Glossary of acronyms and abbreviations

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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 immunisation

AIM – Active ingredient manufacturer

AIMD – Active implantable medical device

ANDA – Abbreviated new drug application

API – Active pharmaceutical ingredient

AQL – Acceptable quality level

AR – Assessment Report (European Union)

ASMF – Active Substance Master File

ATMPs – Advanced therapy medicinal products

B

BA – Bioavailability

BAN – British Approved Name

BAP – Biotechnology Action Programme

BIND – Biological investigational new drug

BWP – Biotech Working Party (EMA)

C

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

Cl – 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 Sale

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 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

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

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

F

FAR – Final assessment report

FMEA – Failure mode and effects analysis

FTE – Full Time Equivalent

G

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

H

HCP – Healthcare professional

HEOR – Health economics and outcomes research

HREC – Human Research Ethics Committee

HTA – Health technology assessment

HTS – High-throughput screening

I

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

K

KIT – Key intelligence topic

KM – Knowledge management

KOL – Key opinion leader

L

LCM – Lifecycle management

LED – Least Effect Dose

LLL – Lifelong learning

M

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

N

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

NME – New molecular entity

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 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

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)

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

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 [template]

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

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 organisation

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

V

VAI – Voluntary action indicated

W

WC – Written confirmation

WL – Wholesale dealer’s licence

WRAC – Worldwide Regulatory Affairs Committee

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