GMP常见英文缩写
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（christmas什么意思PIC/S）
PIC的权威翻译：药品生产检查相互承认公约
API(Active Pharmaceutical Ingredient) 原料药 又称：活性药物组分
Air Lock 气闸 Authorized Person 授权人高庙 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；Consignment（Delivery）托销药品。
FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局
IND蚂蚁和大象的笑话（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紫光输入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带虎字的成语）：（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 Adver Drug Reaction
AE Adver 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
学打羽毛球作文CENTRE FOR DRUG EVALUATION (CDE)
Centre for Pharmaceutical Administration (CPA)
CMS Concerned Member State
CMS每个成员国清远宝晶宫
COS Certificate of Suitability
CPMP Committee for Proprietary Medicinal Products
洋酒十大排名CRA Clinical Rearch Associate
CRF Ca Report Form
CRO Contract Rearch Organization
CTA Clinical Trial Application
CTC Clinical Trial Certificate
CTD Common Technical Document
CTX Clinical Trials Exemption
DDD Defined Daily Do
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 Licen 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 Asssment 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 Harmonization
IDMC Independent Data-Monitoring Committee
IEC Independent Ethics Committee
IND Investigational New Drug
INN International Non-proprietary Name
International Conference on Harmonization (ICH)
IPC In Process Control
IRB Institutional Review Board
LICENCE HOLDER
MA Marketing Authorization
MAA Marketing Authorization Application
MAA上市申请
MAH Marketing Authorization 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 Licen
POM Prescription Only Medicine
PRODUCT OWNER
PSU Periodic Safety Updates
QA Quality Assurance
