The Meaning of Australian TGA registration
AustraliaTherapeuticGoodsAdministration(TGA),afederaldrugauthoritywhichissubordinatetoAustraliaMinistryofHealth,providesaframeworkforariskmanagementapproachthatallowstheAustraliancommunitytoh***etimelyaccesstotherapeuticgoodswhicharec***istentlysafe,effectiveandofhighquality.TGARegistrationcarryoutarangeofasses***entandmonitoringactivitiestoensuretherapeuticgoods***ailableinAustraliaareofanacceptablestandardwiththeaimofensuringthattheAustraliancommunityhasaccess,withinareasonabletime,totherapeuticadvances.ThemeaningofTGAcertification:ItisknowntoallthatthestrictmanagementofAustraliandrugproductionandimportiswidelyrecognizedasoneofthecountriesofstrictestandmostdifficulttoenterthemarket.TGAcertification,GMPcertificationofAustraliangovernment,enjoysahighreputationinternationally.GettingtheTGAcertificationmeansthecompanyisrecognizedbyAustraliangovernmentanditsPIC/Smembers,England,France,Germany,Austria,Italian,Canada,Czechoslovakia,Finland,Greek,Iceland,Belgium,Denmark,Sweden,SingaporeandtheNetherlandsonqualitysystemandproductionenvironmentfacilities.AftergettingTGAcertification,companycanapplyforproductionregistration,aswellassub-contractproductionofsomecountries.TGAcertificationplaysanimportantroleininternationalmarketdevelopmentofthecompany.ThesupervisionoftherapeuticgoodsofTGAregistrationfocusesonthesefollowingthreeaspects:1.Asses***entforgoodsbeforeenteringthemarket.AllthedrugsandmedicaldevicesmustdotheTGAregistrationbeforeenteringthemarketinordertoassessrisk.2.Permissionofpharmaceuticalfactory.AustralianpharmaceuticalmanufacturermustgetTGAandGMPcertification.3.Latersupervisionofthemarket.TGAhastherighttosampleandtestthedrugsonthemarketsothatitcanensureit’squalityandstandard.O***undamedicaldevicec***ultingorganization(Guangzhou,Beijing,Shanghai,Suzhou,ShenzhenandJinan),investinginChinafromCanada,isprofessionallyengagedinmedicaldeviceregulationc***ulting,medicaldeviceregisteredagent,medicaldevicemanagementsystemcertificationandproductcertification,focusingonprovidingmedicaldeviceenterprisesinternationalmedicaldeviceregistration(CE、FDA、CMDCAS、TGA、JPAL、SFDA、PPE)、medicaldevicesystemcertification(ISO13485、YY/T0287、GMP、QSR820、GSP),doingsecondandthirdpartyauditformedicaldevicesuppliers,providingdetailinformationofc***ultingthemedicalproductionmanufacturinglicense.)