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ID:43588763
大小:36.00 KB
页数:3页
时间:2019-10-11
《澳洲注册申请表中涉及的问题》由会员上传分享,免费在线阅读,更多相关内容在工程资料-天天文库。
1、问题是下面标批注的三个问题Device・HTAQuestionsChangestotheMedicalDeviceApplicationformforinclusionsBackgroundHealthTechnologyAssessmentforReimbursementTheTGAassessesapplicationsforentryoftherapeuticgoodsincludingmedicaldevicesandinvitrodiagnosticmedicaldevices(IVDs)
2、ontheAustralianRegisterofTherapeuticGoods(ARTG)toenablesupplyinAustralia.AsponsorormanufacturermayseekpublicorprivatefundingforatherapeuticgoodunderanAustralianGovernmentfundingprogrameitheroncethegoodisapprovedforsupplyoratsometimeinthefuture.Fundingp
3、rogramsthatusehealthtechnologyassessment(HTA)toinformwhetheratherapeuticgoodshouldbelistedforfundinginclude:PhairnaceuticalBenefitsScheme(PBS)forpharmaceuticalsNationalImmunisationProgram(NIP)forvaccinesMedicareBenefitsSchedule(MBS)forhealthtechnologie
4、srequiringamedicalprocedureProsthesesListforprivatehealthinsurancefundingofprosthesesNationalBloodAgreementforbloodandbloodproductsUndertheHTAprocess,healthtechnologiesareassessedinregardtotheircomparativeclinicaleffectivenessandcosteffectiveness.Thisa
5、imstoensurethattaxpayers5moneyisusedtosupportthehealthcareinterventionsthatachievethemaximumhealthimprovementatthelowestcost.Eachoftheaboveprogramshasawebsitethatprovidesinformationaboutthefundingprogram,eligibilitycriteria,makingapplicationandassessme
6、ntprocesses-EntryontheARTGisoneoftheeligibilitycriteriathatmustbemetbeforeatherapeuticgoodcanbelistedforfunding.Applicantsseekingfundingunderanyoftheseprogramsareencouragedtoreviewtherelevantwebsiteand/orcontacttheappropriatesecretariatpriortomakingana
7、pplication.Co-dependentorhybridtechnologiesSometherapeuticgoodscanbeco-dependent(forexample,adrug/diagnostictestcombination)orhybridtechnologies(forexample,amedicaldevicewithanintegrateddrug)andmaythereforeneedtobeconsideredforeligibilityundertwoormore
8、ofthesefundingprograms.Co-dependenttechnologiesaretherapeuticgoodsthataredependentonanothertechnology,eithertoachievetheirintendedeffectortoenhancetheirintendedeffect(forexample,in-situhybridisation(ISH)testingrelatedtoeligibilityfortra
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