医药行业专业英语词汇(非常有用).pdf
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1、FDA 和 EDQM 术语:CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERA TED APPROV AL：加速批准STANDARD DRUG：标准药物INVESTIGA TOR：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（INTERNA TION
2、AL NONPROPRIETARY NAME）：国际非专有名称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 STA TES PHARMACOPEIA）：美国药典NF（NATIONAL FORMULARY）：（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；
3、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REGULA TORY SPECIFICA TION：质量管理规格标准（NDA 提供）REGULA TORY METHODOLOGY：质量管理方法REGULA TORY METHODS V ALIDA TION：管理用分析方法的验证COS/CEP 欧洲药典符合性认证ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for
4、Human Use)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:GMP Q7a:（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：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme,PIC/S(制药检查草案),药品检查协会(PIC/S),也有人称PIC/S 为
5、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(Active Pharmaceutical Ingrediet)原料药又称：活性药物组分AirLock 气闸Authorized Person 授权人Batch/Lot 批次Batch Number/Lot-Number 批号；Batch Numbering System 批次编码系统；Batch Records 批记录；Bulk Product 待包装品；Calibration 校正；Clean area洁净区；Consignmecnt（Delivery）托销药品。FDA（FOOD AND DRUG AD
6、MINISTRATION）：（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 APPLICATION）：简化新药申请TREATMENT 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
7、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
8、试验）PRESCRIPTION DRUG：处方药OTC DRUG（OVER THE COUNTER DRUG）：非处方药GMP 文件常见缩写ABPI Association of the British Pharmaceutical Industry ADR Adverse Drug Reaction AE Adverse Event AIM Active Ingredient Manufacturer ANDA Abbreviated New Drug Application ANOVA Analysis of V ariance ASM:Active Substance Manufactu
9、rer ATC Anatomical Therapeutic Chemical ATX Animal Test Exemption Certificate BAN British Approved Name BIRA British Institute of Regulatory Affairs BNF British National Formulary BP British Pharmacopoeia C of A Certificate of Analysis C of S Certificate of Suitability CENTRE FOR DRUG EV ALUA TION(C
10、DE)Centre for Pharmaceutical Administration(CPA)CMS Concerned Member State CMS 每个成员国COS Certificate of Suitability CPMP Committee for Proprietary Medicinal Products CRA Clinical Research Associate CRF Case Report Form CRO Contract Research Organisation CTA Clinical Trial Application CTC Clinical Tri
11、al Certificate CTD Common Technical Document CTX Clinical Trials Exemption DDD Defined Daily Dose DGC Daily Global Comparison DIA Drug Information Association DMF Drug Master File Drug Registration Branch(DR,Product Evaluation&Registration Division,CPA EDQM(European Directorate for the Quality of Me
12、dicines)欧洲联盟药品质量指导委员会EEA 欧洲经济地区EGMA European Generics Medicine Association ELA Established Licence Application EMEA European Medicines Evaluation Agency EMEA（European Agency for the Evaluation of Medicinal Products）欧洲联盟药品评价机构EP European Pharmacopoeia EPAR European Public Assessment Reports ESRA Euro
13、pean Society of Regulatory Affairs European Pharmacopoeia Commission 欧洲药典委员会FDA FDA Food and Drug Administration final evaluation report(FER)free sale certificates(FSCs)GCP Good Clinical Practice GCP 药品临床研究管理规范GLP Good Laboratory Practice GLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing Practice GMP 药品生产质
14、量管理规范GSP 药品销售管理规范Health Sciences Authority(HSA)HSA s Medicines Advisory Committee(MAC)IB Investigators Brochure ICH International Conference for Harmonisation IDMC Independent Data-Monitoring Committee IEC Independent Ethics Committee IND Investigational New Drug INN International Non-proprietary Na
15、me International Conference on Harmonisation(ICH)IPC In Process Control IRB Institutional Review Board LICENCE HOLDER MA Marketing Authorisation MAA Marketing Authorisation Application MAA 上市申请MAH Marketing Authorisation Holder MAH 销售许可持有者MCA Medicines Control Agency MHW Ministry of Health and Welfa
16、re(Japan)MR Mutual Recognition MRA 美国与欧盟的互认协议MRAs(Mutual Recognition Agreements)互相認證同意MRFG Mutual Recognition Facilitation Group MRP Mutual Recognition Procedure NAS New Active Substance NCE New Chemical Entity NDA New Drug Application new chemical entities(NCEs)new drug applications(NDAs)NSAID Non
17、Steroidal Anti Inflammatory Drug NTA Notice To Applicants OOS Out of Specification OTC Over The Counter PAGB Proprietary Association of Great Britain Ph Eur European Pharmacopoeia PIL Patient Information Leaflet PL Product Licence POM Prescription Only Medicine PRODUCT OWNER PSU Periodic Safety Upda
18、tes QA Quality Assurance QC Quality Control RAJ Regulatory Affairs Journal RMS Reference Member State RMS 相互认可另一成员国RSD Relative Standard Deviation Rx Prescription Only SAE Serious Adverse Event SMF Site Master File SOP Standard Operating Procedure SOP（STANDARD OPERA TION PROCEDURE）标准运作程序SPC/SmPC Sum
19、mary of Product Characteristics summary of product characteristics(SPC)Therapeutic Goods Administration(TGA)USP US Pharmacopoeia VMF V eterinary Master File VPC Veterinary Products Committee A A AAddition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of F
20、ood and Drug Officials 食品与药品官员协会（美国）ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNAAbbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品
21、管理档案CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心CI Corporate Identity(Image)企业识别（形象）CIP Cleaning in Place 在线清洗CSI Consumer Safety Insepctor 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEADrug Enforcement Adminestration 管制药品管理DS Documentation Systim 文件系统FDAFood a
22、nd Drug Administration 食品与药品管理局（美国）GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice
23、 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HVAC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction File 生产记录用表格OTC Over the Counter(Drug)非处方药品PLAProduct License Application
24、产品许可申请QAQuality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDAState Drug Administration 国家药品监督管理局SMP Standard Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USAUneted States Pharmacopeia 美国药典专业英语词汇词素（词根）1.haplo,mono,u
25、ni：单，一，独haploid 单倍体monoxide 一氧化碳monoatomic 单原子的2.bi,di,dipl,twi,du:：二，双，两，偶 biocolor 双色,dichromatic 双色的,diplobacillus 双杆菌dikaryon 双核体twin：孪生dual 双重的3.tri:三，丙triangle 三角triacylglycerol三酰甘油tricarboxylic acid cycle 三羧酸循环4.quadri,quadru,quart,tetr,tetra：四quadrilateral 四边的quadrivalent 四价的quadruped 四足动物te
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