AAA  AdditionandAmendments޶
ABBREVIATEDNEWDRUGҩ
ABPI Association of the British Pharmaceutical  Industry
AC  AirConditionerյ
ACC  Accept
ADNA  AbbreviatedNewDrugApplication򻯵ҩ
ADR  AdverseDrugReactionҩﲻӦ
ADR Adverse Drug  Reaction
AE Adverse  Event
AFDO  AssociationofFoodandDrugOfficialsʳƷҩƷԱЭᣨ
AIM Active Ingredient  Manufacturer
AirLock բ Authorized Person Ȩ Batch/Lot  
ANDA Abbreviated New Drug  Application
ANDAABBREVIATED NEW DRUG  APPLICATIONҩ
ANOVA Analysis of  Variance
API(Active Pharmaceutical Ingrediet) ԭҩ  ֳƣҩ
AQL  AcceptableQualityLevelϸ׼
ASM: Active Substance  Manufacturer
ATC Anatomical Therapeutic  Chemical
ATX Animal Test Exemption  Certificate
BAN British Approved  Name
BATCH  PRODUCTION
Batch Number/Lot-Number ţBatch Numbering System  αϵͳ
BATCH PRODUCTION  RECORDSż¼
Batch Records ¼Bulk Product װƷCalibration УClean  areaྻConsignmecntDeliveryҩƷ
BIRA British Institute of Regulatory  Affairs
BNF British National  Formulary
BOM  BillofMaterial嵥
BP British  Pharmacopoeia
BPC  BulkpharmaceuticalChemicllsԭҩ
C of A Certificate of  Analysis
C of S Certificate of  Suitability
CBER  CenterforBiologicsEvaluationResearchƷо
CDER  CemterforDrugEvaluationamdResearchҩо
CENTRE FOR DRUG EVALUATION  (CDE)
Centre for Pharmaceutical Administration  (CPA)
CFRCODE OF FEDERAL  REGULATION
CFU  ColonyFormingUnetγɵλ
CI  CorporateIdentity(Image)ҵʶ
CIP  CleaninginPlaceϴ
CLP  CleaningLineProcedureϴ
CMS Concerned Member  State
CMSÿԱ
COS Certificate of  Suitability
CPMP Committee for Proprietary Medicinal  Products
CRA Clinical Research  Associate
CRF Case Report  Form
CRO Contract Research  Organisation
CSI  ConsumerSafetyInsepctor߰ȫԱ
CTA Clinical Trial  Application
CTC Clinical Trial  Certificate
CTD Common Technical  Document
CTX Clinical Trials  Exemption
DAL  DefectActionLevelȱˮƽ
DDD Defined Daily  Dose
DEA  DrugEnforcementAdminestrationҩƷ
DGC Daily Global  Comparison
DIA Drug Information  Association
DMF  DrugMasterFileҩƷ
DMF Drug Master  File
DMFDRUG MASTER  FILEҩļΪ׼ıϣ
Drug Registration Branch (DR, Product Evaluation & Registration Division,  CPA
DS  DocumentationSystimļϵͳ
EDQM (European Directorate for the Quality of Medicines)  ŷҩƷָίԱ
EEA  ŷ޾õ
EGMA European Generics Medicine  Association
ELA Established Licence  Application
EMEA European Agency for the Evaluation of Medicinal Products  ŷҩƷۻ
EMEA European Medicines Evaluation  Agency
EP European  Pharmacopoeia
EPAR European Public Assessment  Reports
ESRA European Society of Regulatory  Affairs
European Pharmacopoeia Commission  ŷҩίԱ
FDA
FDA  FoodandDrugAdministrationʳƷҩƷ֣
FDA Food and Drug  Administration
FDAFOOD AND DRUG  ADMINISTRATIONʳƷҩƷ
final evaluation report  (FER)
free sale certificates  (FSCs)
GAP  GoodAgriculturePracticeҩ淶
GATT  GeneralAgreemerntonTariffsandTradeóЭ
GCP  GoodClinicalPracticeҩƷٴʵ淶
GCP Good Clinical  Practice
GCPҩƷٴо淶
GLP  ҩƷٴǰȫо淶
GLP  GoodLaboratoryPracticeʵҹ淶
GLP Good Laboratory  Practice
GMP  ҩƷ淶
GMP  GoodManufacturingPracticeGvpҩƷ淶
GMP Good Manufacturing  Practice
GRP  GookRaTAILPracticeҩƷҵ淶
GSP  GoodSupplyPracticeҩƷҵ淶
GSPҩƷ۹淶
GUP  GookUsePracticeҩƷù淶
GVP  GookValidationPrctice֤淶
Health Sciences Authority  (HSA)
HOLDERDMF
HSA's Medicines Advisory Committee  (MAC)
HVAC  HeatingVentilationAirConditioningյϵͳ
IB Investigators  Brochure
ICH International Conference for  Harmonisation
IDMC Independent Data-Monitoring  Committee
IEC Independent Ethics  Committee
IND Investigational New  Drug
INDINVESTIGATIONAL NEW  DRUGٴо루ָ걨׶,NDA
INFORMED  CONSENT֪ͬ⣨߶ƻ߶ҽ˽ʾͬƻ飩
INN International Non-proprietary  Name
International Conference on Harmonisation  (ICH)
IPC In Process  Control
IRB Institutional Review  Board
ISO  IntematonalOrganizationforStandardizationʱ׼֯
LICENCE  HOLDER
MA Marketing  Authorisation
MAA Marketing Authorisation  Application
MAA
MAH  ɳ
MAH Marketing Authorisation  Holder
MCA Medicines Control  Agency
MHW Ministry of Health and Welfare  (Japan)
MOU  MemorandumofUnderstanding½ⱸ¼
MR Mutual  Recognition
MRA  ŷ˵ĻЭ
MRAs (Mutual Recognition Agreements)  JCͬ
MRFG Mutual Recognition Facilitation  Group
MRP Mutual Recognition  Procedure
NAS New Active  Substance
NCE New Chemical  Entity
NDA New Drug  Application
NDANEW DRUG  APPLICATIONҩ
NDAANDAʱܲοݣ
new chemical entities  (NCEs)
new drug applications  (NDAs)
NSAID Non Steroidal Anti Inflammatory  Drug
NTA Notice To  Applicants
OOS Out of  Specification
OTC  OvertheCounter(Drug)ǴҩƷ
OTC DRUGOVER-THE-COUNTER  DRUGǴҩ
OTC Over The  Counter
PAGB Proprietary Association of Great  Britain
PANELרС
PF  PorductionFile¼ñ
Ph Eur European  Pharmacopoeia
PIC/SȫΪPharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(ҩݰ), ҩƷЭ(PIC/S)  ,Ҳ˳PIC/SΪҽҩ/ƻPIC/S
PICȨ룺ҩƷ໥ϹԼ
PIL Patient Information  Leaflet
PL Product  Licence
PLA  ProductLicenseApplicationƷ
POM Prescription Only  Medicine
POST-OR PRE- MARKET  SURVEILLANCEǰۺල
PRESCRIPTION  DRUGҩ
PRODUCT  OWNER
PSU Periodic Safety  Updates
QA  QualityAssurance֤
QA Quality  Assurance
QC  QualityControl
QC Quality  Control
QMP  QualityManagementProcedure
RAJ Regulatory Affairs  Journal
RMS Reference Member  State
RMS໥ϿһԱ
RSD Relative Standard  Deviation
Rx Prescription  Only
SAE Serious Adverse  Event
SDA  StateDrugAdministrationҩƷල
SMF Site Master  File
SMP  StandardManagmertProcedure׼
SOP  StandardOperatingProcedure׼
SOP STANDARD OPERATION PROCEDURE  ׼
SOP Standard Operating  Procedure
SPC/SmPC Summary of Product  Characteristics
summary of product  characteristics(SPC)
Therapeutic Goods Administration  (TGA)
TQC  TatalQualityControlȫ
TREATMENT  INDоеҩ
USA  UnetedStatesPharmacopeiaҩ
USP US  Pharmacopoeia
VMF Veterinary Master  File
VPC Veterinary Products  Committee
һҩƱӹװ漰豸̻
ƷֻDMF߻ȨȨʽȨFDAFDAIND
ԣоеҩָҩ׶Σҩԣٴǰо
