Kudliwano-ndlebe lwakutsha nje kunye noCindy Pelou, iNtloko ye-APACMed Secretariat yeKomiti yezoBulungisa kwiMicimbi yoLawulo, uMnu. Pak Fikriansyah ovela kwi-Indonesian Ministry of Health (MOH) uchaze amanyathelo amva nje yi-MOH ekulawuleni izixhobo zonyango e-Indonesia kwaye wanikela iingcebiso ezithile. yesixhobo sonyango sase-Indonesia.
A: Ngexesha lenkqubo yokuthumela kwakhona, idilesi endala inokutshintshwa nje kuphela ukuba inkampani eyenza ukuphinda ibhalwe kwakhona inesatifikethi esisemgangathweni kwaye ingabonisa ukuba ukuphinda kubhalwe kwakhona (ngokuqhelekileyo iilebhile zokuzincamathela) akuchaphazeli ukhuseleko, umgangatho kunye nokusebenza kwezonyango. isixhobo.
UMBUZO: Leliphi isebe loMphathiswa wezeMpilo wase-Indonesia ngoku eliphonononga ukubhaliswa kweeseli kunye nonyango lwemfuza?
A: Iimveliso zonyango lweeseli kunye nofuzo zihlaziywa yi-Indonesian Food and Drug Administration (BPOM) kunye neCandelo loLawulo lweZiyobisi kunye neMpatho yezoNyango.
Umbuzo: Kwiinkampani ezifuna ukubhalisa iimveliso zazo, loluphi ulwahlulo lomngcipheko olusebenzayo kwizixhobo zonyango?Lithini ixesha elilindelekileyo lokwamkelwa kobhaliso?
A: Ukuphononongwa kolu lwazi luxanduva lwe-FDA Indonesia (BPOM).
Umbuzo: Ngaba utshintsho olungephi lwelebhile (umzekelo, utshintsho lwesimboli/ukutshintsha kombala) lunokuphunyezwa ngesaziso?
A: Okwangoku, utshintsho luvumelekile ukuba lusebenza kuzo zonke okanye kwiimveliso ezininzi.Nangona kunjalo, ukuba isebenza kwimveliso enye okanye ezimbini kuphela, isaziso sotshintsho siyafuneka.
Umbuzo: Phakathi kukaMeyi no-Agasti ka-2021, saba neengxoxo kunye noMphathiswa wezeMpilo (i-MOH) malunga neleta evela e-Gakeslab equlethe iziphakamiso ze-RUO (ukusetyenziswa kophando kuphela) e-Indonesia.Enye yeengcebiso yayikukukhulula okanye ukwenza lula ukubhaliswa kwe-RUO (ngaphambi kokuthengisa kunye ne-post-market) e-Indonesia.Ukukhululwa kunye nokwenza lula ukubhaliswa kwe-RUO kuya kunceda ukukhuthaza indawo yophando kunye nokuxhasa i-Indonesia ekuguquleni intsika yayo yezempilo.Njengoko siqhubeka nokuxhasa indawo yophando e-Indonesia, ngaba sinokulandela uMphathiswa wezeMpilo kwi-RUO?
A: UMphathiswa wezeMpilo wase-Indonesia uxoxe nge-RUO kwaye wafumana ukuqonda kwindlela elawulwa ngayo yi-Health Sciences Authority (HSA) eSingapore.Sifunde ukuba i-HSA ayilawuli i-RUOs kodwa isebenzisa ulawulo oluluqilima lwasemva kokuthengisa.Kukho izigwebo ezinzima ukuba iimveliso ze-RUO zisetyenziselwa unyango.Nangona kunjalo, ngenxa yemarike enkulu yase-Indonesia enenani elikhulu leebhubhoratri, asiyi kukwazi ukwamkela le modeli.I-Indonesia ngoku isebenza ukuqinisa ummiselo kwaye sivulelekile kwiingxoxo kunye ne-APCMed kunye nabanye abachaphazelekayo ukubonelela ngezona ndlela zilungileyo.
Umbuzo: Ngaba i-Indonesia iyakuvumela ukuleyibhelishwa emva kokungenisa elizweni?(umzekelo, emva kwethenda karhulumente yokukhutshwa kwempahla okanye ukutshintshwa kweelebhile)
A: Ukubhaliswa kwakhona kuvunyelwe emva kokuqinisekiswa kunye nokuqinisekiswa ukuba akukho mpembelelo kumgangatho kunye nokhuseleko lwemveliso.
Umbuzo: Yeyiphi imingcipheko yokungenisa iimpahla ezineeleyibhile ezixutyiweyo?Ngokomzekelo, ibhokisi yebhokisi inegama elitsha lenkampani kodwa ngaphakathi, i-IFU (imiyalelo yokusetyenziswa kwezixhobo zonyango) isenalo igama lenkampani endala.Ngaba i-Ofisi yoMphathiswa wezeMpilo wase-Indonesian ivumela ixesha lenguqu ukwenzela ukuba utshintsho kwi-label / IFU ingaqwalaselwa njengemfuneko yokuyeka ukunyanzeliswa?
IMPENDULO: Ukuba kukho ukungangqinelani phakathi kwe-IFU kunye nokuleyibhelishwa, kuya kwenzeka ukuba yaliwe njengoko kubalulekile ukugcina ukungaguquguquki.Nangona amanye amaxesha eemeko zobabalo anikezelweyo, izibheno kunye nokuqwalaselwa kwempembelelo kuluntu kusafuneka.Ngoko ke kucetyiswa kakhulu ukuba kuqinisekiswe ukuba zonke iimveliso ezibhalwe phantsi zithengiswe ngaphandle ngaphambi kokuba kungeniswe ukuhlaziywa ukuze kuthintelwe ukungeniswa kwakhona kunye nokuqinisekisa utshintsho olululo.Ngokuxhomekeke kwimeko, usenokukwazi ukulebhelisha kwakhona imveliso usebenzisa ugunyaziso oluchanekileyo.
Umbuzo: I-APACMed ikhuthaza inkqubo yokuthembela yokulawula, yintoni imbono yoMphathiswa wezeMpilo wase-Indonesia kule nkqubo?Njengoko umgaqo-nkqubo wangoku ukuvelisa iimveliso ezininzi zasekhaya, i-Indonesia inokuzuza kwimodeli yokuthembela kwaye ivumele ukwandiswa kwemveliso kwezinye iimarike eziphambili ze-ASEAN.
A: UMphathiswa wezeMpilo wase-Indonesia unomdla kakhulu ekulawuleni imodeli yokuthembela kwaye ungathanda ukusebenzisana ne-Health Sciences Authority (HSA) yaseSingapore kunye neGunya lezoNyango lwezoNyango (TGA) lwase-Australia.Eli phulo lisaqala, nangona kulindeleke ukuba liphunyezwe kunyaka ozayo.Ukuqukumbela, i-Indonesia iyavuya ukufunda kunye nokuthatha inxaxheba kwimodeli yokuthembela kwaye ijonge phambili ekusebenzeni ne-APACMed kule projekthi.
Umbuzo: Ngokumalunga nemigaqo yeHalal (uMthetho weHalal), iimveliso ezenziwe ngezinto ezingezizo i-halal kufuneka zibonise ulwazi olufanelekileyo kwileyibhile ngaphambi kokuba zingeniswe kwaye zihanjiswe e-Indonesia.Ngaba kukho izikhokelo zokumisela ukuba ngaba iimveliso zethu zi-halal okanye azikho-halal?
A: Iingxoxo malunga nokukhupha izikhokelo zokuleyibheli ngo-2024 ziyaqhubeka.Sisasebenza ekuphuhliseni izikhokelo ezicacileyo, sizama ukungayifaki nzima inkqubo yokuqala.UMphathiswa wezeMpilo wase-Indonesia wamkela iingcebiso ngeyona ndlela ingcono yokuphuhlisa izikhokelo.
Q: Sithini isicwangciso sikarhulumente xa imveliso/imveliso eveliswe apha ekhaya ifikelela kwipesenti efunekayo yomxholo wengingqi?(Kukhankanywe ngasentla ukuba le mveliso iya kukhenkcezwa kwikhathalogu ye-e-khathalogu, yintoni inyathelo elilandelayo?)
IMPENDULO: Kuphela ziimveliso ezinenkcazelo eyahlukileyo kwezo ziveliswe ekuhlaleni eziya kuvunyelwa ukuba zingene kwimarike yabucala.Lo mgaqo-nkqubo uya kuqhubeka kude kube ngunyaka ozayo kwaye unokutshintsha emva konyulo luka-2024.Siza kuqhubeka ukubeka esweni amathuba ecandelo lezixhobo zonyango.
Umbuzo: Ndingathanda ukwazi ukuba izibhedlele zabucala ziya kuphumeza iNkqubo yokuKhuthaza ukuSetyenziswa okwandisiweyo kweeMveliso zeNdawo (P3DN)?Ukuba kunjalo, leliphi ixesha elilindelekileyo?Ngaba oku kuthetha ukuba izibhedlele zabucala ziya kukwazi ukuthenga iimveliso zalapha ekhaya kuphela?
A: Akukho nkqubo ikhethekileyo yemarike yabucala kunye nezibhedlele ngeli xesha.Ke ngoko, ukhululekile ukuthatha inxaxheba kurhwebo lwabucala kunye nokuthenga.Ukusebenzisa iimarike zabucala ukurhweba kunye nokuthenga.
Umbuzo: I-Indonesia iziphatha njani izixhobo zonyango ezihlaziyiweyo?
IMPENDULO: Sibandakanya ummiselo weSebe lezoRhwebo kunye neSebe lezoShishino elithintela iimpahla ezihlaziyiweyo ukuba zingene kwimarike yase-Indonesia.Lo mmiselo waphunyezwa ekuphenduleni imingeni e-Indonesia ejongene nayo kwixesha elidlulileyo xa kuphela iimpahla ezihlaziyiweyo zangena kwimarike.Injongo yale mimiselo kukuthintela ukungena kwempahla ehlaziyiweyo ngobuninzi.Siza kubeka phambili ukufumaneka kwemveliso kwaye sihlala siqinisekisa umgangatho ongaguqukiyo.
Q: Okwangoku iqela lohlelo loMphathiswa wezeMpilo wase-Indonesia lisekelwe kwiinkcukacha zesixhobo, ezifana neemilo ezohlukeneyo (icatheter yasekhohlo, i-catheter yasekunene), enokufuna ukubhaliswa kweelayisensi ezininzi.Ngaba uMphathiswa wezeMpilo unazo naziphi na izicwangciso zokulungelelanisa iqela ngokusekelwe kwi-ASEAN Medical Device Directive (AMDD)?
A: Ungajonga uxwebhu lwesikhokelo ngokuhlanganisana kwiwebhusayithi yaseIndonesia.Izixhobo zonyango zinokuhlelwa ngokweendidi ezahlukeneyo ezifana nosapho, inkqubo kunye neqela.Akukho ntlawulo eyongezelelweyo yokubhalisa liqela okanye imveliso yomntu.
Umbuzo: Ngaba kukho injongo yokufaka iqela elifanayo kwiimveliso zokuxilongwa kwe-in vitro (IVD)?
A: Iimveliso ze-IVD zihlelwe kwiinkqubo ezivaliweyo nezivulekileyo.Kukho iinkcukacha ezingakumbi ezifumanekayo kuxwebhu lwesikhokelo olufumanekayo kwiwebhusayithi yoMphathiswa wezeMpilo wase-Indonesia.Ukuhlelwa kweemveliso ze-IVD kulandela ipateni efanayo naleyo ye-AMDD.Iingxoxo zisaqhuba malunga nendlela yokulungelelanisa amaqela kunye nenkqubo ye-e-khathalogu.
Umbuzo: Ngaba iimveliso ezingezizo i-halal zibhekisa kwiimveliso ezinemathiriyeli yemvelaphi yezilwanyana kodwa ezingaqinisekiswanga yi-halal, okanye zibhekisa kwiimveliso ezingenazo naziphi na izixhobo zemvelaphi yezilwanyana?
A: Iimveliso zemvelaphi engeyiyo eyezilwanyana azifuni isatifikethi seHalal.Kufuneka kuphela iimveliso ezinemvelaphi yezilwanyana.Ukuba imveliso ayihambelani nenkqubo yesiqinisekiso seHalal, ilebhile efanelekileyo iyafuneka.
Umbuzo: Ngaba kuya kubakho izikhokelo ezahlukeneyo zeemveliso ze-IVD ngokwemigaqo ye-halal?
A: Izikhokelo zangoku zisebenza kuphela kwiimveliso zezixhobo zonyango ezivela kwizilwanyana.Noko ke, xa kucingwa ukuba ii-IVD zidibana ngokuthe ngqo nomzimba wesigulana, kunokwenzeka ukuba kuphuhliswe izikhokelo ezahlukeneyo kubo.Nangona kunjalo, akukho ngxoxo malunga nezikhokelo ze-IVD ngeli xesha.
Q: Kwenzeka ntoni ukuba imveliso yokutya yodidi D indala kunexesha elithathwayo ukufumana isiqinisekiso se-halal kodwa iphuma kwisilwanyana?
A: Le yimeko apho iimfuno zokuleyibhela ezongezelelweyo kuya kufuneka kuhlangatyezwane nazo.Ngoku sikwiingxoxo zokumisela uhlobo oluthile lophawu olufunekayo.Injongo yethu kukuqinisekisa ukuba imimiselo ifanelekile kwaye ilungelelene ukuqinisekisa ukhuseleko lwesigulane kunye nokuphepha ngaphantsi okanye ngaphezulu kokulawulwa.Kubalulekile ukuba uqaphele ukuba oku akusiyo isithintelo kwiimveliso ezingena kwimarike yase-Indonesian, kuphela ukuba ileyibhile iyafuneka ukungena kwimarike.
Q: Xa utshintsho loyilo okanye utshintsho lwemveliso lwenzeka emva kokuvunywa kwemveliso, isenzo sangoku kukubuyisela isicelo.Ngaba kunokwenzeka ukuguqula inkqubo okanye amanye amanyathelo okuthintela ukungeniswa kwakhona?
A: Ukuba utshintsho lubandakanya iilebhile kunye nokupakishwa, inkqubo yokuguqulwa kwenguqu inokwenzeka.Inkqubo yokuguqulwa kwenguqu ivunyelwe ukuba inokuqinisekiswa ukuba utshintsho aluyi kuchaphazela ukhuseleko, umgangatho, okanye ukusebenza kwemveliso.
Ixesha lokuposa: Jul-28-2023