医药行业专业英语词汇(非常有用)FDA和EDQM术语:CLINICALTRIAL:临床试验ANIMALTRIAL:动物试验ACCELERATEDAPPROVAL:加速批准STANDARDDRUG:标准药物INVESTIGATOR:研究人员;调研人员PREPARINGANDSUBMITTING:起草和申报SUBMISSION:申报;递交BENIFIT(S):受益RISK(S):受害DRUGPRODUCT:药物产品DRUGSUBSTANCE:原料药ESTABLISHEDNAME:确定的名称GENERICNAME:非专利名称PROPRIETARYNAME:专有名称;INN(INTERNATIONALNONPROPRIETARYNAME):国际非专有名称ADVERSEEFFECT:副作用ADVERSEREACTION:不良反应PROTOCOL:方案ARCHIVALCOPY:存档用副本REVIEWCOPY:审查用副本OFFICIALCOMPENDIUM:法定药典(主要指USP、NF).USP(THEUNITEDSTATESPHARMACOPEIA):美国药典NF(NATIONALFORMULARY):(美国)国家处方集OFFICIAL=PHARMACOPEIAL=COMPENDIAL:药典的;法定的;官方的AGENCY:审理部门(指FDA)IDENTITY:真伪;鉴别;特性STRENGTH:规格;规格含量(每一剂量单位所含有效成分的量)LABELEDAMOUNT:标示量REGULATORYSPECIFICATION:质量管理规格标准(NDA提供)REGULATORYMETHODOLOGY:质量管理方法REGULATORYMETHODSVALIDATION:管理用分析方法的验证COS/CEP欧洲药典符合性认证ICH(InternationalConferenceonHarmonizationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse)人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类。质量技术要求文件以Q开头,再以a,b,c,d代表小项:Q1:药品的稳定性Q2:方法学Q3:杂质Q4:药典Q5:生物技术产品质量Q6:标准规格Q7:GMPQ7a:(原料药的优良制造规范指南)药物活性成分的GMP.GMP英语PIC/S的全称为:PharmaceuticalInspectionConvention/PharmaceuticalInspectionCooperationScheme,PIC/S(制药检查草案),药品检查协会(PIC/S),也有人称PIC/S为医药审查会议/合作计划(PIC/S)PIC的权威翻译:药品生产检查相互承认公约API(ActivePharmaceuticalIngrediet)原料药又称:活性药物组分AirLock气闸AuthorizedPerson授权人Batch/Lot批次BatchNumber/Lot-Number批号;BatchNumberingSystem批次编码系统;BatchRecords批记录;BulkProduct待包装品;Calibration校正;Cleanarea洁净区;Consignmecnt(Delivery)托销药品。FDA(FOODANDDRUGADMINISTRATION):(美国)食品药品管理局IND(INVESTIGATIONALNEWDRUG):临床研究申请(指申报阶段,相对于NDA而言);研究中的新药(指新药开发阶段,相对于新药而言,即临床前研究结束)NDA(NEWDRUGAPPLICATION):新药申请ANDA(ABBREVIATEDNEWDRUGAPPLICATION):简化新药申请TREATMENTIND:研究中的新药用于治疗ABBREVIATED(NEW)DRUG:简化申请的新药DMF(DRUGMASTERFILE):药物主文件(持有者为谨慎起见而准备的保密资料,可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。只有在DMF持有者或授权代表以授权书的形式授权给FDA,FDA在审查IND、NDA、ANDA时才能参考其内容)HOLDER:DMF持有者CFR(CODEOFFEDERALREGULATION):(美国)联邦法规PANEL:专家小组BATCHPRODUCTION:批量生产;分批生产BATCHPRODUCTIONRECORDS:生产批号记录POST-ORPRE-MARKETSURVEILLANCE:销售前或销售后监督INFORMEDCONSENT:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验)PRESCRIPTIONDRUG:处方药OTCDRUG(OVER—THE—COUNTERDRUG):非处方药GMP文件常见缩写ABPIAssociationoftheBritishPharmaceuticalIndustryADRAdverseDrugReactionAEAdverseEventAIMActiveIngredientManufacturerANDAAbbreviatedNewDrugApplicationANOVAAnalysisofVarianceASM:ActiveSubstanceManufacturerATCAnatomicalTherapeuticChemicalATXAnimalTestExemptionCertificateBANBritishApprovedNameBIRABritishInstituteofRegulatoryAffairsBNFBritishNationalFormularyBPBritishPharmacopoeiaCofACertificateofAnalysisCofSCertificateofSuitabilityCENTREFORDRUGEVALUATION(CDE)CentreforPharmaceuticalAdministration(CPA)CMSConcernedMemberStateCMS每个成员国COSCertificateofSuitabilityCPMPCommitteeforProprietaryMedicinalProductsCRAClinicalResearchAssociateCRFCaseReportFormCROContractResearchOrganisationCTAClinicalTrialApplicationCTCClinicalTrialCertificateCTDCommonTechnicalDocumentCTXClinicalTrialsExemptionDDDDefinedDailyDoseDGCDailyGlobalComparisonDIADrugInformationAssociationDMFDrugMasterFileDrugRegistrationBranch(DR,ProductEvaluation&RegistrationDivision,CPAEDQM(EuropeanDirectoratefortheQualityofMedicines)欧洲联盟药品质量指导委员会EEA欧洲经济地区EGMAEuropeanGenericsMedicineAssociationELAEstablishedLicenceApplicationEMEAEuropeanMedicinesEvaluationAgencyEMEA(EuropeanAgencyfortheEvaluationofMedicinalProducts)欧洲联盟药品评价机构EPEuropeanPharmacopoeiaEPAREuropeanPublicAssessmentReportsESRAEuropeanSocietyofRegulatoryAffairsEuropeanPharmacopoeiaCommission欧洲药典委员会FDAFDAFoodandDrugAdministrationfinalevaluationreport(FER)freesalecertificates(FSCs)GCPGoodClinicalPracticeGCP药品临床研究管理规范GLPGoodLaboratoryPracticeGLP药品临床前安全性研究质量管理规范GMPGoodManufacturingPracticeGMP药品生产质量管理规范GSP药品销售管理规范HealthSciencesAuthority(HSA)HSA’sMedicinesAdvisoryCommittee(MAC)IBInvestigatorsBrochureICHInternationalConferenceforHarmonisationIDMCIndependentData-MonitoringCommitteeIECIndependentEthicsCommitteeINDInvestigationalNewDrugINNInternationalNon-proprietaryNameInternationalConferenceonHarmonisation(ICH)IPCInProcessControlIRBInstitutionalReviewBoardLICENCEHOLDERMAMarketingAuthorisationMAAMarketingAuthorisationApplicationMAA上市申请MAHMarketingAuthorisationHolderMAH销售许可持有者MCAMedicinesControlAgencyMHWMinistryofHealthandWelfare(Japan)MRMutualRecognitionMRA美国与欧盟的互认协议MRAs(MutualRecognitionAgreements)互相認證同意MRFGMutualRecognitionFacilitationGroupMRPMutualRecognitionProcedureNASNewActiveSubstanceNCENewChemicalEntityNDANewDrugApplicationnewchemicalentities(NCEs)newdrugapplications(NDAs)NSAIDNonSteroidalAntiInflammatoryDrugNTANoticeToApplicantsOOSOutofSpecificationOTCOverTheCounterPAGBProprietaryAssociationofGreatBritainPhEurEuropeanPharmacopoeiaPILPatientInformationLeafletPLProductLicencePOMPrescriptionOnlyMedicinePRODUCTOWNERPSUPeriodicSafetyUpdatesQAQualityAssuranceQCQualityControlRAJRegulatoryAffairsJournalRMSReferenceMemberStateRMS相互认可另一成员国RSDRelativeStandardDeviationRxPrescriptionOnlySAESeriousAdverseEventSMFSiteMasterFileSOPStandardOperatingProcedureSOP(STANDARDOPERATIONPROCEDURE)标准运作程序SPC/SmPCSummaryofProductCharacteristicssummaryofproductcharacteristics(SPC)TherapeuticGoodsAdministration(TGA)