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Regulatory Affairs: List of Abbreviations


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Please find below a useful glossary of abbreviations used in regulatory affairs:
 
ADR
Adverse Drug Reaction
 
ADME
Absorption, Distribution, Metabolism and Excretion
 
ADROIT
Adverse Drug Reactions On line Information Tracking
 
AI
Adverse Incident
 
AIMDD
Active Implantable Medical Devices Directive
 
AITS
Adverse Incident Tracking System
 
ARM
Application to Reclassify a Medicine
 
ASPPs
Anonymised Single Patient Print Outs
 
ASR
Annual Safety Report
 
ATC
Anatomical, Therapeutic, Chemical

BAN
British Approved Names
 
BLA
Biological License Application
 
BNF
British National Formulary
 
BP
British Pharmacopoeia
 
BSE
Bovine Spongiform Encephalopathy
CA
Competent Authority
 
CAPLA
Computer Assisted Product Licence Application
 
CANDA
Computer Assisted New Drug Application
 
CD
Controlled Drug
 
CEP
Central Enquiry Point
Certificate of European Pharmacopeia (certificate of suitability)
 
CFC
Chlorofluorocarbons
 
CJD
Creutzfeldt-Jakob Disease
 
CMC
Chemical, Manufacture and Control
 
CMS
Concerned Member State
 
CP
Centralised Procedure
 
CPP
Certificate of Pharmaceutical Product
 
CR
Computed radiology
 
CRO
Contract Research Organisation
 
CT
Computed tomography
 
CTA
Clinical Trial Application
 
CTC
Clinical Trials Certificate
 
CTD
Clinical Trials Directive
Common Technical Document
 
CTX
Clinical Trials Exemption scheme

DB
Device Bulletin
 
DCP
Decentralised Procedure
 
DDX
Doctors and Dentist Exemptions
 
DIR
Diagnostic Imaging Review
 
DMF
Drug Master File
 
DMRC
Defective Medicines Report Centre
 
DR
Digital radiology
EC
European Community
 
eCTD
electronic Common Technical Document
 
EEA
European Economic Area
 
EEC
European Economic Community
 
EP
European Pharmacoepia
 
EPAR
European Public Assessment Report
 
EPID
Extended Public Information Document
 
EQA
European Quality Award
 
ERA
Environmental Risk Assessment
 
EU
European Union
 
EUDRA
European Union Drug Regulatory Authorities
FOI
Freedom Of Information
 
GCP
Good Clinical Practice
 
GDP
Good Distribution Practice
 
GHTF
Global Harmonisation Task Force
 
GLP
Good Laboratory Practice
 
GLPMA
Good Laboratory Practice Monitoring Authority
 
GMDN
Global Medical Device Nomenclature
 
GMO
Genetically Modified Organism
 
GMP
Good Manufacturing Practice
 
GMPLA
Good Manufacturing Practice Licensing Authority
 
GP
General Practitioner
 
GPRD
General Practice Research Database
 
GPvP
Good Pharmacovigilance Practice
 
GSI
Government Secure Intranet
 
GSL
General Sale List
I&AC
Imaging and Acute Care
 
IC
Information Centre
 
ICES
Integrating Community Equipment Services
 
IM
Intramuscular
 
IM(ER)R
Ionising Radiation (Medical Exposure) Regulations
 
ImPACT
Imaging Performance Assessment of CT scanners
 
IMPD
Investigational Medicinal Product Dossier
 
IMS
Information Management Strategy
 
IMP
Investigational Medicinal Products
 
IND
Investigational New Drug
 
INN
International Non-proprietary Names
 
IRR
Ionising Radiation Regulations
 
IVDD
In Vitro Diagnostic Directive
 
ISBN
International Standard Book Number
 
IUCD
IntraUterine Contraceptive Device
 
IUD
IntraUterine Device
 
IVDs
In Vitro Diagnostic Medical Devices
 
IT
Information Technology
 
IV
Intravenous
MA
Marketing Authorisation
 
MAA
Marketing Authorisation Application
 
MAIL
Medicines ACT Information Letter
 
MAL
Medicines Act Leaflet
 
MDA
Medical Device Alert
 
MDD
Medical Devices Directive
 
MDR
Medical Device Reporting
Medical Device Regulation
 
MDLO
Medical Device Liaison Officer
 
MEDDRA (MedDRA)
Medical Dictionary for Drug Regulatory Affairs
 
ML
Manufacturer's Licence
 
MORE
Manufacturer's On-line Reporting Environment
 
MP
Member of Parliament
 
MRA
Mutual Recognition Agreement
 
MRI
Magnetic Resonance Imaging
 
MRP
Mutual Recognition Procedure
 
MTL
Medicines Testing Laboratory
 
MTS
Medicines Testing Scheme
NAS
New Active Substance
 
NB
Notified Body
 
NCE
New Chemical Entity
 
NDA
New Drug Application
 
NOP
Non-Orthodox Practitioner
ODD
Orphan Drug Designation
 
OTC
Over-The-Counter products
 
P (medicine)
Pharmacy medicines
 
PAPs
Product Analysis Prints
 
PCT
Primary Care Trust
 
PD
Pharmacodynamy
 
PET
Positron Emission Tomography
 
PET/CT
Positron Emission Tomography and Computerised Tomography
 
PIL
Patient Information Leaflet
 
PIP
Paediatric Investigation Plan
 
PK
Pharmacokinetic
 
PL
Product Licence
Package Leaflet
 
PL(PI)
Product Licence (Parallel Import)
 
PLR
Product Licence of Right
 
PLUS
Product Licence User System
 
PMS
Post Marketing Surveillance
 
POM
Prescription Only Medicines
 
PPI
Patient Pack Initiative
 
PRRs
Proportioned Reporting Ratios
 
PSURs
Periodic Safety Update Reports
 
PUMA
Paediatric Use Marketing Authorisation
QA
Quality Assurance
 
QC
Quality Control
 
QOS
Quality Overall Summary
 
QP
Qualified Person
 
QRD
Quality Review of Documents
RAMA
Remote Access for Marketing Authorisations
 
R&D
Research & Development
 
rINN
Recommended International Non-proprietary Name
 
RMP
Risk Management Plan
 
RMS
Reference Member State
 
RP
Responsible Person
SABS
Safety Alert Broadcast System
 
SAMM
Safety Assessment of Marketed Medicines
 
SI
Statutory Instrument
 
SMF
Site Master File
 
SOP
Standard Operating Procedure
 
SPC or SmPC
Summary of Product Characteristics
 
SPECT
Single photon emission computed tomography
 
SSRIs
Selective Serotonin Reuptake Inhibitors
TCM
Traditional Chinese Medicine
 
THMPD
Traditional Herbal Medicinal Products Directive
 
THMRS
Traditional Herbal Medicines Registration Scheme
 
THR
Traditional Herbal Registration
 
TSE
Transmissible Spongiform Encephalopathy
USAN
United States Adopted Names
 
USP
United States Pharmacopeia
 
vAIC
Virtual Adverse Incident Centre
 
VAMF
Vaccine Antigen Master File
 
VMD
Veterinary Medicines Directorate
 
VTE
Venous ThromboEmbolism
 
WL
Wholesale Dealer's Licence