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Regulatory Affairs: List of AbbreviationsPlease 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 |
Global House, Painters Lane, Sutton, Ely,
Cambridgeshire, CB6 2NS, UK
Telephone: +44(0)1353 774000
E-mail: enquiries@globalregulatoryservices.com
Cambridgeshire, CB6 2NS, UK
Telephone: +44(0)1353 774000
E-mail: enquiries@globalregulatoryservices.com