Trac Services | Glossary Of Terms | Regulatory Services | TRAC Services
214
page-template,page-template-full_width,page-template-full_width-php,page,page-id-214,page-child,parent-pageid-59358,page-glossary-of-terms,ajax_fade,page_not_loaded,,qode-child-theme-ver-1.0.0,qode-theme-ver-7.5,wpb-js-composer js-comp-ver-5.1.1,vc_responsive

Glossary of Terms

The consultancy for global, pharmaceutical regulatory affairs

A

AADA  Abbreviated Antibiotic Drug Application

ABPI  Association of British Pharmaceutical Industries

ACE  Adverse Clinical Event

ACRA  Associate Commissioner for Regulatory Affairs

ACRPI Association for Clinical Research in the Pharmaceutical Industry (UK)

ACT Applied Clinical Trials

ADE Adverse Drug Event, Adverse Drug Effect

ADR  Adverse Drug Reaction

AERS Adverse Event Reporting System

AHA Area Health Authority

AICRC Association of Independent Clinical Research Contractors (UK)

ANDA Abbreviated New Drug Application

API Active Pharmaceutical Ingredients

AQL Acceptable Quality Level

ARENA Applied Research Ethics National Association

ASMF Active Substance Master Files

ASR Annual Safety Report

ASPR Anonymised Single Patient Report

ATSDR Agency for Toxic Substance & Disease Registry

ADME Absorption, Distribution, Metabolism and Excretion

B

BAPP British Association of Pharmaceutical Physicians

BARQA British Association of Research Quality Assurance

BCE Beneficial Clinical Event

BGMA The British Generic Manufacturer’s Association

BMA British Medical Association

BIO Biotechnology Industry Association

BP British Pharmacopoeia

BROMI Better Regulations of Medicines Initiative

C

CAs Competent Authorities (EU)

CD Controlled Drug

CEP Certificate of European Pharmacopeia (certificate of suitability)

CAPRA Canadian Association of Pharmaceutical Regulatory Affairs

CBER Centre for Biologics Evaluation and Research

CCDS Company Core Data Sheet

CCSI Company Core Safety Information

CDC Centres for Disease Control and Prevention

CDER Centre for Drug Evaluation and Research

CDRH Centre for Devices and Radiological Health

CFSAN Centre for Food Safety and Applied Nutrition

CIB Clinical Investigators Bureau

CIOMS Council for International Organisations of Medical Sciences (WHO)

CHMP Committee for Medicinal Products for Human Use

CMC Chemistry and Manufacturing Controls

CMS Concerned Member State

CPMP Committee for Proprietary Medicinal Products (EMA)

CSD Committee on Safety of Medicines (UK)

CRA Clinical Research Associate

CRC Clinical Research Coordinator

CRO Clinical Research Organisation

CSA Clinical Study Agreement

CSM Committee on Safety of Medicines (UK)

CSR Clinical Study Report

CTA Clinical Trail Application

CTD Common Technical Document

CTD Clinical Trail Directive

CTC Clinical Trial Certificate

CTX Clinical Trial Exemption

CP Centralised Procedure

CPP Certificate of Pharmaceutical Product

CRO Contract Research Organisation

CTA Clinical Trial Application

CTC Clinical Trial Certificate

CUVP The Committee for Veterinary Medicinal Products (EMA)

D

DB Double Blind

DB Device Bulletin

DCF Data Clarification Request Form

DCP Decentralised Procedure

DHCP Dear Healthcare Professional Communication

DCSI Development Core Safety Information

DSUR Development Safety Update Report

DDPS Detailed Description of Pharmacovigilance System

DESI Drug Efficacy Study Implementation

DHR Device History Record

DIA Drug Information Association

DMC Data Monitoring Committee

DMF Drug Master File

DMR Drug Master Record

DMRC Defective Medicines Report Centre

DRF Drug Range Finding (Study)

DSMB Data and Safety Monitoring Board

E

EAB Ethical Advisory Board

EC European Commission

EC European Community

eCTD Electronic Common Technical Document

EEA European Economic Area

EDQM European Directive for the Quality of Medicines and Healthcare

EFPIA European Federation of Pharmaceutical Industry Associations

EFTA European Free Trade Association

EMA European Medicines Agency

EOP1 End of Phase1

EOP2 End of Phase2

EPRG European Pharmacovigilance Research Group

EPAR European Public Assessment Report

EP European Pharmacopeia

ESRA European Society of Regulatory Affairs

EUCOMED European Confederation of Medical Devices Association

EQA European Quality Award

EU European Union

EUDRA European Union Drug Regulatory Authorities

F

FDA Food and Drug Administration

FOI Freedom of Information

FOIA Freedom of Information Act

G

GCP Good Clinical Practice

GDP Good Distribution Practise

GHTF Global Harmonisation Task Force

GGP Good Guidance Practice

GLP Good Laboratory Practice

GMDN Global Medical Device Nomenclature

GMO Genetically Modified Organisms

GMP Good Manufacturing Practise

GPvP Good Pharmacovigilance Practise

H

HIMA Health Industry Manufacturers Association

HCP Health Care Professional

I

IB Investigational Brochure

IBD International Birth Date

ICDRA International Conference of Drug Regulatory Authorities

ICH International Conference on Harmonisation

ICSR Individual Case Safety Report

IDE Investigational Device Exemption

IDR Idiosyncratic Drug Reaction

IDBM Independent Data Monitoring Board

IEC Independent Ethics Committee

ILAR Institute for Laboratory Animal Research

IMB Irish Medicines Board

IMP Investigational Medicinal Products

IMPD Investigational Medicinal Product Dossier

IMS Information Management Strategy

IND Investigational New Drug (application)

INDC Investigational New Drug Committee

INN International Approved Names for Pharmacopoeial Substances

IPRO Independent Pharmaceutical Research Organisation

IRD International Registration Document

IRB Institutional Review Board

ISE Integrated Summary of Efficacy

ISO International Standards Organization

ITT Intent to Treat

IVD In Vitro Device, In Vitro diagnosis

L

LOA Letter of Agreement

LOQ Limit of Quantification

LOD Limit of Detection

M

MA Marketing Authorisation

MAA Marketing Authorisation Application

MAD Multiple Ascending Dose

MAH Marketing Authorisation Holder (EC)

MCA Medicines Control Agency (UK)

MDI Metered Dose Inhaler

MEdDRA Medical Dictionary for Drug Regulatory Affairs

ML Manufacturers Licence

MLD Minimum Lethal Dose

MPA Multiple Project Assurance

MRA Multiple Recognition Agreements

MRD Multiple Rising Dose

MRP Mutual Recognition Procedure

MTD Maximum Tolerated Dose

MHRA Medicines and Healthcare Products Regulatory Agency

N

NADA New Animal Drug Application

NAS New Active Substance

NBs Notified Bodies (EU)

NCBI National Centre for Biotechnology Information

NCCLS National Committee of Clinical laboratory Standards

NCE New Chemical Entity

NCI National Cancer Institute

NCPIE National Council on Patient Information and Education

NCTR National Council for Toxicological Research

NDA New Drug Application

NDBA National Drugs Advisory Board (Ireland)

NDAC Non-prescription Drugs Advisory Committee

NIAID National Institute of Allergies and Infectious Diseases (NIH)

NIBSC National Institute for Biological Standards and Control

NIH National Institutes of Health

NINDS National Institutes of Neurological Disorders and Stroke (NIH)

NME New Molecular Entity

NMI Non Medicinal Ingredients

NPA The National Pharmaceutical Association (UK)

NRC Nuclear Regulatory Commission

NSAID Nonsteroidal Anti-inflammatory Drug

NTA Notice to Applicants

O

ODD Orphan Drug Designation

OTC Over the Counter (drugs)

P

PAGB Proprietary Association of Great Britain

PD Pharmacodynamics

PAPs Product Analysis Prints

PASS Post Authorisation Safety Study

PCT Primary Care Trust

PDA Parenteral Drug Association

PDP Product Development Protocols (for Medical Devices)

PER Pharmaceutical Evalution Reports (EMA)

PI Package Inserts

PIL Patient Information Leaflet

PIP Paediatric Investigation Plan

PL Product Licence

PK Pharmacokinetics

POM Prescription Only Medicine

PMA Pre-Market Approval (Application) (for Medical Devices)

PMS Post Marketing Surveillance

PRRs Proportioned Reporting Ratios

PSI Pharmaceutical Society of Ireland

PSNI Pharmaceutical Society of Northern Ireland

PSUR Periodic Safety Update Report (EMA)

PUMA Paediatric Use Marketing Authorisation

PV Pharmacovigilance

Q

QA Quality Assurance

QC Quality Control

QOS Quality Overall Summary

QRD Quality Review of Documents

QP Qualified Person

QPPV Qualified Person for Pharmacovigilance

QM Quality Management

R

RAMA Remote Access for Marketing Authorisations

R&D Research and Development

rINN recommended International Non-proprietary Name

RMP Risk Management Plan

RAPS Regulatory Affairs Professional Society (USA)

RPSGB Royal Pharmaceutical Society of Great Britain

RMS Reference Member State

RSI Reference Safety Information

RP Responsible Person

S

SAD Single Ascending Dose

SAE Serious Adverse Event

SAL Sterility Assurance Level

SAMM Safety Assessment of Marketed Medicines

SBA Summary Basis of Approval

SCT Society for Clinical Trials

SME Significant Medical Event

SME Subject Matter Expert

SMF Site Master File

SMQ Standardised MedDRA Query

SMT Safety Management Team

SOCRA Society of Clinical Research Associates

SOC System Organ Class

SOP Standard Operating Procedure

SPC Summary of Product Characteristics

SmPC Summary of Product Characteristics

SQA Society of Quality Assurance

SRD Single Rising Dose

SUD Sudden Unexpected Death

SUSAR Suspected, Unexpected, Serious adverse reaction

T

TK Toxicokinetics

TOPRA The Organisation for Professionals in Regulatory Affairs

U

USAN United States Adopted Names

USP United States Pharmacopeia

USPI United States Product Information

UKPAR United Kingdom Public Assessment Report

V

VAERS Vaccine Adverse Event Reporting System

VAMF Vaccine Antigen Master File

W

WHO World Health Organisation

WI Working Instruction

WP Working Practise