Abbreviations Flashcards
1
Q
GRP
A
Good Regulatory Practice
2
Q
GMP
A
Good Manufacturing Practice
3
Q
GLP
A
Good Laboratory Practice
4
Q
GCP
A
Good Clinical Practice
5
Q
GDP
A
Good Distribution Practice
6
Q
GEP
A
Good Engineering Practice
7
Q
GAMP
A
Good Automated Manufacturing Practice
8
Q
cGMP
A
Current GMP
9
Q
aGMP
A
Appropriate GMP
10
Q
EIPG
A
European Industrial Pharmacists Group
11
Q
RA
A
Regulatory Affairs
12
Q
QP
A
Qualified Person
13
Q
QA
A
Quality Assurance
14
Q
R&D
A
Research and Development
15
Q
SmPC
A
Summary of Product Characteristics
16
Q
MAH
A
Marketing Authorization Holder
17
Q
MA
A
Marketing Authorization
18
Q
CMC
A
Chemistry, Manufacturing, and Controls
19
Q
PV
A
Pharmacovigilance
20
Q
RWE
A
Real-World Evidence
21
Q
PMA
A
Progressive Marketing Authorization
22
Q
ICH
A
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
23
Q
VICH
A
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
24
Q
IP
A
Intellectual Property
25
HTA
Health Technology Assessment
26
EMA
European Medicines Agency
27
e-CTD
electronic Common Technical Document
28
CESP
Common European Submission Platform
29
HMA
Heads of Medicines Agencies.
30
SME
Small and Medium-sized Enterprise
31
IRP
International Reference Pricing
32
CA
Competent Authorities
33
TEU
Treaty on European Union
34
EU
European Union
35
CJEU
Court of Justice of the European Union
36
ECB
European Central Bank
37
ECA
European Court of Auditors
38
EDQM
European Directorate for the Quality of Medicines and HealthCare
39
EFTA
European Free Trade Association
40
EEA
European Economic Area
41
MP
Medicinal Product
42
CP
Change Proposal
43
EPAR
European Public Assessment Report
44
CHMP
Committee for Medicinal Products for Human Use
45
PRAC
Pharmacovigilance Risk Assessment Committee
46
CVMP
Committee for Medicinal Products for Veterinary Use
47
COMP
Committee for Orphan Medicinal Products
48
HMPC
Committee on Herbal Medicinal Products
49
PDCO
Pediatric Committee
50
CAT
Committee for Advanced Therapies
51
SAG
Scientific Advisory Groups
52
WP
Working Parties
53
SAWP
Scientific Advice Working Party
54
BMWP
Biosimilar Medicinal Products Working Party
55
ECJ
European Court of Justice
56
ATMP
Advanced Therapy Medicinal Products
57
MAA
Marketing Authorization Application
58
CTA
Clinical Trial Agreement
59
ATIMPs
Advanced Therapy Investigational Medicinal Products
60
PIP
Pediatric Investigation Plan
61
CTR
Clinical Trials Regulation
62
CTIS
Clinical Trials Information System
63
CT
Clinical Trials
64
MSC
Member States Concerned
65
MD
Medical Device
66
UDI
Unique Device Identifiers
67
CE
Conformité Européene
68
SUE
Serious Undesirable Effects
69
CPNP
Cosmetic Products Notification Portal
70
NHC
Nutrition and Health Claims
71
EFSA
European Food Safety Authority
72
ECHA
European Chemicals Agency
73
PPP
Plant Protection Products
74
BP
Biocidal Products
75
REACH
Registration, Evaluation, Authorization, and Restriction of Chemicals
76
NOAELS
No-Observed-Adverse-Effect-Levels
77
MoS
Margin of Safety
78
TCM
Traditional Chinese Medicine
79
CAM
Complementary and Alternative Medicines
80
MRP
Mutual Recognition Procedure
81
DCP
Decentralised Procedure
82
CMS
Concerned Member State
83
RMS
Reference Member State
84
RUP
Repeat Use Procedure
85
AR
Annual Report/Assessment Report
86
BOS
Break Out Session
87
CMDh
Co-ordination Group for Mutual Recognition and Decentralised Procedures
88
DAR
Draft Assessment Report
89
LOI
List of Outstanding Issues
90
LoQ
List of Questions
91
RtQ
Respons to questions
92
NRG
Name Review Group
93
IND
Investigational New Drug
94
FDA
U.S. Food and Drug Administration
95
NDA
New Drug Applicant
96
ANDA
Abbreviated New Drug Application
97
PIP
Pediatric Investigation Plan
98
PDCO
EMA Paediatric Committee
99
SPC
Supplementary Protection Certificate
Specific Product Characteristics
100
PUMA
Paediatric-use Marketing Authorisations
101
PA
Patent Application
102
EUnetHTA
European Network for Health Technology Assessment
103
API
Active Pharmaceutical Ingredient
104
ToC
Table of Contents
105
CTD
Common Technical Document
106
LCM
Life Cycle Management
107
PIL
Patient Information Leaflet
108
GMO
Genetically Modified Organism
109
QRD
Quality Review of Documents
110
AL
Adaptive Licensing
111
CMA
Conditional Marketing Authorization
112
RQ
Risk Quotient
113
PEC
Predicted Environmental Concentration
114
PNEC
Predicted No-Effect Concentration
115
RMA
Risk Minimisation Activities
116
RMP
Risk Management Plan
117
S.S.
Safety Specification
118
RMA
Risk Management Association
119
CEP
Certificate of Suitability to the European Pharmacopoeia
120
TSE
Trading Standards Enforcement
121
QOS
Quality overall Summary
122
MFG
Manufacturing
123
FPP
Finished Pharmaceutical Produc
124
EDMF
European Drug Master File
125
SM
Starting materials
126
DS
Drug Substance
127
DP
Drug Product
128
EoSL
End of Shelf life
129
(a)QbD
(analytical) Quality by Design
130
CQA
Critical Quality Atributes
131
DOEs
Design of Experiments
132
NOR
Normal Operating Region
133
MOR
Maximal Operating Region
134
PAR
Proven Acceptable Range
135
MODR
Method Operable Design Region
136
PAT
Process Analytical Technology
137
GxP
Good Experimental Practice
138
QTPP
Quality Target Product Profile
139
CQA
Critical Quality Attribute
140
CPP
Critical Process Parameter
141
RTR
Real-Time Reporting
142
PQS
Pharmaceutical Quality System
143
ECs
Established Conditions
144
PACMP
Post-approval Change Management Protocol
145
QSAR
Quantitative Structure-Activity Relationship
146
CAESAR
Computer- Assisted Evaluation of Industrial Chemical Substances According to Regulation
147
DEREK
Deductive Estimate of Risk from Existing Knowledge
148
PGI
Potentially Genotoxic Impurities
149
ADI
Acceptable Daily Intake
150
LOEL
Lowest Observed Effect Level
151
PD
Pharmacodynamics
152
ADME
Absorption, Distribution, Metabolism, and Excretion
153
GCCP
Good Cell Culture Practice
154
WHO
World Health Organisation
155
DART
Development And Reproductive Toxicity
156
MRSD
Maximum Recommended Starting Dose
157
FIH
First In Human
158
NCE
New Chemical Entity
159
HED
Human Equivalent Dose
160
PAD
Pharmacologically Active Dose
161
HEPAD
Human Equivalent Pharmacologically Active Dose
162
MABEL
Minimum Anticipated Biological Effect Level
163
CAP
Corrective Action Plan
164
RIP
Responsible for Information and Publicity
165
OTC
Over The Counter
166
FAGG
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten
167
SKP
Samenvatting van de Kenmerken van het Product
168
ADR
Adverse Drug reaction
169
NCAs
National Competent Authorities
170
ISO
International Organization for Standardization
171
RMS
Referential Management Service
172
SPOR portal
Substance, Product, Organisation and Referential master data
173
GVP
Good Pharmacovigilance Practices
174
PSUR
Periodic Safety Update Report
175
PASS
Post-Authorization Safety Study
176
PSMF
Pharmacovigilance System Master File
177
NIHDI
National Institute for Health and Disability Insurance
178
HCP
Healthcare Provider
179
CRM
Committee of Reimbursement of Medical Products
180
VAT
Value Added Tax
181
ICER
Institute for Clinical and Economic Review
Incremental cost-effectivness ratio
182
MOA
Mode of Action
183
ATC code
Anatomical Therapeutic Chemical code
184
HEOR
Health Economics and Outcomes Research
185
CEA
Cost-effectiveness Acceptability curve
186
BI
Budget Impact
187
ASMF
Active substance master file procedure
188
ATP
Analytical target profile
189
HCB
Health Care Budget
190
MEA
managed entry agreement
191
CEA
Cost-effectiveness Acceptability curve
192
TTC
Threshold of Toxicological Concern
193
ePI
electronic Product Information
194
PGx
Pharmacogenomics
195
SA
Scientific Advice/ Safety Assessment
196
MDR
Medical Device Regulation
197
MedDRA
Medical Dictionary for Regulatory Activities
198
SMQ
Standardised MedDRA Queries
199
SOC
System Organ Class
200
HLGT
High Level Group Term
201
HLT
High Level Term
202
PTR
Preferred Term
203
LLT
Lowest Level Term
204
DSUR
Development Safety Update Report
205
RO
Receptor Occupancy
206
QPPV
Qualified Person responsible for Pharmacovigilance
207
PAES
Post-Authorisation Efficacy Study
208
DHT
Digital Health Technologies
209
LBP
Live Biotherpeutic Products
210
IMP
Investigational Medicinal Product
211
EC
Ethical Committees
212
IVDR
In-Vitro Diagnostic Medical Devices Regulation
213
EUTCD
European Union Tissue and Cell Directive
214
BTC
Blood, Tissue and Cells
215
FAVV
Federaal Agentschap voor de Veiligheid van de Voedselketen
216
PARNUTS
Feed for Particular Nutritional Uses
217
FMT
Faecal Microbiota Transplants
218
NP
National Procedure
219
RIZIV
Rijksinstituut voor Ziekte- en Invaliditeitsverzekering
220
INAMI
Institut national d'assurance maladie-invalidité
221
HTAB
Health Technology Assessment Bodies
222
EU-M4All
EU-Medicines for all (Article 58)
223
PRIME
Priority Medicines
224
ASMF
Active Substance Master File
225
ATP
Analytical Target profile
226
EoF
Edge of failure
227
IPEC
International Pharmaceutical Excipient Council
228
PLCM
Product Life Cycle Management
229
LTL
Less-than-lifetime
230
LoD
Limit of Detection
231
LoQ
Limit of Quantification
232
SST
System Suitabilaty Test
233
ALARA
As Low As Reasonable Achievable
234
ICSR
Individual Case Safety Report
235
BSA
Body Surface Area
236
Article 8(3) of Directive 2001/83/EC
Full Applications
237
Article 10 of Directive 2001/83/EC
10.1 Generic
10.3 Hybrids
10.4 Similar biological
238
Article 10a of Directive 2001/83/EC
Well established medicinal use (min 10 years) supported by bibliographic literature
239
Article 10b of Directive 2001/83/EC
New fixed combination
240
Article 10c of Directive 2001/83/EC
Informed consent from MAA
241
Article 16a of Directive 2001/83/EC
Traditional Herbals
242
CTD Module 1
General information
243
CTD Module 2
Developmental summaries
244
CTD Module 3
Quality
245
CTD Module 4
Preclinical
246
CTD Module 5
Clinical
