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8/13/2019 Jargon Buster June 2013
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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