Abkürzungsverzeichnis (PDF | 284 KB)

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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)