Ndondomeko Zoyang'anira Zida Zamankhwala ku Indonesia

Poyankhulana posachedwa ndi Cindy Pelou, Mtsogoleri wa Komiti Yapadera ya APACMed Secretariat on Regulatory Affairs, Bambo Pak Fikriansyah wochokera ku Unduna wa Zaumoyo ku Indonesia (MOH) adalongosola zomwe zachitika posachedwa ndi MOH pakuwongolera zida zamankhwala ku Indonesia ndipo adapereka malingaliro ena. za zida zamankhwala zaku Indonesia.

A: Panthawi yolemberanso, adilesi yakale imatha kusinthidwa bola ngati kampani yomwe ikulembanso ili ndi satifiketi yokhazikika ndipo imatha kuwonetsa kuti kulembanso (nthawi zambiri zilembo zodzimatira) sikukhudza chitetezo, mtundu ndi magwiridwe antchito achipatala. chipangizo.
Q: Ndi dipatimenti iti ya Unduna wa Zaumoyo ku Indonesia pano yomwe ikuwunikanso kalembera wa ma cell ndi majini?

A: Ma cell and gene therapy mankhwala amawunikiridwa ndi Indonesian Food and Drug Administration (BPOM) ndi Directorate General of Drug and Medical Equipment.
Q: Kwa makampani omwe akuyenera kulembetsa malonda awo, ndi magulu ati omwe ali pachiwopsezo pazida zamankhwala?Kodi nthawi yovomerezeka yolembetsa ndi yotani?

A: Kuwunikiridwa kwa chidziwitsochi ndi udindo wa FDA Indonesia (BPOM).
Q: Kodi zosintha zazing'ono zamalebulo (mwachitsanzo kusintha kwa chizindikiro/kusintha mtundu) zitha kukhazikitsidwa ndi chidziwitso?

A: Pakadali pano, kusintha kumaloledwa ngati kukhudza zonse kapena zambiri.Komabe, ngati ikugwira ntchito pa chinthu chimodzi kapena ziwiri zokha, chidziwitso chosintha chimafunika.
Q: Pakati pa Meyi ndi Ogasiti 2021, tidakambirana ndi Unduna wa Zaumoyo (MOH) okhudza kalata yochokera ku Gakeslab yomwe ili ndi malingaliro olembetsa ku RUO (kafukufuku wokha) ku Indonesia.Chimodzi mwazolimbikitsa chinali kumasula kapena kuchepetsa kulembetsa kwa RUO (msika usanachitike komanso msika waposachedwa) ku Indonesia.Kumasula ndikuchepetsa kulembetsa kwa RUO kudzathandizira kulimbikitsa malo opangira kafukufuku ndikuthandizira Indonesia pakusintha mzati waumoyo.Pamene tikupitiriza kuthandizira malo ofufuzira ku Indonesia, kodi tingatsatire ndi Unduna wa Zaumoyo pa RUO?

A: Unduna wa Zaumoyo ku Indonesia wakambirana za RUO ndikupeza chidziwitso kuchokera momwe imayendetsedwa ndi Health Sciences Authority (HSA) ku Singapore.Tinaphunzira kuti HSA sikuyendetsa ma RUOs koma imagwiritsa ntchito maulamuliro amphamvu pambuyo pa malonda.Pali zilango zazikulu ngati mankhwala a RUO amagwiritsidwa ntchito pochiza.Komabe, chifukwa cha msika waukulu waku Indonesia wokhala ndi ma laboratories ambiri, sitingathe kutengera chitsanzo ichi.Indonesia pakali pano ikuyesetsa kukhwimitsa malamulo ndipo tili okonzeka kukambirana ndi APACMed ndi ena omwe akuchita nawo gawo kuti apereke njira zabwino kwambiri.
Q: Kodi Indonesia imalola kulemba zilembo pambuyo potumiza kunja?(monga chiphaso cha boma cha chilolezo cha kasitomu kapena kusintha zilembo)

A: Kulembetsanso kumaloledwa pambuyo pa chiphaso ndi chitsimikizo kuti palibe chokhudza ubwino ndi chitetezo cha mankhwala.
Q: Kuopsa kotenga katundu kuchokera kunja komwe kuli ndi zilembo zosakanikirana ndi chiyani?Mwachitsanzo, bokosi la bokosi lili ndi dzina la kampani yatsopano koma mkati, IFU (malangizo ogwiritsira ntchito zipangizo zamankhwala) akadali ndi dzina la kampani yakale.Kodi Unduna wa Zaumoyo ku Indonesia umalola kuti pakhale nthawi yosinthira kuti kusintha kwa zilembo/IFU kusaganiziridwe kuti ndikofunikira kusiya?

Yankho: Ngati pali kusiyana pakati pa IFU ndi zolembera, zikhoza kukanidwa chifukwa ndizofunikira kusunga kusasinthasintha.Ngakhale kuti nthawi zina zachisomo zimaperekedwa, madandaulo ndi kulingalira za momwe anthu ammudzi akukhudzidwira.Choncho tikulimbikitsidwa kuonetsetsa kuti zinthu zonse zakale zolembedwa zatumizidwa kunja musanatumize zosintha kuti muteteze kuitanitsanso ndikuonetsetsa kuti kusintha kwasintha.Kutengera ndi momwe zinthu ziliri, mutha kuyimbanso chinthucho pogwiritsa ntchito chilolezo cholondola.
Q: APACMed ikulimbikitsa ndondomeko yodalirika, kodi Unduna wa Zaumoyo ku Indonesia uli ndi maganizo otani pa pulogalamuyi?Monga momwe ndondomeko yapano ndikupangira zinthu zambiri zakomweko, Indonesia ikhoza kupindula ndi chitsanzo chodalirika ndikulola kukulitsa kwazinthu kumisika ina yofunika kwambiri ya ASEAN.

A: Unduna wa Zaumoyo ku Indonesia uli wofunitsitsa kuwongolera njira yodalirika ndipo ikufuna kugwirizana ndi Health Sciences Authority (HSA) yaku Singapore ndi Medical Supplies Authority (TGA) yaku Australia.Ntchitoyi idakali yoyambira, ngakhale kuti ikuyembekezeredwa chaka chamawa.Pomaliza, Indonesia ndi yokondwa kuphunzira ndi kutenga nawo gawo mu chitsanzo chodalirika ndipo ikuyembekeza kugwira ntchito ndi APACMed pa ntchitoyi.
Q: Pankhani ya malamulo a Halal (Lamulo la Halal), zinthu zopangidwa kuchokera ku zinthu zomwe si halal ziyenera kuwonetsa zofunikira palembazo zisanatumizidwe ndikugawidwa ku Indonesia.Kodi pali malangizo oti tidziwe ngati malonda athu ndi a halal kapena si a halal?

A: Zokambirana zopereka malangizo olembetsera pofika 2024 zikupitilira.Tikugwirabe ntchito yopanga malangizo omveka bwino, kuyesera kuti tisasokoneze ndondomeko yoyamba.Unduna wa Zaumoyo ku Indonesia ukulandira malingaliro a njira yabwino yopangira malangizowa.

Funso: Boma lili ndi dongosolo lanji ngati katundu/zinthu zomwe zapangidwa kunoko zafika pamlingo wofunikira wa zomwe zili m'deralo?(Zinanenedwa pamwambapa kuti mankhwalawa atsekedwa mu e-catalog, sitepe yotsatira ndi chiyani?)

Yankho: Ndizinthu zokhazo zomwe zimasiyana ndi zomwe zapangidwa kumaloko ndizomwe ziloledwa kulowa mumsika wachinsinsi.Ndondomekoyi ipitilira mpaka chaka chamawa ndipo zitha kusintha pambuyo pa zisankho za 2024.Tipitilizabe kuyang'anira zomwe zikuyembekezeka pagawo la zida zachipatala.
Q: Ndikufuna kudziwa ngati zipatala zapadera zidzakhazikitsa Pulogalamu Yolimbikitsa Kugwiritsa Ntchito Zogulitsa Zam'deralo (P3DN)?Ngati ndi choncho, ndi nthawi yotani yomwe ikuyembekezeka?Kodi izi zikutanthauza kuti zipatala zaboma zitha kugula zinthu zakumaloko?

A: Palibe ndondomeko yeniyeni ya msika wachinsinsi ndi zipatala panthawi ino.Chifukwa chake, ndinu omasuka kuchita nawo malonda amsika achinsinsi ndikugula.Kugwiritsa ntchito misika yabizinesi pochita malonda ndi kugula.
Q: Kodi Indonesia imayendetsa bwanji zida zamankhwala zokonzedwanso?

Yankho: Timaphatikiza malamulo a Unduna wa Zamalonda ndi Unduna wa Zamakampani omwe amaletsa katundu wokonzedwanso kulowa mumsika waku Indonesia.Lamuloli lidakhazikitsidwa poyankha zovuta zomwe dziko la Indonesia lidakumana nalo m'mbuyomu pomwe katundu wokonzedwanso adalowa pamsika.Cholinga cha malamulowa ndikuletsa kuchuluka kwa katundu wokonzedwanso mochuluka.Tidzayika patsogolo kupezeka kwazinthu ndikuonetsetsa kuti zinthu zili bwino nthawi zonse.
Q: Panopa gulu la Unduna wa Zaumoyo ku Indonesia likutengera zomwe zidalipo, monga mawonekedwe osiyanasiyana (katheta yakumanzere, katheta yakumanja), zomwe zingafune kulembetsa ziphaso zingapo.Kodi Unduna wa Zaumoyo uli ndi malingaliro osintha gulu potengera ASEAN Medical Device Directive (AMDD)?

A: Mutha kuwona chikalata chowongolera pakuyika magulu patsamba la Indonesia.Zida zamankhwala zitha kugawidwa m'magulu osiyanasiyana monga banja, dongosolo ndi gulu.Palibenso ndalama zowonjezera zolembetsa ndi gulu kapena chinthu chilichonse.
Q: Kodi pali cholinga chogwiritsa ntchito gulu lomwelo pazamankhwala a in vitro diagnostics (IVD)?

A: Zogulitsa za IVD zimagawidwa m'makina otsekedwa komanso otseguka.Pali zambiri zomwe zikupezeka m'chikalata chowongolera chomwe chili patsamba la Unduna wa Zaumoyo ku Indonesia.Kugawika kwazinthu za IVD kumatsata njira yofananira ndi AMDD.Zokambirana zikupitirirabe za momwe mungayanjanitsire gululo ndi dongosolo la e-catalog.
Q: Kodi zinthu zomwe si halal zimatanthawuza zinthu zomwe zimakhala ndi nyama koma zilibe satifiketi ya halal, kapena amalozera kuzinthu zomwe zilibe nyama?

Yankho: Zogulitsa zomwe sizinali zanyama sizifuna chiphaso cha Halal.Zinthu zomwe zili ndi nyama zokha ndizo zomwe zimafunikira.Ngati malondawo satsatira dongosolo la certification la Halal, zilembo zoyenera zimafunika.
Q: Kodi padzakhala zitsogozo zosiyana pazogulitsa za IVD malinga ndi malamulo a halal?

Yankho: Malangizo apanowa amagwira ntchito pazida zamankhwala zochokera ku nyama.Komabe, poganizira kuti ma IVD amalumikizana mwachindunji ndi thupi la wodwalayo, ndizotheka kuti pakhale malangizo apadera kwa iwo.Komabe, sipanakhalepo zokambirana pa malangizo a IVD panthawiyi.
Q: Kodi chimachitika ndi chiyani ngati chakudya cha Class D ndi chakale kuposa nthawi yomwe imatengera kuti munthu alandire satifiketi ya halal koma amachokera ku nyama?

A: Izi ndizochitika pomwe zofunikira zowonjezera zolembera ziyenera kukwaniritsidwa.Pakali pano tikukambirana kuti tidziwe mtundu wanji wa zilembo zofunika.Cholinga chathu ndikuwonetsetsa kuti malamulowa ndi oyenerera komanso oyenerera kuti atsimikizire chitetezo cha odwala komanso kupewa kuwongolera kapena kuwongolera.Ndikofunika kuzindikira kuti uku sikuletsedwa kwa zinthu zomwe zimalowa mumsika wa ku Indonesia, kokha kuti zilembo zimafunika kuti zilowe mumsika.
Q: Pamene kusintha kwapangidwe kapena kusintha kwazinthu kumachitika pambuyo povomerezedwa ndi chinthu, zomwe zikuchitika pano ndikutumizanso ntchitoyo.Kodi ndizotheka kusintha ndondomeko kapena njira zina kuti mupewe kutumizidwanso?

Yankho: Ngati kusinthaku kuphatikizira kulemba zilembo ndi kuyika, njira yosinthira ndiyotheka.Njira yosinthira kusintha imaloledwa ngati ingatsimikizidwe kuti kusinthako sikungakhudze chitetezo, ubwino, kapena mphamvu ya mankhwala.