Abbreviations and Acronyms - Uppsala Monitoring Centre

Abbreviations and AcronymsA list of abbreviations and acronyms found in the field of, or connected with, pharmacovigilance.ACSoMPACTADEADRAEFIAEMPSANSMAPIARTARVATCBCPNNBfArMBMACDCCEMCENCHMPCIOMSCRODDDDIADSRUDTCDTPEEAEMAENCePPEUE2BFDAAdvisory Committee on Safety of Medicinal Products (WHO)Artemisinin-based combination therapyAdverse drug event/effectAdverse drug reactionAdverse event following immunisationAgencia Española de Medicamentos y Productos Sanitarios (Spanish Medicines andHealthcare Products Agency)Agence nationale de sécurité du médicament et des produits de santé, France(has replaced AFSSAPS)Active pharmaceutical ingredient (WHO)Antiretroviral therapyAntiretroviralsAnatomical, Therapeutic, Chemical classificationBayesian Confidence Propagation Neural NetworkBundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugsand Medical Devices in Germany)British Medical AssociationCenters for Disease Control and PreventionCohort Event MonitoringCentre Européen de Normalisation (the European Committee for Standardization)Committee on Medicinal Products for Human use (EU), previously CPMPCouncil for International Organizations of Medical SciencesContract research organisation (often responsible for clinical trials)Defined Daily DoseDrug Information AssociationDrug Safety Research Unit, Southampton, UKDirect to consumerDirect to patientEuropean Economic AreaEuropean Medicines AgencyEuropean Network of Centres for Pharmacoepidemiology andPharmacovigilanceEuropean UnionThe current international standard for ADR reporting developed by ICHFood and Drug Administration (USA regulatory body)1/4Prepared by the Uppsala Monitoring Centre, January 2012Last update, August 2013

FICFIPFOIFTPGACVSGCPGFGFATMGLPGMPGVSIGxPHAIHATCHICHSAICICDICDRAICHICSRIMBIMMPIMSINNIPCSISOISoPISPEJPMALarebLMICMAH(WHO) Family of International ClassificationsInternational Pharmaceutical FederationFreedom of informationFile transfer protocolGlobal Advisory Committee on Vaccine Safety (WHO)Good clinical practice.Gates Foundation (full name Bill and Melinda Gates Foundation)or Global Fund (see also GFTAM)Global Fund to Fight AIDS, Tuberculosis and MalariaGood laboratory practice For example:www.oecd.org/chemicalsafety/testing/goodlaboratorypracticeglp.htmGood manufacturing practice For example:www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/orggmp.shtmlWHO Global Vaccine Safety Initiativewww.who.int/vaccine_safety/initiative/engeneric term for good practice requirements in the pharmaceutical industryHealth Action International www.haiweb.orgHerbal ATCHigh income countriesHealth Sciences Authority, SingaporeInformation Component (used in BCPNN) – Informed consentInternational Classification of DiseasesInternational Conference for Drug Regulatory AuthoritiesInternational Conference on Harmonisation of Technical Requirements forRegistration of Pharmaceuticals for Human UseIndividual case safety reportIrish Medicines BoardThe Intensive Medicines Monitoring Programme, New ZealandNot an acronym. Company providing statistics and information in the healthcare sectorInternational non-proprietary names (for pharmaceutical substances)International Programme on Chemical Safety www.who.int/pcsInternational Organization for Standardization www.iso.orgInternational Society of Pharmacovigilance www.isoponline.orgInternational Society for Pharmacoepidemiology www.pharmacoepi.orgJapan Pharmaceutical Manufacturer’s AssociationNetherlands Pharmacovigilance Foundation (Landelijke Registratie en Evaluatie vanBijwerkingen)Low- and middle income countriesMarket authorisation holder2/4Prepared by the Uppsala Monitoring Centre, January 2012Last update, August 2013

MedDRAMHRAMSHMSSOMSFNCNCENDANGONMENRANSAIDOTCPCCPDRPDSPEMPEPFARPHRMAPILPMDAPMSPOMPPIPRACPSMPSURPVQAMedical Dictionary for Drug Regulatory AffairsMedicines and Healthcare products Regulatory Agency (UK)Management Sciences for HealthMaintenance and Support Services Organization (for MedDRA)Médecins Sans FrontièresNational centre (for pharmacovigilance)New chemical entityNew Drug ApplicationNon-governmental organisationNew molecular entityNational regulatory authorityNon-steroidal anti-inflammatory drugOver-the-counterPoison Control CentrePhysician’s Desk ReferencePharmacoepidemiology and Drug Safety (journal)Prescription event monitoringUS President’s Emergency Plan for AIDS ReliefPharmaceutical Research and Manufacturers AssociationPackage insert leafletPharmaceuticals and Medical Devices Agency, JapanPost-marketing surveillancePrescription only medicineProton Pump InhibitorPharmacovigilance Risk Assessment Committee (EMA)Procurement and supply managementPeriodic safety update reportPharmacovigilanceQuality AssuranceQSM-WHO Quality Assurance and Safety of Medicines (WHO)RCASFDASMQSOCSOPSPCSSFFCRoot-cause analysisState Food and Drug Administration, ChinaStandardized MedDRA QuerySystem organ classStandard operating procedureSummary of product characteristics (in the EU)Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit (SSFFC) MedicalProducts (WHO)3/4Prepared by the Uppsala Monitoring Centre, January 2012Last update, August 2013

SSRITGATHINTSRUMCUNITAIDVAERSWAHOWHOSelective Serotonin Reuptake Inhibitor (group of anti-depressants)Therapeutic Goods Administration, AustraliaThe Health Improvement Network, UK. A medical research database ofanonymized patient records from general practitionersTargeted spontaneous reportingthe Uppsala Monitoring Centre www.who-umc.orgNot an acronym. Organization cooperating with WHO and others on the WHOmillennium goalsVaccine adverse event reporting systemWest African Health OrganizationWorld Health Organization www.who.intWHO-ART WHO Adverse Reaction TerminologyWHO-CCWHO-DDWHO Collaborating CentreWHO Drug DictionaryWHO-DDE WHO Drug Dictionary EnhancedXMLExtensible Mark-up Language4/4Prepared by the Uppsala Monitoring Centre, January 2012Last update, August 2013