缩写词
API Active Pharmaceutical Ingredient原料药
ANDA Abbreviated New Drug Application简化新药申请仿制药
ASM The Active Substance Manufacturer原料药生产厂家
ADE Adverse Drug Event药物不良事件
ADR Adverse Drug Reaction药物不良反应
CFDA China Food and Drug Administration中国国家食品药品监督管理局
COS Certificate of Suitability欧洲药典适用性认证
CTD Common Technical Documents通用技术文件
COA Certificat of Analysis检验报告
CDE Center for Drug Evaluation药品审评中心
CMC Chemistry,Manufacture and Control化学，生产及质控
CRO Contract Research Orgnization合同研究组织
ChP Chinese Pharmacopoeia中国药典
CAS Chemical Abstracts Service美国化学文摘社
CTA Clinical Trail Application临床试验申请
CMO Cheif Medical Officer首席医学官
CPP Certificate of a Pharmaceutical Product药品证明文书
CAPA Corrective and Preventive Action纠正预防行动
DMF Drug Master File药品主文件
EDMF European Drug Master File欧洲药物管理档案
EMEA European Agency for the Evaluation of Medicinal Product欧洲药物评审局EU European Union欧洲联盟
EP European Pharmacopoeia欧洲药典
FDA Food and Drug Administration食品药品监督管理局（美国药监局）GMP Good Manufacturing Practices良好生产规范
HPLC High Performance Liquid Chromatography高效液相
ICH International Conference of Harmonization国际协调会议
IND Investigational New Drug Application新药临床试验申请
IDL Import Drug License进口药品注册证书
INN International Nonproprietaty Name国际非专有名称
LA Letter of Authorization委托书
LOQ Limit of Quantity定量限
LOD Limit of Detection检测限
MA Marketing Authorization上市许可
NDA New Drug Application新药生产上市申请
NIFDC National Institutes for Food and Drug Control中国食品药品检定研究院
NMT Not More Than不大于
NA Not Analysis未检测
OTC Over The Counter非处方药
OOS Out of Specification不合格
PSUR Periodic Safety Update Reports定期安全性报告QOS The Quality Overall Summary质量整体概述QA Qulitity Assurance质量保证
QC Qulitity Control质量控制
Rx Prescription Drug处方药
RS Reference Standard对照品
SOP Standard Operation Procedure标准操作规范
TS Test Solutions指示剂
UV Ultraviolet紫外分光光度法
USP United States Pharmacopoeia美国药典
药品注册词汇Drug registration application注册申请Supplementary application补充申请
Drug regulatory department药品监管部门
Re-registration application再注册
On-site inspection现场核查
Production site inspection生产现场核查
Causal inspection有因核查
Authenticity真实性
Precision准确性
Integrity完整性
Entrusted agency代理机构
Dosage form剂型
Formula处方
Preparing process生产工艺
Testing methods检验方法
Quality specifications质量指标
Stability稳定性
Drug approval number批准文号
Method verification方法验证
Manufacturer生产厂家
Plant工厂
Production line生产线
Workshop车间
Safety安全性
Efficacy有效性
Acceptance受理
Applicant申请人
Biological product生物制品
Preliminary review初步审核
Variation变更
Raw data原始数据
Specifications verification标准复核
Second review复审
GMP certificate生产质量管理规范证书
Application dossers申请文件
Center for food and drug inspection of CFDA CFDA食品药品审核查验中心
产品英语部分
streptococcus pneumoniae肺炎链球菌
Streptococcus pyogenes酿脓性链球菌
Branhamella catarrhalis卡他布兰汉姆菌
staphylococcus aureus金黄色葡萄球菌
Haemophilus influenzae type BB型流感嗜血杆菌
Klebsiella pneumoniae肺炎克雷伯杆菌
Manufacturing process生产过程
Process control过程控制
Lysate裂解物
Culture培养培养基
Ultrafiltration滤过，超滤
Inactivation灭活
Autolysis自溶
Alkaline碱性的
Bacterial strain菌株
Revitalize复原，激活
Sub-culture传代培养
Inoculate嫁接
Fermenter发酵器
Cultivate培养
Stir搅拌
Concentrate浓缩
Turbidity浑浊度
Fungi真菌
Elimination消除
Identify鉴别
Purity纯度
Germ细菌，病菌
Liter升
Microbiological control微生物控制Thimerosal硫柳汞
Sodium methyl-paraben对羟基苯甲酸甲酯钠Dose and uniformity of dose剂量及均一性Chlorhexidine diacetate乙酰乙酸氯已定Polysorbate80吐温80（聚山梨酯80）Antigenic activity抗原活性
Rocket immunoeletroforesis火箭电泳法Excipient辅料
Sterile distilled water无菌注射用水Purified water纯化水
Appearance性状
Container包装
Surfactant表面活性剂
Preservative防腐剂
Leaflet说明书
Active ingredients活性成分
Approval documents批准证明文件Research data研究资料
Stability稳定性
Validation of method方法学验证。