WIXLIB

CDSCO – Central Drug Standard Organization (India’s clinical trials licensing authority)CDSM – Committee on Dental and Surgical Materials (UK)CDx – Companion DiagnosticsCE Mark – Conformité European (approval for EU medical devices)CEA – Cost-effectiveness analysisCEC – Central ethics committee – and also:CEC – Commission of the European CommunitiesCED – Coverage with evidence developmentCEE – Central and Eastern EuropeCEEC – Central and Eastern European CountriesCEFTA – Central Europe Free Trade AreaCEN – Comité Européan des Normes – European Committee for StandardizationCEP – Central enquiry point (MHRA) – and also:CEP – Certificate of European Pharmacopoeia (aka Certificate of Suitability)CER – Clinical evaluation report – and also:CER – Comparative effectiveness researchCESP – Common European submission portalCF – Cystic fibrosisCFC – ChlorofluorocarbonsCFDA – China Food and Drug Administration (formerly State FDA – SFDA)CFR – Code of Federal Regulations (US)CFS – Certificate of Free SaleCFSAN – Center for Food Safety and Applied Nutrition (US)cGLP – Current good laboratory practicecGMP – Current good manufacturing practiceCGP – Clinical Guidance Panel (Canada)CH – Clinical holdCHAI – Commission for Healthcare Audit and Inspection (UK)CHC – Consumer healthcareCHMB - Creatine kinase Muscle BrainCHMP – Committee for Medicinal Products for Human Use (EMA)CHMP – Committee for Medicinal Products for Human Use (previously: CPMP)CHO – Chinese hamster ovary cellsCHPA – Consumer Healthcare Products AssociationCI – Confidence Interval, and also:CI – ContraindicationCIA – Corporate Integrity Agreement (US)CIOMS – Council for International Organizations of Medical Sciences (WHO)CIRS – Centre for Innovation in Regulatory ScienceCIS (countries) – Commonwealth of Independent States (members are former Soviet Republic countries,currently including Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Usbekistan,Turkmenistan, UkraineCK – Creatine kinaseCl – Total body clearanceClass Im – Class I with measuring function (medical devices)CLIA – Clinical Laboratory Improvement Amendments (US)CLL – Chronic lymphocytic leukaemiaCLO – Clinical overviewCLP – Classification, labelling and packaging (medical devices)CLS – Clinical summaryCm or Cmax – Maximum plasma concentration at steady stateCMA – Conditional marketing authorisation (US)CMC – Chemistry, manufacturing, and controlsCMDCAS – Canadian Medical Devices Conformity Assessment SystemCMDh – Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (EMA)CMDR – Canadian Medical Device RegulationCMDv – Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary (EMA)CMN – Comité de Moléculas Nuevas” (New Molecules Committee) (Mexico)CMP – Certificate of Medicinal Product – and also:CMP – Common product modelCMR – Carcinogenic, mutagenic or reprotoxic [toxic to reproduction] – and also:

CMR – Centre for Medicines ResearchCMS – Concerned member state (EU)CMT – Convergent medical technologiesCOA/CofA – Certificate of analysisCoAg – Cooperative AgreementCOE – Council of EuropeCOMET – Core Outcome Measures in Effectiveness TrialsCOMP – Committee for Orphan Medicinal Products (EMA)COREPER – Committee of Permanent Representatives to the CommunityCOSHH – Control of Substances Hazardous to HealthCOSTART – Coding Symbols for a Thesaurus of Adverse Reaction TermsCoU – Context of UseCP – Centralised procedure (EU) – and also:CP – Comparability protocol (US)CPAC – Central Pharmaceutical Affairs Council (Japan)CPC – Combination Products CoalitionCPD – Continuing professional developmentCPI – Critical Path Initiative (US)CPMP – Committee for Proprietary Medicinal Products (EMA)CPP – Certificate of pharmaceutical product – and also:CPP – Critical process parameterCPQ – Costs per quality-adjusted life yearCPR – Cosmetic Products RegulationCPRD – Clinical Practice Research Datalink (MHRA)CPS – Chemistry – Pharmacy and Standards Subcommittee of the CSM (UK) – and also:CPS – Clinical performance studyCPSP – Clinical performance study planCPU – Clinical pharmacology unitCPWP – Cell-based Products Working Party (EMA)CQA – Clinical quality assurance – and also:CQA – Critical quality attributeCR – Computed radiology – and also:CR – Controlled releasseCRF – Case report formCRG – Clinical reference group (UK)CRO – Clinical Research OrganisationCRP – Canadian reference product (WHO) – and also:CRP – Collaborative registration procedureCRS – The Caribbean Regulatory System – and also:CRS – Cytokine release syndromeCS – Clinically significant – and also:CS – Common specificationsCSA – Controlled Substances Act CSI – Core safety informationCSM – Centralised statistical monitoring – and also:CSM – Committee on Safety of Medicines (UK)CSO – Consumer Safety Officer (US)CSP – Core safety profileCSR – Clinical study report (EU)CSV – Comma-separated valuesCT – Clinical trial – and also:CT – Computed tomographyCTA – Clinical trial application – and also:CTA – Clinical trial assay – and also:CTA – Clinical trial authorisationCTAG – Clinical Trials Action Group (Australia) – and also:CTAG – Clinical Trials Coordination and Advisory GroupCTC – Clinical trial certificate (Hong Kong, Singapore)CTD – Clinical Trials Directive – and also:CTD – Common technical document* [*Although ‘dossier’ has become commonplace – the correct term is‘document’]CTEG – Clinical Trials Expert Group

CTFG – Clinical Trials Facilitation GroupCTIS – Clinical Trials Information System (formerly the EU clinical trial portal and database, EudraCT)CTMP – Cell therapy medicinal productCTMS – Clinical trial management systemCTN – Clinical trial notification (Australia)CTOC – Comprehensive Table of Contents Headings and HierarchyCTR – Clinical Trial RegulationCTS – Common technical specification – and also:CTS – Communication Tracking System (formerly Eudratrack)CTTI – Clinical Trials Transformation InitiativeCTU – Clinical trials unitCTX – Clinical trial exemption (UK)CUA – Cost utility analysisCUP – Compassionate use programmeCV – Controlled vocabularyCVM – Center for Veterinary Medicine (US)CVMP – Committee for Medicinal Products for Veterinary Use (EMA)CVO – Chief Veterinary OfficerCVS – Cardiovascular systemCVZ – Dutch Health Care Insurance BoardCWoW – Combined Ways of WorkingCZ – Climatic zoneDDDDAB – German Pharmacopoeia (Deutsches Arznei Buch)DAC – Data analysis centreDACS – Detailed and critical summaryDAE – Discontinuation due to an adverse eventDAL – Defect action level (US)DAMOS – Drug application methodology with optical storageDB – Device Bulletin (MHRA)DCGI – Drugs Controller General of IndiaDCGI – India’s regulatory authority (Directorate General of Health Services in the Ministry of Health and FamilyWelfare)DCP – Decentralised procedure (EU)DCTs – Decentralised clinical trialsDD – District Director (US)DDC(P) – Drug-device combination (product)DDD – Defined daily doseDDMAC – Division of Drug Marketing, Advertising and Communications (CDER)DDPS – Detailed description of pharmacovigilance systemDDX – Doctors’ and dentists’ exemption (UK)DE – Designated examinationDEA – Drug Enforcement Agency (US)DEREK – Deductive estimate of risk from existing knowledgeDES – Data exchange standard (EU) – and also:DES – Drug eluting stentDESI – Drug efficacy study implementation (US)DG – Directorate-General (at the European Commission)DGEM – Disease-gene expression matchingDGV – Direccao Geral de Veterinaria (Veterinary Medicines Agency) (Portugal)DH – Department of Health (UK) – and also:DH – Digital healthcareDHHS – Department of Health and Human Services (US)DHPC – Direct healthcare professional communication (formerly ‘Dear Doctor Letter’)DIA – Drug Information Association (US)DIBD – Development international birth dateDID – Design inputs documentDIMDI – Deutsches Institut für Medizinische Dokumentation und Information (Germany)DKMA – Lægemiddelstyrelsen/Danish Medicines Agency (Denmark)DLP – Data lock point

DMF – Drug master fileDMPK – Drug metabolism and pharmacokineticsDMRC – Defective Medicines Report Centre (MHRA)DMS – Document management systemDMT – Disease modifying therapyDOE – Design of experimentsDoR – Duration of ResponseDP – Drug productDPI – Dry powder inhalerDPIA – Data protection impact assessmentDPO – Data Protection OfficerDPR – Data Protection Representative – and also:DPR – Dual Pack import RegistrationDR – Deliberate release – and also:DR – Digital radiologyDRA – Drug Regulatory AuthorityDRF(S) – Dose range finding (study)DRMP – Developmental risk management planDRR – Drug Registration Regulation (China) – and also:DRR – Durable response rateDS – Drug substanceDSC – Differential scanning calorimetryDSMC – Data safety monitoring committeeDSRU – Drug Safety Research Unit (EMA)DSUR – Development safety update reportDTaP – Diphtheria, tetanus and pertussisDTC – Direct-to-consumerDTD – Document type definitionDUNS – Data universal numbering systemDUS – Drug utilisation studyDVPHNFS – Department for Veterinary Public Health, Nutrition and Food Safety (Italy)DWH – Data warehouseDx – DiagnosticEEEEA – Environmental assessmentEAC – East African CommunityeAF – electronic Application FormEAI – Estimated acute intakeEAMS – Early Access to Medicines Scheme (UK)EBE – European Biopharmaceutical EnterprisesEbM – Evidence-based medicineEC – Established conditions (ICH Q12 Guideline) – and also:EC – Ethics committee – and also:EC – European Commission – and also:EC – Exceptional circumstancesECDC – European Centre for Disease Prevention and ControlECG – ElectrocardiogramECHAMP – European Coalition on Homoeopathic and Anthroposophic Medicinal ProductsECHR – European Court of Human RightsECJ – European Court of JusticeECPHIN – European Community Pharmaceutical Information NetworkECRAB – European Committee on Regulatory Aspects of Biotechnology (EBCG)eCRF – electronic case report formeCTD – electronic common technical document [not dossier*] *Although ‘dossier’ has become commonplace – thecorrect term is ‘document’ED – Early dialogueEDA – Egyptian Drug AuthorityEDC – electronic data captureEDMF – European drug master fileeDMS – electronic document management system

EPDB – European Data Protection BoardEDQM – European Directorate for the Quality of Medicines EDQM – European Directorate for the Quality ofMedicines EDT – Electronic data transferEDX – Effective dose at X%EEA – European Economic Area (comprising the EU countries, plus Iceland, Liechtenstein and Norway)EEC – European Economic CommunityEEG – ElectroencephalogrameERA – extended Environmental Risk AssessmentEEU – Eurasian Economic UnionEFA – European Federation of Allergy and Airways Diseases Patients' AssociationsEFPIA – European Federation of Pharmaceutical Industries and Associations (http://www.efpia.eu)EFPIA – European Federation of Pharmaceutical Industries and AssociationsEFQM – European Foundation for Quality ManagementEFSA – European Food Safety AuthorityEFTA – European Free Trade AssociationEGA – European Generic medicines Association – Name changed 10 March 2016 to “Medicines for Europe”EGGVP – European Group for Generic Veterinary ProductsEGP – Economic Guidance Panel (Canada)EHR – Electronic health recordEIA – Environmental Impact AssessmentEINECS – European Inventory of Existing Chemical SubstancesELA – Establishment license application (US)EMA – European Medicines Agency (formerly European Medicines Evaluation Agency – EMEA)EMACOLEX – European Medicines Agencies Co-operation of Legal and Legislative IssuesEMCDDA – European Monitoring Centre for Drugs and Drug AddictionEMEA – Europe, Middle East & AfricaEMEA – see above – and also:EMEAA – Europe, Middle East, Africa & AsiaEMR – Electronic medical recordsEMRC – European Medical Research Councils (a unit of the ESF – see below)EMVO – European Medicines Verification OrganisationEMVS – European Medicines Verification SystemENCePP – European Network of Centres for Pharmacoepidemiology and PharmacovigilanceeNDA – Electronic New Drug ApplicationENDS – Electronic nicotine delivery systemENP – European Neighborhood PolicyEnpr-EMA – European Network of Paediatric Research at the European Medicines AgencyENS – Early notification systemEOF – Ethnikos Organismos Farmakon – aka National Organization for Medicines (Greece’s regulatory agency)EoP – End of ProcedureEOP1 – End of Phase 1 (US)EOP2 – End of Phase 2 (US)EOQ – European Organization for QualityEP – European Parliament – and also:EP/Ph Eur – European Pharmacopoeia (aka Pharm Eur)EPA – Environmental Protection Agency (US) and (Ireland)EPAA – European Partnership for Alternative approaches to Animal testingEPAD – European Prevention of Alzheimer’s DementiaEPADES – European Parliament Document Exchange ServerEPAR – European public assessment reportEPC – European Pharmacopoeia CommissionEPHA – European Public Health AllianceePI – Electronic product informationEPI – Essential Program for ImmunisationEPID – Extended (also Expanded) Public Information DocumentEPITT – European Pharmacovigilance Issues Tracking ToolEPL – Effective patent lifeEPO – European Patent OfficeEPPOSI – European Platform for Patients’ Organisation – Science & IndustryEPPV – Early post-marketing phase vigilance (eg, in Japan)

EPRG – European Pharmacovigilance Research GroupEPRUMA – European Platform for the Responsible Use of Medicines in AgricultureEPS – Eco-Pharmaco-StewardshipePSUR – electronic periodic safety update reportEQM – Equivalence marginERs – Essential requirements (devices)ERA – Environmental risk assessment – and also:ERA – European regulatory affairsERB – Ethical review boardeRMR – electronic Reaction Monitoring ReportERMS – European risk management strategyERMS-FG – European Risk Management Strategy Facilitation Group (HMA)ERP – European Reference Medicinal ProductESF – European Science FoundationESG – Electronic submissions gateway (FDA)ESM – European stakeholder modelESPAR – Executive Summary Pharmacovigilance Assessment Report (EU)ESR – Erythrocyte Sedimentation RateESRA – European Society of Regulatory AffairsESTRI – Electronic Standards for the Transfer of Regulatory InformationESVAC – European Surveillance of Veterinary Antimicrobial ConsumptionETASU – Elements to ensure safe use (US)eTMF – electronic Trial Master FileETOMEP – European Technical Office for Medical Products (within EMA)EU – European UnionEU5 – Group of countries comprising Germany, France, Italy, Spain and the UKEUA – Emergency use authorisationEU-ADR – Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records andBiomedical Knowledge (formerly known as ALERT) (EU)EUBAN – European Borderline Assessment NetworkEU-IN – EU Innovation NetworkEUCERD – EU Committee of Experts on Rare DiseasesEUCOMED – European Confederation of Medical Device AssociationsEUDAMED – European Databank on Medical DevicesEUDRA – European Union Drug Regulatory AuthoritiesEudraCT – European Union Drug Regulatory Authorities Clinical Trials databaseEudraNet – European Union Drug Regulatory Authorities NetworkEudraSmPC – Summary of Product CharacteristicsEUnetHTA – European Network for Health Technology AssessmentEU-NTC – EU Network Training CentreEUPATI – European Patients’ Academy on Therapeutic InnovationEUPD – EU Portal and DatabaseEuPFI – European Paediatric Formulation InitiativeEURD – European Union reference dateEUREC – European Network of Research Ethics CommitteesEURL – EU reference laboratoryEUR-OP – EU Office for PublicationsEUTCT – European Union Telematics Controlled TermsEUTMB – EU Telematics Management BoardEV – EudraVigilance – European Union Drug Regulating Authorities PharmacovigilanceEVALI – e-cigarette or vaping product use-associated lung injuryEVCTM – EudraVigilance Clinical Trial ModuleEV-EWG – EudraVigilance Expert Working GroupEVIDENT – Evidence Database on New TechnologiesEVM – European Vaccine ManufacturersEVMPD – EudraVigilance medicinal products dictionaryEVPM – EudraVigilance post-authorisation moduleEVPRM – EudraVigilance product report messageEWG – Expert Working GroupEWP – Efficacy Working Party (EMA)FFF

FACC – Food Additives and Contaminants Committee (UK)FAGG – Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (Belgium)FAIR (data) – Findable, accessible, interoperable and reusable (data)FAMHP – Federal Agency for Medicines and Healthcare Products (Belgium)FAR – Final assessment reportFarmindustria – Association of Italian Pharmaceutical Manufacturers (Italy)FCC – Food and Chemical CodexFDA – Food and Drug Administration (the US regulatory authority)FDAAA – FDA Amendments ActFDAMA – FDA Modernization ActFDASIA – Food and Drug Administration Safety and Innovation ActFDC – Fixed dose combinationFDC Act – Food – Drug and Cosmetic Act (US)FDF – Finished dosage formFIH – First-in-human (aka FIM – first-in-man; and FTIM – first-time-in-human)FIM – First-in-manFIM-A – Federal Institute for Medicines (Austria)FIMEA – Finnish Medicines Agency (Finland)FIP – International Pharmaceutical FederationFMD – Falsified Medicines Directive (EU)FMEA – Failure mode and effect analysisFMECA – Failure Modes Effects and Criticality AssessmentFNOM-CeO – Federazione Nazionale degli Ordini dei Medici-Chirurghi e degli Odontoiatri (IT) Italianorganisation of doctors and dentistsFOB – Follow-on biologicFOFI – Federazione Ordini Farmacisti Italiani (IT) Italian Organisation of PharmacistsFOI Act – Freedom of Information Act (US)FOM – Francophone Overseas MarketsFONSI – Finding of no significant impactFOP – Follow-on proteinFPA – Food producing animalFPFV – First patient first visitFPIF – Finnish Pharmaceutical Industry AssociationFPP – Finished pharmaceutical productFPRC – Final product release controlFPRR – Final product release responsibilityFQA – Full quality assuranceFR – Federal Register (US)FRPs – Facilitated regulatory pathwaysFrP – French Pharmacopoeia (Pharmacopée Française, aka PF)FSCA – Field safety corrective action (medical devices sector)FSIS – Food Safety and Inspection Service (US)FSN – Field safety notice (medical devices)FTA – Fault tree analysisFTC – Federal Trade Commission (US)FTD – Fast track designation (US)FTE – Full Time Equivalent (employee)FTIM – First-time-in-humanFTIR – Fourier Transform infra-redFU – Farmacopea Ufficiale – the Italian PharmacopoeiaFUM – Follow-up measuresFVAR – Final Variation Assessment ReportFY – Fiscal yearGGGGAIN Act – Generating Antibiotic Incentives Now Act (US)GATT – General Agreement on Tariffs and TradeGCC (region) – Gulf Cooperation Council (region)GCC-DR – Gulf Central Committee for Drug RegistrationGCD – Global clinical developm

CMR - Centre for Medicines Research CMS - Concerned member state (EU) CMT - Convergent medical technologies COA/CofA - Certificate of analysis CoAg - Cooperative Agreement COE - Council of Europe COMET - Core Outcome Measures in Effectiveness Trials COMP - Committee for Orphan Medicinal Products (EMA) COREPER - Committee of Permanent Representatives to the Community