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Abkürzungsverzeichnis (PDF | 284 KB)
Abkürzungsverzeichnis List of Abbreviations für den weiterbildenden Studiengang „Master of Drug Regulatory Affairs” Stand: Dezember 2015 1 Short Cut Complete Name AADA AAS ABDA Abbreviated Antibiotics Drug Applications Atomabsorptionsspektroskopie Bundesvereinigung Deutscher Apothekerverbände Geschäftsbereich der Apothekenverbände Amtsblatt der Europäischen Gemeinschaft The Association of the British Pharmaceutical Industry Consultative Committee for Standards and Quality Angiotensin Converting Enzyme Advisory Committee on Safety of Medicinal Products Anti Counterfeiting Trade Agreement ABDATA ABI ABPI ACCSQ ACE ACSoMP ACTA ADBE ADEC ADI ADM ADME ADP ADR ADRAC ADKA ADROIT ADRs ÄA AE AECB AEFI AEGIS ADROIT AEPAR AERS AESGP AEUV AFAR AfLÜ AFSSAPS Ag AGES AGF absorption, distribution, biotransformation, excretion Australian Drug Evaluation Committee accaptable daily intake Administrative Information absorption, distribution, metabolism, excretion Adenosin-Diphosphat Adverse Drug Reaction Noxious/unintended response Adverse Drug Reactions Advisory Committee Arbeitsgemeinschaft Deutscher Krankenhausapotheker Online Information Tracking Änderungsanzeige Adverse Event Untoward medical occurrence acute exacerbation of chronic bronchitis adverse events following immunization Electronically Generated Information Service Asocación Espanola de Profesionales de Actividades de Registro Adverse Event Reporting System Assocaiation Européenne des Specialités Pharmaceutiques Grand Public Vertrag über die Arbeitsweise der Europäischen Union Association Française des Affaires Réglementaires Amt für Lebensmittelüberwachung L’Agence Française de Securité Sanitaire de Produits de Santé Antigen Agentur für Gesundheit und Ernährungssicherheit Alleingeschäftsführer 2 Additional Information Beratungskommitte für die WHO Handelsabkommen zum Schutz vor Produktfälschungen (of a compound) Unterkommitee von ADEC Regulatory Authority in France Österreichische Zulassungsbehörde Short Cut Complete Name AGLMB Arbeitsgemeinschaft der leitenden Medizinalbeamtinnen und –beamten der Länder Animal Health Institute Analytic Hierarchy Process Association of Independent Clinical Research Contractors Acquired Immune Deficiency Syndrome active ingredient manufacturer Active Implantable Medical Devices Directive Accelerated Idioventricular Rhythm Arzneimittelkommission der deutschen Ärzteschaft Akzeptanzlimit Approvable Letter Asociación Latinoamericana de Integración AHI AHP AICRC AIDS AIM AIMDD AIVR AkdÄ AL AL ALADI ALARP ALAT ALIFAR ALT ALV AM AMA AMG AMG-AV AMG-EV AMGAMED AMES AMIS II AMK AMM AMNOG AMR AMR AMRadV AMRL AMTS AMWHV ANDA ANMAT as low as reasonably practicable alanine aminotransferase Asociación Latinoamericana de Industrias Farmacéuticas Latin American association of the generic industry alanine aminotransferase Arzneiliefervertrag Arzneimittel American Medical Association Arzneimittelgesetz Arzneimittelgesetz-Anzeigeverordnung Einreichungsverordnung Allied and Alternative Medicine Verfahren zur Identifizierung von Mutagenen nach dem Amerikaner Bruce Ames Arzneimittel-Informationssystem (BfArM) Arzneimittelkommission der Deutschen Ärzteschaft Autorisation de Mise sur le Marché Arzneimittelneuordnungsgesetz Arzneimittelreport Arzneimittelrichtlinie des G-BA Verordnung über radioaktive oder mit ionisierenden Strahlen behandelte Arzneimittel Arzneimittel-Richtlinien des GBA Arzneimitteltherapiesicherheit Arzneimittel-und Wirkstoffherstellungsverordnung Abbreviated New Drug Application Approval process for generics Administración Nacional de Medicamentos, Alimentos y Tecnologica Médica 3 Additional Information (Schweiz) Latin American Integration Association Synonym: ALT Synonym: ALAT German Drug Law Ersetzt die bisherige PharmBetrV (USA) Argentinische Zulassungsbehörde National Short Cut Complete Name Additional Information Administration for Medicines, food and Medical Technology ANOVA ANSI ANVISA Analysis of Variance American National Standards Institute Agência Nacional de Vigilância Sanitária ANZTPA Australia New Zealand Therapeutic Products Authority AOK aP AP AP ApBetrO APC APEC API APNIC ApoBetrO ApoG APR APTT APV AQL Allgemeine Ortskrankenkasse acellular pertussis Anstaltspackung Alkaline Phosphatase Apothekenbetriebsverordnung adenomatous polyposis coli Asia-Pacific Economic Cooperation Active Pharmaceutical Ingredient Asia Pacific Network Information Centre Apothekenbetriebsordnung Gesetz über das Apothekenwesen Annual Product Review Activated partial thromboplastin time Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik Acceptable Quality Level AQOL AR ARIN ARR ARTG As AS ASA ASCO ASEAN ASI Assessment of Quality of Life Assessment Report American Registry for Internet Numbers absolute risk rate Australian Register of Therapeutic Goods Arsen Aminosäure American Society of Anaesthesiology American Society of Clinical Oncology Association of Southeast Asian Nations Arzneimittelschnellinformation ASK-Nummer Arzneimittelklassifikationsnummer des BfArM Active Substance Master File Amélioration du Service Médical Rendu Aspartate Transaminase American Society for Testing and Materials Acute Toxic Class Anatomical Therapeutical Chemical (Code)/Veterinary Anatomisch Therapeutisch Chemischer 4 ASMF ASMR AST ASTM ATC ATC/Vet. ATC-Code Nationale Behörde für Gesundheitsüberwachung in Brasilien (National Health Surveillance Agency) Gemeinsame Zulassungsbehörde für Australien und Neuseeland pertussis vaccines USA Maximum percent defective that can be considered satisfactory as a process average Maßnahme des BfArM bei Risikoverdacht eines Arzneimittels Short Cut Complete Name ATMP ATP ATP ATS AUC Code der WHO Advanced Therapy Medicinal Product Adenosine-triphosphat Federal Act on Therapeutic Products Application Tracking System Area Under the Curve Audit Synonym AVP AVV-RÜB AVWG AWB AWMF AZT BAÄK BÄ BÄK BÄO BAG BAH BAI BAN Banz Batch BAZ BB BBS BCE BCG BCG BCS BDFA BE BEMA BER BEUC BfArM BfT BGA Inspection Systematic and documented verification of the implementation of a quality management system or elements of such a system. Arzneiverordnung in der Praxis Allgemeine Verwaltungsvorschrift RahmenÜberwachung ArzneimittelversorgungsWirtschaftlichkeitsgesetz Anwendungsbeobachtungen Arbeitsgemeinschaft der wissenschaftlichen Fachgesellschaften Azidothymidin (HIV treatment) Bundesausschuss der Ärzte und Krankenkassen Bioäquivalenz Bundesärztekammer Bundesärzteordnung Bundesamt für Gesundheit Bundesfachverband der Arzneimittelhersteller e.V. Bundesverband der Arzneimittelimporteure British Approved Names Bundesanzeiger Quantity of a product originating from one manufacturing run, assumed to be homogenous Bundesanzeiger Bureau of Biologics Bulletin Board System beneficial clinical event Bacille Calmette Guérin Bio-Coordination Group Biopharmaceutics Classification System Bureau of Food and Drug Analysis Taiwan Bioequivalence Benchmarking of European Medicines Agencies Base Excision Repair Bureau Européen des Unions de Consommateurs Bundesinstitut für Arzneimittel und Medizinprodukte Bundesverband für Tiergesundheit e.V. Bundesgesundheitsamt 5 Additional Information (Schweiz) External and internal audits. (Schweiz) Synomym: Lot jetzt: CBER European Consumers’ Organisation Exekutive des BMG bis 1994 Short Cut Complete Name Additional Information (Auflösung in Einzelinstitute) BGI Bundesgesundheitsinstitut BgVV BMWP Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin Biotechnology Industry Association früher: The British Institute of Regulatory Affairs Bundesverband der Betriebskrankenkassen Medizinprodukte-Gebührenverordnung Biologics Licence Application British Medical Associations Bundesministerium für Gesundheit Bundesministerium des Inneren British Medical Journal biological medicinal product Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit Biosimilar Working Party BNF BOB BOH BOPST BP BP BPAD BPC BPCA British National Formulary Bundesoberbehörde Board of Health Bundesopiumstelle Bündelpackung British Pharmacopeia bipolar affective disorder British Pharmacopoeia Commission Best Pharmaceuticals for Children Act BPD BPI diastolic blood pressure Bundesverband der Pharmazeutischen Industrie British Pharmaceutical Market Research Group systolic blood pressure Blood Product Working Party BIO BIRA BKK-BV BkostV-MPG BLA BMA BMG BMI BMJ BMP BMU BPMRG BPS BPWP BrAAP BS BSI BRAS BSA BSE BSG BTGC BtMAHV BtMBinHV BtMG British Association of Pharmaceutical Physicians Benannte Stelle Bundesamt für Sicherheit in der Informationstechnik Belgian Regulatory Affairs Society Body Surface Area Bovine Spongiforme Encephalopathy Bundessozialgericht Bio-Technology General Corporation Betäubungsmittel-Außenhandelsverordnung BetäubungsmittelBinnenhandelsverordnung Betäubungsmittelgesetz 6 jetzt: BVL jetzt: TOPRA Expertenfachgruppe bei der EMA Abt. des BfArM US, previsously known as “pediatric exclusivity” Expertenfachgruppe bei der EMA Sitz in Bonn Short Cut Complete Name BtMVV BetäubungsmittelVerschreibungsverordnung Bundesverwaltungsgericht BverwG BVL Additional Information BWP Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Biologics Working Party C CA CA Kohlenstoff Conjoint Analysis competent authority CA CABG CAD CADREAC Contract Acceptor Coronary Artery Bypass Graft Surgery Coronary Artery Disease The Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries Canadian Adverse Drug Reaction Monitoring Program Computer Assisted Marketing Application US Computer Assisted New Drug Application Electronic Submission in the US Community Acquired Pneumonia centrally authorised product corrective and preventive actions Computer-assisted Product License Application (see PLA) Computer-assisted Product License Agreement Review (FDA) Canadian Association of Pharmaceutical Regulatory Affairs The Caribbean Community and Common Market Chemical Abstracts Service Cardiac Arrhythmia Suppression Trial Committee of Advanced Therapies Clinical Added Value of Orphan Drugs Community Based Clinical Trials Network Changes Being Effected Center for Biologics Evaluation and Research Committee for the evaluation of biologic Products at the FDA cerebral blood flow Confederation of British Industry Change Control Canadian Drugs Directorate Certified Clinical Research Coordinator. See also ACP CADRMP CAMA CANDA CAP CAP CAPA CAPLA CAPLAR CAPRA CARICOM CAS CAST CAT CAVOD CBCTN CBE CBER CBF CBI CC CCD CCDC Expertenfachgruppe bei der EMA (Regulatory body charged with monitoring compliance with national, European Member State, statutes and regulations) 7 no longer existing organization of 15 caribbean nations and dependencies (American Chemical Society) (USA) Working Party (scientific body) Short Cut Complete Name CCDS Company Core Data Sheet CCS Canadian Cardiovascular Society (scoring system) container closure system Company Core Safety Information Cadmium circular dichronism Clinical Document Architecture Centres for Disease Control (Atlanta, GA) Center for Drug Evaluation technical evaluation CCS CCSI Cd CD CDA CDC CDE Additional Information CDER Center for Drug Evaluation and Research Committee for the evaluation of human drugs at the FDA CDP CDP CDRH CDS CDSM Clinical Data Package Clinical Development Plan Centre for Drug Evaluation and Research (FDA) Core Data Sheet Committee on Drug Safety of Medicines CE CE CEC CEEC CEO CEN Conformité Européenne capillary electrophoresis Commission of the European Committee Central Eastern European Countries Chief Executive Officer Comité Européen de Normalisation CENELEC Europäisches Komitee für elektrotechnische Normung Certificate of Suitability to the Monographs of the European Pharmacopoeia Comparative Effectiveness Research chlorofluorocarbon Code of Federal Regulations Official Regulatory Announcements in the US contract giver current Good Manufacturing Practices US GMP document 21CFR211 Coronary Heart Disease German Law on Chemicals congestive heart failure Committee for Medicinal Products for Human Use Chinese Hamster ovary collision-induces dissociation Council for International Organisations of Medical Science Postapproval international CEP CER CFC CFR CG cGMP CHD ChemG CHF CHMP CHO CID CIOMS 8 institution for drug registration administration of the Chinese SFDA (scientific body) Committee of external experts empowered by MCA (advisory board) Geographically assigned Geschäftsführer, Vorstand European Committee for Standardization Chemikaliengesetz UK Short CIOMS CIS Cl CLIA CLL Cmax CME CMC CMDh group CMDv CMR CMS Cut Complete Name Additional Information ADR reporting Centerwide Oracle Management Information System US (FDA) Commonwealth of Independent States Chlor Clinical Laboratory Improvements Amendments chronische lymphatische Leukämie maximale Plasmakonzentration continuing medical education Chemistry, Manufacturing, Control Coordination group for Mutual recognition and Decentralized procedure (human) group Coordination group for Mutual recognition and Decentralized procedure (veterinary) Centre for Medicines Research Concerned Member State CMV CND CNS CNSLD CO COA COC COFEPRIS Cytomegalovirus Commission on Narcotic Drugs central nervous system Chronic Non-Specific Lung Disease clinical overview certificate of analysis Cyclic Olefin Copolymer Comisión Federal para la Protección contra Riesgos Sanitarios COM COMET COMISA Commission (Document) Single Cell Gel Electrophoresis assay Confédération Mondiale de l’Industrie de la Santé Animale Committee for Orphan Medicinal Products National Commission for Ethics in Research COMP CONEP COPD COS COSTART CP CP CPA CPI CPM CPMP Term used in the US and corresponds to Modul 3 in the EU (CMD h = human; CMD v = veterinary) Subsequent member states in the MRP Suchtstoffkommission (UN) Mexikanische Gesundheitsbehörde (Bundeskommission zum Schutz gegen Gesundheitsrisiken) Located at the EMA Ethikkommission in Lateinamerika Chronic Obstructive Pulmonary Disease Certificate of Suitability Coding Symbols for a Thesaurus of Adverse Reaction Terms Centralised Procedure One of the procedures for market authorization in the EU Concept Paper Commonwealth of Pharmaceutical Association Consumer price index Centre for Pharmaceutical Medicine Committee for Proprietary Medicinal siehe auch: CVMP 9 Short Cut Complete Name CPP (CoPP) Products Certificate of Pharmaceutical Product CPR CPSC CPV CQA CQA Cr CR CR CR CRA CRADA CRC CRD CRF CRF CRIOC CRO CSDD C-Section CSI CSM CSM CSO cSPC CSS CSV CT CT CTA CTC CTD CTMP CTN CTS Cardiopulmonary Resusciation Consumer Product Safety Commission continuous process verification clinical quality assurance Critical quality attribute Chrom Commission Regulation Child resistant Clinical Reviewer Clinical Resarch Assistant/Associate Cooperateive Research and Development Agreement (with NIH) Clinical Resarch Coordinator Common Renewal Date Case Report Form / Record Form Patient forms from clinical studies Code of Federal Regulations Centre de Recherche et d’Information des Organisations de Consommateurs Contract Research Organization Centre for the Study of Drug Development Cesarian-Section core safety information Committee on Safety of Medicines Clinical Study Manager Consumer Safety Officer (FDA) core Summaries of Products Characteristics Company Sponsored Study Computer Systems Validation clinical trial Controlled Terms Clincal Trial Application/Authorisation Clinical Trial Certificate Clinical trial licence in the UK Common Technical Document CTWP Clinical Trial on Marketed Product Clinical Notification Procedure Communication Tracking System (of MRP)/Central Tracking System Cell Therapy Working Party CTX Clinical Trial Exemption Cu CVM CVMP Kupfer Centre for Veterinary Medicine Committee for Medicinal Products for Veterinary Use 10 Additional Information Synonym to FSC (Free Sales Certificate) (USA) siehe auch SF See also CCRC Comparable to A-Kommission of BfArM in Germany Single dossier structure for the EU, USA and Japan (UK) Australien Expertenfachgruppe bei der EMA Clinical trial licence in the UK and Australia (FDA) Committee for the evaluation of animal drugs at the EMA Short Cut Complete Name Additional Information (scientific body) CYP CZ CZE DA DAB DAC DAD DAHTA DALY DAMOS DARE DAV DAWN DAZ DCC DCP DDD DDM DDPS DDR DDX DEA DEEC DEL DEN DeNIC DER DEREK Cytochrome P450 Climatic zone Capillar zone elctrophorese Decision Analysis Modul 12, Unterlagen Herr Jopp Deutsches Arzneibuch Deutscher Arzneimittel Codex Diodenarray-Detector Deutsche Agentur für Health Technology Assessment Disability-Adjusted Life Years oder DiseaseAdjusted Life Years Drug Application Methodology on Optical Storage Datebase of Abstracts of Reviews of Effects Deutscher Apothekerverein Drug Application Methodology with Optical Storage Deutsche Apotheker Zeitung deleted in colorectal cancer Decentralised Procedure defined daily dose Drug Dossier Manager Detailed Description of the Pharmacovigilance System Drug Registratioh Department of SFDA Doctor´s and Dentist´s Exemption Drug Enforcement Agency (US) Drug Evaluation Experts Committee (China) DES DES Defect evaluation lists Drug Experience Network Deutsches Network Information Center Drug-Extract-Ratio Deductive Estimation of Risk from Existing Knowledge Data Exchange Standard Specification Diethylstilbestrol DESI Drug Efficacy Study Implementation Notice DFG DG Deutsche Forschungsgemeinschaft Directorate Generale Directorate General of the Commission in Brussels DG Enterprise and Industry DG ENTR DG SANCO DG III DGD DG Health and Consumer Protection Directorate Generale III Now OGD 11 Co-operative approach on electronic submission between BfArM and industry Dezentrales Verfahren Constituted of specialists to provice evaluation advice to the Chinese synthet. Östrogen (FDA, to evaluate drugs in use prior to 1962) (e.g. DG III for Pharmaceuticals) formerly CBER`s Division of Short Cut Complete Name Additional Information Generic Drugs DGPT DG XIII DGPharMed DHEW DHPC DHSS DHT DIA DiätV DIMDI DIMDIV DIR DITR DKFZ DKG DLP DMC DMF DMP DMS DOD DoH DP DPC-PTR Act. DPhG DPI DQ DR DRA DRAM DRG DRG DS DSC DSC DSEB DSI DSM DSMB Deutsche Gesellschaft für experimentelle und klinische Pharmakologie und Toxikologie European Commission Directorate-General XIII Deutsche Gesellschaft für Pharmazeutische Medizin Department of Health, Education and Welfare Direct Healthcare Professional Communication Department of Health and Social Services Dihydrotestosteron Drug Information Association Diätverordnung Deutsches Institut für Medizinische Dokumentation und Information DIMDI-Verordnung Directive Deutsches Informationszentrum für technische Regeln Deutsches Krebsforschungszentrum Deutsche Krankenhausgesellschaft Data Lock Point Date monitoring committee jetzt: ASMF Disease Management Program Document Management System Department of Defense Department of Health Drug Product Drug Price Competition and Patent Term Restoration ACT Deutsche Pharmazeutische Gesellschaft Dry Powder Inhaler Design Qualification Subset of Validation Discipline Review Letter Drug Regulatory Affairs Drug Regulatory Affairs Manager Diagnosis Related Groups Division of Research Grants Drug Safety Drug Safety Communication Differential Scanning Calorimetry Drug Safety and Evaluation Branch Division of Scientific Investigations (FDA) Diagnostic and Statistical Manual Data and Safety Monitoring Board 12 Telecommunications, information market, and exploitation of research ehemals FÄPI now split into Department of Health & Human-Services and Department of Education UK (s. PSU) (UK and South Africa) 1984 (also known as WaxmanHatobill) (NIH) Australien (of the American Psychiatry (Association) Short Cut Complete Name DSMC DSNP Data and Safety Monitoring Committee Development of Standardized Nomenclature Project Differenz(ial)-thermische Analyse Document Type Definition Department of Trade and Industry (UK) Diphtherie-Tetanus-Pertussis-Impfung Data Universal Numbering System-Number Developing Countries´ Vaccine Regulators´ Network DTA DTD DTI DTP DUNS-Nr DCVR E2B EAB Standard für elektronische Nebenwirkungsmeldungen an die Behörde ICH guideline reg. pharmacovigilance planning European Alliance for Access to Safe Medicines Ethical Advisory Board EAD EAMS EA-Report EATG EbD EBHC EBM EBU EC early after depolarization Earlier Access to Medicines environment assessment report European AIDS Treatment Group Ergänzende bilanzierte Diäten evidence-based health care evidence-based medicine European Blind Union European Commission EC EC ECARS Ethics Committee European Community European Computer Assisted Regulatory Submission Electrocardiogram European Court of Justice Enterprise Content Management System European Carton Makers Association Economic and Social Council European Community Pharmaceutical Products Information Network Emergency Care Research Institute electronic Common Technical Document European Currency Unit Electronic Data Interchange for Administration, Commerce, and Transportation Electronic Data interchange European Drug Master File Electronic Document Management System Electronic Data Submission European Directorate for the Quality of Medicines and HealthCare 13 E2E EAASM ECG ECJ ECM ECMA ECOSOC ECPHIN ECRI eCTD ECU EDIFACT EDI EDMF EDMS EDS EDQM Additional Information FDA E2B ICH guideline re. Electronic format for exchange of drug safety information term used in some nations for groups similar to IRBs and IECs evidenzbasierte Medizin in documents older than the mid 1980s UNO Gremium des Europarates mit Sitz in Straßburg Short Cut Complete Name EEA EEC European Economic Area European Economic Community, EEG EFGCP EFPIA EFSA electroencephalogram European Forum on Good Clinical Practice European Federation of Pharmaceutical Industries’ Associations European Foundation for Quality Management European Food Safety Authority EFTA European Free Trade Association EG EGA eGK EGRL EGV Europäische Gemeinschaft European Generic Medicines Association elektronische Gesundheitskarte EG-Richtlinie Vertrag zur Gründung der Europäischen Gemeinschaft European register of old chemicals Europäisches Altstoffverzeichnis Establishment Inspection Report Ethikkommission Establishment License Application European list of registered chemicals Enzym-Linked Immunosorbent Assay European Medicines Agency European Monitoring Centre for Drug and Drug Addiction Essential Medicines Library siehe EuroPharm Electronic Mail Service Einreichungsnummer Expression of Interest European Parliament European Public Assessment Report European Pharmaceutical Marketing Research Association European Product Index Expanded Programme on Immunization European Pharmacovigilance Issues Tracking Tool European Patent Office erythropoietin European Pharmacovigilance Research Group Entwicklungs-ProjekteSteuerungskonferenz Environmental Risk Assessment Electroretonogram European Scientific Cooperative for 14 EFQM EINECS EIR EK ELA ELINCS ELISA EMA EMCDDA EmLib EMP EMS ENR EOI EP EPAR EPHMRA EPI EPI EPITT EPO EPO EPRG EPS ERA ERG ESCOP Additional Information now EU; some regulatory documents still have EEC document numbers Evere, Belgium Europäische Behörde für Lebensmittelsicherheit Western Europe countries which are not members of the EC FDA FDA Bindungsassay vor 11/2009: EMEA WHO WHO WHO Short ESG ESI ESOP ESR ESRA ESTRI ETF ETOMEP EU EUDRACT EUDRANET EUFEPS EuG EuGH EU-KOM EURD EuroPharm EURS EUSES EVCTM EVMPD EVPM EVPRM EVV EW EWP EWR F FÄPI FAH FAO FD FDA FDASIA Cut Complete Name Additional Information Phytotherapy Electronic Submission Gateway Electrospray Ionization European Society for Pharmacovigilance Erythrocyte Sedimentation Rate European Society of Regulatory Affairs Electronic Standards for the Transmission of Regulatory Information EMA Task Force European Technical Office for Medicinal Products European Union European Clinical Trials Database European Union Drug Regulatory Authorities Network European Federation of Pharmaceutical Sciences Europäisches Gericht, Europäischer Gerichtshof Europäische Kommission European Union Reference Date European Pharmacopoeia European Review System European Union System for the Evaluation of Substances EudraVigilance Clinical Trial Module EudraVigilance Medicinal Products Directory Earned Value Project Management Eudra Vigilance Medicinal Product Report Message Eudra Vigilance Veterinary Module Entwicklung Efficacy Working Party Europäischer Wirtschaftsraum Fläche Fachgesellschaft der Ärzte in der Pharmazeutischen Industrie e.V. Forschungsvereinigung der Arzneimittelhersteller Food and Agriculture Organisation of the United Nations Farmindustria Floppy disk Food and Drug Administration FDA Safety andn Innovation Act 15 EMA Cooperation of 26 European Countries (EMA) erste Instanz Reviewsystem, das die Behörden bei der Prüfung von e-CTDbasierten Zulassungsdossiers unterstützt Mittlerweile aufgelöst German Association of Physicians in the Pharmaceutical Industry The Association of the Italian Pharmaceutical Manufacturers FCC Food Chemical Codex (US) USA Short Cut Complete Name FD&C FDC FDLI Fe F&E FEDESA Food, Drugs and Cosmetics Act (US) Fixed-dose Combination The Food and Drug Law Institute Eisen Forschung und Entwicklung Fédération Européenne de la Santé Animale Factor Eight Inhibitor Bypassing Activity First Human Dose Fachinformation Federation of Irish Chemical Industries Flammenionisationsdetektor Federación Latinoamericana de La Industria Latin American Federation of the Farmacéutica Pharmaceutical Industry first-in-man Féderation Internationale Pharmaceutique Fachinformation Technik Failure Mode Effect Analysis Failure Mode, Effects and Criticality Analysis Forschung Freedom of Information Freedom of Information Act (USA) FDA self-obligation to publish information Family Planning Association Family Practitioner Committees Federal Partners Collaboration The Finnish Pharmaceutical Industry Association Federal Register Fellow of the Royal College of Physicians, sometimes followed by a place name – for example, FRCP (Edin.) – that indicates a university medical school Free Sales Certificate information on product and manufacturer from the country of origin siehe auch CPP Field Safety Corrective Action Sicherheitsrelevante korrektive Maßnahme im Feld Follikel-stimulierendes Hormon Freitext fault tree analysis Federal Trade Commission USA File Transfer Protocol Final Variation Assessment Report Gramm Guideline Gegenanzeigen Gamma-aminobutyric acid Good Agricultural and Collection Practice Good Automated Laboratory Practice Good Automated Manufacturing Practice 16 FEIBA FHD FI FICI FID FIFARMA FIM FIP FIZ Technik FMEA FMECA FO FOI FOIA FPA FPC FPC FPIF FR FRCP FSC FSCA FSH FT FTA FTC FTP FVAR g G GA GABA GACP GALP GAMP Additional Information Short Cut Complete Name Additional Information GAO GAP GATB GATT G-BA/GBA GC GCC General Accounting Office Good Analytical Practices Global Alliance for Tuberculosis General Agreement of Tariffs and Trade Gemeinsamer Bundesausschuss gas chromatography Gulf Cooperation Council U.S. government GCC-DR Gulf Central Committee for Drug Registration GCP GCRP G-CSF GDP GDUFA GenTG Good Clinical Practice Good Clinical Research Practice granulocyte colony stimulating factor good distribution practice Generic Drug User Fee Amendment Gentechnikgesetz GEROLIT Gerontologische Literaturdatenbank des deutschen Zentrums für Altersfragen (DZA) Gewerbeordnung Glial Fibrillary Acidic Protein Guidance for Industry Gute fachliche Praxis Gerência de Inspeção e Control de Medicamentos e Productos Gew.O. GFAP GfI GFP GGIMP GGMED Gerência de Medicamentos GHTF GI GI GK GKV GKV-SpiV Global Harmonization Task Force Gebrauchsinformation Gastrointestinal Globale Konzeption Gesetzliche Krankenversicherung Spitzenverband der Gesetzlichen Krankenversicherungen GKV-Wettbewerbsstärkungsgesetz Guideline Good Laboratory Practice General Medical Council Granulocyte Macrophage Colony Stimulating Factor Global Medical Device Nomenclature Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V GKV-Modernisierungsgesetz Genetically Modified Organism Good Manufacturing Practice General Medical Services Committee 17 GKV-WSG GL GLP GMC GM-CSF GMDN GMDS GMG GMO GMP GMSC Kooperationsrat der arabischen Golfstaaten Behörde zur Förderung der Zusammenarbeit der GCCMitglieder im Bereich der AMZulassung Gesetz zur Regelung von Fragen der Gentechnik Brasilianische Überwachungsbehörde (General Office of Inspection and Control of Inputs, Drugs, and Products Brasilianische Zulassungsbehörde (General Office of Drug) Short Cut Complete Name GNP GÖ GOS GP GPIA Gross National Product Gesundheitsökonomie Glasgow Outcome Score General Practitioner Generic Pharmaceutical Industry Association Groupement de Pharmaciens Européens Good Regulatory Practice Gesundheitsstrukturgesetz General Sales List (U.K.) Glutathion-S-Transferase Gene Therapy Working Party GPUE GRP GSG GSL GST GTWP GUI GÜG GUSTO GVD GVO GVP GWG HAB HACCP HAI HAS HAZOP HBV HC HCQC HC HMBC HC COSY HCV HCFA HDPE HDL HED HepB HEVRA Hg HGB Hgb HH ROESY HHS Hib HIMA HISPP Additional Information Graphical User Interface Grundstoff-Überwachungsgesetz Global Utilisation of Streptokinase and TPA in the Occlusion of Coronary Arteries gemeinsames Verlängerungsdatum Genetisch veränderter Organismus Good Pharmacovigilance Practice Geldwäschegesetz Homöopathisches Arzneibuch Hazard Analysis of Critical Control Point Health Action International Haute Authorité de Santé French National Authority for Health Hazard Operability Analysis Hepatitis B virus Proton-carbon Heteronuclear single Quantum Correlation Proton-carbon Heteronuclear Multiple-bond Correlation Proton-carbon Correlated Spectroscopy Hepatitis C Virus Health Care Financing Administration High density polyethylene high-density lipoprotein human equivalent dose Hepatitis B Heads of European Veterinary Regulatory Authorities for Medicinal Products Quecksilber Handelsgesetzbuch Hemoglobin Proton-carbon rotating frame Overhauser effect spectroscopy Health and Human Services haemophilus influenza Typ b Health Industry Manufacturers Association Healthcare Informatics Standards Planning Panel 18 Expertenfachgruppe bei der EMA (s. GMOS) (of the HHS) Short Cut Complete Name HIV HL7 HMA HMEC HMG-CoA reductase Human Immunodeficiency Virus Healthcare Linkage version 7 Heads of Medicines Agencies Human Medicines Expert Committee (Schweiz) 3-Hydroxy-3-methylglutaryl-Coenzym-AReduktase oder ß-Hydroxy-ß-methylglutarylCoenzym-A-Reduktase Health Maintenance Organisation (US) Herbal Medicinal Product Committee on Herbal Medicinal Products Herbal Medicinal Products Working Party Highest Non-Severly Toxic Dose Heads of Agencies Healthcare Professional Health Products and Food Branch kanadische Überwachungsbehörde; s. auch TPD high performance liquid chromatography human papillomavirus heart rate Host related impurities Hormone Replacement Therapy Headspace-Gas Chromatography Health Services Research Health Technology Assessment Hypertext Mark-up Language Hypertext Transfer Protocol Secure Heating, Ventilation and Air conditioning Sammelbegriff für Lüftungssysteme half value duration Halbwertzeit Heilmittelwerbegesetz Harnwegsinfektion Internet Assigned Numbers Authority International Agency for Research on Cancer, Lyon International Accounting Standards Investigator’s Brochure International Birth Date International biometric society Internationale biometrische Gesellschaft Deutsche Region der Internationalen Biometrischen Gesellschaft Informed Consent Ion Chromatography International Classification of Diseases International Classification of Diseases for Oncology International Conference of Drug Regulatory Authorities Incremental cost-effectiveness ratio Internationale Klassifikation der Funktionsfähigkeit, Behinderung und 19 HMO HMP HMPC HMPWP HNSTD HOA HP HPFB HPLC HPV HR HRI HRT HS-GC HSR HTA HTML HTTPS HVAC HVD HWG HWI IANA IARC IAS IB IBD IBS IBS-DR IC IC ICD ICD-O ICDRA ICER ICF Additional Information Short ICH ICP-AES ICP-MS ICP-OES ICPM ICSR ICTH IDE IDMA IDMC IDMP IDP IDR IEC IEF IFA IFAH IFAPP IFG IFPMA IfSG IG IGPA IHE IHTA IIT IKS ILSI IMAP IMMED IMP IMPACT IMPD INAHTA INCB Cut Complete Name Additional Information Gesundheit International Conference on the Harmonisation (of Technical Requirements for Registration of Pharmaceuticals for Human Use) Inductively coupled plasma – atomic emission spectroscopy Inductively coupled plasma – mass spectroscopy Inductive Coupled Plasma Optical Emission Spectroscopy International Clinical Project Manager Individual Case Safety Report International Committee on Thrombosis and Haemostases Investigational Device Exemption Indian Drug Manufacturers’ Association Independent Data Monitoring Committee Identification of Medicinal Product Import Drug Permission Idiosyncratic drug reaction Independent ethics committee Isoelectric focusing Informationsstelle für Arzneimittel GmbH International Federation of Animal Health International Federation of Association of Pharmaceutical Physicians Informationsfreiheitsgesetz International Federation of Pharmaceutical Manufacturers Association Infektionsschutzgesetz The Office of the Inspector General International Generic Pharmaceutical Alliance Swedish Institute for Health Economics International Health Technology Assessment investigator initiated study Interkantonale Kontrollstelle für Heilmittel International Life Science Institute International Medical Advisory Panel International Marketed Medicines Database investigational medicinal product International Medicinal Products AntiCounterfeiting Task Force Investigational Medicinal Product Dossier International Health Technology Assessment Database International Narcotics Control Board 20 FDA See also EAB, IRB, NRB Sitz in Brüssel HHS Schweiz (jetzt: Swissmedic) Sitz in Washington D.C. Netzwerkaus zahlreichen Interessenverbänden, Organisationen und staatlichen bzw. internationalen Behörden (UNO) (Internationaler Suchtstoffkontrollrat Short Cut Complete Name IND INN INTDIS INTERNIC IPA IPC IPK IPM IPPF IRF ISE Investigational New Drug Application International Non-proprietary Name WHO database of side-effects The Internet´s Network Information Centre International Pharmaceutical Abstracts In-Process-Control Inprozesskontrolle International Project Manager International Planned Parenthood Federation Independent Pharmaceutical Research Organization. Industrial Pharmacists Section Inactivated Poliomyelitis Vaccination/Virus Institute for Prospective Technological Studies Installation Qualification Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Iridium Infrarotspektroskopie Information Request Letter Institutional Review Board International Registration Document Industrial Research and Development Advisory Committee International Reviewer Forum Integrated Summary on Efficacy ISO ISOC ISS International Standards Organization Internet Society Integrated Summary on Safety IT IT ITCVDR Information Technology Index Terms International Technical Consultation on Veterinary Drug Registration Intention to treat IPRO IPS IPV IPTS IQ IQWiG Ir IR IR IRB IRD IRDAC ITT IUB IUD IUPAC IVD IVDMDD Additional Information International Union of Biochemistry Enzyme Nomenclature intrauterine device International Union of Pure and Aplied Chemistry a In Vitro Diagnostics In-vitro-Diagnostikum In Vitro Diagnostics Medical Devices Directive 21 See also CRO. USA Part of the NDA for FDA (Efficacy) Part of the NDA for FDA (Safety) Analyse-Technik, bei der die Patienten nach ihrer ursprünglichen Gruppenzuteilung analysiert werden, unabhängig davon, ob sie die zugeordnete (intendierte) Therapieform vollständig, partiell oder gar nicht erhalten haben Short Cut Complete Name IVF IVF/ET IVR JAMA JAN JAPIC JCAH In Vitro Fertilization In Vitro Fertilization/Embryo Transfer Interactive Voice Responding Journal of the American Medical Association Japanese approved names Japan Pharmaceutical Information Center Joint Commission for the Accreditation of Hospitals Joint Commission of Accreditation of Health Care Organizations Japanese Central Pharmaceutical Affairs Council JCAHO JCPAC JCPT JCRDD JCRP JDI JEFA JGMP JP JPMA JRC KALP KBE KBV KK KFDA KFEB KM KMU KPT KS KV kwV KZBV LACNIC LAG LAL-Test LAS LAS LAT LB LBBB Journal of Clinical Pharmacology and Therapeutics Journal of Clinical Research and Drug Development Journal of Clinical Research and Pharmacoepidemiology Joint Declaration of Intent Joint FAO/WHO Expert Committee on Food Additives Japanese GMP Japanese Phamacopeia Japan Pharmaceutical Manufacturers Association European Commission Joint Research Centre Kalenderpackung keimbildende Einheiten Kassenärztliche Bundesvereinigung Krankenkasse Korea Food and Drug Administration Committee for Clinical Pharmacology and Ethics Knowledge Management Kleine und mittlere Unternehmen Kern Projekt Team Kaposi’s sarcoma Kassenärztliche Vereinigung keine weitere Verlängerung Kassenzahnärztliche Bundesvereinigung Latin American and Carribean Internet Adresses Registry Länderausschuss Limulus Amoebocyte Lysate Test Pyrogenic endotoxins in injectable preparations Labor-Automationssystem Lymphadenopathy Syndrome Light Authorig Tool deutsche Landesbehörde Left Bundle Branch Block 22 Additional Information Gentechnik (= AIDS) Short Cut Complete Name LC LCM LDH LDL LEEM Liquid chromatography Life-cycle-management Laktatdehydronegase low-density lipoprotein Les Entreprises du Médicament LFGB LH LIGA LIMS Lebensmittel-und Futtermittelgesetzbuch Luteinisierendes Hormon life gained table Laboratory Information Management System Lösemittel Lebensmittel-und Bedarfsgegenständegesetz Lebensmittelrecht Lebensmittel-Kennzeichnungsverordnung Locally Operating Company Limit of Detection Last Observation Carried Forward Lowest Observed Effect Level Logical Observation Identifier Names and Codes List of Outstanding issues limit of quantification List of Questions franz; Synonym: Batch Last Patient Last Visit Lower Specification Limit Lager-und Versandzentren marketing authorization Marketing Authorisation Application monoclonal antibody minimally anticipated biological effect level Marketing Authorization Holder Medicines Act Information Letter Medicines Act Leaflet Matrix assisted laser desorption/ionization Marketing Authorisation by Network Submission and Evaluation Monoamine Oxidase Manual of Policies and Procedures LM LMBG LMR LMKV LOC LOD LOCF LOEL LOINC LoOI LoQ LoQ Lot LPLV LSL LVZ MA MAA MAB MABEL MAH MAIL MAL MALDI MANSEV MAO MAPP MCA MCASE MCC MCH MCHC MCM MCRC Additional Information früher: Medicines Control Agency (UK); Multiple Computer Automated Structure Evaluation Medicines Control Council Mean Corpuscular Hemoglobin Mean Corpuscular Hemoglobin Concentration multi-component mixture Medical and Clinical Research Consultants 23 Französischer Verband der Medikamentenhersteller Nachweisgrenze Day 180 (CP) Day 120 (CP) (U.K.) (U.K.) Regulatory procedures manual issued by the FDA jetzt: MHRA Südafrikan. Zulassungsbehörde (UK) Short Cut Complete Name MCV MD MDA MDCG MDD MDI Mean Corpuscular Volume Multiple dose Medical Devices Agency (UK) Medical Device Coordination Group Medical Device Directives (EU) Metered Dose Inhaler; Manic Depressive Illness Medizinischer Dienst der Krankenkassen Message Disposition Notification Medizinischer Dienst der Spitzenverbände Master Data Sheet Medical Device Vigilance Medicines Evaluation Board Million ECU MEDical DEVices Medical Dictionary for Drug Regulatory Activities Medical Literature Analysis and Retrieval System Neuseeländische Zulassungsbehörde The Association of the Danish Pharmaceutical Industry Mitteleuropäische Gesellschaft für Regulatorische Angelegenheiten e.V. Medicines Evaluation and Monitoring Organisation Middle East & North Africa Member of the European Parliament Mercado Común del Sur MDK MDN MDS MDS MDV MEB MECU MEDDEV MedDRA MEDLARS Medsafe MEFA MEGRA MEMO MENA MEP MERCOSUR MERS MeSH Mg MGMT MGV MHRA MHLW MIC MIHWAF MIMS MIST ml mm MMR MMV Mn MNA Mo Multiagency Electronic Regulatory Submission Medical Subject Headings Milligram Methylguaninemethyltransferase maximale prozentuale Gesamtverunreinigung Medicines and Healthcare products Regulatory Agency Ministry of Health, Labour and Welfare Minimum Inhibitory Concentration Ministry of Healthcare, Welfare and Family Monthly Index of Medical Specialities Mexico, Indonesia, South Korea and Turkey milliliter millimeter Maser-Mumps-Röteln-Schutzimpfung Medicines for Malaria Venture Mangan µ-Agonist + NA-Reuptake-Inhibitor: Analgetika mit doppeltem Wirkprinzip Molybdän 24 Additional Information (Netherlands) Result of ICH M1 (Nahost und Nordafrika) Gemeinsamer Markt Südamerikas (UK) (Japan) Korea Short Cut Complete Name MOH MOU Ministry of Health China Memorandum of Understanding MP medicinal product MPA Medical Products Agency MPAV Verordnung zur Regelung der Abgabe von Medizinprodukten Medizinprodukte-Betreiberverordnung Medizinproduktegesetz Allgemeine Verwaltungsvorschrift zur Durchführung des MPG Medizinisch-pharmazeutische Studiengesellschaft Medizinprodukte-Sicherheitsplanverordnung Medizinprodukteverordnung Verordnung über die Verschreibungspflicht von Medizinprodukten Verordnung über Vertriebswege für Medizinprodukte Relative molecular mass Mutual Recognition Mutual Recognition Agreement Medical Research Associate Medical Research Council (U.K.) Mutual Recognition Facilitation Group Magnetic Resonance Imaging maximum residue limit Mutual Recognition Procedure MPBetreibV MPG MPGVwV MPS MPSV MPV MPVerschrV MPVertrV Mr MR MRA MRA MRC MRFG MRI MRL MRP MRSD MRT MRT MS MS MTC MTD MTPT MUMS MVI N n.d. NA NA NADA NAF NAFTA NAI maximum recommended starting dose Magnet-Resonanz-Tomographie Mean residence time Member State(s) mass spectrometry mixed treatment comparison maximum tolerated dose Methylphenyltetrahydropyridine Minor Use and Minor Species Malaria Vaccine Initiative Stickstoff not detected Norepinephrine New Approach/Neuer Ansatz New Animal Drug Application Notice of Adverse Findings North American Free Trade Agreement no action indicated 25 Additional Information between FDA and a regulatory agency in another country that allows mutual recognition of inspections Deutsch: Arzneimittel (nicht Medizinprodukt !!) Schwedische Zulassungsbehörde One of the procedures for marketing authorization in the EU Mittlere Verweilzeit Countries organized in the EU (FDA post-audit letter) (most favourable FDA post- Short Cut Complete Name Additional Information inspection classification) NAP NAS NAS-NRC NAT NATRIK NBE NB-MED NCA NCE NCHS NCHSR NCI NCO NCPIE NCR NCRP NCVIA NDA NDAB NDS NDS NECSI NEDO NEFARMA NEI NEM NemV NF NfG NG NGO NHI NHLBI NHS NHW Ni NIAID nationally authorised product New Active Substance National Academy of Sciences – National Research Council National National Reporting and Investigation Centre new biological entity Empfehlungspapiere, welche vom Europäischen Erfahrungsaustausch der Benannten Stellen im Bereich Medizinprodukte (NB-MED), an dem auch Vertreter der Herstellerverbände und EGKommission teilnehmen, verabschiedet wurden National Competent Authority New Chemical Entity National Centre for Health Statistics (in CDC) National Center for Health Services Research (and Health Care Technology Assessment) National Cancer Institute (NIH) Non-clinical Overview National Council on Patient Information and Education no carbon required Northwest Clinical Research Professionals National Childhood Vaccine Injury Act (1986) New Drug Approval/Application National Drug Advisory Board New Drug Submission new drug study New England Complex Systems Institute National Economic Development Office The Dutch Association of the Innovative Pharmaceutical Industry National Eye Institute (NIH) Nahrungsergänzungsmittel Nahrungsergänzungsmittelverordnung national formulary Note for Guidance Nachweisgrenze Non-Governmental Organisation National Health Insurance (Japan) National Heart, Lung and Blood Institute National Health Service (UK) National Health and Welfare Department Nickel National Institute of Allergies and Infectious Diseases 26 UK (USA) (Washington, DC) Portland, OR (Kanada) (Canada’s new drug application) NIH Canada USA) Short Cut Complete Name NICE NIP NIR NIS NIT NITR NJW nK NMDA NME NMR NMT NNH NNT NOAEL National Institute for Health and Clinical Excellence National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute of Food and Drug Safety Evaluation National Institutes of Health (USA) not invented here Non-Investigational Medicinal Product National Institute of Neurological Disorders & Stroke (NIH) National Institute of Pharmacy Nah-Infrarot Nichtinterventionelle Studie non-interventional trial National Institute of Toxicological Research Neue Juristische Wochenschrift neue Konzeption N-Methyl-D-aspartate New Molecular Entity nuclear magnetic resonance not more than that number needed to harm number needed to treat non-observed adverse effect level NOC NOEC NOEL NRB Notice of Compliance No Observed Effect Concentration no observed effect level Non-institutional Review Board, NRC NRF NRG NSAID NtA NTP NUB Nuclear Regulatory Commission Neues Rezept Formularium Name Review Group non-steroidal anti-inflammatory drug Notice to Applicants National Toxicology Program Neue Untersuchungs- und Behandlungsmethoden Non-Urgent Information System New Use marketing authorization Neue Zeitschrift für Verwaltungsrecht Nebenwirkungen New York Heart Association (scoring system) New Zealand Nachzulassung Nachzulassungsbescheid Official Action Indicated NICHD NIDA NIFDE NIH nih NIMP NINDS NUIS NUMA NvWZ NW NYHA NZ NZL NZLB OAI Additional Information 27 NIH Korean Technical Evaluation Institute Korea höchste toxische Dosis, die nichts zeigt Canada, India also known as an independent review board. See also EAB, IEC, IRB (serious FDA post-inspection classification) Short Cut Complete Name OC OC OCABR OCI OCLC OD ODE Operationscharakteristik Oral Contraceptive Official control authority batch release Office of Criminal Investigation Online Computer Library Center optical disk Office of Drug Evaluation OE OECD oral explanation Organisation for Economic Co-operation and Development OFT OGD OGE Office of Fair Trading Office of Generic Drugs Office of Government Ethics OHE OHIM Office of Health Economics (U.K.) Office for Harmonisation in the Internal Market (Warenzeichen) Office for Human Research Protection International Office of Epizootics Office Journal of the EU-C Series (Information) Official Journal of the European Community Office Journal of the EU-L Series (Legislation) European Anti-Fraud Office Oberlandesgericht Office of Management and Budget (USA) Official Medicines Control Laboratories Sammelbegriff für Spezialdisziplinen aus dem Bereich der Biotechnologie mit der Endsilbe „-omics“ overall migration limit Observational Medical Outcomes Partnership Orphan Medicinal Product out of specification Originalpackung Organisation of Pharmaceutical Producers of India Office of Protection from Research Risks Operationsschlüssel nach Paragraph 301 SGB V Operational Qualification Office of Regulatory Affairs Optische Rotationsdispersion OHRP OIE OJC OJEC OJL OLAF OLG OMB OMCL OMICS OML OMOP OMP OOS OP OPPI OPRR OPS OQ ORA ORD Additional Information 28 (CDER now has five such offices: ODE I, II, III, IV, and V.) (Organisation für wirtschaftliche Zusammenarbeit und Entwicklung) franz.: OCDE (organisation de coopération et de devéloppement économiques) (CDER, formerly DGB) (formerly part of Office of Personnel Management, separate executive branch in 1989) USA Internationales Tierseuchenamt NIH Short Cut Complete Name Os OSPAR OSHA OTA Osmium Oslo-Paris-Konvention Occupational Safety Health Administration Office of Technology Assessment OTC OVG OwiG P-i PA PAD PAES PAF PAG PAGB PAHO PAI PAP PALC PANDRH over-the-counter Oberverwaltungsgericht Ordnungswidrigkeitengesetz parallel-imported Proprietory Association Pharmacologically Active Dose Post Authorisation Efficacy Studies platelet activating factor Post authorisation guidance (EMA) Proprietary Association of Great Britain Pan-American Health Organisation pre-approval inspection Programmablaufplan Pre-Accession Linguistic Checking Pan American Network for Drug Regulatory Harmonization pain relief Foods for Particular Nutritional Use post Authorisation Safety Study process analytical technology Patentgesetz Blei Pharmaceutical Benefit Scheme (AUS) Packungsbeilage pharmacy benefit management patient controlled analgesia Poison Control Centre Pneumocystis Carnii Pneumonia Polymerase-Kettenreaktion (engl. polymerase chain reaction) Preclinical Reviewer packed cell volume Patients’ and Consumers’ Working Party PAR PARNUTS PASS PAT PatG Pb PBS PBL PBM PCA PCC PCP PCR PCR PCV PCWP Pd PD PDCO PDE pdf PDG PDQ PDR PDUFA Additional Information Palladium pharmacodynamics Paediatric Committee permitted daily exposure portable document format Pharmacopeial Discussion Group Physicians’ Data Query (NCI-sponsored cancer trial registry) Physician Desk Reference Prescription Drug User Fee Act US act for 29 USA USA; Congress abolished, fall 1995 non-prescription medicines German Law on Misdemeanors EMA Human Scientific Committees Working Party with Patients’ and Consumers’ Organisations Short PDVE PE PEAKPID PEC PEFRAS PEI PEM PER scheme Cut Complete Name faster review of drug applications PIM DES Validation Engine Polyethylene peak pain intensity difference Predicted Environmental Concentration Pan-European Federation of Regulatory Affairs Societies Paul-Ehrlich-Institut PET PET PfSchG PFT Prescription Event Monitoring (UK) Pharmaceutical Evaluation Report Scheme for mutual recognition of evaluation reports Pharmaceutical Education & Research Institute positron emission tomography Polyethylene Terephthalate Pflanzenschutzgesetz pulmonary function tests PGP PHA PharmBetr.V pretty good privacy preliminary hazard analysis Pharmazeutische Betrieb-Verordnung PHI Ph.Eur. Ph. Helv. Private Health Insurance European Pharmacopoeia Pharmacopoeia Helvetica Arzneibuch der Schweiz Pharmaceutical Research and Manufacturers of America Public Health Service Pharmazeutischer Unternehmer Pharmakovigilanz Pharmacovigilance Working Party principle investigator parallel Import/Importeur package insert Produktinformation (FI + GI) Product Information (SPC, PIL, labeling) Pre-Approval Inspections (USA) Pharmaceutical Inspection Convention Hilfsschema für die Formulierung einer klinischen Frage zur Wirkung von Interventionen: patient, intervention, Vergleichsintervention (comparison), Zielgrösse (outcome) Explanatory notes for industry on the preparation of a Site Master File PIC-Scheme pain intensity difference pelvic inflammatory disease products information form 30 PERI PhRMA PHS Ph.U. PhV PhVWP PI PI PI PI PI PIA PIC PICO PIC Site Master File PIC-S PID PID PIF Additional Information Siehe auch PIM und DES Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Deutschland Verschlüsselungssoftware wurde durch die AMWHV ersetzt auch: PU relevant bei der Nutzenbewertung von AM guidelines for GMP Short Cut Complete Name PIL = PL PIM PIP PK PK PKV PL PL(PI) PLA patient information leaflet Product Information Management Paediatric Investigation Plan pharmacokinetics Produktkonferenz Private Krankenversicherung package leaflet Product License for Parallel Imports Product Licence Application (biological in the US) Plättchenhemmung und PatientenOutcomes (PLATO) Studie Product Licence User System Pharmaceutical Manufacturers Association Premarket approval application Pharmaceuticals and Medical Device Evaluation Center Plant Master File (US); Plasma Master File(EU) Pre-Migration Quality Review post-marketing surveillance Paul-Martin-Stiftung predicted no effect concentration Pharmazeutischer Unternehmer-Nummer des BfArM Proof of Concept prescription only medicines Polypropylene potential problem analysis plasma products biotechnology producer price index proton pump inhibitor patient package insert peak pain intensity difference Preferred Provider Organization; Policy and Procedure Order Pregnancy Prevention Program Poison Prevention Packaging Act Pharmaceutical Price Regulation Scheme Prothrombinkonzentrat PLATO PLUS PMA PMA PMDA PMF PMQR PMS PMS PNEC PNR PoC POM PP PPA PPB PPI PPI PPI PPID PPO PPP PPPA PPRS PPSB PPSR PQ PQR PR PR PRAC PREA PRIMR Proposed Pediatric Study Request performance qualification product quality review Public Relations pain relief Pharmacovigilance Risk Assessment Committee Pediatric Research Equity Act Public Responsibility in Medicine and 31 Additional Information Packungsbeilage now PhRMA FDA japan. Zulassungsbehörde Modul 12, Unterlagen Herr Jopp UK Blutprodukt, in dem bestimmte Vitamin-K-abhängige Gerinnungsfaktoren konzentriert sind USA (Boston, MA) Short Cut Complete Name Additional Information PVC PVP PZ PZN PZU QA QALY QOS QALY QAU QbD QBR QC Research PSUR Reference Member State PIM Review System Pharmaceutical Committee Particle size distribution Pharmacovigilance System Master File Potential Serious Risk to Public Health Periodic Safety Update Report Platin Percutaneous Transluminal Angioplasty Physikalisch-Technische Bundesanstalt points to consider Percutaneous Transluminal Coronary Angioplasty Patent Term Extension Peak Trough Flukt. Parathormon Product Team Leader EMA Product Team Products Team Member EMA Product Team Previously Treated Patients proficiency testing study Pharmazeutischer Unternehmer peptic ulcer disease Paediatric Use Marketing Authorisation previously untreated patients Pharmacovigilance Polyvinyl Alcohol Preliminary Variation and Assessment Report Polyvinyl Chloride polyvinylpyrollidone Pharmazeutische Zeitung Pharmazentralnummer Postzustellungsurkunde Quality Assurance Quality Adjusted Life Year Quality Overall Summary quality-adjusted life year Quality Assurance Unit Quality by Design question-based review quality control QCO QM QM Quality Control Organization Quality Management Maximum Quantity QMS Quality Management System P-RMS PRS PSC PSD PSMF PSRPH PSU/PSUR Pt PTA PTB ptc PTCA PTE PTF PTH PTL PTM PTP PTS PU PUD PUMA PUP PV PVA PVAR 32 Unterkommitee von ADEC auch: Ph.U. qualitätsadjustiertes Lebensjahr concerned with sampling, specifications, testing and documentation and release procedures Max. allowed monomeric residue in plastic compnents Short Cut Complete Name QL / QOL QP QPPV QR QRD QS QT-interval quality of life Qualified Person Qualified Person for Pharmacovigilance Quality Reviewer Quality Review of Documents Qualitätssicherung QT-Zeit QTPP QWP R&D R&TD RA RAD-AR Quality Target Product Profile Quality Working Party Research and Development Research and Technological Development Rheumatoid Arthritis Risk-Benefit Assessment of Drugs-Analysis and Response Regulatory Affairs Manager Regulatory Affairs Professionals Society rapid alert system red blood cell Royal College of Physicians (London, UK) randomized clinical trial recommended daily allowances remote data entry Regulatory Data Protection Radioactive Drug Research Committee relative effectiveness assessment Registration, Evaluation and Authorisation of Chemicals Regulation Registrierungsnummer Risk Evaluation and mitigation strategy request for designation Rhodium Regional Health Authorities Radioimmunpräzipitation Richtlinie der Bundesärztekammer zur Qualitätssicherung quantitativer laboratoriumsmedizinischer Untersuchungen rINN recommended International Nonproprietary Name Robert-Koch-Institut Regulatory Letter Richtlinie risk management plan Reference Member State Member state which issued the first marketing authorization in the EU rechnerische mittlere Tagesdosis Regulated Product Submission Risk quotient Research Quality Assurance RAM RAPS RAS RBC RCP RCT RDA RDE RDP RDRC REA REACh Reg. Reg. Nr. REMS RFD Rh RHA RIA RiliBÄK RKI RL RL RMP RMS rm TD RPS RQ RQA Additional Information 33 (gesamte intraventrikuläre Erregungsdauer) Forschung und Entwicklung rotes Blutkörperchen (FDA post-audit letter) (base of a MRP) Short Cut Complete Name RRR RSA RTF RTR RTRT RX Relative Risk Reduction Risikostrukturausgleich refuse/refusal to file real-time release real-time release testing prescription only medicines SA SA SAA SADC SADR SAE SAG SAMM scientific advice situation appraisal Standard-Arbeits-Anweisung Southern African Development Community serious adverse drug reaction serious adverse event Scientific Advisory Group EMA Guidelines for Company Sponsored Safety Assessment of Marketed Medicines structure activity relationship statistical analysis system Scientific Advice Working Party Summary Basis of Approval SAR SAS SAWP SBA SBD SC SCI SCM SCT SD SD SD SDH SDAT SDO SDV SE S/E-Pre SEA SEC SEC SEDAMM SEER SESAR SEQ SF SF SFC SFDA SGB SGB V Additional Information Modul 11 Ablehnender Bescheid der FDA Verschreibungspflichtiges Medikament Summary Basis of Decision Kanada Study Coordinator. See also CCRC, CRC. spinal cord injury Suppy Change Management Society for Clinical Trials source data / source document single dose standard deviation Sorbitol Dehydrogenase Senile Dementia of the Alzheimer’s Type Standard Development Organization Source Data Verification standard error Safety and efficacy, pre-authorisation Single European Act of 1987 Stock Exchange Commission Size-exclusion chromatography Submissions Electronique de Dossiers d’France de Mise sur le Marche Surveillance, Epidemiology, and End Results (Registry of NCI) Suspected Expected Serious Adverse Reaction Safety, Efficacy, Quality safety factor Senior friendly Supercritical fluid chromatography State Food and Drug Administration Sozialgesetzbuch Sozialgesetzbuch, Fünftes Buch 34 Modul 12, Unterlagen Herr Jopp (UK) USA, now: New Drug Approval Package Siehe auch CR Chin. Zulassungsbehörde Short Cut Complete Name SGML SH SHR SI SIAMED Standard Generalised Mark-up Language Subject Heading SIAR SICA SIDA Additional Information Système International d’Unités Model System for Computer-assisted Drug Registration Società Italiana Attività Registrativa Sistema de la Integración Centroamericana SOMED SOP SPA SPC The Spanish (syndrome inmunodeficiencia adquirida), Italian and French abbreviation for AIDS: see AIDS. Strukturnummer List of Pharmaceutical Specialities Selbstmedikation Submission Management and Review Tracking Safe Medical Devices Act Significant Medical Event small and medium enterprises Swissmedic Medicines Expert Committees Site Master File specific migration limit summary of opinion Summary of product characteristics Syndicat National de l’Industrie Pharmaceutique Scientific Advice and Orphan Drugs Sector EMA Datenbank der Sozialmedizin Standard Operating Procedure Special Protocol Assessment Supplementary Protection Certificate SPC (SmPC) Summary of Product Characteristics Spec SPID SPIDt SPOC SPS SRA SRS SSI SSL SSM SSRA SST STD STD STE Specification sum of pain intensity difference sum of pain intensity difference over time Single Points of Contact EDQM Summary of Pharmacovigilance System Scientific Research Associates Sleep Research Society Structured Substance Information secure sockets layer skin surface microscopy Swedish Society of Regulatory Affairs System Suitability Test sexually transmitted disease Severely Toxic Dose Surrogate Threshold Effect SKNR SL-List SM SMART SMDA SME SME SMEC SMF SML SMOP SmPC SNIP SAOD 35 WHO Zentralamerikanisches Integrationssystem Vierstellige Nummer (Schweiz) (s.OTC) (FDA) (1990) (Schweiz) (France) binding advice in US Extension of the period of patent protection in the EU Corresponds to the German Fachinformation (Systemeignungstest) Short Cut Complete Name StGB STIKO Strafgesetzbuch Ständige Impfkommission STP STR STS STT SUD SUPAC SUSAR sewage treatment plant Scientific Technical and Regulatory standard toxicity study short term tests Sudden Unexpected Death Scale-up and Post Approval Changes Suspected Unexpected Serious Adverse Reaction sustained virologic response SVR SWEDIS SWISSMEDIC SWP t½ TCM Additional Information (des Robert-Koch-Instituts (RKI)) A computer system used by the Swedish MPA Swiss Agency for Therapeutic Products TOTPAR TPA TPD Safety Working Party half life time Traditionelle Chinesische Medizin Traditional Chinese Medicine Transmission Control Protocol Protokoll in der Informationstechnik T-cell Dependent Antibody Response Total Daily Intake Therapeutice Equivalence Tissue Engineered Products Tabular Formats Therapeutic Goods Authority Technical Guidance Document Telematics Implememtation Group Traditional Herbal Medicinal Product Treatment IND totale intravenöse Anaesthesie toxicokinetics toxicokinetic measurements Thin Layer Chromatography Zeitpunkt der maximalen Plasmakonzentration Trial Master File Plasma concentration at time zero Total Organic Carbon Gesamter organischer Kohlenstoff Table of Contents The Organisation for Pharmaceutical Regulatory Affairs total pain relief tissue plasminogen activator Therapeutic Products Directorate TPM third party manufacturer TCP TDAR TDI TE TEP TF TGA TGD TIGes THMP TIND TIVA TK TKM TLC tmax TMF T (O) TOC TOC TOPRA 36 dauerhaftes virologisches Ansprechen Schweizerisches Heilmittelinstitut Regulatory authority in Australia See also IND. Büro innerhalb der kanadischen HPFB, zuständig für die Arzneimittelzulassung Short Cut Complete Name TQM TRGS USC USDA USL USP USP USPTO USR UT UTI UTN UV V VA VA Total Quality Management technische Regeln für Gefahrstoffe zur Gefahrstoffverordnung Trade-Related Aspects of Intellectual Property Rights Telematics Steering Committee target standard deviation Thyroidea-stimulierendes Hormon Treshold of Toxicological Concern traditional use registration Unerwünschte Arzneimittelwirkung Uridine 5'-diphosphounplanmäßige DANN-Synthese Unerwünschtes Ereignis UDP-Glucuronosyltransferase UK Coordinating Committee on Cancer Research Unverkäufliches Muster Uppsala Monitoring Center Universal Medical Device Nomenclature System Unified Medical Language System United Nations Educational, Scientific and Cultural Organisation Gemeinsames Programm der Vereinten Nationen für HIV/Aids United Nations Drug Control Programme Unique Ingredient Identifiers United Nations Office on Drugs and Crime Uniform Resource Locator Dictionary of US Adopted Names and International Drug Names United States Code United States Department of Agriculture upper specification limit United States Pharmacopeia unique selling position US Patent & Trademark Office Urgent Safety Restriction Uncontrolled Terms urinary tract infection Universal Trial Number Ultraviolettspektroskopie Vanadium Verlängerungsantrag Veterans Administration VAI Voluntary Action Indicated VAMF VAS Vaccine Antigen Master File Visual analogue scale TRIPS TSC TSD TSH TTC TUR UAW UDPUDS UE UGT UKCCR UM UMC UMDNS UMLS UNESCO UNAIDS UNDCP UNII UNODC URL USAN USP Additional Information 37 (Zielstandardabweichung) Siehe: UGT Siehe: UDP (book of laws) Amerikanisches Arzneibuch Marketing term (officially, United States Department of Veterans Affairs) (FDA post-audit inspection classification) Short Cut Complete Name VAR VB VCJD VEDDRA VwV Variation Assessment Report Verlängerungsbescheid Variant Creutzfeldt-Jakob Disease Veterinary Dictionary for Drug Related Affairs Verband forschender Arzneimittelhersteller Voluntary Harmonisation Procedure Veterinary International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Veterinary Use Veterinary Medicines Expert Committee Veterinary Medicinal Product Veterinary Mutual Recognition Facilitation Group Verordnung value of information analysis Verordnung über homöopathische Arzneimittel virtual private network verbal rating scale versus vesciculärer stomatis virus Verunreinigung von Willebrand Faktor Verwaltungsgerichtsordnung Vaccine Working Party Expertenfachgruppe bei der EMA Verwaltungsvorschrift VwVfG WBC WCO Verwaltungsverfahrensgesetz white blood cell World Customs Organization WE WEU WGEO WHO-ECDD Wareneingang well-established use Working Group of Enforcement Officers by Heads of Medicines Agensies (HMA) Working Group QM World Health Assembly World Health Organization (Weltgesundheitsorganisation) World Health Organization Adverse Reaction Terminology Expert Committee on Drug Dependence WI WIDO Working Instructions Wissenschaftliches Institut der vfa VHP VICH VMEC VMP VMRF VO VOI analysis VohA VPN VRS vs VSV VU vWF VwGO VWP WGQM WHA WHO WHOART Additional Information 38 (Schweiz) (German Administrative Procedure) Internationale Organisation mit Sitz in Brüssel (Belgien), die sich darauf spezialisiert hat, die Zollformalitäten zwischen den internationalen Handelspartnern zu vereinfachen. UN: Sachverständigenausschuss Short Cut Complete Name WIPO WL Ortskrankenkassen World Intellectual Property Organization Warning Letter WMA WOCP wP WP WSMI WSP WTO WVFR WW WWW XCOMP (X)EVMPD (X)EVPRM XML XPA ZEBET ZLG ZLS Zn ZKA ZKBS ZQ Zul. Nr. ZZulV Additional Information World Medical Association Worldwide Organization for Collaborations in the Pharmaceutical Industry whole-cell pertussis Working Party World Self Medication Industry Worksharing Project World Trade Organization Water Vapor Transmission Rate Wechselwirkungen World Wide Web Eudra Vigilance External Compliance (Extended) Eudra Vigilance Medicinal Product Dictionary (Extended) Eudra Vigilance Medicinal Product Report Message Extensible Markup Language Xeroderma pigmentosum group A Zentrale Erfassungs-und Bewertungsstelle für Ersatz-und Ergänzungsmethoden zum Tierversuch Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Zentralstelle der Länder für Sicherheitstechnik Zink Zollkriminalamt Zentrale Kommission für Biologische Sicherheit Zentralstelle für Qualitätssicherung Zulassungsnummer Zusatzstoff-Zulassungsverordnung 39 Teilorganisation der UN (most serious FDA post-audit letter, demands immediate action within 15 days) Weltärztebund pertussis vaccines Eudra Vigilance External Compliance (XCOMP) Testing Environment (D)
