Glossary of acronyms and abbreviations
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A
AADA – Abbreviated antibiotic drug application
ABHI – Association of British Healthcare Industries
ABPI – Association of the British Pharmaceutical Industry
ACTD – ASEAN common technical dossier
ADC – Additional data collection
ADI – Acceptable daily intake
ADR – Adverse drug reaction
AE – Adverse event
AEFI – Adverse event following immunisation
AIM – Active ingredient manufacturer
AIMD – Active implantable medical device
ANDA – Abbreviated new drug application
API – Active pharmaceutical ingredient
AQL – Acceptable quality level
AR – Assessment Report (European Union)
ASMF – Active Substance Master File
ATMPs – Advanced therapy medicinal products
B
BA – Bioavailability
BAN – British Approved Name
BAP – Biotechnology Action Programme
BIND – Biological investigational new drug
BWP – Biotech Working Party (EMA)
C
C&P – Chemistry and Pharmacy
CA – Commercial appraisal
CA – Competent authority
CANDA – Computer assisted new drug application
CAP – Centrally authorised product
CAPA – Corrective action and preventive action
CAPLA – Computer Assisted Product Licence Application
CC – Candidate country
CCDS – Company core data sheet
CCG – Clinical Commissioning Group (UK)
CD – Controlled drug
CDSCO – Central Drug Standard Organisation (India)
cGLP – Current good laboratory practice
cGMP – Current good manufacturing practice
Cl – Total body clearance
CLO – Clinical overview
CLS – Clinical summary
CMC – Chemistry – manufacturing – controls
CMP – Certificate of Medicinal Product
COA – Certificate of analysis
CoFS – Certificate of Free Sale
CP – Centralised procedure (European Union)
CP – Comparability protocol (USA)
CPD – Continuing professional development
CPP – Certificate of pharmaceutical product
CPP – Critical process parameter
CQA – Clinical quality assurance
CR – Controlled release
CRF – Case report form
CRO – Clinical Research Organisation
CSI – Core safety information
CSP – Core safety profile
CSR – Clinical study report (European Union)
CT – Clinical trial
CTA – Clinical trial application
CTA – Clinical trial authorisation
CTC – Clinical trial certificate (UK)
CTD – Clinical Trials Directive
CTD – Common technical document/dossier
CTMS – Clinical trial management system
CTS – Common technical specification
CTX – Clinical trial exemption (UK)
CVM – Center for Veterinary Medicine (US)
D
DACS – Detailed and critical summary
DAE – Discontinuation due to an adverse event
DDD – Defined daily dose
DDPS – Detailed description of pharmacovigilance system
DMF – Drug master file
DMS – Document management system
DOE – Design of experiments
DP – Drug product
DS – Drug substance
DSUR – Development safety update report
DTC – Direct-to-consumer
DUS – Drug utilisation study
E
EA – Environmental assessment
EC – Ethics committee
eCTD – electronic common technical document
EDC – electronic data capture
EDMF – European drug master file
EDT – Electronic data transfer
ENS – Early notification system
EPI – Essential Program for Immunisation
EPL – Effective patent life
ePSUR – electronic periodic safety update report
ERB – Ethical review board
ESPAR – Executive Summary Pharmacovigilance Assessment Report
EWG – Expert Working Group
EWP – Efficacy Working Party
F
FAR – Final assessment report
FMEA – Failure mode and effects analysis
FTE – Full Time Equivalent
G
GCP – Good clinical practice
GDP – Good distribution practice
GGP – Good guidance practice
GLP – Good laboratory practice
GMP – Good manufacturing practice
GMP – Good management practice
GPP – Good paediatric practice
GPP – Good pharmacoepidemiology practice
GpvP – Good pharmacovigilance practice
GRB – Global Regulatory Board
GRP – Good regulatory practice
GSL – General sales list
GSP – Good statistics practice
GVP – Good pharmacovigilance practice
H
HCP – Healthcare professional
HEOR – Health economics and outcomes research
HREC – Human Research Ethics Committee
HTA – Health technology assessment
HTS – High-throughput screening
I
IB – Investigator’s brochure
IC – Informed consent
ICD – Informed consent document
ICSR – Individual case safety report
IDE – Investigational Device Exemption
IDMP – Identification of medicinal products
IEC – Independent ethics committee
IM – Issue management
IME – Important medical event
IMI – Innovative Medicines Initiative
IMP – Investigational medicinal product
IMPD – Investigational medicinal product dossier
IMRDF – International Medical Device Regulatory Forum
IMS – Information management strategy
INDA – Investigational new drug application (USA)
INDC – Investigational New Drug Committee
IP – Intellectual property
IPO – Intellectual Property Office
IPR – Intellectual property rights
IQM – Integrated quality management
IRB – Institutional review board
IRD – International registration document
IRN – Incident Review Network
IS – Internal standard
ISE – Integrated summary of efficacy
ISRB – Integrated summary of risk benefit
ISS – Integrated summary of safety
K
KIT – Key intelligence topic
KM – Knowledge management
KOL – Key opinion leader
L
LCM – Lifecycle management
LED – Least Effect Dose
LLL – Lifelong learning
M
MA – Marketing authorisation
MAA – Marketing authorisation application (EU)
MAH – Marketing authorisation holder
MAIL – Medicines Act Information Letter (UK)
MAL – Medicines Act Leaflet (UK)
MDCG – Medical Device Coordination Group
MDD – Medical Device Directive
MDEG – Medical Device Expert Group
MDLO – Medical Device Liaison Officer
MDR – Medical device reporting
MERS – Multi-agency electronic regulatory system
MHRA – Medicines and Healthcare products Regulatory Agency (UK)
ML – Manufacturer’s licence (UK)
MOU – Memorandum of Understanding
MRA – Mutual recognition agreement
N
NAP – Nationally authorised product
NBE – New biological entity
NCE – New chemical entity
NCO – Non clinical overview
NCS – Non clinical summary
NDAC – New Drug Advisory Committee (India)
NED – Non effect dose
NIMP – Non-investigational medicinal product
NME – New molecular entity
O
OD – Orphan drug
ODA – Orphan Drugs Act (USA)
ODD – Orphan drug designation
OIA – Official action indicated
OOS – Out of specification
OPD – Original pack dispensing
OTC – Over-the-counter
P
P&R – Pricing and reimbursement
P – Pharmacy only
P to GSL – Pharmacy to General Sales List
PA – Product authorisation
PAI – Pre-approval inspection
PAR – Preliminary assessment report
PASS – Post authorisation safety study
PAT – Process analytical technology
PCT – Primary care trust
PDE – Personal daily exposure
PER – Pharmaceutical evaluation report
PGD – Patient group direction
PI – Prescribing information
PI – Production information
PIL – Patient information leaflet
PIM – Product information management (EMA)
PIP – Paediatric investigation plan
PMS study – Post-marketing safety study
PMS – Postmarket(ing) surveillance
POM – Prescription-only medicine
POM to P – Prescription-only medicine to pharmacy
PPI – Patient and Public Involvement (UK)
PRSPH – Potential serious risk to public health
PSMF – Pharmacovigilance system master file
PTE – Patent term extension
PUMA – Paediatric-use marketing authorisation
PV – Pharmacovigilance
PVAR – Preliminary Variation Assessment Report
Q
QA – Quality assurance
QbD – Quality by design
QC – Quality control
QMS – Quality management system
QOL – Quality of life
QoS – Quality overall summary
QP – Qualified person
QPPV – Qualified person for pharmacovigilance
QRD – Quality review of documents [template]
R
RA – Regulatory affairs
RCFID – Registration Certificate for Import of Drug
RCT – Randomised controlled trial
RDE – Remote data entry
RDS – Repeat dose study
RDT – Rising-dose tolerance
REACH – Registration, evaluation, authorisation and restriction of chemicals
RI – Regulatory intelligence
RING – Regulatory Intelligence Network Group
rINN – Recommended international non-proprietary name
RMM – Risk minimisation measure
RMP – Reference medicinal product
RMR – Reaction monitoring report
ROI – Return on investment
RoW – Rest of world
RP – Responsible person
RPS – Regulated product submission
Rx – Prescription
S
S+T – Sampling and testing
SAG – Scientific Advisory Group
SAP – Scientific advice procedure
SAWP – Scientific Advice Working Party
SI – Statutory instrument
SLA – Service level agreement
SME – Significant medical event
SMF – Site master file
SMO – Site management organisation
SMQ – Standardised MedDRA query
SOP – standard operating procedure
SPIN – Special interest network
SSC – Scientific Steering Committee
SWOTs – Strengths – weaknesses – opportunities – threats
T
TAG – Therapeutic Advisory Group
TLV – Threshold limit value
TOC – Table of contents
TOD – Table of decisions
TOPRA – The Organisation for Professionals in Regulatory Affairs
TPP – Target product profile
V
VAI – Voluntary action indicated
W
WC – Written confirmation
WL – Wholesale dealer’s licence
WRAC – Worldwide Regulatory Affairs Committee
