Industry Acronyms

ABPI - Association of the Pharmaceutical Industry

AIIM - Association for Information and Image Management

ACRP - Association of Clinical Research Professionals

ADE - Adverse Drug Event

ADR - Adverse Drug Reaction

AE - Adverse Event

AIOPI - Association of Information Officers of the Pharmaceutical Industry

ARMA - Originally, ARMA was the acronym for the Association of Records Managers and Administrators. Over the past several years, ARMA noticed a broadening of the profession as records management has become a recognized and integral part of information management which is key to doing business. To reflect the changing environment and this "expansion" of the profession, the association's Board of Directors decided to discontinue using ARMA as an acronym and adopted "ARMA International" as a general descriptor of the association.

BfArM - German Federal Institute for Drugs and Medical Devices

BIA - Bio-Industry Association

BINAS - Biosafety Information Network and Advisory Service

BMA - British Medical Association

BMJ - British Medical Journal

BPC - Bulk Pharmaceutical Chemicals

BPI - British Pharmaceutical Index

BrAPP - British Association of Pharmaceutical Physicians

BSE - Bovine Spongiform Encephalopathy

CA - Competent Authority e.g.MHRA

CFR - Code of Federal Regulations

CGMP - Current Good Manufacturing Practice

CHI - Commission for Health Improvement

CHMP - Committee for Human Medicinal Products

CI - Chief Investigator

CIOMS - Council for International Organisations of Medical Sciences

CJD - Creutzfeldt-Jakob Disease

CMC - Chemistry, Manufacturing and Controls

COA - Certificate of Analysis

COMP - Committee for Orphan Medicinal Products

COREC - Central Office for Research Ethics Committees

CRA - Clinical Research Associate

CRC - Clinical Research Council

CRF - Case Report Form

CRN - Clinical Research Network

CRO - Contract Research Organisation

CTA - Clinical Trial Authorisation (formerly the CTX, CTC, DDX)

CSM - Committee on Safety of Medicines

CTC - Clinical Trials Centre

CTC - Clinical Trial Certificate (Now CTA)

CTD - Common Technical Document

CTX - Clinical Trial Exemption (Now CTA)

DDD - Defined Daily Dose

DDX - Doctors' and Dentists' Exemption Scheme

DMC - Data Monitoring Committee

DMF - Drug Master File

DMR - Device Medical Record

DSMC - Data Safety Monitoring Committee

DUMP - Disposal of Unwanted Medicines and Poisons

EC - Ethics Committee

EDMF - European Drug Master File

EDMS - Electronic Document Management System

EurdaCT - European Clinical Trial Database

EEA - European Economic Area

EEC - European Economic Community

EFGCP - European Forum for Good Clinical Practice

EFPIA - European Federation of Pharmaceutical Industries & Associations

EFTA - European Free Trade Area

EMEA - European Medicines Agency

EPC - European Patent Convention

EPO - European Patent Office

EPS - European Patent System

EV - Eudravigilance

EWP- Efficacy Working Party

FDA - Food and Drug Administration

FOI - Freedom of Information

GAfREC - Governance Arrangement for Research Ethics Committees

GATT - General Agreement of Tariffs and Trade

GCP - Good Clinical Practice

GLP - Good Laboratory Practice

GM - Genetically Modified

GMC - General Medical Council

GMDN - Global Medical Device Nomenclature

GMO - Genetically Modified Organism

GMP - Good Manufacturing Practice

GPCG - General Practice Computing Group

GPRD - General Practice Research Database

HA - Health Authority (Health Boards in Scotland )

HCP - Health Care Professional

HGP - Human Genome Project

HIPPA - Health Insurance Portability and Accountability Act

HTA - Health Technology Assessment

HUGO - Human Genome Organisation

IACUC - Institutional Animal Care and Use Committee

IB - Investigator Brochure

ICH - International Conference on Harmonisation

ID - Identification (Patient)

IEC - Independent Ethics Committee

IFPMA- International Federation of Pharmaceutical Manufacturers Association

IMA- Independent Medical Advisor

IMPD- Investigational Medicinal Product Dossier

IMP - Investigational Medicinal Products

IRB - Institutional Review Board

IP - Intellectual Property

IPP - Intellectual Property Protection

IPR - Intellectual Property Rights

IRCC - International Register of Certificated Auditors

ISO - International Standardisation Organisation

IU - International Unit

LIMS - Laboratory Information Management System

LMC - Local Medical Committee

LREC - Local Research Ethics Committee

MA - Medical Advisor

MA - Marketing Authorisation

MAH - Marketing Authorisation Holder

MCA - Medicines Control Agency (now MHRA)

MDA - Medical Devices Agency

MDI - Medical Data Index

MDU - Medical Defence Union

MDR - Medical Device Report

MEDDEC - Medical Devices Guidance Document (for the European Commission)

MeDRA - Medical Dictionary for Regulatory Activities

MHRA - Medicines and Healthcare Products Regulatory Agency

MIC - Model Informed Concent

MIMS - Monthly index of medical Specialities

MPI - Medical Pharmaceutical Index

MRC - Medical Research Council

MREC - Multi-centre Research Ethics Committee

NCRN - National Cancer Research Network

NDA - New Drug Application

NGO - Non-Governmental Organisation

NHS - National Health Service

NHSnet - National Health Service for Health Care Professional

NHSE - National Health Service Executive

NHSIS - National Health Service Scotland

NICE - National Institute for Clinical Excellence

NIBSC - National Institute of Biological Standards and Control

NSF - National Service Framework

OHE - Office for Health Economics (part of ABPI)

OMCL - Official Medicines Control Laboratories

ONS - Office of National Statistics

OOS - Out-of-Specification

OPD - Original Pack Dispensing

OTC - Over the Counter

P - Pharmacy Medicine

PA - Pharmacy Advisor

PAI - Pre-Approval Inspection

PCT - Primary Care Trust

PCT - Patent Co-operation Treaty

PFI - Private Finance Initiative

PH.EUR - European Pharmacopoeia

PhVWP - Pharmacovigilance Working Party

PI - Prescribing Information

PI - Principal Investigator

PIC - Pharmaceutical Inspection Convention

PICs - Pharmaceutical Industry Co-operation Scheme

PIL - Patient Information Leaflet

PIS - Patient Information Sheet

PK - Pharmacokinetics

PL - Product Licence

PLA - Product Licence Application

PMA - Pre-Market Approval

PMS - Post Marketing Surveillance

POM - Prescription Only Medicine

PSUR - Periodic Safety Update Report

QA - Quality Assurance

QC - Quality Control

QM - Quality Management

QMS - Quality Management System

QoL - Quality of Life

QP - Qualified Person

QS - Quality System

QWP - Quality Working Party

RAPS - Regulatory Affairs Professionals Society

RCT - Randomised Clinical Trials

R&D - Research and Development

RDE - Remote Data Entry

RDS - Research Defence Society

REC - Research Ethics Committee

RGN - Registered General Nurse

RPSGB - Royal Pharmaceutical Society of Great Britain

RSM - Royal Society of Medicine

Rx - Prescription

SAE - Serious Adverse Event

SAMM - Safety Assessment of Marketed Medicines

SCMO - Senior Clinical Medical Officer

SHA - Strategic Health Authority

SI - Statutory Instrument

SIGAR - Special Interest Group on Adverse Reactions

SIS - Subject Information Sheet

SMF - Site Master File

SMO - Site Management Organisation

SmPC / SPC - Summary of Product Characteristics

SOP - Standard Operating Procedure

SPC - Supplementary Protection Certificate

SSA - Site-Specific Assessment

SUSAR - Serious Unexpected Serious Adverse Effect

TMF - Trial Master File

TOPRA - The Organisation for Professionals in Regulatory Affairs

UDV - Unit Dose Vial

UKECA - United Kingdom Ethics Committee Authority

USP - United States Pharmacopoeia

WCMS - WaveFront Clinical Management Services

WHO - World Health Organisation or OMS Organisation Mondiale de la Santé

WIPO - World Intellectual Property Organisation

WTO - World Trade Organisation