Wednesday, 10th March 2010

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Glossary

Abbreviation	Term
ABPI	Association of British Pharmaceutical Industry
ADR	Adverse drug reaction
AE/SAE	Adverse event/Serious adverse event
AEGIS	Adverse Experience Gathering Information System
AIM	Active ingredient manufacturer
ANDA	Abbreviated New Drug Application (US generic marketing application)
ASR	Annual safety report
ATC	Anatomical Therapeutic Chemical code
BARQA	British Association of Research Quality Assurance
BLA	Biologic License Application
BNF	British National Formulary
BP	British Pharmacopoeia
BWP	Biotechnology Working Party (CHMP)
CADREAC	Collaboration Agreement between Drug Regulatory Authorities in EU-Associated Countries
CAPLA	Computer Assisted Product Licence Application
CCDS	Company core data sheet
CDER/CBER	Centre for Drug Evaluation and Research/Centre for Biological Evaluation and Research (US)
CE	Conformité European (approval for EU medical devices)
CEP (COS)	Certificate of Suitability of the European Pharmacopoeia
CFR	Code of Federal Regulations
CIOMS	Committee for International Organisation of Medical Sciences
CHMP	Committee for Medicinal Products for Human Use
CMD	Co-ordination Group for Mutual Recognition and Decentralised Procedures
CMS	Concerned Member State
COMP	Committee for Orphan Medicinal Products
CVMP	Committee for Medicinal Products for Veterinary Use
CP	Centralised procedure
CRF	Case report/record form
CSR/CTR	Clinical study report/clinical trial report
CTA	Clinical Trial Authorisation
CTD	Common Technical Document
CTD	Clinical Trials Directive
CTMP	Clinical Trial of a Marketed Product
CTX	Clinical Trial Exemption (now a CTA)
DCP	Decentralised procedure
DDD	Defined Daily Dose
DDPvS	Detailed Description of the Pharmacovigilance System
DMF	Drug master file
EC	Ethics Committee
eCTD	Electronic Common Technical Document
EDC	Electronic Data Capture
EDMF	European Drug Master File
EDQM	European Directorate for the Quality of Medicines
EEA	European Economic Area (EU + EEA, excluding Switzerland)
EMEA	European Medicines Agency
EPAR	European Public Assessment Report
EP/Ph Eur	European Pharmacopoeia
ERA	Environmental Risk Assessment
ESTRI	Electronic Standards for the Transfer of Regulatory Information
EUDRACT	EU Clinical Trial Database
EV	Eudravigilance
EVMPD	Eudravigilance Medicinal Product Dictionary
EWP	Efficacy Working Party (CHMP)
FDA	Food and Drug Administration (US)
FOIA	Freedom of Information Act
GCP/GDP/GLP/GMP	Good Clinical / Distribution / Laboratory / Manufacturing Practice
GMO	Genetically Modified Organism
GSL	General Sales List
HMA	Heads of Medicines Agencies
HMPC	Committee for Herbal Medicinal Products
HPB	Health Protection Branch (CAN)
HTA	Health Technologies Appraisal
IB	Investigators Brochure
IBD	International Birth Date
ICH	International Committee for Harmonisation
ICSR	Individual Case Safety Report
IMB	Irish Medicines Board
IMP	Investigational Medicinal Product
IMPD	Investigational Medicinal Product Dossier
IND	Investigational New Drug
INN	International Non-proprietary Name
IRB	Institutional Review Board
ISS/ISE	Integrated summary of safety/integrated summary of efficacy
ISSN/ISBN	International standard serial number/International standard book number
JNDA	Japanese New Drug Application
KOL	Key Opinion Leader
LREC	Local Research Ethics Committee
MAA	Marketing Authorisation Application
MAH	Marketing Authorisation Holder
MedDRA	Medical Dictionary for Regulatory Activities
MHLW	Ministry of Health, Labour and Welfare (Japan)
ML	Manufacturers Licence
MRP	Mutual Recognition Procedure
MREC	Multicentre Research Ethics Committee
NDA	New Drug Application
NICE	National Institute for health and Clinical Excellence
NME	New molecular entity
OTC	Over the counter
P	Pharmacy medicine
PAGB	Proprietary Association of Great Britain
PAR	Public Assessment Report
PASS	Post-Authorisation Safety Studies
PhVWG	Pharmacovigilance Working Party (CHMP)
PI	Package Insert
PIL	Patient Information Leaflet
PIM	Product Information Management
PIQ	Product Information Quality Review Group (MHRA)
PL	Product Licence
PL	Package Leaflet
PMCPA	Prescription Medicines Code of Practice Authority
POM	Prescription only medicine
PSUR	Periodic Safety Update Report
PV	Pharmacovigilance
PVAR	Preliminary Variation Assessment Report
QA	Quality Assurance
QC	Quality Control
QP	Qualified Person
RAPS	Regulatory Affairs Professionals Society (US)
RMP	Risk Management Plan
RMS	Reference Member State
SAG	Scientific Advisory Group (EMEA)
SAP	Statistical Analysis Plan
SAS	Statistical Analytical Software
SAWG	Scientific Advice Working Party (EMEA)
SBA	Summary Basis of Approval
SMC	Scottish Medicines Consortium
SMF	Site Master File
SPC/SmPC	Summary of Product Characteristics
SNDA	Supplementary New Drug Application
SOP	Standard Operating Procedure
SPS	Summary of Pharmacovigilance Systems
SUSAR	Suspected Unexpected Serious Adverse Reaction
SWP	Safety Working Party (CHMP)
TAG	Therapeutic Advisory Group
TGA	Therapeutic Goods Administration (Australia)
TOPRA	The Organisation for Professionals in Regulatory Affairs
USP	United States Pharmacopoiea
WHO	World Health Organisation

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