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Glossary of acronyms and abbreviations

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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


BA - Bioavailability

BAN - British Approved Name

BAP - Biotechnology Action Programme

BIND - Biological investigational new drug

BWP - Biotech Working Party (EMA)


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)


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


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


FAR - Final assessment report

FMEA - Failure mode and effects analysis

FTE - Full Time Equivalent


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


HCP - Healthcare professional

HEOR – Health economics and outcomes research

HREC - Human Research Ethics Committee

HTA - Health technology assessment

HTS - High-throughput screening


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


KIT - Key intelligence topic

KM - Knowledge management

KOL - Key opinion leader


LCM - Lifecycle management

LED - Least Effect Dose

LLL - Lifelong learning


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


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


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&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


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]


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+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


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


VAI - Voluntary action indicated


WC - Written confirmation

WL - Wholesale dealer’s licence

WRAC - Worldwide Regulatory Affairs Committee

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