: Kusintha kwa kapangidwe kazinthu kapena kusintha kwa malonda kumachitika pambuyo kuvomereza kwa mankhwala, zomwe zilipo ndikusinthanso ntchito. Kodi ndizotheka kusintha njira kapena njira zina zopewera kugawa?
Yankho: Ngati kusintha kumaphatikizapo kulembera ndi kuyika, njira yosinthira kusintha ndikotheka. Njira yosinthira imaloledwa ngati ingatsimikizidwe kuti kusintha sikungakhudze chitetezo, chabwino, kapena luso la malonda.
Post Nthawi: Jul-282023