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
reaction schemeICH(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
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(患者对或受试者对医疗试验了解后表示同意接受或试验)
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

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