药品常用英语缩写

《GMP英语词汇及缩写》

第一部分

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

第二部分 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