The impact of off-label, compassionate and unlicensed use on health care laws in preselected countries [Elektronische Ressource] / vorgelegt von Vanessa Plate

Vanessa Plate

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• Gesundheit

Informations

• Publié par: rheinische_friedrich-wilhelms-universitat_bonn
• Publié le: 01 janvier 2009
• Nombre de lectures: 35
• Langue: Deutsch
• Poids de l'ouvrage: 1 Mo

Extrait

The Impact of Off-Label, Compassionate
and Unlicensed Use on Health Care Laws
in preselected Countries



Dissertation 
zur
Erlangung des Doktorgrades (Dr. rer. nat.)
der
Mathematisch-Naturwissenschaftlichen Fakultät
der
Rheinischen Friedrich-Wilhelms-Universität Bonn


vorgelegt von
Vanessa Plate
aus
Bad Neuenahr-Ahrweiler





Bonn 2009Die vorliegende Arbeit wurde in der Zeit vom August 2006 bis Juli 2009 unter der
Leitung von Herrn Prof. Dr. Harald G. Schweim am Lehrstuhl für Drug Regulatory
Affairs des Pharmazeutischen Instituts der Rheinischen Friedrich-Wilhelms-
Universität Bonn angefertigt.





















Angefertigt mit Genehmigung der Mathematisch-Naturwissenschaftlichen
Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn

1. Referent: Prof. Dr. Harald G. Schweim
2. Referent: PD Dr. Harald Enzmann
Tag der Promotion: 23. Oktober 2009  Yesterday’s outsider-method is today’s academic medicine
and tomorrow’s error in treatment!
(Die Außenseitermethode von gestern ist die Schulmedizin von heute und der 
Behandlungsfehler von morgen!) 
 
G. Schroeder‐Printzen, ehem. Vors. Richter am BSG 


















Für Hans-Joachim List of abbreviations
ABDA Federal Union of German Associations of Pharmacists
ABDATA Pharma Data Service
ABO Ordinance on the Operation of pharmacies (Austria)
ABPI Association of the British Pharmaceutical Industry
ABGB Austrian Civil Code of 1811
ÄG Austrian National Law on Physicians
ADR Adverse Drug Reaction
ADE g Event
AERS Adverse Event Reporting System (FDA)
AFSSAPS French Health Products Safety Agency
AGES Austrian Agency for Health and Food Safety
AKW Vienna Pharmaceutical Chamber
ÄKW Vienna Medical Chamber
AMA American Medical Association
AMD Age Related Macular Degeneration
AMG German Drug Act as amended on 12.12.2005
AMG-Au Austrian Drug Act as amended on BGBl. I Nr. 112/2007
AMGKostV AMG Cost Ordinance
AMK (ABDA) Drug Commission of the German pharmaceutical
Association
APhA American Pharmacist Organisation
ApBetrO Ordinance on the Operation of pharmacies (Germany)
ASP Drug Safety in Psychiatry (Austria, Germany)
ATC Anatomical Therapeutic Chemical
ATU Temporary Use Authorization (France)
AWEG Austrian Medicines’ Importation Act as amended on 02.01.2006
BÄO German National Law on Physicians
BAG Federal Office of Health (Switzerland)
BAH Federal Association of Drug Manufacturers (Germany)
BAS Biological Active Substance
BCCA British Columbia Cancer Agency (Canada)
BfArM Federal Institute for Medicinal Products and Devices
(Germany)
BGB German Civil Code as amended on 02.01.2002
BMG Federal Ministry of Health (Germany)
BNF-C British National Formulary for Children
BPCA Best Pharmaceuticals for Children Act (U.S.)
CADRAMP Canadian Adverse Drug Reaction Monitoring Program Adverse
Reaction Database
CADRMP ogram
CADTH Canadian Agency for Drugs and Technologies in Health
CAP Compassionate Access Program
CAQDA Computer-Aided Qualitative Data Analysis
CDC Centers for Disease Control and Prevention (U.S.)
CDER Center for Drug Evaluation and Research (FDA)
CHF Swiss Franc
CHLIA Canadian Life and Health Insurance Association
CHMP Committee for Medicinal Products for Human Use (E.U.)
CIRS Critical Incident Reporting System
CMS Centers for Medicare & Medicaid Services (U.S.)
CNOM National Medical Professional Association (France)
CNOP National Council of French Pharmacists
COMP Committee for Orphan Medicinal Products (E.U.)
CP Centralized Procedure (E.U.)
CPA Canadian Pharmacists Association CPSO College of Physicians and Surgeons of Ontario (Canada)
CRO Contract Research Organization
CSP Public Health Act (France)
CTEP Cancer Therapy Evaluation Program (U.S.)
DCP Decentralized Procedure
DDL Dear Doctor Letter
DIN Drug Identity Number (Canada)
DLH German Leukemia and Lymphoma Group
DSP Drug Shortage Program (U.S.)
DSRU Drug Safety Research Unit (U.K.)
EAP Expanded Access Programs
EC European Commission
EDRP Emergency Drug Release Program (Canada)
EEA European Economic Area
EFPIA European Federation of Pharmaceutical Industries and
Associations
EMA European Medical Association
EMEA European Medicines Agency
EML-C (WHO) Essential Medicines’ List for Children
ESIP European Social Insurance Partners
EU European Union
EUnetHTA European network for Health Technology Assessment
FD&C Food, Drug and Cosmetic Act as amended through December
31, 2004
FDA Food and Drug Administration
FDAMA Food and Drug Administration Modernization Act of 1997
FDR Food and Drug Regulations as amended in October 2006
(Canada)
FMH Swiss Medical Association
*G-BA Federal Joint Committee (Germany)
GCP Good Clinical Practice
HAS French National Authority for Health
HCC (UK) Health Care Commission
HCP Health Care Professional
HEK Committee for Drug Evaluation (Austria)
HMG Swiss Federal Law on Medicinal Products and Medical Devices
2002
HTA Health Technology Assessment
HV Main Association of Austrian Social Security Institutions
ICH International Conference on Harmonization
IIT Investigator Initiated Trial
IMPD Investigational Medicinal Products Dossier
IND nal New Drug
Interpharma Association of Drug Manufacturers (Austria)
IQWIG Institute for Quality and Efficiency in Health Care (Germany)
IRB Institutional Review Board
JMA Japan Medical Association
JPA Japan Pharmaceutical Association
JPMA Japanese Pharmaceutical Manufacturers Association
KAKJ Committee for Children’s and Adolescent’s Medicines
(Germany)
KVB Association of Statutory Health Insurance Physicians (Bavaria)
LEEM Union of the drug industry companies (France)
                                                            
* self-governing bodies of service providers and health insurance funds m Million
MA Marketing Authorization
MAH Marketing Authorization Holder
MDK Medical Service for Health Insurance Companies (Germany)
MHRA Medicines and Healthcare Products Regulatory Agency (U.K.)
MICE Medicines Investigation for the Children of Europe
MP Medicinal Product
MRP Mutual Recognition Procedure (EU)
MS Member State (EU)
NCE New Chemical Entity
NCI National Cancer Institute (U.S.)
NDA New Drug Application
NDU Nonlicensed Drug Use (i.e., off-label, compassionate,
unlicensed use)
NHI National Health Insurance (Japan)
NHS National Health Service (UK)
NICE National Institute for Clinical Excellence (UK)
NIPH itute of Public Health (Japan)
NME New Molecular Entity
NOC Notice of Compliance (Canada)
OMP Orphan Medicinal Products
PAL Pharmaceutical Affairs Law as of July 2002 (Japan)
PASS Post-Authorization Safety Studies
PatG German Patent Law
PCMA Pharmaceutical Care Management Association
PCT Primary Care Trust
PDCO (EMEA -) Pediatric Committee
PDMA Pharmaceuticals and Medical Devices Agency (Japan)
PEM Prescription Event Monitoring
PGEU Pharmaceutical Group of the European Union
Ph.Helv. Swiss Pharmacopeia
Pharma Forum Swiss Pharmacists Association
Pharmig Association of the Austrian Pharmaceutical Industry
PhRMA Pharmaceutical Research and Manufacturers of America
PIP Pediatric Investigation Plan (E.U.)
PMDA Pharmaceuticals and Medical Devices Agency (Japan)
PREA Pediatric Research Equity Act (U.S.)
PSUR Periodic Safety Update Report (E.U.)
PUMA Pediatric Use Marketing Authorization (E.U.)
RCPLondon Royal College of Physicians (U.K.)
(R)CT (randomized) controlled trial
RPSGB Royal Pharmaceutical Society of Great Britain
Rx&D Canada's Research-Based Pharmaceutical Companies
SABRE Serious Adverse Blood Reactions and Events (UK)
SAMS Special Access Management System (Canada)
Santesuisse Umbrella Association of the Swiss Social Health Insurance
Sector
SAP Special Access Program (Canada)
SAR Special Access Request (Canada)
SmPC Summary of Product Characteristics
SMUD Safety Management System for Unapproved Drugs (Japan)
SPC Supplementary Protection Certificate
SPSU Swiss Paediatric Surveillance Unit
StGB penal code
Swissmedic Swiss Agency for Therapeutic Products
TEDDY Task-force for Drug Development for the Young (E.U.) U.S. United States (of America)
UNCAM Health Insurance Fund National Union (France)
VAM Swiss Ordinance on D