Imprint Magazine

ACRONYMS	FULL FORM
AADA	Abbreviated Antibiotic Drug Application
ABHI	Associated of British Healthcare Industries
ABPI	Associated of the British Pharmaceutical Industry
ACTD	ASEAN Common Technical Dossier
ADC	Aditional 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 Implantable medical Device
AQL	Acceptable Quality Level
AR	Assessment Report(European Union)
ASMF	Active Substance Master File
ATMPs	Advanced Therapy Medicinal Products
BA	Bioavailability
BAN	British Approved Name
BAP	Biotechnology Action Programme
BIND	Biological Investigational New Drug
BWP	Biotech Working Party (EMA)
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
CI	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 Sales
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 Trial 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)
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
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
FAR	Final assessment report
FMEA	Failure mode and effects analysis
FTE	Full Time Equivalent
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
HCP	Healthcare professional
HEOR	Health economics and outcomes research
HREC	Human Research Ethics Committee
HTA	Health technology assessment
HTS	High-throughput screening
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
KIT	Key intelligence topic
KM	Knowledge management
KOL	Key opinion leader
LCM	Lifecycle management
LED	Least Effect Dose
LLL	Lifelong learning
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
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
NIMP	Non-investigational medicinal product
NME	New molecular entity
OD	Orphan drug
ODA	Orphan Drugs Act (USA)
ODD	Orphan drug designation
OIA	Orphan drug designation
OOS	Out of specification
OPD	Original pack dispensing
OTC	Over-the-counter
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
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
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]
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+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
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
VAI	Voluntary action indicated
WC	Written confirmation
WL	Wholesale dealer’s licence
WRAC	Worldwide Regulatory Affairs Committee