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Regulatory affairs > Abbreviations > Flashcards

Abbreviations Flashcards

1
Q

GRP

A

Good Regulatory Practice

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2
Q

GMP

A

Good Manufacturing Practice

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3
Q

GLP

A

Good Laboratory Practice

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4
Q

GCP

A

Good Clinical Practice

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5
Q

GDP

A

Good Distribution Practice

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6
Q

GEP

A

Good Engineering Practice

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7
Q

GAMP

A

Good Automated Manufacturing Practice

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8
Q

cGMP

A

Current GMP

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9
Q

aGMP

A

Appropriate GMP

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10
Q

EIPG

A

European Industrial Pharmacists Group

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11
Q

RA

A

Regulatory Affairs

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12
Q

QP

A

Qualified Person

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13
Q

QA

A

Quality Assurance

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14
Q

R&D

A

Research and Development

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15
Q

SmPC

A

Summary of Product Characteristics

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16
Q

MAH

A

Marketing Authorization Holder

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17
Q

MA

A

Marketing Authorization

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18
Q

CMC

A

Chemistry, Manufacturing, and Controls

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19
Q

PV

A

Pharmacovigilance

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20
Q

RWE

A

Real-World Evidence

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21
Q

PMA

A

Progressive Marketing Authorization

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22
Q

ICH

A

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

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23
Q

VICH

A

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

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24
Q

IP

A

Intellectual Property

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25
Q

HTA

A

Health Technology Assessment

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26
Q

EMA

A

European Medicines Agency

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27
Q

e-CTD

A

electronic Common Technical Document

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28
Q

CESP

A

Common European Submission Platform

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29
Q

HMA

A

Heads of Medicines Agencies.

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30
Q

SME

A

Small and Medium-sized Enterprise

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31
Q

IRP

A

International Reference Pricing

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32
Q

CA

A

Competent Authorities

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33
Q

TEU

A

Treaty on European Union

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34
Q

EU

A

European Union

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35
Q

CJEU

A

Court of Justice of the European Union

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36
Q

ECB

A

European Central Bank

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37
Q

ECA

A

European Court of Auditors

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38
Q

EDQM

A

European Directorate for the Quality of Medicines and HealthCare

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39
Q

EFTA

A

European Free Trade Association

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40
Q

EEA

A

European Economic Area

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41
Q

MP

A

Medicinal Product

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42
Q

CP

A

Change Proposal

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43
Q

EPAR

A

European Public Assessment Report

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44
Q

CHMP

A

Committee for Medicinal Products for Human Use

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45
Q

PRAC

A

Pharmacovigilance Risk Assessment Committee

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46
Q

CVMP

A

Committee for Medicinal Products for Veterinary Use

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47
Q

COMP

A

Committee for Orphan Medicinal Products

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48
Q

HMPC

A

Committee on Herbal Medicinal Products

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49
Q

PDCO

A

Pediatric Committee

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50
Q

CAT

A

Committee for Advanced Therapies

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51
Q

SAG

A

Scientific Advisory Groups

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52
Q

WP

A

Working Parties

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53
Q

SAWP

A

Scientific Advice Working Party

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54
Q

BMWP

A

Biosimilar Medicinal Products Working Party

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55
Q

ECJ

A

European Court of Justice

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56
Q

ATMP

A

Advanced Therapy Medicinal Products

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57
Q

MAA

A

Marketing Authorization Application

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58
Q

CTA

A

Clinical Trial Agreement

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59
Q

ATIMPs

A

Advanced Therapy Investigational Medicinal Products

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60
Q

PIP

A

Pediatric Investigation Plan

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61
Q

CTR

A

Clinical Trials Regulation

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62
Q

CTIS

A

Clinical Trials Information System

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63
Q

CT

A

Clinical Trials

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64
Q

MSC

A

Member States Concerned

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65
Q

MD

A

Medical Device

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66
Q

UDI

A

Unique Device Identifiers

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67
Q

CE

A

Conformité Européene

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68
Q

SUE

A

Serious Undesirable Effects

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69
Q

CPNP

A

Cosmetic Products Notification Portal

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70
Q

NHC

A

Nutrition and Health Claims

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71
Q

EFSA

A

European Food Safety Authority

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72
Q

ECHA

A

European Chemicals Agency

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73
Q

PPP

A

Plant Protection Products

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74
Q

BP

A

Biocidal Products

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75
Q

REACH

A

Registration, Evaluation, Authorization, and Restriction of Chemicals

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76
Q

NOAELS

A

No-Observed-Adverse-Effect-Levels

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77
Q

MoS

A

Margin of Safety

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78
Q

TCM

A

Traditional Chinese Medicine

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79
Q

CAM

A

Complementary and Alternative Medicines

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80
Q

MRP

A

Mutual Recognition Procedure

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81
Q

DCP

A

Decentralised Procedure

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82
Q

CMS

A

Concerned Member State

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83
Q

RMS

A

Reference Member State

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84
Q

RUP

A

Repeat Use Procedure

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85
Q

AR

A

Annual Report/Assessment Report

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86
Q

BOS

A

Break Out Session

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87
Q

CMDh

A

Co-ordination Group for Mutual Recognition and Decentralised Procedures

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88
Q

DAR

A

Draft Assessment Report

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89
Q

LOI

A

List of Outstanding Issues

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90
Q

LoQ

A

List of Questions

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91
Q

RtQ

A

Respons to questions

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92
Q

NRG

A

Name Review Group

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93
Q

IND

A

Investigational New Drug

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94
Q

FDA

A

U.S. Food and Drug Administration

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95
Q

NDA

A

New Drug Applicant

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96
Q

ANDA

A

Abbreviated New Drug Application

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97
Q

PIP

A

Pediatric Investigation Plan

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98
Q

PDCO

A

EMA Paediatric Committee

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99
Q

SPC

A

Supplementary Protection Certificate
Specific Product Characteristics

100
Q

PUMA

A

Paediatric-use Marketing Authorisations

101
Q

PA

A

Patent Application

102
Q

EUnetHTA

A

European Network for Health Technology Assessment

103
Q

API

A

Active Pharmaceutical Ingredient

104
Q

ToC

A

Table of Contents

105
Q

CTD

A

Common Technical Document

106
Q

LCM

A

Life Cycle Management

107
Q

PIL

A

Patient Information Leaflet

108
Q

GMO

A

Genetically Modified Organism

109
Q

QRD

A

Quality Review of Documents

110
Q

AL

A

Adaptive Licensing

111
Q

CMA

A

Conditional Marketing Authorization

112
Q

RQ

A

Risk Quotient

113
Q

PEC

A

Predicted Environmental Concentration

114
Q

PNEC

A

Predicted No-Effect Concentration

115
Q

RMA

A

Risk Minimisation Activities

116
Q

RMP

A

Risk Management Plan

117
Q

S.S.

A

Safety Specification

118
Q

RMA

A

Risk Management Association

119
Q

CEP

A

Certificate of Suitability to the European Pharmacopoeia

120
Q

TSE

A

Trading Standards Enforcement

121
Q

QOS

A

Quality overall Summary

122
Q

MFG

A

Manufacturing

123
Q

FPP

A

Finished Pharmaceutical Produc

124
Q

EDMF

A

European Drug Master File

125
Q

SM

A

Starting materials

126
Q

DS

A

Drug Substance

127
Q

DP

A

Drug Product

128
Q

EoSL

A

End of Shelf life

129
Q

(a)QbD

A

(analytical) Quality by Design

130
Q

CQA

A

Critical Quality Atributes

131
Q

DOEs

A

Design of Experiments

132
Q

NOR

A

Normal Operating Region

133
Q

MOR

A

Maximal Operating Region

134
Q

PAR

A

Proven Acceptable Range

135
Q

MODR

A

Method Operable Design Region

136
Q

PAT

A

Process Analytical Technology

137
Q

GxP

A

Good Experimental Practice

138
Q

QTPP

A

Quality Target Product Profile

139
Q

CQA

A

Critical Quality Attribute

140
Q

CPP

A

Critical Process Parameter

141
Q

RTR

A

Real-Time Reporting

142
Q

PQS

A

Pharmaceutical Quality System

143
Q

ECs

A

Established Conditions

144
Q

PACMP

A

Post-approval Change Management Protocol

145
Q

QSAR

A

Quantitative Structure-Activity Relationship

146
Q

CAESAR

A

Computer- Assisted Evaluation of Industrial Chemical Substances According to Regulation

147
Q

DEREK

A

Deductive Estimate of Risk from Existing Knowledge

148
Q

PGI

A

Potentially Genotoxic Impurities

149
Q

ADI

A

Acceptable Daily Intake

150
Q

LOEL

A

Lowest Observed Effect Level

151
Q

PD

A

Pharmacodynamics

152
Q

ADME

A

Absorption, Distribution, Metabolism, and Excretion

153
Q

GCCP

A

Good Cell Culture Practice

154
Q

WHO

A

World Health Organisation

155
Q

DART

A

Development And Reproductive Toxicity

156
Q

MRSD

A

Maximum Recommended Starting Dose

157
Q

FIH

A

First In Human

158
Q

NCE

A

New Chemical Entity

159
Q

HED

A

Human Equivalent Dose

160
Q

PAD

A

Pharmacologically Active Dose

161
Q

HEPAD

A

Human Equivalent Pharmacologically Active Dose

162
Q

MABEL

A

Minimum Anticipated Biological Effect Level

163
Q

CAP

A

Corrective Action Plan

164
Q

RIP

A

Responsible for Information and Publicity

165
Q

OTC

A

Over The Counter

166
Q

FAGG

A

Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten

167
Q

SKP

A

Samenvatting van de Kenmerken van het Product

168
Q

ADR

A

Adverse Drug reaction

169
Q

NCAs

A

National Competent Authorities

170
Q

ISO

A

International Organization for Standardization

171
Q

RMS

A

Referential Management Service

172
Q

SPOR portal

A

Substance, Product, Organisation and Referential master data

173
Q

GVP

A

Good Pharmacovigilance Practices

174
Q

PSUR

A

Periodic Safety Update Report

175
Q

PASS

A

Post-Authorization Safety Study

176
Q

PSMF

A

Pharmacovigilance System Master File

177
Q

NIHDI

A

National Institute for Health and Disability Insurance

178
Q

HCP

A

Healthcare Provider

179
Q

CRM

A

Committee of Reimbursement of Medical Products

180
Q

VAT

A

Value Added Tax

181
Q

ICER

A

Institute for Clinical and Economic Review
Incremental cost-effectivness ratio

182
Q

MOA

A

Mode of Action

183
Q

ATC code

A

Anatomical Therapeutic Chemical code

184
Q

HEOR

A

Health Economics and Outcomes Research

185
Q

CEA

A

Cost-effectiveness Acceptability curve

186
Q

BI

A

Budget Impact

187
Q

ASMF

A

Active substance master file procedure

188
Q

ATP

A

Analytical target profile

189
Q

HCB

A

Health Care Budget

190
Q

MEA

A

managed entry agreement

191
Q

CEA

A

Cost-effectiveness Acceptability curve

192
Q

TTC

A

Threshold of Toxicological Concern

193
Q

ePI

A

electronic Product Information

194
Q

PGx

A

Pharmacogenomics

195
Q

SA

A

Scientific Advice/ Safety Assessment

196
Q

MDR

A

Medical Device Regulation

197
Q

MedDRA

A

Medical Dictionary for Regulatory Activities

198
Q

SMQ

A

Standardised MedDRA Queries

199
Q

SOC

A

System Organ Class

200
Q

HLGT

A

High Level Group Term

201
Q

HLT

A

High Level Term

202
Q

PTR

A

Preferred Term

203
Q

LLT

A

Lowest Level Term

204
Q

DSUR

A

Development Safety Update Report

205
Q

RO

A

Receptor Occupancy

206
Q

QPPV

A

Qualified Person responsible for Pharmacovigilance

207
Q

PAES

A

Post-Authorisation Efficacy Study

208
Q

DHT

A

Digital Health Technologies

209
Q

LBP

A

Live Biotherpeutic Products

210
Q

IMP

A

Investigational Medicinal Product

211
Q

EC

A

Ethical Committees

212
Q

IVDR

A

In-Vitro Diagnostic Medical Devices Regulation

213
Q

EUTCD

A

European Union Tissue and Cell Directive

214
Q

BTC

A

Blood, Tissue and Cells

215
Q

FAVV

A

Federaal Agentschap voor de Veiligheid van de Voedselketen

216
Q

PARNUTS

A

Feed for Particular Nutritional Uses

217
Q

FMT

A

Faecal Microbiota Transplants

218
Q

NP

A

National Procedure

219
Q

RIZIV

A

Rijksinstituut voor Ziekte- en Invaliditeitsverzekering

220
Q

INAMI

A

Institut national d’assurance maladie-invalidité

221
Q

HTAB

A

Health Technology Assessment Bodies

222
Q

EU-M4All

A

EU-Medicines for all (Article 58)

223
Q

PRIME

A

Priority Medicines

224
Q

ASMF

A

Active Substance Master File

225
Q

ATP

A

Analytical Target profile

226
Q

EoF

A

Edge of failure

227
Q

IPEC

A

International Pharmaceutical Excipient Council

228
Q

PLCM

A

Product Life Cycle Management

229
Q

LTL

A

Less-than-lifetime

230
Q

LoD

A

Limit of Detection

231
Q

LoQ

A

Limit of Quantification

232
Q

SST

A

System Suitabilaty Test

233
Q

ALARA

A

As Low As Reasonable Achievable

234
Q

ICSR

A

Individual Case Safety Report

235
Q

BSA

A

Body Surface Area

236
Q

Article 8(3) of Directive 2001/83/EC

A

Full Applications

237
Q

Article 10 of Directive 2001/83/EC

A

10.1 Generic
10.3 Hybrids
10.4 Similar biological

238
Q

Article 10a of Directive 2001/83/EC

A

Well established medicinal use (min 10 years) supported by bibliographic literature

239
Q

Article 10b of Directive 2001/83/EC

A

New fixed combination

240
Q

Article 10c of Directive 2001/83/EC

A

Informed consent from MAA

241
Q

Article 16a of Directive 2001/83/EC

A

Traditional Herbals

242
Q

CTD Module 1

A

General information

243
Q

CTD Module 2

A

Developmental summaries

244
Q

CTD Module 3

245
Q

CTD Module 4

A

Preclinical

246
Q

CTD Module 5

Regulatory affairs (1 decks)

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