省政府各厅委、各直属机构:Tothepeople'sgovernmentsofvariouscities,prefectures,counties,anddistricts,aswellasthedepartments,commissions,anddirectlyaffiliatedinstitutionsoftheprovincialgovernment:根据《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》要求,推动药品(含医疗器械、化妆品)高水平安全和生物医药产业高质量发展,(省科技厅、省发展改革委、省工业和信息化厅、省财政厅、省商务厅、省卫生健康委、省药品监管局等按职责分工负责)(1)Supporttheconstructionofbiopharmaceuticalinnovationplatforms.Fornewlyapprovednationallevelscienceandtechnologyinnovationcenters,eachplatformwillreceiveaone-timesubsidyof5millionyuanperyearforthreeconsecutiveyears,supportedbyrelevantspecialfunds.Fornewlyrecognizedindustryapplicationbasicplatformsthatmeettheconditions,aswellasserviceplatformsthathaveactuallyparticipatedinbiopharmaceuticalresearchanddevelopmentandobtainedevaluationrecognition,one-timerewardsandsubsidieswillbeprovidedaccordingtorelevantstandards.Themaximumrewardandsubsidyforeachplatformshallnotexceed5millionyuan.Fornewlyintroducedplatforms,therewardandsubsidyfundswillbesupportedbytheprovincialspecialfundsforthedevelopmentofopeneconomyandcirculationindustries.(TheProvincialDepartmentofScienceandTechnology,ProvincialDevelopmentandReformCommission,ProvincialDepartmentofIndustryandInformationTechnology,ProvincialDepartmentofFinance,ProvincialDepartmentofCommerce,ProvincialHealthCommission,ProvincialDrugAdministration,etc.areresponsiblefortheirrespectiveduties.)(二)支持产品研发创新,(省科技厅、省财政厅、省工业和信息化厅、省卫生健康委、省药品监管局、省统计局等按职责分工负责)(2)Supportproductresearchanddevelopmentinnovation.Increaseinvestmentinscientificresearch,guideandintegratesocialresourcesintotheresearchandproductionofdrugs,medicaldevices,andcosmetics,andfocusonsupportinginnovativebiopharmaceuticalindustryprojects.Givefullplaytotheguidingroleofourprovince'sNaturalScienceFoundationandsupportthedevelopmentofbasicandappliedresearchinbiomedicine.Theprovincialscienceandtechnologyinnovationplanwillprovidepreferentialsupportforinvestigationalvarietieswithclinicalvalue.Forenterprisesthathaveestablishedaresearchanddevelopmentreservesystemandfiledforrecord,andhaveinvestedselfraisedfundsinthefieldofbiomedicine,incentiveswillbegivenaccordingtorelevantpolicies,andappropriatetiltwillbegiventohigh-techenterprises.Therewardandsubsidyfundswillbesupportedbytheenterprise'sR&Drewardandsubsidyfinancialfunds.(TheProvincialDepartmentofScienceandTechnology,ProvincialDepartmentofFinance,ProvincialDepartmentofIndustryandInformationTechnology,ProvincialHealthCommission,ProvincialDrugAdministration,ProvincialBureauofStatistics,etc.areresponsiblefortheirrespectiveduties.)(三)支持细胞和基因研究,(省卫生健康委、省科技厅、省商务厅、省药品监管局等按职责分工负责)(3)Supportcellandgeneresearch.Supporttheconstructionofcellstoragecentersandcellpreparationcenters,supportenterprisesthatmeetrelevantrequirementstoapplyforhumangeneticresourcepreservationqualifications,andsupportmedicalinstitutionswithintheprovincethatmeetrelevantqualificationsandconditionstocarryouthumangeneticresourceandcellcollectionbusinessinaccordancewiththelaw.Supportandencourageenterprises,researchinstitutions,universities,medicalandhealthinstitutions,andresearcherswithintheHunanPilotFreeTradeZonetostrengthenmajororiginalresearchandcutting-edgeinterdisciplinaryresearchoncellsandgenes,aswellastheirtranslationalapplications.Supportthecooperationoftheseinstitutionsinconductingclinicalresearchandtrialsoncellsandgenes.Supportthedevelopmentofgenetechnologywithcoreintellectualpropertyrights,aswellassupportingequipment,software,anddatabases,andsupporttheconstructionofaninnovativeandindustrialchainthatintegrates"cellstoragecellproductionpreparationcelldrugresearchandclinicaltechnologyresearch".Supportmedicalinstitutionsthatmeetrelevantqualificationsandconditionstousecellandgeneproductsandtechnologiesforthepreventionandtreatmentofmajordiseasessuchasbirthdefectsandtumors.(TheProvincialHealthCommission,ProvincialDepartmentofScienceandTechnology,ProvincialDepartmentofCommerce,ProvincialDrugAdministration,etc.areresponsiblefortheirrespectiveduties.)(四)支持创新产品产业化落地,对首次获得药品注册批件的创新药、获得生产批件的第三类创新医疗器械和第二类创新医疗器械企业,(省工业和信息化厅、省商务厅、省科技厅、省财政厅、省药品监管局等按职责分工负责)(4)Supporttheindustrializationofinnovativeproducts.Forinnovativedrugsthathaveobtaineddrugregistrationapprovalforthefirsttime,ClassIIIinnovativemedicaldevicesthathaveobtainedproductionapproval,andClassIIinnovativemedicaldeviceenterprisesthatmeettherelevantconditionsforindustrializationlanding,aone-timebonusofnomorethan5millionyuan,1millionyuan,and500000yuanwillbegivenrespectively;Forthefirstspecialcosmeticnewingrediententerprisetoobtainregistrationapproval,aone-timebonusofnomorethan1millionyuanwillbegiven.Thesubsidyfundswillbesupportedbytheprovincialadvancedmanufacturinghighlandconstructionfunds.(TheProvincialDepartmentofIndustryandInformationTechnology,ProvincialDepartmentofCommerce,ProvincialDepartmentofScienceandTechnology,ProvincialDepartmentofFinance,ProvincialDrugAdministration,etc.areresponsiblefortheirrespectiverolesandresponsibilities.)(五)支持中医药传承创新发展,(省数据局、省科技厅、省卫生健康委、省药品监管局、省医保局等按职责分工负责)(10)Supportdatascenarioapplications.Promotetheauthorizedoperationofmedical,medicalinsurance,andpharmaceuticalpublicdataresources,promotedatafusionapplications,innovateanddevelopanumberofpublicdataproductsandservices,promotetheconstructionofhigh-qualitydatasetsinthemedicalandpharmaceuticalfields,andstrengthentheapplicationofdataininnovativedrugresearchanddevelopment,clinicaldiagnosisandtreatment,andrelatedscientificresearchscenarios.Conductresearchonalarge-scalemodelofartificialintelligence(AI)regulation,andestablishanintelligentsupervisionandriskwarningsystembefore,during,andaftertheevent.Acceleratetheconstructionofastandardizedclinicaldatasystemandpromotetheempowermentofdrugresearchanddevelopmentwithartificialintelligencetechnology.Supportthecooperationbetweenpharmaceuticalcompaniesandmedicalinstitutionstobuildanelectronicsharingplatformforfirst-timedata,andsupportmedicalinstitutionstoacceleratetheconstructionofintelligentlogisticsinformationsystemswithinthehospital.(ProvincialDataBureau,ProvincialDepartmentofScienceandTechnology,ProvincialHealthCommission,ProvincialDrugAdministration,ProvincialMedicalInsuranceBureau,etc.areresponsibleaccordingtotheirrespectiveduties)三、支持创新产品临床运用与推广3、Supporttheclinicalapplicationandpromotionofinnovativeproducts(十一)推进创新药品、医疗器械产品临床运用,加大临床用药质量控制中心对全省药事管理和药学服务的技术支持力度;强化医疗机构医疗器械管理质量控制中心对全省医疗器械临床管理和使用等工作的技术支撑,(省卫生健康委、省医保局、省公共资源交易中心、省工业和信息化厅等按职责分工负责)(11)Promotetheclinicalapplicationofinnovativedrugsandmedicaldeviceproducts.StrengthenthetechnicalsupportoftheClinicalDrugQualityControlCenterforpharmaceuticalmanagementandpharmaceuticalservicesthroughouttheprovince;StrengthenthetechnicalsupportoftheQualityControlCenterforMedicalDeviceManagementinmedicalinstitutionsforclinicalmanagementanduseofmedicaldevicesthroughouttheprovince.Encouragemedicalinstitutionstousedrugsthathavepassedthequalityandefficacyconsistencyevaluationofgenericdrugs.Promotemedicalinstitutionsatorabovethethirdlevelinourprovincetotimelyequipinnovativedrugsandequipmentforusewithin6monthsoftheupdateandreleaseofthenationalmedicalinsurancedrugcatalogbasedonclinicalneedsandhospitalcharacteristics.InnovativemedicaldevicesrecognizedasthefirstmajortechnologicalequipmentinHunanProvinceshallbeincludedinthe"HunanProvinceFirstPurchaseProductCatalog",andmedicalinstitutionsshallimplementgovernmentfirstpurchaseandorderinginaccordancewithregulations.(TheProvincialHealthCommission,ProvincialMedicalInsuranceBureau,ProvincialPublicResourceTradingCenter,ProvincialDepartmentofIndustryandInformationTechnology,etc.areresponsiblefortheirrespectiverolesandresponsibilities.)(十二)加强医保体系对创新产品应用的支撑,引导医疗机构采购使用创新和临床认可度高的药品医疗器械,(省医保局、省工业和信息化厅、省卫生健康委、省药品监管局、省公共资源交易中心等按职责分工负责)(12)Strengthenthesupportofthemedicalinsurancesystemfortheapplicationofinnovativeproducts.Reasonablydeterminethepaymentstandardsformedicalinsuranceforinnovativedrugsandmedicaldevices.Belongingtomedicalnewtechnologyprojectssuchascellandgenediagnosisandtreatmenttechnology,afterbeinglegallyapprovedforclinicalapplicationandformingmedicaltechnologyprojectstandards,medicalinstitutionsshallapplyforprojectapprovaltothemedicalsecuritydepartmentaccordingtothenewlyaddedmedicalservicepriceitems,andgraduallypromoteeligiblemedicalserviceprojectstobeincludedinthemedicalinsurancecatalogaccordingtoprocedures.Formajorinnovativedrugsandmedicaldevicesthatmeettheconditions,itisrecommendedtoincludetheminthenationalmedicalinsuranceorprovincialmedicalinsurancecatalog,appropriatelyincreasethereimbursementratioofmedicalinsurance,andacceleratetheonlinelistingontheprovincialmedicalprocurementplatforminaccordancewithregulationstoimprovetheefficiencyofonlineservices.Guidemedicalinstitutionstopurchaseanduseinnovativeandclinicallyrecognizeddrugsandmedicaldevices.Accordingtotheprinciplesof"qualityfirst,reasonableprice,andconvenientlogistics",wewillprudentlyimplementdesignatedprocurementofbasicinfusionproducts.InnovativedrugsthathavecompletedPhaseI-IIIclinicaltrialsandobtainedmarketingapprovalwithinChina,aswellasClassIIandIIIinnovativemedicaldevicesthathaveobtainedmarketingregistration,willbedirectlyusedbymedicalinstitutionswithintheprovinceaccordingtotheprincipleof"batchandpurchase",andwillnotbeincludedintheassessmentscopeof"drugproportion"and"consumptionproportion"ofmedicalinstitutions.(TheProvincialMedicalInsuranceBureau,ProvincialDepartmentofIndustryandInformationTechnology,ProvincialHealthCommission,ProvincialDrugAdministration,ProvincialPublicResourceTradingCenter,etc.areresponsiblefortheirrespectiveduties.)四、支持生物医药产业做优做强4、Supporttheoptimizationandstrengtheningofthebiopharmaceuticalindustry(十三)培育发展优质企业和龙头产品,(省科技厅、省工业和信息化厅、省商务厅、省卫生健康委、省医保局、省中医药局、省市场监管局、省药品监管局、长沙海关等按职责分工负责)(13)Cultivateanddevelophigh-qualityenterprisesandleadingproducts.Cultivatehigh-qualityenterpriseswithindustryleadingandexemplaryroles.Wewillfocusonsupportingtheaccelerateddevelopmentofinnovativedrugs,nationalorprovincialexclusivevarieties(exclusivedosageforms),genericdrugsofcategory4orabovethathavepassedconsistencyevaluation,medicaldevicesofcategory2orabove,andclassicChinesemedicineformulas.Wewillprovidesupportinresearchanddevelopmentinnovation,clinicaltrials,registrationapproval,importofrawmaterialsandequipment,pricedetermination,anddistribution.(TheProvincialDepartmentofScienceandTechnology,ProvincialDepartmentofIndustryandInformationTechnology,ProvincialDepartmentofCommerce,ProvincialHealthCommission,ProvincialMedicalInsuranceBureau,ProvincialTraditionalChineseMedicineBureau,ProvincialMarketSupervisionBureau,ProvincialDrugAdministration,ChangshaCustoms,etc.areresponsiblefortheirrespectiveduties.)(十四)支持生物医药产业链布局,(省科技厅、省人力资源社会保障厅、省教育厅、省财政厅、省住房城乡建设厅、省卫生健康委、省药品监管局等按职责分工负责)(16)Strengthentalentguarantee.Intensifyeffortstoattract,cultivate,andretainleadingtalentsinthefieldofbiomedicineandurgentlyneededprofessionalandtechnicaltalentsinenterprises,supporthigh-leveltalentswhomeettheconditionstoapplyforvarioustalentprojectswithintheprovince,andenjoyrelevantbenefits.Encouragevariousuniversitiestoaddpharmaceuticalrelatedmajorsbasedonthedevelopmentofthebiopharmaceuticalindustryinourprovince.Promotethedeepeningofindustryeducationintegrationbetweenpharmaceuticalenterprisesandhighereducationinstitutionswithintheprovince,andactivelyexplorenewmodelsoftalentcultivationwiththecharacteristicof"medicalengineeringintersection".(TheProvincialDepartmentofScienceandTechnology,ProvincialDepartmentofHumanResourcesandSocialSecurity,ProvincialDepartmentofEducation,ProvincialDepartmentofFinance,ProvincialDepartmentofHousingandUrbanRuralDevelopment,ProvincialHealthCommission,ProvincialDrugAdministration,etc.areresponsiblefortheirrespectiverolesandresponsibilities.)(十七)加大金融支持,在湖南省实质从事生物医药研发、临床试验、成果转化、生产经营和服务管理等活动的企业、医疗机构。