Kudliwanondlebe lwakutsha nje noCindy Pelou, intloko yeKomiti eNcedisayo ye-DEACED kwiMicimbi yoLawulo, Mnu. Kwi-Indonesia yeSixhobo seCosystem.
A: Ngexesha lokudibana, idilesi yakudala inokutshintshwa okoko iNkampani ivela kwi-inxulumene nesatifikethi kwaye inokubonisa ukuba i-Labals ye-adhed) ayichaphazeli ukhuseleko, umgangatho kunye nokusebenza kwezonyango isixhobo.
Q: Leliphi iSebe lezeMpilo le-Indonesia lezempilo ngoku liphonononge iSeli yoNyango loNyango?
A: Iiseli zonyango kunye nemveliso yemfuza ziphononongwa nguLawulo lweNdawo ye-Indonesia kunye noLawulo lweZiyobisi (i-BPOm) kunye neCandelo ngokubanzi lamachiza kunye nezinto zonyango.
Q: Iinkampani ezifuna ukubhalisa iimveliso zabo, yintoni ilungelo lokuhlelwa komngcipheko osetyenziswayo kwizixhobo zonyango? Leliphi ixesha elilindelekileyo lemvume yokuvunywa?
A: Uvandlakanyo lolo lwazi luxanduva lwe-FDA Indonesia (bpom).
Q: Ngaba unokutshintsha iilebheli ezincinci (umz. Utshintsho lwe-Sysul / Gala yoMbala) Iphunyezwe ngeSaziso?
A: Okwangoku, utshintsho luvunyelwe ukuba liyasebenza kuzo zonke iimveliso okanye uninzi lweemveliso. Nangona kunjalo, ukuba iyasebenza kwimveliso enye okanye ezimbini, isaziso sokutshintsha siyadingeka.
Q: Phakathi kwe-Meyi nangeAgasti 2021, sasinengxoxo nenkonzo yempilo (moh) ngokubhekisele kwileta evela kwi-Gakeslab enezindululo zeRoo (Uphando kuphela) ubhaliso kwi-Indonesia. Enye yeengcebiso yayikukuxolelwa okanye ukwenziwa lula ukubhaliswa kwe-RO (intengiso yangaphambi kwentengiso) kwi-Indonesia. Ukuxolelwa kunye nokwenza ubhaliso lwe-RO lwe-ROO luya kunceda ukukhuthaza imeko yophando kunye nenkxaso iIndonesia ekuguquleni intsika yayo yempilo. Njengoko siqhubeka nokuxhasa imeko yophando eIndonesia, ngaba singakwazi ukulandela ubulungiseleli bempilo kwi ruo?
A: Icandelo loMphathiswa Wezempilo lixoxe kwi-ROO kwaye lafumana ulwazi oluvela kwindlela elawulwa ngayo nguMgunyazisi weSayensi yezeMpilo (HSA) eSingapore. Sifundile ukuba i-HSA ayilawule i-ROS kodwa isebenzisa iOfisi yoLawulo yePosi eyomeleleyo yasemva kwentengiso. Kukho izohlwayo ezinzima ukuba iimveliso ze-ROO zisetyenziselwa unyango. Nangona kunjalo, ngenxa yemakethi enkulu yaseIndonesia enenani elikhulu leelebhu, asiyi kukwazi ukwamkela le modeli. I-Indonesia okwangoku isebenza ngokuqinisa ummiselo kwaye sivulelekile kwiingxoxo kunye nabenziweyo kunye nabanye ababandakanyekayo ukubonelela ngezona ndlela zilungileyo.
Q: Ngaba i-Indonesia ivumela iilebheli emva kokungenisa elizweni? .
A: Ukuvelela kuvunyelwe emva kokuqinisekiswa kunye nesiqinisekiso sokuba akukho mpembelelo kumgangatho kunye nokhuseleko lwemveliso.
Q: Zithini iingozi zokungenisa iimpahla ngeelebheli ezixubileyo? Umzekelo, ileyibhile yebhokisi inegama lenkampani entsha kodwa ngaphakathi, i-IFU (imiyalelo yokusetyenziswa kwezixhobo zonyango) inegama lenkampani endala. Ngaba inkonzo yase-Indonesia ivumela ixesha lotshintsho ukuze utshintsho kwiilebheli / ukuba alujongwa njengemfuneko yokunyanzelwa?
A: Ukuba kukho ukungangqinelani phakathi kwe-IFu kunye neelebheli, kuyakwenzeka njengoko kubaluleke kakhulu ukugcina ukungangqinelani. Nangona amanye amaxesha athile-emadongwe anikezelwa, izibheno kunye nokuqwalaselwa kwempembelelo kuluntu kufuneka kusafuneka. Kucetyiswa ke ukuqinisekisa ukuba zonke iimveliso ezindala zingenisiwe ngaphambi kokuba zingenise uhlaziyo ukuthintela ukungenisa elizweni kunye nokuqinisekisa utshintsho olugudileyo. Kuxhomekeka kwimeko yesimo, unokukwazi ukubandakanyeka kwimveliso usebenzisa ugunyaziso oluchanekileyo.
Q: Ifakiwe ikhuthaza inkqubo yeTrasti elawulayo, ithini iMbusebenzi yeIndonesia yeMpilo yeZempilo kule nkqubo? Njengoko umgaqo-nkqubo wangoku kukuvelisa iimveliso zasekhaya, i-Indonesia inokuxhamla kwimodeli yentembeko kwaye ivumele ukwanda kwemveliso kwezinye iimarike eziphambili zeAsean.
A: Icandelo loMphathiswa wezeMpilo le-Indonesia sinomdla kakhulu ekulawuleni imodeli yentembeko kwaye singathanda ukusebenzisana noGunyaziwe weSayensi yezeMpilo (HSA) yeSingamela kunye neGunya lezoNdwerha zoNyango (i-TGA) ye-Australia. Eli phulo lisesebusaneni, nangona ukuphunyezwa kulindeleke kunyaka olandelayo. Ukuqukumbela, i-Indonesia inomdla wokufunda nokuthatha inxaxheba kwimodeli yentembeko kwaye ijonge phambili ekusebenzeni nakwele projekthi.
Q: Malunga neMigaqo yeHalal (umthetho weHalal), iimveliso ezenziwe ngezinto ezingezizo zeHalal kufuneka zibonise ulwazi olufanelekileyo kwileyibhile ngaphambi kokuba zingeniswe kwi-Indonesia. Ngaba zikho izikhokelo zokufumanisa ukuba ngaba iimveliso zethu zihamba nge-halal okanye ezingeyo-halal?
A: Iingxoxo zokukhupha izikhokelo zelebheli ngo-2024 ziyaqhubeka. Sisasebenza ekuphuhliseni izikhokelo ezicacileyo, ukuzama ukungabi lula inkqubo yoqobo. Inkonzo yaseIndonesia yeZempilo yamkela iingcebiso malunga neyona ndlela yokuphuhlisa isikhokelo.
Q: Yintoni isicwangciso sikarhulumente xa imveliso eveliswe indawo / imveliso ifikelela kwipesenti efunekayo yomxholo wengingqi? (Kwakhankanywa apha ngasentla ukuba le mveliso iya kuba ngumkhenkce kwi-e-ikhathalogu, lithini inyathelo elilandelayo?)
A: Iimveliso ezineenkcukacha ezahlukeneyo ezivela kwezo ziveliswayo ziya kuvunyelwa ukuba zingene kwimakethi yabucala. Lo mgaqo-nkqubo uza kuqhubeka de kube unyaka olandelayo kwaye unokutshintsha emva konyulo lwe-2024. Siza kuqhubeka nokubeka esweni amathemba e-COSTE yecandelo lezonyango.
Q: Ndingathanda ukwazi ukuba izibhedlele zabucala ziya kuphumeza le nkqubo ukukhuthaza ukusetyenziswa kweemveliso zalapha ekhaya (P3DN)? Ukuba kunjalo, ngubani ixesha elilindelekileyo? Ngaba oku kuthetha ukuba izibhedlele zabucala ziya kuba nakho ukuthenga iimveliso zalapha ekhaya?
A: Akukho nkqubo ikhethekileyo yentengiso yabucala kunye nezibhedlele ngeli xesha. Ke ngoko, ukhululekile ukuba uthathe inxaxheba kwintengiso yabucala yentengiso kunye nokuthenga. Sebenzisa iimarike zabucala zokurhweba nokuthenga.
Q: I-Indonesia ibamba njani izixhobo zonyango ezihlaziyiweyo?
A: Sibandakanya ukulawulwa kobulungiseleli borhwebo kunye nobulungiseleli bemveliso ekwalela iimpahla ezihlaziyiweyo ukuba zingangeni kwimakethi yaseIndonesia. Lo mmiselo wenziwa ukuphendula ngemiceli mngeni kwi-Indonesia edlulileyo kwixesha elidlulileyo xa iimpahla ezihlaziyiweyo zifakwe kwimakethi. Injongo yale migaqo kukuthintela i-influx yempahla ehlaziyiweyo kwizixa ezikhulu. Siza kubeka phambili ukufumaneka kwemveliso kwaye soloko kuqinisekisa umgangatho oguqukayo.
Q: Okwangoku i-Indonesia yeCandelo le-Indonesia yoqulunqo lisekwe kwinkcazo yezixhobo, ezinje ngemilo eyahlukeneyo (i-catheter yasekhohlo, i-catheter elungileyo), eyayifuna ukubhaliswa kweelayisensi ezininzi. Ngaba ubulungiseleli bezempilo banezicwangciso zokulungisa ukulungisa iqela ngokusekwe kumyalelo wesixhobo se-ASEAN)?
A: Ungalujonga uxwebhu lwezikhokelo kwiqela kwiwebhusayithi ye-Indonesia. Izixhobo zonyango zinokuhlelwahlulwahlulwahlulwahlulwahluka okwahlukeneyo ezinjengentsapho, inkqubo kunye neqela. Akukho ntlawulo yongezelelo yobhaliso liqela okanye imveliso yomntu ngamnye.
Q: Ngaba ikhona injongo yokusebenzisa iqela elifanayo le-VITROOstic TOUTIT (IVD)?
A: Iimveliso ze-IVD zihlelwe kwiinkqubo ezivaliweyo nezivulekileyo. Zininzi iinkcukacha ezifumanekayo kuxwebhu lweSikhokelo ezifumaneka kwi-Indonesia yewebhusayithi ye-Indonesia yewebhusayithi yezeMpilo. Iingxoxo zisaqhutywa ngendlela yokulungelelanisa iqela kunye ne-e-catalogi ye-e-catalogi.
Q: Ngaba iimveliso ezingezizo i-HALAL zibhekisa kwiimveliso eziqukethe izixhobo zemvelaphi yesilwanyana kodwa azingqinwa i-halal, okanye ngaba zibhekisa kwiimveliso ezingabinazo naziphi na izixhobo zemvelaphi yesilwanyana?
A: Iimveliso zemvelaphi engeyiyo yezilwanyana azifuni ukuqinisekiswa kweHalal. Iimveliso kuphela ezinemvelaphi yezilwanyana ziyafuneka. Ukuba imveliso ayihambelani nenkqubo yokuqinisekiswa kweHalal, ilebheli efanelekileyo iyafuneka.
Q: Ngaba kuya kubakho izikhokelo ezahlukeneyo zemveliso ye-IVD ngokwemigaqo yeHalal?
A: Izikhokelo ezikhoyo ngoku zisebenza kuphela kwiimveliso zezonyango ezivela kwizilwanyana. Nangona kunjalo, ukujonga ukuba ii-IVD zingena ekunxibelelaneni ngqo nomzimba wesigulana, kunokwenzeka ukuba izikhokelo ezahlukeneyo ziya kuphuhliswa kuzo. Nangona kunjalo, akukho ngxoxo kwiZikhokelo ze-IVD ngeli xesha.
Q: Kwenzeka ntoni ukuba imveliso yokutya yeklasi indala kunexesha elithathayo ukufumana isiqinisekiso seHalal kodwa sivela kwisilwanyana?
A: Le yimeko apho iimfuno ezongezelelweyo zokwenza iilebheli ziya kufuneka zifezekiswe. Okwangoku sizingxoxo ukumisela uhlobo oluthile lweelebheli ezifunekayo. Injongo yethu kukuqinisekisa ukuba imigaqo efanelekileyo kwaye ilungelelene ekuqinisekiseni ukhuseleko lwezigulana kwaye uphephe phantsi okanye ukwenzela umsebenzi. Kubalulekile ukuba uqaphele ukuba oku asisivalo kwiimveliso ezingena kwimarike yaseIndonesia, kuphela ukuba iilebheli ziyafuneka ukuba zingene kwintengiso.
Q: Xa utshintsho lotshintsho okanye utshintsho lwemveliso lwenzeka emva kokuvunywa kwemveliso, inkqubo yangoku kukuhambisa kwakhona isicelo. Ngaba kunokwenzeka ukuba uguqule inkqubo okanye amanye amanyathelo ukuthintela ukuyeka ukutshatyalaliswa?
A: Ukuba utshintsho lubandakanya iilebheli kunye nokupakisha, inkqubo yokutshintsha kwenguqu inokwenzeka. Inkqubo yokuhlengahlengiswa kotshintsho ivunyelwe ukuba inokuqinisekiswa ukuba utshintsho aluyi kuchaphazela ukhuseleko, umgangatho, okanye ukusebenza kwemveliso.
I-Post Ixesha: IJUL-28-2023