附件暂无
FDA和EDQM术语:
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
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
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；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
REGULATORY METHODS VALIDATION：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 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 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
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
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 Variance
ASM: Active Substance Manufacturer
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 EVALUATION (CDE)
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 Trial 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 Medicines) 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 European 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 Name
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 Welfare (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 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 Updates
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 OPERATION PROCEDURE） 标准运作程序
SPC/SmPC Summary of Product Characteristics
summary of product characteristics(SPC)
Therapeutic Goods Administration (TGA)
USP US Pharmacopoeia
VMF Veterinary Master File
VPC Veterinary Products Committee
A．A．A Addition 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 Food 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
ADNA Abbreviated 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
DEA Drug Enforcement Adminestration 管制药品管理
DS Documentation Systim 文件系统
FDA Food and 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 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
PLA Product License Application 产品许可申请
QA Quality Assurance 质量保证
QC Quality Control 质量控制
QMP Quality Management Procedure 质量管理程序
SDA State 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
USA Uneted States Pharmacopeia 美国药典
