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Regulatory `jargon busters some key acronyms and abbreviations

510(K) Pre-market notification in US(devices)

ACP Associates of ClinicalPharmacology

ADE Adverse Drug Event/AdverseDrug Experience

ADEC Australian Drug EvaluationCommittee

ADR Adverse Drug ReactionADRAC Australian Drug Reactions

Advisory CommitteeAE Adverse EventAEM Agencia Espanola del

Medicamento (SpanishAgency for Drugs)

AFSSAPS Agence Franaise de SecuritSanitaire des Produits de Sant

AESGP Association Europenne desSociets Grands PubliquesAIDS Acquired Immunodeficiency

SyndromeAIM Active Ingredient

Manufacturer (EC)AMM Autorisation Mise sur le

March (French MarketingAuthorisation)

ANDA Abbreviated New DrugApplication (US)

ANDS Abbreviated New DrugSubmission (Canada)

AODM Adult Onset Diabetes MellitusAPI Active Pharmaceutical

Ingredient (FDA)APMA Australian Pharmaceutical

Manufacturers AssociationAR Assessment Report (EC)ASAP As Soon As PossibleATC Anatomical Therapeutic

Chemical Classification (WHOCode)

AUC Area under CurveBA BioavailabilityBAN British Approved NameBE BioequivalenceBfArM Bundesinstitut fr Arzneimittel

und MedizinprodukteBGTD Biologics and Genetic

Therapies Directorate(Canada)

BID Two Times a DayBLA Biologics Licence Application

(US)BMF Biologics Master File (US)

BNF British National FormularyBP British PharmacopoeiaBPH Benign Prostatic

Hyperplasia/HypertrophyBPM Beats Per MinuteBRAS Belgian Regulatory Affairs

SocietyBT BiotechnologyC&S Culture & SensitivityCAGR Cumulative Average Growth

RateCANDA Computer Aided New Drug

Application (US) now ELACAP Color Additive Petition (US)CAPLA Computer Assisted Product

Licence Application (EC)CBC Complete Blood Count

CBER Center for BiologicsEvaluation & Research (FDA)CCRC Certified Clinical Research

CoordinatorCDC Centers for Disease Control

(US)CDER Center for Drug Evaluation &

Research (FDA)CDRH Center for Radiologic Health

(US)CE Chemical Entity (Canada)CE Device marking in EUCEN Comit Europen de

Normalisation (EuropeanCommittee forStandardisation)

CFR Code of Federal Regulations(US)

cGMP Current Good ManufacturingPractice

CIOMS Council for InternationalOrganisations of MedicalScience

CMC Chemistry, Manufacturing andControls (US)

CMS Concerned Member State (EC)CNS Central Nervous SystemCOMP Committee for Orphan

Medicinal ProductsCOP Clinical Operating PlanCOSTART Dictionary used to code

adverse experiencesCPAC Central Pharmaceutical Affairs

Council (Japan)CPMP Committee for Proprietary

Medicinal Products (EC)

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CPS Chemistry, Pharmacy andStandards Sub-Committee ofthe UK Committee on Safetyof Medicines

CRA Clinical Research AssociateCRC Clinical Research Co-ordinatorCRF Case Report FormCRO Contract Research

OrganisationCS Clinically SignificantCSA Clinical Support AssociateCSI Consulting Statisticians

InternationalCSM Committee on Safety of

Medicines (UK)CSO Consumer Safety OfficerCTC Clinical Trial Certificate (UK)CTD Common Technical DocumentCTD-E Common Technical Document

(Clinical Efficacy File)CTD-Q Common Technical Document

(Quality File)CTD-S Common Technical Document

(Nonclinical Safety File)CTE Clinical Trial Exemption

(Australia)CTMP Clinical Trial on Marketed

Product (UK)CTN Clinical Trial Notification (EU

and other countries)CTX Clinical Trial eXemption (UK)CUF Italian Drug CommissionCV Curriculum Vitae

CVMP Committee for VeterinaryMedicinal Products (EC)

CXR Chest x-rayCY Calendar YearDAB Deutsche Arzneibuch

(German Pharmacopoeia)DB double-blindDB Dunn & BradstreetDG (EC) Directorate GeneralDHHS/HHS Department of Health &

Human Services (US)DIA Drug Information AssociationDIN Drug Identification Number

(Canada)DMF Drug Master FileDNA Deoxyribonucleic AcidDRG Data Review GuidelineDRG Diagnosis Related Group (used

in hospitals, insurance term)DTD Document Type Definition

defines tags in an XML fileEC European CommunityEC Ethics Committee

ECG ElectrocardiogramECJ European Court of Justicee-CTD Electronic Common Technical

Document (ICH)ECU European Currency UnitEEA European Economic AreaEEC European Economic

CommunityEFPIA European Federation of

Pharmaceutical IndustryAssociations

EFTA European Free Trade AreaEGA European Generic Medicines

AssociationEIR Establishment Inspection

Report (US)ELA Electronic Licence Application

(US)EMEA European Medicines

Evaluation AgencyEOF National Drug Organisation

(Greece)EOS End of StudyEP European ParliamentEPAR European Public Assessment

Report (EU)ESRA European Society for

Regulatory AffairsESTRI Electronic Secure

Transmission of RegulatoryInformation (ICH WorkingGroup)

ETT Exercise Tolerance Test

ETT Endotrachael TubeEU European UnionEU Evaluation Unit in the

Therapeutic GoodsAdministration (Australia)

Euro European Currency (Euroland)FAP Food Additive Petition (US)FCI For Cause InspectionFD&C Federal Food, Drug &

Cosmetic Act (US)FDA Food and Drug Administration

(US)FDA 1572 Statement of Investigator

FDA 1639 Serious Adverse EventReporting FormFEDESA Fedration Europenne de la

Sant Animale (Europe)FOI Freedom of Information (US)FPL Final Printed LabelingFR Federal RegisterFTC Federal Trade Commission

(US)FTIR Fourier Transform Infra Red

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FU Farmacopoeia Ufficiale(Italian Pharmacopoeia)

FUM Follow up Measure (EMEA)FY Fiscal YearGCP Good Clinical PracticesGdN Guidizio de Notorietia (clinical

trial notification sent to aregistered Italian EthicsCommittee)

GGT Gamma GlutamylTranspeptidase

GI GastrointestinalGLC Gas Liquid ChromatographyGLP Good Laboratory PracticesGMO Genetically Modified

OrganismGMP Good Manufacturing PracticesGRAS Generally Recognized As Safe

(food additives in US)GSL General Sales List (legal status

for medicine in the UK)HCQIA Health Care Quality

Improvement ActHIV Human Immunodeficiency

VirusHPB Health Protection Branch

(Canada)HPLC High Pressure Liquid

ChromatographyHR Human ResourcesHTN HypertensionIC Informed ConsentICD 9 International Classification of

Diseases dictionaryICH International Conference on

HarmonisationIDDM Insulin Dependent Diabetes

MellitusIDE Investigational Device

Exemption (US)IM IntramuscularIMB Irish Medicines BoardIND Investigational New Drug

Application (US)INN International Nonproprietary

Name

IPRO Independent PharmaceuticalResearch OrganisationIR Infra RedIRB Institutional Review BoardISO International Standards

OrganisationISBR Integrated Summary of Benefit

Risk (FDA)ISE Integrated Summary of

Efficacy (FDA)

ISS Integrated Summary of Safety(FDA)

IV IntravenousK+ PotassiumKIKOU see OPSR (Japan) LD Lethal DoseLKP Lnder Ethical Committee

(Germany)LOA Letter of AgreementLOI Letter of IntentMA Marketing Authorisation (EC)MAA Marketing Authorisation

Application (EC)MAH Marketing Authorisation

HolderMCA Medicines Control Agency

(UK)MCC Medicines Control Council

(South Africa)MDL Monitoring Deficiency ListMEB Medicines Evaluation Board

(Netherlands)MedDRA Medical Dictionary for

Regulatory Activities (ICH)MHW Ministry of Health & Welfare

(Japan)MIMS Monthly Index of Medical

Specialities (UK)MPA Medicinal Products Agency

(Sweden)MPAR Mutual Recognition Public

Assessment Report (EC)MR Mutual Recognition (EC)

MRA Mutual RecognitionAgreement (MRA)

MS Member States (EC)MSC Ministerio de Sanidad y

Consumo (Spanish Ministry ofHealth)

NA Not Applicable NAF Notice of Adverse Findings

(letter from FDA) NAI No Action Indicated, FDA

compliance code NAS New Active Substance (EC) NC Notifiable Change (Canada)

NCE New Chemical Entity NCI National Cancer Institute (US) NCS Not Clinically Significant NDA New Drug Application (US) NDS New Drug Submission

(Canada) NEJM New England Journal of

Medicine NF National Formulary (US)

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NHIS National Hygienic SciencesInstitute (Japan)

NIH National Institutes of Health(US)

NLM National Library of Medicine(US)

NLT Not Less Than NME New Molecular Entity NMR Nuclear Magnetic Resonance NMT Not More Than NPAR National Public Assessment

Report NSAID Nonsteroidal Anti-

Inflammatory Drug NSR Nonsignificant RiskOE Oral Explanation (EMEA)OHA Office of Health Affairs (FDA)OI Outstanding Issues (EMEA)OJ Official Journal of the

European CommunitiesOPPR Office for Protection from

Research Risks (US)OPSR Office for Pharmaceutical and

Safety Research (KIKOU)(Japan)

OTC Over the CounterP Pharmacy Sale (legal status for

medicine in the UK)PAI Pre-Approval InspectionPC Personal ComputerPDF Portable Document Format

Adobe proprietary standard forelectronic transfer of

documentsPDR Physician's Desk Reference

(US)PEI Paul Ehrlich Institut

(Germany)PERF Pan-European Regulatory

ForumPEFRAS Pan-European Federation of

Regulatory Affairs SocietiesPh. Eur Pharmacope Europen

(European Pharmacopoeia)Ph. Fr. Pharmacope Franaise

(French Pharmacopoeia)

PHS Public Health Service (US)PI Principal InvestigatorPLA Product License Application in

US (for biologics)PMA Pre-Market Approval (for

devices, sometimes PMAA)PMS Post-Marketing SurveillancePO Per Os (by mouth)

POM Prescription Only Medicine(legal status for medicine inUK)

PR Pulse RatePR Public RelationsPRN As NeededPTC Points to consider (FDA)QA Quality AssuranceQC Quality ControlQD Once DailyQID Four Times a DayQNS Quantity Not SufficientR&D Research and DevelopmentRAPID Rapid Access Physician

Investigator Data BaseRAPS Regulatory Affairs

Professional SocietyRDE Remote Data EntryrDNA recombinant DNARMS Reference Member State (EC)RNA Ribonucleic AcidSAE Serious Adverse EventSANDS Supplemental Abbreviated

New Drug Submission(Canada)

SAS Special Access Scheme(named patient usage inAustralia)

SAS Statistical Analysis Software(commercial software fromSAS Corporation)

SBA Summary Basis of Approval(drugs, US)

SCOTT Standing Committee onTherapeutic Trials (NewZealand)

SD Source DocumentSGML Standard Generalised Markup

Language (a metalanguage toconstruct other markuplanguages)

SGOT/(AST) Serum Glutamic OxalaceticTransaminase/AspartateTransaminase

SGPT/(ALT) Serum Glutamic PyruvicTransaminase/Alanine

TransaminaseSIAR Societa Italiana AttivaRegolatore

SLK Norwegian Medicines ControlAgency

SNDA Supplemental NDA (US)SNDS Supplemental New Drug

Submission (Canada)

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SNIP Syndicat National delIndustrie Pharmaceutique(French pharma industryassociation)

SO Specific Obligations (EMEA)SOP Standard Operating ProcedureSPC (SmPC) Summary of Product

Characteristics (EC)SPC Supplementary Patent

Certificate (EC)SC SubcutaneousSSE Summary of Safety and

Effectiveness (devices)TGA Therapeutic Goods

Administration (Australia)TID Three Times a DayTLC Thin Layer Chromatography

TPD Therapeutic ProductsDirectorate (Canada)

TSH Thyroid Stimulating HormoneUA UrinalysisUK United KingdomURI Upper Respiratory InfectionUSA United States of AmericaUSAN United States Approved NameUSP U.S. PharmacopeiaUTI Urinary Tract InfectionVAR Variation Assessment Report

(EC)VICH Veterinary International

Conference on HarmonisationWHO World Health OrganisationWNL Within Normal LimitsXML eXtensible Markup Language

a dialect of SGML