Engxoxweni yakamuva noCindy Pelou, inhloko yeKomidi elikhethekile le-Ecterariat Secretariat ezindabeni zokulawula, uMnu Pak Fikriansyah kusukela uMnyango Wezempilo wase-Indonesia (Moh) uchaze imizamo yakamuva ye-MOH ekulawuleni amadivaysi ezokwelapha e-Indonesia futhi wanikela ngeziphakamiso ezithile ukuthola i-ecosystem yezokwelapha yase-Indonesia.
A: Ngesikhathi senqubo yokuhlelwa kabusha, ikheli lakudala lingathathelwa indawo inqobo nje uma inkampani eyenza ukuvumelanisa inesitifiketi esijwayelekile futhi ingakhombisa ukuthi amalebula okuhleleka (ikhwalithi nokusebenza kwezokwelapha idivaysi.
Q: Yimuphi uMnyango Wezempilo wase-Indonesia njengamanje ukubuyekezwa amaseli weseli kanye nokwelashwa kwe-gene?
A: Imikhiqizo yeseli ne-gene Therapy ibuyekezwa yi-Indonesia Food and Drug Administration (BPOM) kanye ne-Directorate Jikelele yezidakamizwa nezinto zokwelashwa.
Q: Izinkampani ezidinga ukubhalisa imikhiqizo yazo, yini ukuhlukaniswa kobungozi obukhona kwamadivayisi wezokwelapha? Yini umugqa wesikhathi olindelwe ukuvunyelwa ukubhaliswa?
A: Ukubuyekezwa kwalolu lwazi kungumsebenzi we-FDA Indonesia (BPOM).
Q: Ngabe izinguquko ezincane zokulebula (isib. Ukushintshwa kohlobo / ukuguqulwa kombala) kusetshenziswe ngesaziso?
A: Okwamanje, ushintsho luvunyelwe uma lusebenza kuyo yonke imikhiqizo noma iningi lemikhiqizo. Kodwa-ke, uma isebenza kwimikhiqizo eyodwa noma ezimbili kuphela, isaziso sokushintsha.
UMB: Phakathi kukaMeyi no-Agasti 2021, saba nezingxoxo noMnyango Wezempilo (Moh) maqondana nencwadi evela kwaGakeslab equkethe iziphakamiso ze-RUO (ukusetshenziswa kokusetshenziswa kuphela) e-Indonesia. Enye yezincomo kwakuwukuphuma noma ukwenza lula ukubhaliswa kwe-RUO (imakethe yangaphambi kanye nemakethe yasemuva) e-Indonesia. Ukukhipha kanye nokwenza lula ukubhaliswa kweRuco kuzosiza ukukhuthaza imvelo yocwaningo nokusekelwa kwe-Indonesia ekuguquleni insika yayo yezempilo. Njengoba siqhubeka nokusekela imvelo yocwaningo e-Indonesia, singakwazi yini ukulandela inkonzo yezempilo kuRuo?
A: Inkonzo yezempilo yase-Indonesia iye yaxoxa nge-ruo futhi yathola ukuqonda okuvela endleleni ephethwe ngayo yi-Health Science Authority (HSA) eSingapore. Sifunde ukuthi i-HSA ayilawuli ama-roo kepha isebenzisa izilawuli eziqinile zokuthengisa ngemuva kokuthengisa. Kunemikhiqizo enzima uma imikhiqizo ye-Ruo isetshenziselwa ukwelashwa. Kodwa-ke, unikezwe imakethe enkulu yase-Indonesia enenombolo enkulu yama-laboratories, ngeke sikwazi ukwamukela le modeli. Njengamanje i-Indonesia isebenza ukuqinisa umthetho futhi sivulekele izingxoxo nge-apacmed nabanye ababambe iqhaza ukuhlinzeka ngemikhuba emihle kakhulu.
Q: Ngabe i-Indonesia ivumela ukulebula ngemuva kokungenisa? (isib
A: Ukuhlelwa kabusha kuvunyelwe ngemuva kokuqinisekiswa kanye nesiqinisekiso sokuthi akukho mthelela kwikhwalithi nokuphepha komkhiqizo.
Q: Yiziphi izingozi zokungenisa izimpahla ngamalebula ahlanganisiwe? Isibonelo, ilebula lebhokisi linegama lenkampani elisha kodwa ngaphakathi, i-IFU (Imiyalo yokusetshenziswa kwamadivayisi wezokwelapha) isaqukethe igama lenkampani yakudala. Ngabe inkonzo yezempilo yase-Indonesia ivumela isikhathi sokushintshana ukuze ushintsho ekulebula / i-IFU lungabhekwa njengemfuneko yokuncipha okuphoqelelwe?
A: Uma kunokungafani phakathi kwe-IFU nokulebula, kuzokwenqatshwa kakhulu njengoba kubalulekile ukugcina ukuvumelana. Yize ezinye zezikhathi zomusa wecala, zinikezwe, izikhalazo kanye nokucatshangelwa komthelela emphakathini kusadingeka. Ngakho-ke kunconywa kakhulu ukuqinisekisa ukuthi yonke imikhiqizo yakudala enelebuli ingenisiwe ngaphambi kokuthumela isibuyekezo ukuvikela ukungenisa kabusha futhi kuqinisekiswe ushintsho olubushelelezi. Ngokuya ngesimo, ungakwazi futhi ukuvumelanisa umkhiqizo usebenzisa ukugunyazwa okulungile.
UMB: U-Apacmed uthuthukisa uhlelo lokulawula ukwethembana, yini inkonzo yezempilo yase-Indonesia kulolu hlelo? Njengoba inqubomgomo yamanje ukukhiqiza imikhiqizo eminingi yendawo, i-Indonesia ingahlomula kwimodeli ye-trust futhi ivumele ukunwetshwa komkhiqizo kwaba ezinye izimakethe zokhiye.
A: UMnyango Wezempilo wase-Indonesia unesifiso esikhulu sokulawula imodeli ye-Trust futhi angathanda ukusebenzisana ne-Health Sciences Authority Authority (HSA) eSingapore kanye ne-Medical Supply Authority of Australia. Lesi sinyathelo sisekusencane, yize kulindeleke ukuthi kusetshenziswe kulindeleke ngonyaka olandelayo. Ekuphetheni, i-Indonesia ijabule ukuyifunda futhi ibambe iqhaza kwimodeli ye-trust futhi ibheke phambili ekusebenzeni nge-apacmed kule phrojekthi.
UMB: Ngokuphathelene nemithetho ye-halal (umthetho we-halal), imikhiqizo eyenziwe ngezinto ezingezona ze-halal idinga ukubonisa imininingwane efanelekile kwilebula ngaphambi kokuthi ingeniswe e-Indonesia. Ngabe zikhona imihlahlandlela ukuthola ukuthi imikhiqizo yethu iyi-halal noma i-non-halal?
A: Izingxoxo ngokukhipha imihlahlandlela yokulebula ngo-2024 ziyaqhubeka. Sisasebenza ekuthuthukiseni imihlahlandlela ecacile, sizama ukungayibizi inqubo yasekuqaleni. UMnyango Wezempilo wase-Indonesia wamukela iziphakamiso ngendlela engcono kakhulu yokuthuthukisa imihlahlandlela.
Q: Luyini uhlelo lukahulumeni lapho umkhiqizo / umkhiqizo okhiqizwa endaweni ofinyelela ephesenti elidingekayo lokuqukethwe kwasendaweni? (Kukhulunywe ngenhla ukuthi lo mkhiqizo uzoba yiqhwa kukhathalogi ye-e-i-e-Calogu, yisiphi isinyathelo esilandelayo?)
A: Imikhiqizo kuphela enemininingwane ehlukile evela kwalawo akhiqizwa endaweni ozovunyelwa ukungena emakethe yangasese. Le nqubomgomo izoqhubeka kuze kube unyaka olandelayo futhi ingashintsha ngemuva kokhetho luka-2024. Sizoqhubeka nokubheka amathuba omkhakha wedivayisi yezokwelapha.
Q: Ngingathanda ukwazi ukuthi ngabe izibhedlela ezizimele zizosebenzisa lolu hlelo lokukhuthaza ukusetshenziswa okwengeziwe kwemikhiqizo yasendaweni (P3DN)? Uma kunjalo, yini umugqa wesikhathi olindelwe? Ngabe lokhu kusho ukuthi izibhedlela ezizimele zizokwazi ukuthenga imikhiqizo yendawo kuphela?
A: Alukho uhlelo oluthile lwemakethe yangasese kanye nezibhedlela ngalesi sikhathi. Ngakho-ke, ukhululekile ukubamba iqhaza ekuhwebeni kwemakethe yangasese nokuthenga. Sisebenzisa izimakethe zangasese zokuhweba nokuthenga.
Q: I-Indonesia ibamba kanjani imishini yezokwelapha esetshenzisiwe?
A: Sifaka ukulawulwa kwenkonzo yezohwebo kanye noMnyango Wezimboni ovimbela izimpahla ezivuselelwe ukufudumala kusuka ekungeneni emakethe yase-Indonesia. Lo mthethonqubo wawenziwa ngokuphendula izinselelo i-Indonesia ebhekene nazo esikhathini esidlule lapho izimpahla eziguqukayo zingena emakethe kuphela. Inhloso yale mithethonqubo ukuvikela ukungena kwezimpahla ezivuselelwe ngamanani amakhulu. Sizobeka phambili ukutholakala komkhiqizo futhi sihlale siqinisekisa ikhwalithi engaguquki.
UMB: Njengamanje uMnyango Wezempilo wase-Indonesia we-Indonesia we-Clagesation Grouding ususelwa ekucacisweni kwemishini, njengezimo ezahlukahlukene (i-catheter yesobunxele, i-catheter yangakwesobunxele), okuzodinga ukubhaliswa kwamalayisense amaningi. Ingabe uMnyango Wezempilo unamasu anazo amacebo okuguqula amaqembu asuselwa kwisiqondisi se-Asean Medical Discy (AMDD)?
A: Ungabuka idokhumenti yokuholwa eqoqweni lewebhusayithi e-Indonesia. Amadivaysi ezokwelapha angahlukaniswa ngezigaba ezahlukahlukene ezifana nomndeni, uhlelo kanye neqembu. Akukho mali eyengeziwe yokubhalisa ngeqembu noma umkhiqizo ngamunye.
Q: Ingabe kunenhloso yokusebenzisa iqembu elifanayo lemikhiqizo yokuxilonga i-vitro (IVD)?
A: Imikhiqizo ye-IVD ihlukaniswe ezinhlelweni ezivaliwe nezivulekile. Kunemininingwane eminingi etholakala kudokhumenti yokuholwa etholakala kwi-Indonesia Ministry of Health Website.Izigaba zemikhiqizo ye-IVD zilandela iphethini efanayo yakwa-AMDD. Izingxoxo zisaqhubeka nokuthi zivumelanisa kanjani ukuhlanganisa amaqembu ngohlelo lwe-e-Catalog.
Q: Ngabe imikhiqizo engeyona ye-halal ibhekisa kwimikhiqizo equkethe izinto zemvelaphi yezilwane kepha akayona i-halal eqinisekisiwe, noma ingabe zibhekisela kwimikhiqizo engaqukethe noma yiziphi izinto zemvelaphi yezilwane?
A: Imikhiqizo yemvelaphi engeyona yezilwane ayidingi isitifiketi se-halal. Imikhiqizo kuphela equkethe imvelaphi yezilwane edingekayo. Uma umkhiqizo ungahambisani nohlelo lwe-Halal Certification, kudingeka ilebula efanele.
Q: Ngabe kuzoba nezinkombandlela ezihlukile zemikhiqizo ye-IVD ngokuya ngemithetho ye-halal?
A: Imihlahlandlela yamanje isebenza kuphela kwimikhiqizo yedivayisi yezokwelapha ethathwe ezilwaneni. Kodwa-ke, uma ucabanga ukuthi ama-Ivds ahlangana ngqo nomzimba wesiguli, kungenzeka ukuthi imihlahlandlela ehlukile izothuthukiswa. Kodwa-ke, bekungekho ngxoxo ngeziqondiso ze-IVD ngalesi sikhathi.
Q: Kwenzekani uma umkhiqizo we-class d mdala kunesikhathi esithathayo ukuthola isitifiketi se-halal kodwa uvela esilwaneni?
A: Lesi yisimo lapho izidingo ezingeziwe zokulebula zizodinga ukufelana khona. Njengamanje sisezingxoxweni zokuthola uhlobo oluthile lokulebula oludingekayo. Umgomo wethu ukuqinisekisa ukuthi imithethonqubo ifanelekile futhi inokulinganisela ukuqinisekisa ukuphepha kweziguli futhi igweme ngaphansi- noma ukulawulwa ngokweqile. Kubalulekile ukuqaphela ukuthi lokhu akuyona ukuvinjelwa kwemikhiqizo efaka imakethe yase-Indonesia, yilokho ukulebula kuphela okudingekayo ukungena emakethe.
Q: Lapho ushintsho lokuqamba noma ukuguqulwa komkhiqizo kwenzeka ngemuva kokuvunywa komkhiqizo, umkhuba wamanje ukuhambisa kabusha uhlelo lokusebenza. Kungenzeka yini ukuguqula inqubo noma ezinye izindlela zokugwema ukuhanjiswa kabusha?
A: Uma ushintsho lubandakanya ilebula nokupakisha, inqubo yokuguqulwa kwenguquko kungenzeka. Inqubo yokuguqulwa kwenguquko ivunyelwe uma ingaqinisekiswa ukuthi ushintsho ngeke luthinte ukuphepha, ikhwalithi, noma ukusebenza komkhiqizo.
Isikhathi sePosi: Jul-28-2023