AAMI Association for the Advancement of Medical Instrumentation
AAPS American Association of Pharmaceutical Scientists
AdvaMed Advanced Medical Technology Association
AESGP Association Européenne des Specialités Grand Public
ANDA Abbreviated New Drug Application
ANSI American National Standards Institute
APIC Active Pharmaceutical Ingredients Committee
ASQ American Society for Quality
BP British Pharmacopoeia
BSE Bovine Spongiform Encephalopathy
CDRH FDA Center for Devices and Radiological Health
CEO Chief/Corporate Executive Officer
CEFIC European Chemical Industry Council
CPMP Committee of Proprietary Medicinal Products (EU)
CVMP Committee of Proprietary Veterinary Products (EU)
CRO Contract Research Organization
CTD Common Technical Document (Register ICH)
DIA Drug Information Association (USA)
DOE Department of Energy (USA)
DSHEA Dietary Suplement Health and Education Act (USA)
DSMA Division of Small Manufacturers
EIR Establishment Inspection Report
EMI Electro-Magnetic Interference
ESD Electro-static Discharge
EDQM European Directorate for the Quality of Medicines
EGA European Generics Association
EMEA European Medicines Evaluation Agency
EFPIA European Federation of Pharmaceutical Industries Associations
EUR PH European Pharmacopoeia (Commission)
FDA Food and Drug Administration (USA)
FDLI The Food and Drug Law
FEDESA Federation Européenne de la Santé Animale
GCP Good Clinical Practice
GMO Genetically Modified Organisms
GMP Good Manufacturing Practice
GLP Good Laboratory Practice (For Safety Evaluation)
GPIA Generic Pharmaceutical Industry Association
HIMA The Health Industry Manufacturers Association
ICH International Conference of Harmonization
IDE Investigational Device Exemption
IEEE Institute of Electrical and Electronic Engineering
IVD InVitro Diagnostic Devices
IFPMA International Federation of Pharmaceutical Manufacturers Associations
IGPA International Generic Pharmaceutical Association
IPEC International Pharmaceutical Excipients Council
ISPE International Society for Pharmaceutical Engineering
MCA Medicines Control Agency (UK)
MDMA Medical Device Manufacturers Association
MDR Medical Device Reporting (21 CFR Part 803 )
NAFL Notice of Adverse Findings
NAI No Action Indicated
NEMA National Electrical Manufacturers Association
NIST National Institute for Standards and Technology
NAFTA North American Free Trade Agreement
NAPM National Association of Pharmaceutical Manufacturers
NAS National Academy of Sciences (USA)
NCE New Chemical Entity
NDA New Drug Application
NIST National Institute of Science and Technology (USA)
NPA National Pharmaceutical Alliance
NSE Not Substantially Equivalent
OAI Official Action Indicated
ODE FDA Office of Device Evaluation
ORA FDA Office of Regulatory Affairs
OC Oral Contraceptive
OEM Original Equipment Manufacturer
PCR Polymerase Chain Reaction
PDUFA Prescription Drug User Fee Act (USA, 1992)
PEFRAS Pan European Federation of Regulatory Affairs Society
PhARMA Pharmaceutical Association of Research-based Manufacturers (PMA, USA)
PIC Pharmaceutical Inspection Convention (EFTA)
PICS Pharmaceutical Inspection Cooperation Scheme
PRP FDA's Problem Reporting Program
PTO Patent and Trademark Office (USA)
QSR Quality System Regulations (devices)
SE Substantially Equivalent
SMDA Safe Medical Devices
SMO Site Management Organization
SPC Summary of Product Characteristics or Statistical Process Control
SRM Specified Risk Material (EU)
TSE Transmissible Spongiform Encephalopathies (Veure BSE)
USP United States Pharmacopoeia
VAI Voluntary Action Indicated
VFA Verband der Forschender Artzneitmittelherstellern
VOC Volatile Organic Compound
WHO World Health Organization (OMS)
WTO World Trade Organization
