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 |