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 License
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 Summary of Product Characteristics
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 Chemicals 原料药
CBER Center for Biologics Evaluation Research 生物制品评价与研究中心
CFU Colony Forming Unit 菌落形成单位
DMF Drug Master File 药品管理档案
CDER Center for Drug Evaluation and 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 Inspector 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 Administration 管制药品管理
DS Documentation System 文件系统
FDA Food and Drug Administration 食品与药品管理局（美国)
GATT General Agreement on Tariffs and Trade 关贸总协会
GMP Good Manufacturing Practice 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 Good Retail Practice 药品零售业质量管理规范
GAP Good Agriculture Practice 药材生产管理规范
GVP Good Validation Practice 验证管理规范
GUP Good Use Practice 药品使用规范
HVAC Heating Ventilation Air Conditioning 空调净化系统
ISO International Organization for Standardization 国际标准化组织
MOU Memorandum of Understanding 谅解备忘录
PF Production 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 Management Procedure 标准管理程序
SOP Standard Operating Procedure 标准操作程序
TQC Total Quality Control 全面质量管理
USA United States Pharmacopoeia 美国药典
