缩写词
APIActivePharmaceuticalIngredient原料药
ANDAAbbreviatedNewDrugApplication简化新药申请仿制药ASMTheActiveSubstanceManufacturer原料药生产厂家ADEAdverseDrugEvent药物不良事件ADRAdverseDrugReaction药物不良反应CFDACOSCTDCOACDECMCCROChPCASCTACMOCPPCAPADMFEDMFEMEAEUEPFDAGMPHPLCICHINDIDLINNLALOQLOD
ChinaFoodandDrugAdministration中国国家食品药品监督管理局CertificateofSuitability欧洲药典适用性认证CommonTechnicalDocuments通用技术文件CertificatofAnalysis检验报告
CenterforDrugEvaluation药品审评中心
Chemistry,ManufactureandControl化学，生产及质控ContractResearchOrgnization合同研究组织ChinesePharmacopoeia中国药典
ChemicalAbstractsService美国化学文摘社ClinicalTrailApplication临床试验申请CheifMedicalOfficer首席医学官
CertificateofaPharmaceuticalProduct药品证明文书CorrectiveandPreventiveAction纠正预防行动
DrugMasterFile药品主文件
EuropeanDrugMasterFile欧洲药物管理档案
EuropeanAgencyfortheEvaluationofMedicinalProduct欧洲药物评审局EuropeanUnion欧洲联盟
EuropeanPharmacopoeia欧洲药典
FoodandDrugAdministration食品药品监督管理局（美国药监局）GoodManufacturingPractices良好生产规范
HighPerformanceLiquidChromatography高效液相InternationalConferenceofHarmonization国际协调会议InvestigationalNewDrugApplication新药临床试验申请ImportDrugLicense进口药品注册证书
InternationalNonproprietatyName国际非专有名称LetterofAuthorization委托书LimitofQuantity定量限LimitofDetection检测限
MAMarketingAuthorization上市许可
NDANewDrugApplication新药生产上市申请
NIFDCNationalInstitutesforFoodandDrugControl中国食品药品检定研究院
NMTNotMoreThan不大于NANotAnalysis未检测
OTCOverTheCounter非处方药OOSOutofSpecification不合格
PSURPeriodicSafetyUpdateReports定期安全性报告QOSTheQualityOverallSummary质量整体概述QAQulitityAssurance质量保证QCQulitityControl质量控制RxPrescriptionDrug处方药RSReferenceStandard对照品
SOPStandardOperationProcedure标准操作规范TSTestSolutions指示剂
UVUltraviolet紫外分光光度法
USPUnitedStatesPharmacopoeia美国药典
药品注册词汇
Drugregistrationapplication注册申请Supplementaryapplication补充申请
Drugregulatorydepartment药品监管部门Re-registrationapplication再注册On-siteinspection现场核查
Productionsiteinspection生产现场核查Causalinspection有因核查Authenticity真实性Precision准确性Integrity完整性
Entrustedagency代理机构Dosageform剂型Formula处方
Preparingprocess生产工艺Testingmethods检验方法
Qualityspecifications质量指标Stability稳定性
Drugapprovalnumber批准文号Methodverification方法验证Manufacturer生产厂家Plant工厂
Productionline生产线
Workshop车间Safety安全性Efficacy有效性Acceptance受理Applicant申请人
Biologicalproduct生物制品Preliminaryreview初步审核Variation变更
Rawdata原始数据
Specificationsverification标准复核Secondreview复审
GMPcertificate生产质量管理规范证书Applicationdossers申请文件
CenterforfoodanddruginspectionofCFDACFDA食品药品审核查验中心
产品英语部分
streptococcuspneumoniae肺炎链球菌Streptococcuspyogenes酿脓性链球菌Branhamellacatarrhalis卡他布兰汉姆菌staphylococcusaureus金黄色葡萄球菌
HaemophilusinfluenzaetypeBB型流感嗜血杆菌Klebsiellapneumoniae肺炎克雷伯杆菌Manufacturingprocess生产过程Processcontrol过程控制Lysate裂解物
Culture培养培养基Ultrafiltration滤过，超滤Inactivation灭活Autolysis自溶Alkaline碱性的Bacterialstrain菌株Revitalize复原，激活Sub-culture传代培养Inoculate嫁接Fermenter发酵器Cultivate培养Stir搅拌
Concentrate浓缩
Turbidity浑浊度Fungi真菌
Elimination消除Identify鉴别Purity纯度
Germ细菌，病菌Liter升
Microbiologicalcontrol微生物控制
Thimerosal硫柳汞
Sodiummethyl-paraben对羟基苯甲酸甲酯钠Doseanduniformityofdose剂量及均一性Chlorhexidinediacetate乙酰乙酸氯已定Polysorbate80吐温80（聚山梨酯80）Antigenicactivity抗原活性
Rocketimmunoeletroforesis火箭电泳法Excipient辅料
Steriledistilledwater无菌注射用水Purifiedwater纯化水
Appearance性状Container包装
Surfactant表面活性剂Preservative防腐剂Leaflet说明书
Activeingredients活性成分
Approvaldocuments批准证明文件Researchdata研究资料Stability稳定性
Validationofmethod方法学验证
