FDA常用词中英文对照

合集下载

FDA常用英文词汇翻译

FDA常用英文词汇翻译FDA（FOOD AND DRUG ADMINISTRA TION)：（美国)食品药品管理局IND（INVESTIGA TIONAL NEW DRUG)：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（NEW DRUG APPLICATION)：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION)：简化新药申请EP诉（EXPORT APPLICATION)：出口药申请（申请出口不被批准在美国销售的药品) TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW)DRUG：简化申请的新药DMF（DRUG MASTER FILE)：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（CODE OF FEDERAL REGULATION)：（美国)联邦法规PANEL：专家小组BA TCH PRODUCTION：批量生产；分批生产BA TCH PRODUCTION RECORDS：生产批号记录POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：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)PRE<I>script</I>ION DRUG：处方药OTC DRUG（OVER—THE—COUNTER DRUG)：非处方药U．S．PUBLIC HEALTH SERVICE：美国卫生福利部NIH（NATIONAL INSTITUTE OF HEALTH)：（美国)全国卫生研究所CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROV AL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFIT（S)：受益RISK（S)：受害DRUG PRODUCT：药物产品DRUG SUBSTANCE：原料药ESTABLISHED NAME：确定的名称GENERIC NAME：非专利名称PROPRIETARY NAME：专有名称；INN（INTERNATIONAL NONPROPRIETARY NAME)：国际非专有名称NARRA TIVE SUMMARY记叙体概要ADVERSE EFFECT：副作用ADVERSE REACTION：不良反应PROTOCOL：方案ARCHIV AL COPY：存档用副本REVIEW COPY：审查用副本OFFICIAL COMPENDIUM：法定药典（主要指USP、NF)．USP（THE UNITED STATES PHARMACOPEIA)：美国药典（现已和NF合并一起出版) NF（NATIONAL FORMULARY)：（美国)国家药品集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门（指FDA) 医学全在线www.med126.c omSPONSOR：主办者（指负责并着手临床研究者)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)LABELED AMOUNT：标示量REGULATORY SPECIFICATION：质量管理规格标准（NDA提供)REGULATORY METHODOLOGY：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤)REGULATORY METHODS V ALIDATION：管理用分析方法的验证（FDA对NDA提供的方法进行验证)Dietary supplement：食用补充品PRE<I>script</I>ION DRUG：处方药OTC DRUG（OVER—THE—COUNTER DRUG)：非处方药U．S．PUBLIC HEALTH SERVICE：美国卫生福利部NIH（NATIONAL INSTITUTE OF HEALTH)：（美国)全国卫生研究所CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROV AL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFIT（S)：受益医.学全,在.线,提供w w w.m e d126.c omRISK（S)：受害DRUG PRODUCT：药物产品DRUG SUBSTANCE：原料药ESTABLISHED NAME：确定的名称GENERIC NAME：非专利名称PROPRIETARY NAME：专有名称；INN（INTERNATIONAL NONPROPRIETARY NAME)：国际非专有名称NARRA TIVE SUMMARY记叙体概要ADVERSE EFFECT：副作用ADVERSE REACTION：不良反应PROTOCOL：方案ARCHIV AL COPY：存档用副本REVIEW COPY：审查用副本OFFICIAL COMPENDIUM：法定药典（主要指USP、NF)．USP（THE UNITED STATES PHARMACOPEIA)：美国药典（现已和NF合并一起出版) NF（NATIONAL FORMULARY)：（美国)国家药品集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门（指FDA)SPONSOR：主办者（指负责并着手临床研究者)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)LABELED AMOUNT：标示量REGULATORY SPECIFICATION：质量管理规格标准（NDA提供)REGULATORY METHODOLOGY：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤)REGULATORY METHODS V ALIDATION：管理用分析方法的验证（FDA对NDA提供的方法进行验证)Dietary supplement：食用补充品。

FDA有关术语中英对照

FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：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（NEW DRUG APPLICATION）：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药DMF（DRUG MASTER FILE）：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。

FDA-GMP中英文对照标准版

DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDATable of Contents目录1. INTRODUCTION1.1 Objective目的1.2 Regulatory Applicability法规的适用性1.3 Scope范围2. QUALITY MANAGEMENT.质量管理2.1 Principles总则2.2 Responsibilities of the Quality Unit(s)质量部门的责任2.3 Responsibility for Production Activities生产作业的职责2.4 Internal Audits (Self Inspection)内部审计（自检）2.5 Product Quality Review产品质量审核3. PERSONNEL人员3.1 Personnel Qualifications人员的资质3.2 Personnel Hygiene人员卫生3.3 Consultants顾问4. BUILDINGS AND FACILITIES建筑和设施4.1 Design and Construction设计和结构4.2 Utilities公用设施4.3 Water水4.4 Containment限制4.5 Lighting照明4.6 Sewage and Refuse排污和垃圾4.7 Sanitation and Maintenance卫生和保养5. PROCESS EQUIPMENT工艺设备5.1 Design and Construction设计和结构5.2 Equipment Maintenance and Cleaning设备保养和清洁5.3 Calibration.校验5.4 Computerized Systems计算机控制系统6. DOCUMENTATION AND RECORDS文件和记录6.1 Documentation System and Specifications文件系统和质量标准6.2 Equipment cleaning and Use Record设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records)生产工艺规程（主生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)批生产记录（批生产和控制记录）6.6 Laboratory Control Records实验室控制记录6.7 Batch Production Record Review批生产记录审核7. MATERIALS MANAGEMENT物料管理7.1 General Controls控制通则7.2 Receipt and Quarantine接收和待验7.3 Sampling and Testing of Incoming Production Materials进厂物料的取样与测试7.4 Storage储存7.5 Re-evaluation复验8. PRODUCTION AND IN-PROCESS CONTROLS生产和过程控制8.1 Production Operations生产操作8.2 Time Limits时限8.3 In-process Sampling and Controls工序取样和控制8.4 Blending Batches of Intermediates or APIs中间体或原料药的混批8.5 Contamination Control污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES原料药和中间体的包装和贴签9.1 General总则9.2 Packaging Materials包装材料9.3 Label Issuance and Control标签发放与控制9.4 Packaging and Labeling Operations包装和贴签操作10. STORAGE AND DISTRIBUTION.储存和分发10.1 Warehousing Procedures入库程序10.2 Distribution Procedures分发程序11. LABORATORY CONTROLS实验室控制11.1 General Controls控制通则11.2 Testing of Intermediates and APIs中间体和原料药的测试11.3 Validation of Analytical Procedures分析方法的验证11.4 Certificates of Analysis分析报告单11.5 Stability Monitoring of APIs原料药的稳定性监测11.6 Expiry and Retest Dating有效期和复验期11.7 Reserve/Retention Samples留样12. VALIDATION.验证12.1 Validation Policy验证方针12.2 Validation Documentation验证文件12.3 Qualification确认12.4 Approaches to Process Validation工艺验证的方法12.5 Process Validation Program工艺验证的程序12.6 Periodic Review of Validated Systems验证系统的定期审核12.7 Cleaning Validation清洗验证12.8 Validation of Analytical Methods分析方法的验证13. CHANGE CONTROL变更的控制14. REJECTION AND RE-USE OF MATERIALS.拒收和物料的再利用14.1 Rejection拒收14.2 Reprocessing返工14.3 Reworking重新加工14.4 Recovery of Materials and Solvents物料与溶剂的回收14.5 Returns退货15. COMPLAINTS AND RECALLS投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者17.1 Applicability适用性17.2 Traceability of Distributed APIs and Intermediates已分发的原料药和中间体的可追溯性17.3 Quality Management质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates原料药和中间体的重新包装、重新贴签和待检17.5 Stability稳定性17.6 Transfer of Information信息的传达17.7 Handling of Complaints and Recalls投诉和召回的处理17.8 Handling of Returns退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation用细胞繁殖/发酵生产的原料药的特殊指南18.1 General总则18.2 Cell Bank Maintenance and Record Keeping细胞库的维护和记录的保存18.3 Cell Culture/Fermentation细胞繁殖/发酵18.4 Harvesting, Isolation and Purification收取、分离和精制18.5 Viral Removal/Inactivation steps病毒的去除/灭活步骤19. APIs for Use in Clinical Trials用于临床研究的原料药19.1 General总则19.2 Quality质量19.3 Equipment and Facilities设备和设施19.4 Control of Raw Materials原料的控制19.5 Production生产19.6 Validation验证19.7 Changes变更19.8 Laboratory Controls实验室控制19.9 Documentation文件20. Glossary术语1. INTRODUCTION 1.简介1.1 Objective1.1目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP）提供指南。

美国FDA医疗器械中英文翻译

1272-1299 [预留的] [Reserved]
第Ⅱ章―司法部毒品强制执行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）
1300 定义 DEFINITIONS
1301 管制物质的制造者、分销者和调剂者的登记 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
1302 对管制物质的标识与包装要求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
1303 定额 QUOTAS
1304 登记者的记录与报告 RECORDS AND REPORTS OF REGISTRANTS
878 普通与整形外科器械 GENERAL AND PLASTIC SURGERY DEVICES
880 普通医院与个人使用器械 GENERAL HOSPITAL AND PERSONAL USE DEVICES
882 神经学器械 NEUROLOGICAL DEVICES
884 产科与妇科学器械 OBSTETRICAL AND GYNECOLOGICAL DEVICES
809 人用体外诊断产品 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
810 医疗器械召回权 MEDICAL DEVICE RECALL AUTHORITY
812 试验用器械豁免 INVESTIGATIONAL DEVICE EXEMPTIONS
1004 电子产品的回购、修理或者置换 REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS

美国FDA药品中英文翻译

8.对完成的药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
9.药房配药 PHARMACY COMPOUNDING
10. 对含药饲料的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
6.处方药的药物治疗指导 MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
7.制造、加工、包装或者保存药品的现行良好制造规范；总则 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
13.管制的药品 CONTROLLED DRUGS
14.药品；正式名称与已确定的名称 DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
美国FDA药品中英文翻译
1.处方药广告 PRESCRIPTION DRUG ADVERTISING
ቤተ መጻሕፍቲ ባይዱ
2.处方药销售 PRESCRIPTION DRUG MARKETING
3.对批发处方药销售商颁发州执照的指南 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS （奥咨达医疗器械咨询）
11.对A型含药物品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES

FDA临床试验常见词汇中译文对照.doc

FDA 临床试验常见词汇中译文对照Aaction letter 决定通知active comparator 活性药物对照组active control = AC 阳性对照，活性对照active ingredient 有效成分Active Substance Master File (ASMF) 欧洲药物主文件acute myocardial infarction 急性心肌梗死acute tibial fractures 急性胫骨骨折adalimumab (Humira) 阿达木单抗adaptive design 自适应设计adaptive randomization 自适应随机ADE = adverse drug event 药物不良事件Adenoviral Vectors 腺病毒载体adequate and well-controlled studies 充分严格的对照研究ADHD = Attention-deficit hyperactivity disorder注意力缺陷多动障碍; 注意力不足过动症; 多动症adhesion barrier product 防黏著产品adjuvant 助剂 ; 佐剂 auxiliary;adjuvant therapy 佐药疗法，辅助疗法ADL = activities of daily living 日常生活活动能力ADME = absorption, distribution, metabolism, and excretion(药物 )吸收、分配、代谢和排除ADR = adverse drug reaction 药物不良反应adrenal cortex 肾上腺皮质adrenal cortical hormone 肾上腺皮质激素adrenal gland 肾上腺adrenaline 肾上腺素adulterated devices 掺假器械adverse drug reaction = ADR 药物不良反应adverse effect 副作用adverse event = AE 不良事件adverse medical events 不良医学事件adverse reaction (adverse event) 药物不良反应advisory 提醒advocacy and support groups 倡导和支持团体AE = adverse event 不良事件AERS = Adverse Event Reporting System 不良事件报告系统BBIMO Bioresearch Monitoring Program 生物研究监测bioavailability (F) 生物利用度biochemical drugs 生化药品biocides 生物杀灭剂 ; 杀生物剂biocompatibility 生物相容性biodegradable 生物分解bio-engineered, transgenic food 转基因食物bioequivalence; bioequivalent 生物等效应biofilm 细菌薄膜 , 生物膜biologic 生物制品biological response modifiers BRM 生物应答调节剂biological therapeutic agents 生物治疗药剂biomarker 生物标志物biometrics 生物统计 ; 生物识别技术bion stimulator 生物体刺激器bionic knee 仿生膝关节biopharma: biopharmaceutical products 生物药物产品bipolar 双相燥郁症birth defect 出生缺陷 , 新生儿缺陷 , 先天缺陷BLA = biologic license application 生物制品许可申请blank control 空白对照blend uniformity analysis 混合均匀度分析blind 盲法blind codes 编制盲底blind review 盲态审核blinding method 盲法blinding/ masking 盲法，设盲blister packaging 泡罩包装 ; 水泡眼block 分段 ;层block size 每段的长度blocked randomization 区组随机Ccase history 病历case record form = CRF 病例报告表 / 病例记录表case report form 病例报告表cash curve 现金曲线cash trap 现金陷阱 ; 现金套牢categorical variable 分类变量CLIA Clinical Laboratory Improvement Amendments临床实验室改进修订案clinical (human) data 临床数据clinical endpoint 临床终点clinical equivalence 临床等效应clinical hold 临床试验暂停通知clinical investigator 临床研究者Clinical Pharmacists 临床药师Clinical Research Coordinator = CRC 临床研究协调者clinical study 临床研究Clinical Study Application = CSA 临床研究申请clinical study reportclinical trialclinical trial application = CTAclinical trial exemption = CTXclinical trial protocol = CTPClinical Trial Report = CTRclinically significant resultscohortcohort studiesco-investigator = CIcomparisonCompassionate Usecompetitive labelingComplementary And Alternative Therapy Complete responsecompliancecomposite variableCompression Testcomputer-assisted trial design= CATD Con Meds = concomitant medications confidence intervalconfidence levelConfidentiality Regarding Trial Participants controlcontrol groupcontrolled clinical trialsControlled TrialsCritical PathCRM = continual reassessmentmethod crossover designcross-over studycrossover therapyCRF = case report formdosage formdosage regimendose-ranging studydose-reaction relationdose-related adverse reactionsdouble blindingdouble dummydouble dummydouble dummy techniquedouble-blind studyDouble-Masked Study 临床试验的总结报告临床试验临床试验申请临床试验免责临床试验方案临床试验报告有临床意义队列队列研究合作研究者对照体恤使用优越标签补充性和非传统治疗完全有效遵守；对遵守法规情况的监管复合变量压缩试验计算机辅助试验设计联合用药可信区间置信水平为试验参与者保密对照对照组临床对照实验对照试验关键路径连续重新评估方法交叉设计交叉研究交叉治疗病例报告表剂型给药方案剂量范围研究剂量－反应关系剂量相关的不良反应双盲双模拟双模拟双盲双模拟技术双盲研究双盲研究DRGs = Diagnosis Related Group System drop outdrop testdrug eluting coronary stentsdrug productdrug substancedrug-drug interaction56drug-food interaction 疾病诊断相关分组脱落落震试验 ;跌落试验药物洗脱支架药物产品原料药药物 -药物相互作用药物 -食物的相互作用effectivenessefficacyefficacy (Of a drug or treatment) 疗效有效性测定药效；药品疗效EEMEA = European Medical Evaluation Agency; European Agency for the Evaluation of Medicinal Products; European Medicines Agency 药物评价机构emergency envelope 应急信件 Empiric Bayesian MultipleGamma-Poisson Shrinker; 欧洲医药品管理局empiricalendpointendpoint criteriafactorial designfactorial trialfailureFair Packaging and Labeling Act (1966) False Claims Actfalse therapeutic claimsfull analysis setfull factorial design 经验性贝氏法（伽玛泊松分布缩检法）经验性终点终点指标析因设计析因试验无效，失败公平包装和标签法防制不实请求法错误的疗效声明全分析集全因子试验法Iinclusion criteria入选标准inclusion/exclusion criteria入选/排除标准incremental exposure食品中递增摄入量incubation period/latency period潜伏期IND = Investigational New Drug临床研究新药INDA = investigational new drug application NDA前申报阶段indemnity insurance赔偿保险Independent Data Monitoring = IDM独立数据监察Independent Data Monitoring Committee = IDMC独立数据监察委员会independent ethics committee = IEC indicationsinvestigational new drug= IND investigational product 独立伦理委员会适应症临床研究新药试验药物investigatorinvestigator's brochure = IB 调研人员研究者手册Mmaskedmean absorption time = MAT mean disintegration time = MDIT 设盲(药物在体内的(药物在体内的)平均吸收时间)平均崩解时间Mean Dissolution Time = MDT Mean Residence Time = MRT (药物在体内的(药物在体内的)平均释放时间)平均滞留时间medical governanceMedicaremedication guides (for patients) Medicines Control Agency = MCA MisbrandingMiscodingmissing valuemixed effect modelMLD = minimal lethal doseMoA = Mechanism of Actionmonitormonitoring planmonitoring reportMR = moderate responseMRA = Agreement on Mutual Recognition MTD = maximal tolerance dose multicenter trialmulti-drug resistancemultiple arm trialsmutual recognition procedure (EU) 医药治理老年医疗保险制度；联邦老年医保用药指南英国药品监督局错误标签 ; 冒牌编码错误缺失值混合效应模式最小致死剂量作用机制 ;作用机理监查员监查计划监查报告好转相互承认协定最大耐受剂量多中心试验多药物抗药性多治疗组的试验相互承认程序OOS = Overall survival 总生存率Pparallel group designparameter estimationparametric releaseparametric statisticspatient filepatient global; pt globalpatient historyper protocol ( PP) analysisPFS = progression-free survival PGE = patient global evaluation PHA = preliminary hazards analysis pharmaceutical equivalence pharmaceutics 平行组设计参数估计参数放行参数统计方法病人档案病人总体评价病历符合方案分析无疾病进展存活率病人总体评价预先危险分析药剂等效性药剂学pharmacodynamics=PD 药物效应动力学 ; 简称药效学pharmacoepidemiology 药物流行病学pharmacokinetics = PK 药代动力学 ; 简称药动学pharmacology 药理学Pharmacovigilance105 药物警戒pharmacy 配药学PharMetrics claims database 索赔数据库PhRMA = Pharmaceutical Research and Manufacturers of America美国药物研究与生产商协会PIC=Pharmaceutical Inspection Convention 药品检查协定PIC/S Pharmaceutical Inspection Cooperation Scheme 药物检查合作计划pipeline assets 开发中产品PK = pharmacokinetics 药物代谢动力学 ; 药动学，药代动力学placebo 安慰剂placebo control 安慰剂对照placebo controlled study 安慰剂对照研究placebo effect 安慰剂效应PMA = premarket approval 上市前许可 ; 销售前批准PMCs = post marketing commitments 承诺药品上市后的继续研究PMDRA = Post Marketing Drug Risk Assessment 上市后药品风险评估 (办公室 ) PMHx = Past Medical History 既往病史PMN = Premarket Notification 销售前通知PMS = Premenstrual syndrome 经前综合症POC (Proof-of-concept) Clinical Trials 概念证明POC = point-of-care testing 床旁分析polytomies 多分类pooled analysis = PA 荟萃分析postmarket surveillance 上市后监督post-marketing surveillance; postmarket safety surveillance 销售（上市）后监督power 把握度 ; 检验效能Pp = Process Performance 工序绩效Ppk = Process Performance Index 工序绩效指数precautions 慎用；注意事项precision 精密度preclinical (animal) data 临床前 (动物实验 )数据preclinical study 临床前研究predicate device = legally marketed device that is not subject to Premarket Approval (PMA)和已合法在市场上销售的且不需要做PMA“销售前批准”的Pre-market Approval (Application) = PMA 上市前许可（申请）premarket notification 上市前通知pre-marketing surveillance 销售（上市）前监督preparing and submitting 起草和申报prescription drug 处方药preservation 保藏prevalenceprevention trialsprimary (coronary) eventprimary endpointprimary mode of action = PMOA primary variableprincipal investigator = PIPrinciples of Qualificationprocess controlsprocess validationproduct codesproduct differentiationproduct license =PLproduct life cycle (PLC)prognosisprogression-free survival = PFS progressive Disease PDproof of principle studypropensity scoreprotocolprotocol amendmentprototype designprotozoaproven acceptable Range = PAR PTC = Product Technical ComplaintsQqualification system for licensed pharmacist qualified health claims Qualified Person = QPquality assurance = QAquality assurance unit = QAUquality control = QC quality management systemsquality of life trials or supportive care trials quality risk management = QRM quantitative risk assessmentRrandomizationrandomized trialrandomized, double blinded clinical trial range checkrating scaleRCT = randomized clinical trialsRCT = randomized controlled trial 患病率预防试验原位病变主要终点首要作用模式主要变量主要研究者确认（验证）原则工艺控制工艺验证产品的号码产品差异化，产品特色化产品许可证产品生命周期预后无进展生存病情进展原理循证研究倾向性评分试验方案 ; 方案方案补正原型设计原生动物门确定可接受范围药品技术投诉执业药师资格准入制度有保留的健康宣称受权人质量保证质量保证部门质量控制质量管理体系生存质量试验质量风险管理量化风险评估随机化随机化试验随机双盲对照研究范围检查量表随机临床试验随机对照试验RDE: remote data entry 远距数据输入ready-to-eat foods 即食食品reagents 试剂recall 召回 ; 强制回收RECIST = Response Evaluation Criteria in Solid Tumors 实体瘤的疗效评价标准reconditioning 整改 ; 货物重整理；货物重包装recycled plastics 可循环利用塑料制品reference product 参比制剂reference samples 标准样品regulatory methodology 质量管理方法regulatory methods validation 管理用分析方法的验证（ FDA 对 NDA 提供的方法进行验证）regulatory specification 质量管理规格标准（ NDA 提供）rejection 排异remote monitoring system 远程监测系统 ; 远程监控REMS = Risk Evaluation and Mitigation Strategies 风险评估和减缓战略risk 受害risk assessment (risk analysis + risk evaluation) 风险评估，论证risk classification 风险分类 ;Risk Communications Advisory Committee 风险交流咨询委员会risk evaluation (part of risk assessment) 风险评价risk/ benefit analysis 风险 -获益分析risk-benefit ratio 效益 / 风险比route of administration 给药途径royalties 专利使用费RPN = Risk Priority Number 风险优先指数RR = Response rate 缓解率RSD = (intra-day and inter-day) relative standard deviations (日内和日间 ) 相对标准差Ssafety advisory 安全建议safety evaluation 安全性评价safety evaluators 安全性评估人员safety set 安全性评价的数据集screening trials 筛选性试验SD = standard deviation 标准 (偏 )差SE = substantial equivalence 实质上的等同Seal Strength Test 密封强度试验sequence 试验次序SFDA 129= State Food And Drug Administration 国家食品药品监督管理局SG & A= Sales, General and Administration 销售、管理和一般费用shaft 传动轴SHEA = Society for Healthcare Epidemiology of America 美国医院流行病学学会sheaths 护套shelf life 保存期限 ; 保质期SIC codes = Standard Industrial Classification codes 标准产业分类代码side effects 副作用significance level 显著性水平Significant Risk (SR) 显著的危险性simple randomization 简单随机simulation model 仿真模型single blinding 单盲single-blind study 单盲研究single-masked study 单盲研究site assessment = SA 现场评估site audit 试验机构稽查SMDA = Safe Medical Devices Act of 1990 1990 年安全医疗器械法SMF = Site Master File 生产场所主文件sNDA = supplemental NDA 疗效补充新药上市申请sponsor-investigator = SI 申办研究者spontaneous reports; voluntary reports 药品不良反应自愿报告SPS = Agreement on the Application Of Sanitary and Phytosanitary Measures卫生与植物卫生措施实施协议;简称 SPS协议SSI = surgical site infection 手术部位感染SSOPs = Sanitation Standard Operating Procedures 卫生标准操作程序standard curve 标准曲线standard deviation 标准偏差standard drug 标准药物standard operating procedure = SOP 标准操作规程standard treatment 标准治疗Standards Of Care131 医护标准State Food and Drug Administration = SFDA 国家食品药品监督管理局statistic 统计量statistical analysis plan = SAP 统计分析计划statistical model 统计模型statistical significance 统计学意义statistical tables 统计分析表Statisticians in the Pharmaceutical Industry = PSI 制药业统计学家协会steady-state Area Under the Curve = AUCss稳态药时曲线下面积/ 稳态血药浓度－时间曲线下面积stratified 分层study audit 研究稽查study endpoint 研究终点Study Personnel List = SPL 研究人员名单study site 研究中心study type 研究类型subchronic toxicity studies 亚慢性毒性研究subgroup 亚组sub-investigator 助理研究者subject 受试者subject diary = SD 受试者日记subject enrollment 受试者入选subject enrollment log = SEL 受试者入选表Subject Identification Code List = SIC 受试者识别代码表subject recruitment 受试者招募subject screening log = SSL 受试者筛选表submission 申报；递交subspecialties, internal medicine 亚专科 ,内科substantial equivalence to legally marketed (predicate) device 和已合法在市场上销售的且不需要做 PMA“销售前批准”的相似产品有实质上的等同Ttrain-the-trainer program 培训者培训计划treatment group 试验组treatment IND 治疗性试验性新药申请treatment trials 治疗性试验trial error 试验误差trial initial meeting 试验启动会议trial master file 试验总档案trial objective 试验目的trial site 试验场所TRICARE 军队医疗系统triple blinding 三盲two one-side test 双单侧检验UAE = unexpected adverse event 预料外不良事件unblinding 破盲 ;揭盲under reporting bias 少报偏差unexplained syncope 不明原因晕厥unresectable 不能手术切除variability 变异variable 变量WHO International Collaborating Center for Drug Monitoring(世界卫生组织 )国际药物监测合作中心WHO International Conference of Drug Regulatory Authorities = WHO-ICDRAWHO 国际药品管理当局会议WHO Programme for International Drug Monitoring = PIDMWHO 国际药物监测合作计划。

常用临床申报资料翻译中英文对照

FDA（FOOD AND DRUG ADMINISTRA TION）：（美国）食品药品管理局IND（INVESTIGA TIONAL NEW DRUG）：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（NEW DRUG APPLICA TION）：新药申请ANDA（ABBREVIA TED NEW DRUG APPLICA TION）：简化新药申请EP诉（EXPORT APPLICA TION）：出口药申请（申请出口不被批准在美国销售的药品）TREA TMENT IND：研究中的新药用于治疗ABBREVIA TED（NEW）DRUG：简化申请的新药DMF（DRUG MASTER FILE）：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。

FDA常用词汇中英文，请收好！

FDA常用词汇中英文，请收好！AAccelerated: 加速条件 Accuracy: 准确性AIP（Application Integrity Policy）: 申请完全政策制裁ANDA（Abbreviation New Drug Application）:仿制药或仿制新药申请API（Active Pharmaceutical Ingredient）:原料药或活性药。

原简称BPC（Bulk Pharmaceutical Chemical）,现常用API。

在药典和一些论文中也常用Drug Substance 或Substance 来代表原料药。

Appearance: 外观Assay:含量Assessment: 药厂自我评估（厂家组织进行的对药厂本身设施有关文件的模拟FDA检查）Audit:审查（预审查，多用于美方原料药用户，在FDA和PAI之前到药厂进行现场预检查）Auditor:审核员Audit trail: 审计踪迹BBasket:篮子式Batch production records: 批生产纪录Batch records:批号（量）纪录（即batch production and control records 批量生产和检验纪录）BPC:（Bulk Pharmaceutical chemical）原料药Bracketing stability design:稳定性试验的括号分组设计Blend uniformity: 均匀度CCalibration: 校正或校准（对设备，仪器和衡器等的准确度进行校正）Certification of Areas for GMP compliance: (检验企业实施现行药品生产管路规范部门的标准操作规程)CFR 21 Part 11（Code of federal Registry Part11）：联邦法规法典标题21第11部分CGMP（Current Good Manufacturing Practice）：现行药品生产质量管理规范Change control form：也简称CCF 变更控制表Change control：变更控制Cleaning validation：清洁验证CMC（Chemistry and manufacture control）化学和生产的控制Compliance：符合性Compatibility：共存性或兼容性Content uniformity test: 产品含量均匀性测定Container closure system: 容器封闭系统 COA（Certification of analysis ）：分析合格证书，检验报告或检验报告单DDelayed release：延期放行Design qualification: 设计确认Dissolution test：溶出度测试 Deviation records：偏差纪录DMF（drug master file）:药物主文件或原料药档案Drug product：成品药 Drug substance：原料药EEIR（Establishment inspection report）：确定检查报告Electronic signature：电子签名Equipment qualification：对设备，设施，仪器等性能的鉴定Excipients：赋形剂或辅料Excit meeting：现场检查结束会 Extended release: 缓慢释放EMEA（The European Medicines Evaluation Agency）:欧洲医药评审委员会FFinished pharmaceuticals （drug product, finishes product, finished dosage form）:制剂药（成品药）其定义位已原料药为起始物料，加一定的赋形剂，制成具有一定剂型可直接用于治疗的药剂。

FDA-GMP中英文对照标准版

DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDATable of Contents 目录1. INTRODUCTION1.1 Objective 目的1.2 Regulatory Applicability法规的适用性1.3 Scope 范围2. QUALITY MANAGEMENT .质量管理2.1 Principles 总则2.2 Responsibilities of the Quality Unit(s) 质量部门的责任2.3 Responsibility for Production Activities 生产作业的职责2.4 Internal Audits (Self Inspection) 内部审计（自检）2.5 Product Quality Review 产品质量审核3. PERSONNEL 人员3.1 Personnel Qualifications 人员的资质3.2 Personnel Hygiene 人员卫生3.3 Consultants 顾问4. BUILDINGS AND FACILITIES 建筑和设施4.1 Design and Construction 设计和结构4.2 Utilities 公用设施4.3 Water 水4.4 Containment 限制4.5 Lighting 照明4.6 Sewage and Refuse 排污和垃圾4.7 Sanitation and Maintenance 卫生和保养5. PROCESS EQUIPMENT 工艺设备5.1 Design and Construction 设计和结构5.2 Equipment Maintenance and Cleaning 设备保养和清洁5.3 Calibration. 校验5.4 Computerized Systems 计算机控制系统6. DOCUMENTATION AND RECORDS 文件和记录6.1 Documentation System and Specifications 文件系统和质量标准6.2 Equipment cleaning and Use Record 设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records)生产工艺规程（主生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)批生产记录（批生产和控制记录）6.6 Laboratory Control Records 实验室控制记录6.7 Batch Production Record Review 批生产记录审核7. MATERIALS MANAGEMENT 物料管理7.1 General Controls 控制通则7.2 Receipt and Quarantine 接收和待验7.3 Sampling and Testing of Incoming Production Materials 进厂物料的取样与测试7.4 Storage 储存7.5 Re-evaluation 复验8. PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制8.1 Production Operations 生产操作8.2 Time Limits 时限8.3 In-process Sampling and Controls 工序取样和控制8.4 Blending Batches of Intermediates or APIs 中间体或原料药的混批8.5 Contamination Control 污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES原料药和中间体的包装和贴签9.1 General 总则9.2 Packaging Materials 包装材料9.3 Label Issuance and Control 标签发放与控制9.4 Packaging and Labeling Operations 包装和贴签操作10. STORAGE AND DISTRIBUTION.储存和分发10.1 Warehousing Procedures 入库程序10.2 Distribution Procedures 分发程序11. LABORATORY CONTROLS 实验室控制11.1 General Controls 控制通则11.2 Testing of Intermediates and APIs 中间体和原料药的测试11.3 Validation of Analytical Procedures 分析方法的验证11.4 Certificates of Analysis分析报告单11.5 Stability Monitoring of APIs 原料药的稳定性监测11.6 Expiry and Retest Dating 有效期和复验期11.7 Reserve/Retention Samples 留样12. VALIDATION .验证12.1 Validation Policy 验证方针12.2 Validation Documentation 验证文件12.3 Qualification 确认12.4 Approaches to Process Validation 工艺验证的方法12.5 Process Validation Program 工艺验证的程序12.6 Periodic Review of Validated Systems 验证系统的定期审核12.7 Cleaning Validation 清洗验证12.8 Validation of Analytical Methods 分析方法的验证13. CHANGE CONTROL 变更的控制14. REJECTION AND RE-USE OF MATERIALS.拒收和物料的再利用14.1 Rejection 拒收14.2 Reprocessing 返工14.3 Reworking 重新加工14.4 Recovery of Materials and Solvents 物料与溶剂的回收14.5 Returns 退货15. COMPLAINTS AND RECALLS 投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者17.1 Applicability 适用性17.2 Traceability of Distributed APIs and Intermediates已分发的原料药和中间体的可追溯性17.3 Quality Management 质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates原料药和中间体的重新包装、重新贴签和待检17.5 Stability 稳定性17.6 Transfer of Information 信息的传达17.7 Handling of Complaints and Recalls 投诉和召回的处理17.8 Handling of Returns 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation用细胞繁殖/发酵生产的原料药的特殊指南18.1 General 总则18.2 Cell Bank Maintenance and Record Keeping 细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 收取、分离和精制18.5 Viral Removal/Inactivation steps 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials 用于临床研究的原料药19.1 General 总则19.2 Quality 质量19.3 Equipment and Facilities设备和设施19.4 Control of Raw Materials 原料的控制19.5 Production 生产19.6 Validation 验证19.7 Changes 变更19.8 Laboratory Controls 实验室控制19.9 Documentation 文件20. Glossary 术语1. INTRODUCTION 1. 简介1.1 Objective 1.1目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP）提供指南。

FDA英语术语大全.docx

FDA英语术语大全FDA是什么意思， FDA得英文全称是什么？FDA（ FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（ INVESTIGATIONAL NEW DRUG）：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（ NEW DRUG APPLICATION）：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请EP诉（ EXPORTAPPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药DMF（ DRUG MASTER FILE）：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（ CODE OF FEDERAL REGULATION）：（美国）联邦法规PANEL：专家小组BATCH PRODUCTION：批量生产；分批生产BATCH PRODUCTION RECORDS：生产批号记录POST-OR PRE- MARKET SURVEILLANCE：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）PRESCRIPTION DRUG：处方药OTC DRUG（OVER—THE—COUNTER DRUG）：非处方药U．S．PUBLIC HEALTH SERVICE：美国卫生福利部NIH（ NATIONAL INSTITUTE OF HEALTH）：（美国）全国卫生研究所CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROVAL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFIT（S）：受益RISK（S）：受害DRUG PRODUCT：药物产品DRUG SUBSTANCE：原料药ESTABLISHED NAME：确定的名称GENERIC NAME：非专利名称PROPRIETARY NAME：专有名称；INN（ INTERNATIONAL NONPROPRIETARY）NAME：国际非专有名称NARRATIVE SUMMARY记叙体概要ADVERSE EFFECT：副作用ADVERSE REACTION：不良反应PROTOCOL：方案ARCHIVAL COPY：存档用副本REVIEW COPY：审查用副本OFFICIAL COMPENDIUM：法定药典（主要指USP、 NF）．USP（THE UNITED STATES PHARMACOPEIA）：美国药典（现已和NF 合并一起出版）NF（NATIONAL FORMULARY）：（美国）国家药品集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门（指FDA）SPONSOR：主办者（指负责并着手临床研究者）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）LABELED AMOUNT：标示量REGULATORY SPECIFICATION：质量管理规格标准（ NDA提供）REGULATORYMETHODOLOGY：质量管理方法（ FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）REGULATORY METHODS VALIDATION：管理用分析方法的验证（FDA对 NDA提供的方法进行验证）Dietary supplement：食用补充品。

美国FDA人用药品中英文翻译

14. 用于非处方的人类使用的止吐药品 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
15. 用于非处方的人类使用的帮助夜间睡眠的药品 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
12. 用于非处方的人类使用的局部抗菌药品 TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
13. 用于非处方的人类使用的止泻药品 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
10.用于非处方的人类使用的抗酸产品 D PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
11. 用于非处方的人类使用的抗胃肠气胀产品 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
5.诊断用放射性药品 DIAGNOSTIC RADIOPHARMACEUTICALS（奥咨达医疗器械咨询）
6.罕见病药 ORPHAN DRUGS
7.生物利用度与生物等效性要求 BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
8.含有酒精的预期用于口部摄入的非处方药品 OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
26.用于非处方的人类使用的防龋药品 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

FDA临床试验常见词汇中译文对照

本资料由药智网收集整理action letter 决定通知active comparator 活性药物对照组active control = AC 阳性对照，活性对照active ingredient 有效成分Active Substance Master File (ASMF) 欧洲药物主文件acute myocardial infarction 急性心肌梗死acute tibial fractures 急性胫骨骨折adalimumab (Humira) 阿达木单抗adaptive design 自适应设计adaptive randomization 自适应随机ADE = adverse drug event 药物不良事件Adenoviral V ectors 腺病毒载体adequate and well-controlled studies 充分严格的对照研究ADHD = Attention-deficit hyperactivity disorder 注意力缺陷多动障碍; 注意力不足过动症; 多动症adhesion barrier product 防黏著产品adjuvant 助剂; 佐剂auxiliary;adjuvant therapy 佐药疗法，辅助疗法ADL = activities of daily living 日常生活活动能力ADME = absorption, distribution, metabolism, and excretion (药物)吸收、分配、代谢和排除ADR = adverse drug reaction 药物不良反应adrenal cortex 肾上腺皮质adrenal cortical hormone 肾上腺皮质激素adrenal gland 肾上腺adrenaline 肾上腺素adulterated devices 掺假器械adverse drug reaction = ADR药物不良反应adverse effect 副作用adverse event = AE 不良事件adverse medical events 不良医学事件adverse reaction (adverse event) 2 药物不良反应advisory 提醒advocacy and support groups3 倡导和支持团体AE = adverse event 4 不良事件AERS = Adverse Event Reporting System 不良事件报告系统药品注册。

FDA-GMP中英文对照标准版

DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDATable of Contents 目录1. INTRODUCTION1.1 Objective 目的1.2 Regulatory Applicability法规的适用性1.3 Scope 范围2. QUALITY MANAGEMENT .质量管理2.1 Principles 总则2.2 Responsibilities of the Quality Unit(s) 质量部门的责任2.3 Responsibility for Production Activities 生产作业的职责2.4 Internal Audits (Self Inspection) 内部审计（自检）2.5 Product Quality Review 产品质量审核3. PERSONNEL 人员3.1 Personnel Qualifications 人员的资质3.2 Personnel Hygiene 人员卫生3.3 Consultants 顾问4. BUILDINGS AND FACILITIES 建筑和设施4.1 Design and Construction 设计和结构4.2 Utilities 公用设施4.3 Water 水4.4 Containment 限制4.5 Lighting 照明4.6 Sewage and Refuse 排污和垃圾4.7 Sanitation and Maintenance 卫生和保养5. PROCESS EQUIPMENT 工艺设备5.1 Design and Construction 设计和结构5.2 Equipment Maintenance and Cleaning 设备保养和清洁5.3 Calibration. 校验5.4 Computerized Systems 计算机控制系统6. DOCUMENTATION AND RECORDS 文件和记录6.1 Documentation System and Specifications 文件系统和质量标准6.2 Equipment cleaning and Use Record 设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records)生产工艺规程（主生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)批生产记录（批生产和控制记录）6.6 Laboratory Control Records 实验室控制记录6.7 Batch Production Record Review 批生产记录审核7. MATERIALS MANAGEMENT 物料管理7.1 General Controls 控制通则7.2 Receipt and Quarantine 接收和待验7.3 Sampling and Testing of Incoming Production Materials 进厂物料的取样与测试7.4 Storage 储存7.5 Re-evaluation 复验8. PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制8.1 Production Operations 生产操作8.2 Time Limits 时限8.3 In-process Sampling and Controls 工序取样和控制8.4 Blending Batches of Intermediates or APIs 中间体或原料药的混批8.5 Contamination Control 污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES 原料药和中间体的包装和贴签9.1 General 总则9.2 Packaging Materials 包装材料9.3 Label Issuance and Control 标签发放与控制9.4 Packaging and Labeling Operations 包装和贴签操作10. STORAGE AND DISTRIBUTION.储存和分发10.1 Warehousing Procedures 入库程序10.2 Distribution Procedures 分发程序11. LABORATORY CONTROLS 实验室控制11.1 General Controls 控制通则11.2 Testing of Intermediates and APIs 中间体和原料药的测试11.3 Validation of Analytical Procedures 分析方法的验证11.4 Certificates of Analysis分析报告单11.5 Stability Monitoring of APIs 原料药的稳定性监测11.6 Expiry and Retest Dating 有效期和复验期11.7 Reserve/Retention Samples 留样12. VALIDATION .验证12.1 Validation Policy 验证方针12.2 Validation Documentation 验证文件12.3 Qualification 确认12.4 Approaches to Process Validation 工艺验证的方法12.5 Process Validation Program 工艺验证的程序12.6 Periodic Review of Validated Systems 验证系统的定期审核12.7 Cleaning Validation 清洗验证12.8 Validation of Analytical Methods 分析方法的验证13. CHANGE CONTROL 变更的控制14. REJECTION AND RE-USE OF MATERIALS.拒收和物料的再利用14.1 Rejection 拒收14.2 Reprocessing 返工14.3 Reworking 重新加工14.4 Recovery of Materials and Solvents 物料与溶剂的回收14.5 Returns 退货15. COMPLAINTS AND RECALLS 投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者17.1 Applicability 适用性17.2 Traceability of Distributed APIs and Intermediates已分发的原料药和中间体的可追溯性17.3 Quality Management 质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates原料药和中间体的重新包装、重新贴签和待检17.5 Stability 稳定性17.6 Transfer of Information 信息的传达17.7 Handling of Complaints and Recalls 投诉和召回的处理17.8 Handling of Returns 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation 用细胞繁殖/发酵生产的原料药的特殊指南18.1 General 总则18.2 Cell Bank Maintenance and Record Keeping 细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 收取、分离和精制18.5 Viral Removal/Inactivation steps 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials 用于临床研究的原料药19.1 General 总则19.2 Quality 质量19.3 Equipment and Facilities设备和设施19.4 Control of Raw Materials 原料的控制19.5 Production 生产19.6 Validation 验证19.7 Changes 变更19.8 Laboratory Controls 实验室控制19.9 Documentation 文件20. Glossary 术语1. INTRODUCTION 1. 简介1.1 Objective 1.1目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. 本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP）提供指南。

FDA临床试验常见词汇中译文对照

FDA临床试验常见词汇中译文对照Aaction letter 决定通知active comparator 活性药物对照组active control = AC 阳性对照，活性对照active ingredient 有效成分Active Substance Master File (ASMF) 欧洲药物主文件acute myocardial infarction 急性心肌梗死acute tibial fractures 急性胫骨骨折adalimumab (Humira) 阿达木单抗adaptive design 自适应设计adaptive randomization 自适应随机ADE = adverse drug event 药物不良事件Adenoviral Vectors 腺病毒载体adequate and well-controlled studies 充分严格的对照研究ADHD = Attention-deficit hyperactivity disorder注意力缺陷多动障碍; 注意力不足过动症; 多动症adhesion barrier product 防黏著产品adjuvant 助剂; 佐剂auxiliary;adjuvant therapy 佐药疗法，辅助疗法ADL = activities of daily living 日常生活活动能力ADME = absorption, distribution, metabolism, and excretion(药物)吸收、分配、代谢和排除ADR = adverse drug reaction 药物不良反应adrenal cortex 肾上腺皮质adrenal cortical hormone 肾上腺皮质激素adrenal gland 肾上腺adrenaline 肾上腺素adulterated devices 掺假器械adverse drug reaction = ADR药物不良反应adverse effect 副作用adverse event = AE 不良事件adverse medical events 不良医学事件adverse reaction (adverse event) 药物不良反应advisory 提醒advocacy and support groups 倡导和支持团体AE = adverse event 不良事件AERS = Adverse Event Reporting System 不良事件报告系统BBIMO Bioresearch Monitoring Program 生物研究监测bioavailability (F) 生物利用度biochemical drugs 生化药品biocides 生物杀灭剂; 杀生物剂biocompatibility 生物相容性biodegradable 生物分解bio-engineered, transgenic food 转基因食物bioequivalence; bioequivalent 生物等效应biofilm 细菌薄膜, 生物膜biologic 生物制品biological response modifiers BRM 生物应答调节剂biological therapeutic agents 生物治疗药剂biomarker 生物标志物biometrics 生物统计; 生物识别技术bion stimulator 生物体刺激器bionic knee 仿生膝关节biopharma: biopharmaceutical products 生物药物产品bipolar 双相燥郁症birth defect 出生缺陷, 新生儿缺陷, 先天缺陷BLA = biologic license application 生物制品许可申请blank control 空白对照blend uniformity analysis 混合均匀度分析blind 盲法blind codes 编制盲底blind review 盲态审核blinding method 盲法blinding/ masking 盲法，设盲blister packaging 泡罩包装; 水泡眼block 分段;层block size 每段的长度blocked randomization 区组随机Ccase history 病历case record form = CRF病例报告表/病例记录表case report form 病例报告表cash curve 现金曲线cash trap 现金陷阱; 现金套牢categorical variable 分类变量CLIA Clinical Laboratory Improvement Amendments临床实验室改进修订案clinical (human) data 临床数据clinical endpoint临床终点clinical equivalence 临床等效应clinical hold 临床试验暂停通知clinical investigator 临床研究者Clinical Pharmacists 临床药师Clinical Research Coordinator = CRC临床研究协调者clinical study 临床研究Clinical Study Application = CSA临床研究申请clinical study report 临床试验的总结报告clinical trial 临床试验clinical trial application = CTA 临床试验申请clinical trial exemption = CTX 临床试验免责clinical trial protocol = CTP 临床试验方案Clinical Trial Report = CTR临床试验报告clinically significant results 有临床意义cohort 队列cohort studies 队列研究co-investigator = CI合作研究者comparison 对照Compassionate Use 体恤使用competitive labeling 优越标签Complementary And Alternative Therapy 补充性和非传统治疗Complete response 完全有效compliance 遵守；对遵守法规情况的监管composite variable 复合变量Compression Test 压缩试验computer-assisted trial design= CATD计算机辅助试验设计Con Meds = concomitant medications 联合用药confidence interval 可信区间confidence level 置信水平Confidentiality Regarding Trial Participants 为试验参与者保密control对照control group 对照组controlled clinical trials 临床对照实验Controlled Trials 对照试验Critical Path 关键路径CRM = continual reassessment method 连续重新评估方法crossover design 交叉设计cross-over study 交叉研究crossover therapy 交叉治疗CRF = case report form 病例报告表dosage form 剂型dosage regimen 给药方案dose-ranging study 剂量范围研究dose-reaction relation 剂量－反应关系dose-related adverse reactions 剂量相关的不良反应double blinding 双盲double dummy 双模拟double dummy 双模拟double dummy technique 双盲双模拟技术double-blind study 双盲研究Double-Masked Study 双盲研究DRGs = Diagnosis Related Group System 疾病诊断相关分组drop out 脱落drop test 落震试验;跌落试验drug eluting coronary stents 药物洗脱支架drug product 药物产品drug substance 原料药drug-drug interaction56 药物-药物相互作用drug-food interaction 药物-食物的相互作用EEPS = Electronic Entry Processing System 电子录入处理系统effectiveness 疗效efficacy 有效性测定efficacy (Of a drug or treatment) 药效；药品疗效EEMEA = European Medical Evaluation Agency; European Agency for the Evaluation of Medicinal Products; European Medicines Agency 药物评价机构; 欧洲医药品管理局emergency envelope 应急信件Empiric Bayesian Multiple Gamma-Poisson Shrinker经验性贝氏法（伽玛泊松分布缩检法）empirical 经验性endpoint 终点endpoint criteria 终点指标factorial design 析因设计factorial trial 析因试验failure 无效，失败Fair Packaging and Labeling Act (1966) 公平包装和标签法False Claims Act 防制不实请求法false therapeutic claims 错误的疗效声明full analysis set 全分析集full factorial design 全因子试验法Iinclusion criteria 入选标准inclusion/exclusion criteria 入选/排除标准incremental exposure 食品中递增摄入量incubation period/latency period 潜伏期IND = Investigational New Drug 临床研究新药INDA = investigational new drug application NDA前申报阶段indemnity insurance 赔偿保险Independent Data Monitoring = IDM独立数据监察Independent Data Monitoring Committee = IDMC独立数据监察委员会independent ethics committee = IEC 独立伦理委员会indications 适应症investigational new drug = IND 临床研究新药investigational product 试验药物investigator 调研人员investigator's brochure = IB 研究者手册Mmasked 设盲mean absorption time = MAT(药物在体内的)平均吸收时间mean disintegration time = MDIT(药物在体内的)平均崩解时间Mean Dissolution Time = MDT (药物在体内的)平均释放时间Mean Residence Time = MRT(药物在体内的)平均滞留时间medical governance 医药治理Medicare 老年医疗保险制度；联邦老年医保medication guides (for patients) 用药指南Medicines Control Agency = MCA英国药品监督局Misbranding 错误标签; 冒牌Miscoding 编码错误missing value 缺失值mixed effect model 混合效应模式MLD = minimal lethal dose 最小致死剂量MoA = Mechanism of Action 作用机制;作用机理monitor 监查员monitoring plan监查计划monitoring report 监查报告MR = moderate response 好转MRA = Agreement on Mutual Recognition 相互承认协定MTD = maximal tolerance dose 最大耐受剂量multicenter trial 多中心试验multi-drug resistance 多药物抗药性multiple arm trials 多治疗组的试验mutual recognition procedure (EU) 相互承认程序OOS = Overall survival 总生存率Pparallel group design 平行组设计parameter estimation 参数估计parametric release 参数放行parametric statistics 参数统计方法patient file 病人档案patient global; pt global 病人总体评价patient history 病历per protocol ( PP) analysis 符合方案分析PFS = progression-free survival 无疾病进展存活率PGE = patient global evaluation 病人总体评价PHA = preliminary hazards analysis 预先危险分析pharmaceutical equivalence 药剂等效性pharmaceutics药剂学pharmacodynamics=PD 药物效应动力学; 简称药效学pharmacoepidemiology 药物流行病学pharmacokinetics = PK 药代动力学; 简称药动学pharmacology 药理学Pharmacovigilance105 药物警戒pharmacy 配药学PharMetrics claims database 索赔数据库PhRMA = Pharmaceutical Research and Manufacturers of America美国药物研究与生产商协会PIC=Pharmaceutical Inspection Convention 药品检查协定PIC/S Pharmaceutical Inspection Cooperation Scheme 药物检查合作计划pipeline assets 开发中产品PK = pharmacokinetics 药物代谢动力学; 药动学，药代动力学placebo 安慰剂placebo control 安慰剂对照placebo controlled study 安慰剂对照研究placebo effect 安慰剂效应PMA = premarket approval 上市前许可; 销售前批准PMCs = post marketing commitments 承诺药品上市后的继续研究PMDRA = Post Marketing Drug Risk Assessment 上市后药品风险评估(办公室) PMHx = Past Medical History 既往病史PMN = Premarket Notification 销售前通知PMS = Premenstrual syndrome 经前综合症POC (Proof-of-concept) Clinical Trials 概念证明POC = point-of-care testing 床旁分析polytomies 多分类pooled analysis = PA 荟萃分析postmarket surveillance 上市后监督post-marketing surveillance; postmarket safety surveillance 销售（上市）后监督power 把握度; 检验效能Pp = Process Performance 工序绩效Ppk = Process Performance Index 工序绩效指数precautions 慎用；注意事项precision 精密度preclinical (animal) data 临床前(动物实验)数据preclinical study 临床前研究predicate device = legally marketed device that is not subject to Premarket Approval (PMA)和已合法在市场上销售的且不需要做PMA“销售前批准”的Pre-market Approval (Application) = PMA上市前许可（申请）premarket notification 上市前通知pre-marketing surveillance 销售（上市）前监督preparing and submitting 起草和申报prescription drug 处方药preservation 保藏prevalence 患病率prevention trials预防试验primary (coronary) event 原位病变primary endpoint 主要终点primary mode of action = PMOA 首要作用模式primary variable 主要变量principal investigator = PI主要研究者Principles of Qualification 确认（验证）原则process controls 工艺控制process validation 工艺验证product codes 产品的号码product differentiation 产品差异化，产品特色化product license = PL 产品许可证product life cycle (PLC) 产品生命周期prognosis 预后progression-free survival = PFS 无进展生存progressive Disease PD 病情进展proof of principle study 原理循证研究propensity score 倾向性评分protocol 试验方案; 方案protocol amendment 方案补正prototype design 原型设计protozoa 原生动物门proven acceptable Range = PAR 确定可接受范围PTC = Product Technical Complaints 药品技术投诉Qqualification system for licensed pharmacist 执业药师资格准入制度qualified health claims 有保留的健康宣称Qualified Person = QP 受权人quality assurance = QA质量保证quality assurance unit = QAU质量保证部门quality control = QC 质量控制quality management systems 质量管理体系quality of life trials or supportive care trials 生存质量试验quality risk management = QRM 质量风险管理quantitative risk assessment 量化风险评估Rrandomization 随机化randomized trial 随机化试验randomized, double blinded clinical trial 随机双盲对照研究range check 范围检查rating scale 量表RCT = randomized clinical trials 随机临床试验RCT = randomized controlled trial 随机对照试验RDE: remote data entry 远距数据输入ready-to-eat foods 即食食品reagents 试剂recall 召回; 强制回收RECIST = Response Evaluation Criteria in Solid Tumors 实体瘤的疗效评价标准reconditioning 整改; 货物重整理；货物重包装recycled plastics 可循环利用塑料制品reference product 参比制剂reference samples 标准样品regulatory methodology 质量管理方法regulatory methods validation 管理用分析方法的验证（FDA对NDA提供的方法进行验证）regulatory specification 质量管理规格标准（NDA提供）rejection 排异remote monitoring system 远程监测系统; 远程监控REMS = Risk Evaluation and Mitigation Strategies 风险评估和减缓战略risk 受害risk assessment (risk analysis + risk evaluation) 风险评估，论证risk classification 风险分类;Risk Communications Advisory Committee 风险交流咨询委员会risk evaluation (part of risk assessment) 风险评价risk/ benefit analysis 风险-获益分析risk-benefit ratio 效益/风险比route of administration 给药途径royalties 专利使用费RPN = Risk Priority Number 风险优先指数RR = Response rate 缓解率RSD = (intra-day and inter-day) relative standard deviations (日内和日间) 相对标准差Ssafety advisory 安全建议safety evaluation 安全性评价safety evaluators 安全性评估人员safety set 安全性评价的数据集screening trials 筛选性试验SD = standard deviation 标准(偏)差SE = substantial equivalence 实质上的等同Seal Strength Test 密封强度试验sequence 试验次序SFDA 129= State Food And Drug Administration 国家食品药品监督管理局SG & A= Sales, General and Administration 销售、管理和一般费用shaft 传动轴SHEA = Society for Healthcare Epidemiology of America 美国医院流行病学学会sheaths 护套shelf life 保存期限; 保质期SIC codes = Standard Industrial Classification codes 标准产业分类代码side effects 副作用significance level 显著性水平Significant Risk (SR) 显著的危险性simple randomization 简单随机simulation model 仿真模型single blinding单盲single-blind study 单盲研究single-masked study 单盲研究site assessment = SA现场评估site audit 试验机构稽查SMDA = Safe Medical Devices Act of 1990 1990年安全医疗器械法SMF = Site Master File 生产场所主文件sNDA = supplemental NDA 疗效补充新药上市申请sponsor-investigator = SI 申办研究者spontaneous reports; voluntary reports 药品不良反应自愿报告SPS = Agreement on the Application Of Sanitary and Phytosanitary Measures卫生与植物卫生措施实施协议;简称SPS协议SSI = surgical site infection 手术部位感染SSOPs = Sanitation Standard Operating Procedures 卫生标准操作程序standard curve 标准曲线standard deviation 标准偏差standard drug 标准药物standard operating procedure = SOP 标准操作规程standard treatment 标准治疗Standards Of Care131 医护标准State Food and Drug Administration = SFDA国家食品药品监督管理局statistic 统计量statistical analysis plan = SAP 统计分析计划statistical model 统计模型statistical significance 统计学意义statistical tables 统计分析表Statisticians in the Pharmaceutical Industry = PSI制药业统计学家协会steady-state Area Under the Curve = AUCss稳态药时曲线下面积/稳态血药浓度－时间曲线下面积stratified 分层study audit 研究稽查study endpoint 研究终点Study Personnel List = SPL研究人员名单study site研究中心study type 研究类型subchronic toxicity studies 亚慢性毒性研究subgroup 亚组sub-investigator 助理研究者subject 受试者subject diary = SD 受试者日记subject enrollment 受试者入选subject enrollment log = SEL受试者入选表Subject Identification Code List = SIC受试者识别代码表subject recruitment 受试者招募subject screening log = SSL受试者筛选表submission 申报；递交subspecialties, internal medicine 亚专科,内科substantial equivalence to legally marketed (predicate) device 和已合法在市场上销售的且不需要做PMA“销售前批准”的相似产品有实质上的等同Ttrain-the-trainer program 培训者培训计划treatment group 试验组treatment IND 治疗性试验性新药申请treatment trials 治疗性试验trial error 试验误差trial initial meeting 试验启动会议trial master file 试验总档案trial objective 试验目的trial site 试验场所TRICARE 军队医疗系统triple blinding 三盲two one-side test 双单侧检验UAE = unexpected adverse event 预料外不良事件unblinding 破盲;揭盲under reporting bias 少报偏差unexplained syncope 不明原因晕厥unresectable 不能手术切除variability 变异variable 变量WHO International Collaborating Center for Drug Monitoring(世界卫生组织)国际药物监测合作中心WHO International Conference of Drug Regulatory Authorities= WHO-ICDRAWHO国际药品管理当局会议WHO Programme for International Drug Monitoring = PIDMWHO 国际药物监测合作计划。

美国FDA技术术语译名参考

英文全名
Ampule Bottle Clinical units Electrolyte Hydrobromide Inhalation Millicurie Milliliter Square centimeter microgram
中文译名
安瓿瓶临床单位电解质氢溴酸吸入毫居里毫升平方厘米微克
中文译名
大约颈动脉弯曲反射作用相当于克（张培贤编译）
4
英文名称
英文名称 Spray, metered Suppository Suspension Suspension/drops Suspension, extended release Swab Syrup Tablet Tablet, chewable Tablet, coated particles Tablet, delayed release Tablet, dispersable Tablet, effervescent Tablet, extended release Tampon Tape Tincture Troche/lozenge
缩写
AMPICIL CI DIPROP ER HCL IU MEQ N/A U UMOLAR
英文全名
Ampicillin Curie Dipropionate Extended release Hydrochloride International units Milliequivale nt Not applicable Units Micromolar
美国 FDA 技术术语译名参考
新药研究开发信息
美国 FDA 批准的新药剂型英汉译名对照表
英文名称 Aerosol Aerosol, metered Bar, chemable Capsule Capsule, coated pellets Capsule, delayed rel pellets Capsule, extended release Capsule, microemulsion Concentrate Cream Cream, augmented Dressing Elixir emulsion Enema Fiber, extended release Film, extended release Gas 中文名称气雾剂定量气雾剂龃嚼棒胶囊包衣微丸胶囊延迟释放小丸胶囊缓释胶囊微乳胶囊浓缩剂霜剂，乳膏强化乳剂敷料酏剂乳剂灌肠剂缓释纤维缓释膜气体英文名称 Gel Granule Granule, delayed release Granule, effervescent Granule, for reconstitution Granule, for reconstitution er Gum, cheming Implant Injectable Injectable, lipid complex Injectable, liposomal Insert Insert, extended release Intrauterine device Jelly Liquid Lotion Lotion, augmented 中文名称凝胶剂颗粒剂延迟释放颗粒剂泡腾颗粒剂重整颗粒剂重整颗粒剂龃嚼胶植入剂注射剂复合脂质体注射剂脂质体注射剂插入剂缓释插入剂宫内装置凝胶，胶冻液体洗剂强化洗剂

FDA英语术语大全

FDA英语术语⼤全FDA英语术语⼤全FDA是什么意思，FDA得英⽂全称是什么？FDA（FOOD AND DRUG ADMINISTRATION）：（美国）⾷品药品管理局IND（INVESTIGATIONAL NEW DRUG）：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（NEW DRUG APPLICATION）：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请EP诉（EXPORT APPLICATION）：出⼝药申请（申请出⼝不被批准在美国销售的药品）TREATMENT IND：研究中的新药⽤于治疗ABBREVIATED（NEW）DRUG：简化申请的新药DMF（DRUG MASTER FILE）：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（CODE OF FEDERAL REGULATION）：（美国）联邦法规PANEL：专家⼩组BATCH PRODUCTION：批量⽣产；分批⽣产BATCH PRODUCTION RECORDS：⽣产批号记录POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：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）PRESCRIPTION DRUG：处⽅药OTC DRUG（OVER—THE—COUNTER DRUG）：⾮处⽅药U．S．PUBLIC HEALTH SERVICE：美国卫⽣福利部NIH（NATIONAL INSTITUTE OF HEALTH）：（美国）全国卫⽣研究所CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROVAL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究⼈员；调研⼈员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFIT（S）：受益RISK（S）：受害DRUG PRODUCT：药物产品DRUG SUBSTANCE：原料药ESTABLISHED NAME：确定的名称GENERIC NAME：⾮专利名称PROPRIETARY NAME：专有名称；INN（INTERNATIONAL NONPROPRIETARY NAME）：国际⾮专有名称NARRATIVE SUMMARY记叙体概要ADVERSE EFFECT：副作⽤ADVERSE REACTION：不良反应PROTOCOL：⽅案ARCHIVAL COPY：存档⽤副本REVIEW COPY：审查⽤副本OFFICIAL COMPENDIUM：法定药典（主要指USP、NF）．USP（THE UNITED STATES PHARMACOPEIA）：美国药典（现已和NF合并⼀起出版）NF（NATIONAL FORMULARY）：（美国）国家药品集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官⽅的AGENCY：审理部门（指FDA）SPONSOR：主办者（指负责并着⼿临床研究者）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）LABELED AMOUNT：标⽰量REGULATORY SPECIFICATION：质量管理规格标准（NDA提供）REGULATORY METHODOLOGY：质量管理⽅法（FDA⽤于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）REGULATORY METHODS VALIDATION：管理⽤分析⽅法的验证（FDA对NDA提供的⽅法进⾏验证）Dietary supplement：⾷⽤补充品。

1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。

FDA常用词中英对照
FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：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（NEW DRUG APPLICATION）：新药申请
ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请
EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）
TREATMENT IND：研究中的新药用于治疗
ABBREVIATED（NEW）DRUG：简化申请的新药
DMF（DRUG MASTER FILE）：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I ND、
NDA、ANDA时才能参考其内容）
HOLDER：DMF持有者
CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规
PANEL：专家小组
BATCH PRODUCTION：批量生产；分批生产
BATCH PRODUCTION RECORDS：生产批号记录
POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：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）
PRESCRIPTION DRUG：处方药
OTC DRUG（OVER—THE—COUNTER DRUG）：非处方药U．S．PUBLIC HEALTH SERVICE：美国卫生福利部
NIH（NATIONAL INSTITUTE OF HEALTH）：（美国）全国卫生研究所CLINICAL TRIAL：临床试验
ANIMAL TRIAL：动物试验
ACCELERATED APPROVAL：加速批准
STANDARD DRUG：标准药物
INVESTIGATOR：研究人员；调研人员
PREPARING AND SUBMITTING：起草和申报
SUBMISSION：申报；递交
BENIFIT（S）：受益
RISK（S）：受害
DRUG PRODUCT：药物产品
DRUG SUBSTANCE：原料药
ESTABLISHED NAME：确定的名称
GENERIC NAME：非专利名称
PROPRIETARY NAME：专有名称；
INN（INTERNATIONAL NONPROPRIETARY NAME）：国际非专有名称NARRATIVE SUMMARY记叙体概要
ADVERSE EFFECT：副作用
ADVERSE REACTION：不良反应
PROTOCOL：方案
ARCHIVAL COPY：存档用副本
REVIEW COPY：审查用副本
OFFICIAL COMPENDIUM：法定药典（主要指USP、 NF）．
USP（THE UNITED STATES PHARMACOPEIA）：美国药典（现已和NF合并一起出
版）
NF（NATIONAL FORMULARY）：（美国）国家药品集
OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门（指FDA）
SPONSOR：主办者（指负责并着手临床研究者）
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）LABELED AMOUNT：标示量
REGULATORY SPECIFICATION：质量管理规格标准（NDA提供）REGULATORY METHODOLOGY：质量管理方法（FDA用于考核原料药或药物产品是
否符合批准了的质量管理规格标准的整套步骤）
REGULATORY METHODS VALIDATION：管理用分析方法的验证（FDA对N DA提
供的方法进行验证）
Dietary supplement：食用补充品。