Pharmaceutical Regulatory Affairs - Glossary of acronyms and abbreviations

Pharmaceutical Regulatory Affairs - Glossary of acronyms and abbreviations

 

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 immunization
AEMPS	Agencia Española de Medicamentos y Productos Sanitarios (Spanish Medicines and Healthcare Products Agency)
AGES	Austrian Agency for Health and Food Safety
AIFA	Agenzia Italiana del Farmaco (Italian Medicines Agency)
AIM	Active ingredient manufacturer
AIMD	Active implantable medical device
ANDA	Abbreviated new drug application
ANSM	Agence nationale de sécurité du médicament et des produits de santé (French Medicines Agency)
API	Active pharmaceutical ingredient
AQL	Acceptable quality level
AR	Assessment Report (European Union)
ASMF	Active Substance Master File
ASR	Annual safety report
ATMPs	Advanced therapy medicinal products
ATC	Anatomical Therapeutic Chemical
B
BA	Bioavailability
BAN	British Approved Name
BAP	Biotechnology Action Programme
BfArM	Bundesinstitut für Arzneimittel und Medisinprodukte (Federal Institute for Drugs and Medical Devices in Germany)
BIND	Biological investigational new drug
BNF	British National Formulary
BOS	Break-out session (happens during a DCP/MRP/CP)
BP	British Pharmacopoeia
BWP	Biotech Working Party (EMA)
C
C&P	Chemistry and Pharmacy
CA	Commercial appraisal
CA	Competent authority (a medicines regulatory authority in the European Union)
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 Drugs Standard Control Organisation
CEP	Certification of suitability to the Monographs of the European Pharmacopoeia
CHMP	Committee for Medicinal Products for Human Use
cGLP	Current good laboratory practice
cGMP	Current good manufacturing practice
Cl	Total body clearance
CIOMS	Council for International Organisations of Medical Sciences
CLO	Clinical overview
CLS	Clinical summary
CMC	Chemistry- manufacturing- controls
CMDh	Co-ordination group for Mutual recognition and Decentralised procedures – Human
CMDv	Co-ordination group for Mutual recognition and Decentralised procedures – Veterinary
CMP	Certificate of Medicinal Product
CMS	Concerned Member State (European Union)
CO	clinical overview
COA	Certificate of analysis
CoFS	Certificate of Free Sale
COMP	Committee on Orphan Medicinal Products
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
CRO	Contract 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
DCP	Decentralised procedure
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
EDQM	European Directorate for the Quality of Medicines & Healthcare
EDMF	European drug master file
EDT	Electronic data transfer
EEA	European economic area
EMA	European Medicines Agency
ENS	Early notification system
EP	European Pharmacopeia
EPI	Essential Program for Immunisation
EPL	Effective patent life
ePSUR	Eelectronic periodic safety update report
ERA	Environmental risk assessment
ERB	Ethical review board
ESPAR	Executive Summary Pharmacovigilance Assessment Report
EWG	Expert Working Group
EWP	Efficacy Working Party
F
FAMHP	Federal Agency for Medicines and Health Products (of Belgium)
FAR	Final assessment report
FAR	Field Alert Report
FDA	Food and Drug Administration
FMEA	Failure mode and effects analysis
FIMEA	Finnish Medicines Agency
FTE	Full Time Equivalent
G
GCP	Good clinical practice
GDP	Good distribution practice
GGP	Good guidance practice
GLP	Good laboratory practice
GMO	Genetically modified organism
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
HMA	Heads of Medicines Agencies (EU)
HPRA	Health Product Regulatory Authority
HREC	Human Research Ethics Committee
HTA	Health technology assessment
HTS	High-throughput screening
I
IB	Investigator’s brochure
IC	Informed consent
ICH	International Council on Harmonisation
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
IMA	Icelandic Medicines Agency
IMI	Innovative Medicines Initiative
IMP	Investigational medicinal product
IMPD	Investigational medicinal product dossier
IMRDF	International Medical Device Regulatory Forum
IMS	Information management strategy
INN	International non –proprietary names
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
LOA	letter of authorisation
M
MA	Marketing authorisation
MAA	Marketing authorisation application (EU)
MAH	Marketing authorisation holder
MAIL	Medicines act information letter (UK)
MAL	Medicines Act Leaflet (UK)
MAT	Marketing authorisation transfer
MDCG	Medical Device Coordination Group
MDD	Medical Device Directive
MDEG	Medical Device Expert Group
MDLO	Medical Device Liaison Officer
MDR	Medical device reporting
MedDRA	Medical Dictionary for Regulatory Activities
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
MRP	Mutual recognition procedure
MS	Member state(EU)
N
NAP	Nationally authorised product
NBE	New biological entity
NCA	National Competent Authority
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
NOMA	The Norwegian Medicines Agency
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 authorization
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)
PRAC	Pharmacovigilance Risk Assessment Committee
PRSPH	Potential serious risk to public health
PSMF	Pharmacovigilance system master file
PTE	Patent term extension
PUMA	Paediatric-use marketing authorization
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
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
RMS	Reference Member State
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 organization
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
TSE	Transmissible Spongiform Encephalopathy
U
USP	United States Pharmacopeia
V
VAMF	Vaccine antigen master file
VAI	Voluntary action indicated
W
WC	Written confirmation
WHO	World Health Organization
WL	Wholesale dealer’s licence
WRAC	Worldwide Regulatory Affairs Committee