MAA上市申請(qǐng)
MAH Marketing Authorization Holder
MAH 銷售許可持有者
MCA Medicines Control Agency
MHW Ministry of Health and Welfare (Japan)
MR Mutual Recognition
MRA 美國與歐盟的互認(rèn)協(xié)議
MRAs (Mutual Recognition Agreements) 互相認(rèn)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相互認(rèn)可另一成員國
RSD Relative Standard Deviation
Rx Prescription Only
SAE Serious Adverse Event
SMF Site Master File
SOP Standard Operating Procedure
SOP （STANDARD OPERATION PROCEDURE) 標(biāo)準(zhǔn)運(yùn)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 增補(bǔ)和修訂
AC Air Conditioner 空調(diào)器
ADR Adverse Drug Reaction 藥物不良反應(yīng)
AFDO Association of Food and Drug Officials 食品與藥品官員協(xié)會(huì)（美國)
ACC Accept 接受
AQL Acceptable Quality Level 合格質(zhì)量標(biāo)準(zhǔn)
ADNA Abbreviated New Drug Application 簡化的新藥申請(qǐng)
BOM Bill of Material 物料清單
BPC Bulk pharmaceutical Chemicals 原料藥
CBER Center for Biologics Evaluation Research 生物制品評(píng)價(jià)與研究中心
CFU Colony Forming Unit 菌落形成單位
DMF Drug Master File 藥品管理檔案
CDER Center for Drug Evaluation and Research 藥物評(píng)價(jià)與研究中心
CI Corporate Identity (Image) 企業(yè)識(shí)別（形象)
CIP Cleaning in Place 在線清洗
CSI Consumer Safety Inspector 消費(fèi)者安全調(diào)查員
CLP Cleaning Line Procedure 在線清洗程序
DAL Defect Action Level 缺陷作用水平
DEA Drug Enforcement Administration 管制藥品管理
DS Documentation System 文件系統(tǒng)
FDA Food and Drug Administration 食品與藥品管理局（美國)
GATT General Agreement on Tariffs and Trade 關(guān)貿(mào)總協(xié)會(huì)
GMP Good Manufacturing Practice 藥品生質(zhì)量管理規(guī)范
GCP Good Clinical Practice 藥品臨床實(shí)驗(yàn)管理規(guī)范
GLP Good Laboratory Practice 實(shí)驗(yàn)室管理規(guī)范
GSP Good Supply Practice 藥品商業(yè)質(zhì)量規(guī)范
GRP Good Retail Practice 藥品零售業(yè)質(zhì)量管理規(guī)范
GAP Good Agriculture Practice 藥材生產(chǎn)管理規(guī)范
GVP Good Validation Practice 驗(yàn)證管理規(guī)范
GUP Good Use Practice 藥品使用規(guī)范
HVAC Heating Ventilation Air Conditioning 空調(diào)凈化系統(tǒng)
ISO International Organization for Standardization 國際標(biāo)準(zhǔn)化組織
MOU Memorandum of Understanding 諒解備忘錄
PF Production File 生產(chǎn)記錄用表格
OTC Over the Counter (Drug) 非處方藥品
PLA Product License Application 產(chǎn)品許可申請(qǐng)
QA Quality Assurance 質(zhì)量保證
QC Quality Control 質(zhì)量控制
QMP Quality Management Procedure 質(zhì)量管理程序
SDA State Drug Administration 國家藥品監(jiān)督管理局
SMP Standard Management Procedure 標(biāo)準(zhǔn)管理程序
SOP Standard Operating Procedure 標(biāo)準(zhǔn)操作程序
TQC Total Quality Control 全面質(zhì)量管理
USA United States Pharmacopoeia 美國藥典
